WORLD TRADE ORGANIZATION  
ORGANISATION MONDIALE DU COMMERCE  
ORGANIZACIÓN MUNDIAL DEL COMERCIO  IP/N/1/USA/I/2 
9 February 2004 
 (04-0494) 
Council for Trade-Related Aspects of 
Intellectual Property Rights Original:   English/ 
 anglais/  inglés 
 
MAIN DEDICATED INTELLECTUAL PROPERTY 
LAWS AND REGULATIONS NOTIFIED UNDER 
ARTICLE 63.2 OF THE AGREEMENT 
 
UNITED STATES 
  The present document reproduces the text
1 of the consolidated version of Title 35 of the 
United States Code, Patent Law, as amended through 13 December 2003, notified by the United 
States under Article 63.2 of the Agreement in a communication dated 23 January 2004 . 
 
 
Conseil des aspects des droits de propriété 
intellectuelle qui touchent au commerce  
 
 
PRINCIPALES LOIS ET RÉGLEMENTATIONS CONSACRÉES À LA 
PROPRIÉTÉ INTELLECTUELLE NOTIFIÉES AU TITRE 
DE L'ARTICLE 63:2 DE L'ACCORD 
 
ÉTATS-UNIS 
 
 Le présent document contient le texte1 de la version mise à jour du Titre 35 du Code des 
États-Unis, Loi sur les brevets, tel qu'il a été modi fié au 13 décembre 2003, notifié par les États-Unis 
au titre de l'article 63:2 de l'Accord dans  une communication datée du 23 janvier 2004. 
 
 
Consejo de los Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio  
 
 
PRINCIPALES LEYES Y REGLAMENTOS DEDICADOS A LA 
PROPIEDAD INTELECTUAL NOTIFICADOS EN VIRTUD 
DEL PÁRRAFO 2 DEL ARTÍCULO 63 DEL ACUERDO 
 
ESTADOS UNIDOS 
  En el presente documento se reproduce el texto
1 de la versión consolidada del Título 35 del 
Código de los Estados Unidos, Ley de Patentes, modificado el 13 de diciembre de 2003, notificado 
por los Estados Unidos en virtud del párrafo 2 de l artículo 63 del Acuerdo en una comunicación de 
fecha 23 de enero de 2004. 
                                                      
 1 In English only./En anglais seulement./En inglés solamente. IP/N/1/USA/I/2 
Page 2  
 
  
 
UNITED STATES CODE 
 
TITLE 35  
 PATENTS - As amended through December 13, 2003 
 
 
PART I. UNITED STATES PATENT AND TRADEMARK OFFICE  
 
 CHAPTER 1. ESTABLISHMENT, OFFI CERS AND EMPLOYEES, FUNCTIONS   
    
   "1. Establishment.    "2. Seal. 
   "3. Officers and employees. 
   "4. Restrictions on officers and employees as to interest in patents. 
   "[5. Repealed] 
   "6. Duties of Commissioner.    "7. Board of Patent Appeals and Interferences. 
   "8. Library. 
   "9. Classifica tion of patents. 
   "10. Certified copies of records. 
   "11. Publications. 
   "12. Exchange of copies of  patents with fo reign countries. 
   "13. Copies of patents for public libraries. 
   "14. Annual report to Congress.". 
    
§ 1. Establishment 
 
(a) Establishment. The United States Patent and Trademark Office is established as an 
agency of the United States , within the Department of Commerce. In carrying out its 
functions, the United States Patent and Trademark Office  shall be subject to the policy 
direction of the Secretary of Commerce, but otherwise shall retain  responsibility for 
decisions regarding the management and admi nistration of its operations and shall 
exercise independent control of its budget allocations and expenditures, personnel 
decisions and processes, procurements, an d other administrative and management 
functions in accordance with this title and applicable provisions of law. Those operations designed to grant and issue patents and those operations which are designed to facilitate 
the registration of trademarks shall be trea ted as separate operating units within the 
Office. 
  
(b) Offices. The United States Patent and Trademark Office shall maintain its principal 
office in the metropolitan Washington, D.C., area, for the service of process and papers 
and for the purpose of carry ing out its functions. The United States Patent and 
Trademark Office shall be deemed, for purposes of venue in civil action s, to be a resident 
of the district in which its principal office is located, except where jurisdiction is otherwise provided by law. Th e United States Patent and Tr ademark Office may establish 
satellite offices in such other places in the United States as it considers necessary and 
appropriate in the conduct of its business. 
  
(c) Reference. For purposes of this title, the United States  Patent and Trademark Office 
shall also be referred to as the "Offic e" and the "Patent and Trademark Office".
 
  IP/N/1/USA/I/2 
 Page 3 
 
 
 § 2.  Powers and duties 
 
(a) In general. The United States Patent and Trademark Office, subject to the policy 
direction of the Secretary of Commerce-- 
   (1) shall be responsible for the granting and issuing of patents an d the registration of 
trademarks; and    (2) shall be responsible for disseminating to the public information with respect to 
patents and trademarks. 
  
(b) Specific powers. The Office-- 
   (1) shall adopt and use a seal of the Offi ce, which shall be judici ally noticed and with 
which letters patent, certificates of trademar k registrations, and papers issued by the 
Office shall be authenticated; 
   (2) may establish regulations, not inconsistent with law, which-- 
      (A) shall govern the conduct of proceedings in the Office;       (B) shall be made in acco rdance with section 553 of title 5; 
      (C) shall facilitate and expedite the processing of patent applications, particularly 
those which can be filed, stored, processe d, searched, and retrieved electronically, 
subject to the provisions of section 122 relating  to the confidential status of applications; 
      (D) may govern the recognition and co nduct of agents, attorneys, or other persons 
representing applicants or other parties befo re the Office, and may require them, before 
being recognized as representatives of applican ts or other persons, to show that they are 
of good moral character and reputation and are possessed of the necessary qualifications 
to render to applicants or other persons valu able service, advice, and assistance in the 
presentation or prosecution of their applic ations or other business before the Office; 
      (E) shall recognize the public interest in continuing to safeguard broad access to the 
United States patent system through the reduced fee struct ure for small entities under 
section 41(h)(1) of this title; and 
      (F) provide for the development of  a performance-based process that includes 
quantitative and qualitative measures and standards for evaluati ng cost-effectiveness 
and is consistent with the principles of impartiality and competitiveness; 
   (3) may acquire, construct, purchase, lease, hold, manage, operate, improve, alter, 
and renovate any real, person al, or mixed property, or an y interest therein, as it 
considers necessary to carry out its functions; 
   (4) (A) may make such purchases, cont racts for the construction, maintenance, or 
management and operation of facilities, and contracts for supplies or services, without 
regard to the provisions of the Federal Prop erty and Administrative  Services Act of 1949 
(40 U.S.C. 471
 et seq.), the Public Buildings Act (40 U.S.C. 601  et seq.) [ 40 USCS §§ 
3301 et seq.], and the Stewar t B. McKinney Homeless Assi stance Act [McKinney-Vento 
Homeless Assistance Act] (42 U.S.C. 11301  et seq.); and 
      (B) may enter into and perform such purchases and contracts for printing services, 
including the process of composition, platem aking, presswork, silk screen processes, 
binding, microform, and the pr oducts of such processes, as  it considers necessary to 
carry out the functions of th e Office, without regard to sections 501 through 517 and 
1101 through 1123 of title 44; 
   (5) may use, with their consent, services, equipment, personnel, and facilities of other 
departments, agencies, and instrumenta lities of the Federal Government, on a 
reimbursable basis, and cooperate with such other departments, agencies, and 
instrumentalities in the establishment and use of services, equipment, and facilities of 
the Office; 
   (6) may, when the Director determines that it is practicable, efficient, and  cost-
effective to do so, use, with the consen t of the United Stat es and the agency, 
instrumentality, Patent and Trademark Office , or international organization concerned, 
the services, records, facilities, or personnel of any State or local government agency or 
instrumentality or foreign patent and trademark office  or international organization to  IP/N/1/USA/I/2 
Page 4  
 
 perform functions on its behalf; 
   (7) may retain and use all of its revenues and receipts, including revenues from the 
sale, lease, or disposal of any real, personal , or mixed property, or any interest therein, 
of the Office; 
   (8) shall advise the President, through the Secretary of Commerc e, on national and 
certain international intellectual property policy issues;    (9) shall advise Federal departments and ag encies on matters of intellectual property 
policy in the United States and intellectual property protection in other countries; 
   (10) shall provide guidance, as appropriat e, with respect to proposals by agencies to 
assist foreign governments and international intergovernmental organizations on matters 
of intellectual property protection; 
   (11) may conduct programs, studies, or  exchanges of items or services regarding 
domestic and international intellectual property law and the effectiveness of intellectual 
property protection domestical ly and throughout the world; 
   (12) (A) shall advise the Secretary of Commerce on programs and studies relating to intellectual property policy that are cond ucted, or authorized to be conducted, 
cooperatively with foreign intellectual property offices and international 
intergovernmental organizations; and 
      (B) may conduct programs and studies described in subparagraph (A); and 
   (13) (A) in coordination with the Department of State, may conduct programs and 
studies cooperatively with foreign intellectual property offices and international 
intergovernmental organizations; and 
      (B) with the concurrence of the Secret ary of State, may author ize the transfer of not 
to exceed $ 100,000 in any year to the Depart ment of State for the purpose of making 
special payments to international intergovernmental organizations for studies and 
programs for advancing international cooper ation concerning patents, trademarks, and 
other matters. 
  
(c) Clarification of specific powers. 
   (1) The special payments under subsection (b)(13)(B) shall be in addition to any other 
payments or contributions to international organizations described in subsection 
(b)(13)(B) and shall not be subject to any limitations imposed by law on the amounts of 
such other payments or contributions by the Unit ed States Government. 
   (2) Nothing in subsection (b) shall deroga te from the duties of the Secretary of State 
or from the duties of the United States Tr ade Representative as set forth in section 141 
of the Trade Act of 1974 (19 U.S.C. 2171).
 
   (3) Nothing in subsection (b) shall derogate from the duties and functions of the 
Register of Copyrights or otherwise alter current authorities re lating to copyright 
matters. 
   (4) In exercising the Director's powers under paragraphs (3) and (4)(A) of subsection 
(b), the Director shall consult with the Administrator of General Services. 
   (5) In exercising the Director's powers an d duties under this sect ion, the Director shall 
consult with the Register of Copyrights  on all copyright and related matters. 
  
(d) Construction. Nothing in this section shall be construed to nullify, void, cancel, or 
interrupt any pending request-for-proposal let or contract issued by the General Services 
Administration for the specific purpose of relocating or leasin g space to the United States 
Patent and Trademark Office. 
 
§ 3.  Officers and employees 
 (a) Under Secretary and Director. 
   (1) In general. The powers and duties of the United States Patent and Trademark 
Office shall be vested in an Under Secret ary of Commerce for Intellectual Property and 
Director of the United States Patent and Trademark Office (in this title referred to as the  IP/N/1/USA/I/2 
 Page 5 
 
 
 "Director"), who shall be a citizen of the Unit ed States and who shall be appointed by the 
President, by and with  the advice and consent of the Senate. The Director shall be a 
person who has a professional background an d experience in patent or trademark law. 
   (2) Duties. 
      (A) In general. The Director shall be responsible for providing policy direction and 
management supervision for the Office an d for the issuance of patents and the 
registration of trademarks. The Director shall perform these duties in a fair, impartial, 
and equitable manner. 
      (B) Consulting with the Public Advi sory Committees. The Direct or shall consult with 
the Patent Public Advisory Committee estab lished in section 5 on a regular basis on 
matters relating to the patent operations of  the Office, shall consult with the Trademark 
Public Advisory Committee established in sectio n 5 on a regular basis on matters relating 
to the trademark operations of the Office, an d shall consult with the respective Public 
Advisory Committee before subm itting budgetary proposals to the Office of Management 
and Budget or changing or proposing to change  patent or trademark user fees or patent 
or trademark regulations which are subject to the requirement to provide notice and 
opportunity for public comment under sect ion 553 of title 5, as the case may be. 
   (3) Oath. The Director shall, before taking  office, take an oath to discharge faithfully 
the duties of the Office. 
   (4) Removal. The Director may be removed from office by the Pr esident. The President 
shall provide notification of any such removal to both Houses of Congress. 
  
(b) Officers and employees of the Office. 
   (1) Deputy Under Secretary and Deputy Director. The Secretary of Commerce, upon 
nomination by the Director, shall appoint a Deputy Under Secretary of Commerce for 
Intellectual Property and Deputy Director of  the United States Patent and Trademark 
Office who shall be vested with the authority to  act in the capacity of the Director in the 
event of the absence or incapaci ty of the Director. The Deputy  Director sha ll be a citizen 
of the United States who has a professional background an d experience in patent or 
trademark law. 
   (2) Commissioners. 
      (A) Appointment and duties. Th e Secretary of Commerce shall appoint a 
Commissioner for Patents an d a Commissioner for Trademarks, without regard to 
chapter 33, 51, or 53 of title 5 [ 5 USCS §§ 3301  et seq., 5101 et seq., or 5301 et seq.]. 
The Commissioner for Patents sha ll be a citizen of the United States with demonstrated 
management ability and professional background and experience in patent law and serve 
for a term of 5 years. The Commissioner for Tr ademarks shall be a citizen of the United 
States with demonstrated management ability and professional background and 
experience in trademark law and serve for a term of 5 years. The Commissioner for 
Patents and the Commissioner for Trademarks sh all serve as the chief operating officers 
for the operations of the Office relating to patents and trademarks, respectively, and 
shall be responsible for the management and di rection of all aspects of the activities of 
the Office that affect the administrati on of patent and trademark operations, 
respectively. The Secretary may reappoint a Commissioner to subsequent terms of 5 
years as long as the performance of the Commissioner  as set forth in the performance 
agreement in subparagraph (B) is satisfactory. 
      (B) Salary and performance agreemen t. The Commissioners shall be paid an annual 
rate of basic pay not to exceed the maximum rate of basic pay for the Senior Executive 
Service established under section 5382 of title 5, including any applic able locality-based 
comparability payment that may be authoriz ed under section 5304(h) (2)(C) of title 5. 
The compensation of the Commissioners shall be considered, for purposes of section 
207(c)(2)(A) of title 18, to be the equivalent of that descr ibed under clause (ii) of 
section 207(c)(2)(A) of title 18. In addition, the Commission ers may receive a bonus in 
an amount of up to, but not in excess of, 50 percent of the Commissioners' annual rate 
of basic pay, based upon an evaluation by the Secretary of Commerce, acting through IP/N/1/USA/I/2 
Page 6  
 
 the Director, of the Commissioners' performa nce as defined in an annual performance 
agreement between the Commi ssioners and the Secretary.  The annual performance 
agreements shall incorporate measurable or ganization and indivi dual goals in key 
operational areas as delineated in an an nual performance plan agreed to by the 
Commissioners and the Secretary.  Payment of a bonus under this subparagraph may be 
made to the Commissioners only to the extent that such payment does not cause the Commissioners' total aggregate compensation in  a calendar year to equal or exceed the 
amount of the salary of the Vice Pr esident under section 104 of title 3. 
      (C) Removal. The Commissioners may be  removed from office by the Secretary for 
misconduct or nonsatisfactory performance under the performance agreement described 
in subparagraph (B), without regard to the provisions of title 5. The Secretary shall 
provide notification of any such removal to both Houses of Congress. 
   (3) Other officers and em ployees. The Director shall-- 
      (A) appoint such officers, employees (including attorneys), and agents of the Office 
as the Director considers necessary to ca rry out the functions of the Office; and 
      (B) define the title, authority, and duties of such officers and employees and 
delegate to them such of the powers vested in the Office as the Director may determine. 
   The Office shall not be subject to any administratively or statutorily imposed limitation 
on positions or personnel, and no positions or personnel of th e Office shall be taken into 
account for purposes of applying any such limitation. 
   (4) Training of examiners. The Office shall submit to the Congress a proposal to 
provide an incentive program to retain as employees patent and trademark examiners of 
the primary examiner grade or higher who are eligible for retirement, for the sole 
purpose of training patent  and trademark examiners. 
   (5) National securi ty positions. The Director, in consultation with the Director of the 
Office of Personnel Management, shall maintain a program for identifying national 
security positions and providing for appropriat e security clearances, in order to maintain 
the secrecy of certain inventions, as described  in section 181, and to prevent disclosure 
of sensitive and strategic information in the interest of national security. 
  
(c) Continued applicability of title 5. Officers and employees of the Office shall be subject 
to the provisions of title 5, relating to Federal employees. 
  (d) Adoption of existing labo r agreements. The Office sha ll adopt all labor agreements 
which are in effect, as of the day before th e effective date of the Patent and Trademark 
Office Efficiency Act, with respect to  such Office (as then in effect). 
  
(e) Carryover of personnel. 
   (1) From PTO. Effective as of the effect ive date of the Patent and Trademark Office 
Efficiency Act, all officers and employees of  the Patent and Tradem ark Office on the day 
before such effective date sh all become officers and employees of the Office, without a 
break in service.    (2) Other personnel. Any individual who, on the day before the effective date of the 
Patent and Trademark Office Efficiency Act, is an officer or employee of the Department 
of Commerce (other than an officer or employee under paragraph (1)) shall be 
transferred to the Office, as necessary to carry out the purposes of this Act, if-- 
      (A) such individual serves in a position for which a major function is the performance 
of work reimbursed by the Patent and Tradem ark Office, as determined by the Secretary 
of Commerce; 
      (B) such individual serves in a positi on that performed work in support of the Patent 
and Trademark Office during at least half of  the incumbent's work time, as determined 
by the Secretary of Commerce; or 
      (C) such transfer would be in the interest of the Office, as determined by the 
Secretary of Commerce in consultation with the Director. 
   Any transfer under this paragraph shall be  effective as of the same effective date as  IP/N/1/USA/I/2 
 Page 7 
 
 
 referred to in paragraph (1), and shall be made without a break in service. 
  
(f) Transition provisions. 
   (1) Interim appointment of Director. On or  after the effective date of the Patent and 
Trademark Office Efficiency Act,  the President shall appoint an individual to serve as the 
Director until the date on which a Director qu alifies under subsection  (a). The President 
shall not make more than one such appointment under this subsection. 
   (2) Continuation in o ffice of certain officers. 
      (A) The individual serving as the Assistant Commissioner fo r Patents on the day 
before the effective date of the Patent and Trademark Office Efficiency Act may serve as 
the Commissioner for Patents until the date  on which a Commissioner for Patents is 
appointed under subsection (b). 
      (B) The individual serving as the A ssistant Commissioner for Trademarks on the day 
before the effective date of the Patent and Trademark Office Efficiency Act may serve as 
the Commissioner for Trademarks until th e date on which a Commissioner for 
Trademarks is appointed under subsection (b). 
 
§ 4.  Restrictions on officers and employees as to interest in patents 
 
Officers and employees of the Patent and Trad emark Office shall be incapable, during the 
period of their appointments and for one year thereafter, of applying  for a patent and of 
acquiring, directly or indirectly, except by i nheritance or bequest, an y patent or any right 
or interest in any patent, issued or to be issued by the Office. In patents applied for 
thereafter they shall not be entitled to any priority date earlier than one year after the 
termination of their appointment. 
 
§ 5.  Patent and Trademark Office Public Advisory Committees 
 
(a) Establishment of Public Advisory Committees. 
   (1) Appointment. The United States Pate nt and Trademark Office shall have a Patent 
Public Advisory Committee and a Trademark Pu blic Advisory Committee, each of which 
shall have nine voting members who shall be  appointed by the Secretary of Commerce 
and serve at the pleasure of  the Secretary of Commerce.  Members of each Public 
Advisory Committee shall be appointed for a term of 3 years, except that of the 
members first appointed, three shall be appo inted for a term of 1 year, and three shall 
be appointed for a term of 2 years. In ma king appointments to  each Committee, the 
Secretary of Commerce shall consider the ri sk of loss of competitive advantage in 
international commerce or other harm to United States companies as a result of such 
appointments. 
   (2) Chair. The Secretary shall designat e a chair of each Advi sory Committee, whose 
term as chair shall be for 3 years. 
   (3) Timing of appointments. Initial appointments to each Advisory Committee shall be made within 3 months after the effective date of the Pa tent and Trademark Office 
Efficiency Act. Vacancies shall be filled within 3 months after they occur. 
  
(b) Basis for appointments. Member s of each Advisory Committee-- 
   (1) shall be citizens of the United States  who shall be chosen so as to represent the 
interests of diverse users of the United States Patent and Trademark Office with respect 
to patents, in the case of the Patent Public Advisory Committee, and with respect to 
trademarks, in the case of the Tr ademark Public Advisory Committee; 
   (2) shall include members who represent small and large entity applicants located in the United States in proportion to the numbe r of applications filed by such applicants, 
but in no case shall members who represent small entity patent applicants, including 
small business concerns, independent inventors,  and nonprofit organizations, constitute 
less than 25 percent of the members of the Patent Public Advisory Committee, and such IP/N/1/USA/I/2 
Page 8  
 
 members shall include at least one independent inventor; and 
   (3) shall include individuals with substa ntial background and achievement in finance, 
management, labor relations, science, technology, and office automation. 
  
In addition to the voting members, each Advisory Committee shall include a 
representative of each labor organization recognized by th e United States Patent and 
Trademark Office. Such repres entatives shall be nonvoting members of the Advisory 
Committee to which they are appointed. 
  
(c) Meetings. Each Advisory Committee shall meet  at the call of the chair to consider an 
agenda set by the chair. 
  
(d) Duties. Each Advisory Committee shall-- 
   (1) review the policies, goals, performance,  budget, and user fees of the United States 
Patent and Trademark Office with respect to patents, in the case of the Patent Public 
Advisory Committee, and with respect to Tr ademarks, in the case of the Trademark 
Public Advisory Committee, and advi se the Director on these matters; 
   (2) within 60 days after the end of each fiscal year-- 
      (A) prepare an annual report on  the matters referred to in paragraph (1); 
      (B) transmit the report to the Se cretary of Commerce, th e President, and the 
Committees on the Judiciary of the Senate  and the House of Representatives; and 
      (C) publish the report in the Offici al Gazette of the Unit ed States Patent and 
Trademark Office. 
  (e) Compensation. Each member of each Ad visory Committee shall be compensated for 
each day (including travel time) during which such member is attending meetings or 
conferences of that Advisory Committee or ot herwise engaged in the business of that 
Advisory Committee, at the rate which is the daily equivalent of the annual rate of basic 
pay in effect for level III of the Executive Sc hedule under section 5314 of title 5. While 
away from such member's home or regula r place of business such member shall be 
allowed travel expenses, including per diem in lieu of subsistence, as authorized by 
section 5703 of title 5. 
  (f) Access to information. Members of each Advisory Committee shal l be provided access 
to records and information in the United Stat es Patent and Trademark Office, except for 
personnel or other privileged information and information concerning patent applications 
required to be kept in confidence by section 122. 
  
(g) Applicability of certain ethics laws. Me mbers of each Advisory Committee shall be 
special Government employees within th e meaning of section 202 of title 18. 
  
(h) Inapplicability of Federal Advisory Committee Act. The Federal Advisory Committee Act (5 U.S.C. App.) shall not apply to each Advisory Committee. 
  
(i) Open meetings. The meetin gs of each Advisory Commi ttee shall be open to the 
public, except that each Ad visory Committee may by majori ty vote meet in executive 
session when considering personnel, privileged, or other confidential information. 
  
(j) Inapplicability of patent prohibition. Section 4 shall not apply to voting members of 
the Advisory Committees. 
 § 6.  Board of Patent Appeals and Interferences 
 
(a) Establishment and composition. There sh all be in the United States Patent and 
Trademark Office a Board of Patent Appe als and Interferences. The Director, the  IP/N/1/USA/I/2 
 Page 9 
 
 
 Commissioner for Patents, the Commissioner  for Trademarks, and the administrative 
patent judges shall constitute the Board. The administrative pa tent judges shall be 
persons of competent legal knowledge and scientific ability who are appointed by the 
Director. 
  
(b) Duties. The Board of Patent  Appeals and Interferences sha ll, on written appeal of an 
applicant, review adverse deci sions of examiners upon applications for patents and shall 
determine priority and patentability of invention in interferences declared under section 
135(a). Each appeal and interference shall be  heard by at least three members of the 
Board, who shall be designated by the Dire ctor. Only the Board of Patent Appeals and 
Interferences may grant rehearings. 
 
§ 7.  Library 
 
The Director shall maintain a library of scien tific and other works an d periodicals, both 
foreign and domestic, in the Patent and Trad emark Office to aid the officers in the 
discharge of their duties. 
 
§ 8.  Classifica tion of patents 
 
The Director may revise and maintain the cl assification by subject matter of United 
States letters patent, and such other pate nts and printed publications as may be 
necessary or practicable, for the purpose of determining with readiness and accuracy the 
novelty of inventions for which applications for patent are filed.  
§ 9.  Certified copies of records 
 
The Director may furnish certified copies of specifications and drawings of patents issued 
by the Patent and Trademark Offi ce, and of other records available either to the public or 
to the person applying therefor. 
 
§ 10.  Publications 
 (a) The Director may publish in printed, typewritten, or electronic form, the following: 
   1. Patents and published applications for patents, including specifications and 
drawings, together with copies of the same . The Patent and Trademark Office may print 
the headings of the drawings for patent s for the purpose of photolithography. 
   2. Certificates of trade-mark regist rations, including stat ements and drawings, 
together with copies of the same. 
   3. The Official Gazette of the Unit ed States Patent and Trademark Office. 
   4. Annual indexes of patents and pate ntees, and of trade-marks and registrants. 
   5. Annual volumes of decision s in patent and trade-mark cases. 
   6. Pamphlet copies of the patent laws and rules of practice, laws and rules relating to 
trade-marks, and circulars or other publications relating to the business of the Office. 
  
(b) The Director may exchange any of the publications specified in items 3, 4, 5, and 6 
of subsection (a) of this section for publications desirable for the use of the Patent and 
Trademark Office. 
 
§ 11.  Exchange of copies of patents and applications with foreign countries 
 The Director may exchange copies of specif ications and drawings of United States 
patents and published applications for pate nts for those of foreign countries. The 
Director shall not enter into an agreement to  provide such copies of specifications and 
drawings of United States pa tents and applications to a foreign country, other than a IP/N/1/USA/I/2 
Page 10  
 
 NAFTA country or a WTO member country, without the express authorization of the 
Secretary of Commerce. For purposes of this  section, the terms "NAFTA country" and 
"WTO member country" have the meanin gs given those terms in section 104(b). 
 
§ 12.  Copies of patents and ap plications for public libraries 
 The Director may supply copies of specificat ions and drawings of patents and published 
applications for patents in printed or electron ic form to public libraries in the United 
States which shall maintain such copies for the use of the public, at the rate for each 
year's issue established for this purpose in section 41(d) of this title. 
 
§ 13.  Annual report to Congress 
 
The Director shall report to the Congress, no t later than 180 days after the end of each 
fiscal year, the moneys received and expended  by the Office, the pu rposes for which the 
moneys were spent, the quality and quantity of the work of the Office, the nature of 
training provided to examiner s, the evaluation of the Commissioner of Patents and the 
Commissioner of Trademarks by the Secretar y of Commerce, the compensation of the 
Commissioners, and other information relating to the Office. 
 
[§ 14.  Redesignated] 
 
CHAPTER 2. PROCEEDINGS IN THE PATENT AND TRADEMARK OFFICE 
 § 21.  Filing date and day for taking action 
 
(a) The Director may by rule prescribe that an y paper or fee required to be filed in the 
Patent and Trademark Office will be considered filed in the Office on the date on which it 
was deposited with the United States Postal Service or woul d have been de posited with 
the United States Postal Service but for po stal service interruptions or emergencies 
designated by the Director. 
  
(b) When the day, or the last day, for taking any action or paying any fee in the United States Patent and Trademark Office falls on Saturday, Sunday, or a federal holiday 
within the District of Columbia, the action may be taken, or the fee paid, on the next 
succeeding secular or business day. 
 
§ 22.  Printing of papers filed 
 
The Director may require papers filed in the Patent and Trademark O ffice to be printed, 
typewritten, or on an electronic medium. 
 § 23.  Testimony in Patent and Trademark Office cases 
 
The Director may establish rules for taking affi davits and depositions required in cases in 
the Patent and Trademark Office . Any officer authorized by law to take depositions to be 
used in the courts of the United States, or of the State where he resides, may take such 
affidavits and depositions. 
 
§ 24.  Subpoenas, witnesses 
 The clerk of any United States court for the district wherein testimony is to be taken for 
use in any contested case in the Patent and Trademark Office, shall, upon the application 
of any party thereto, issue a subpoena for any witness resi ding or being within such 
district, commanding him to a ppear and testify before an officer in such district  IP/N/1/USA/I/2 
 Page 11 
 
 
 authorized to take depositi ons and affidavits, at the ti me and place stated in the 
subpoena. The provisions of the Federal Rules of Civil Procedure relating to the 
attendance of witnesses and to the producti on of documents and things shall apply to 
contested cases in the Pate nt and Trademark Office. 
  
Every witness subpoenaed and in  attendance shall be allo wed the fees and traveling 
expenses allowed to witnesses attendin g the United States district courts. 
  
A judge of a court whose clerk issued a subp oena may enforce obedience to the process 
or punish disobedien ce as in other like cases, on proof  that a witness, served with such 
subpoena, neglected or refused to appear or to testify. No witness shall be deemed 
guilty of contempt for disobeying such subpo ena unless his fees an d traveling expenses 
in going to, and returning from, and one day' s attendance at the place of examination, 
are paid or tendered him at the time of the service of the subpoena; nor for refusing to 
disclose any secret matter except upon appr opriate order of the court which issued the 
subpoena. 
 
§ 25.  Declaration in lieu of oath 
 
(a) The Director may by rule prescribe that any document to be filed in the Patent and 
Trademark Office and which is required by any law, rule, or other regulation to be under 
oath may be subscribed to by a written decl aration in such form as the Director may 
prescribe, such declaration to be in lieu of the oath otherwise required. 
  (b) Whenever such written de claration is used, the docume nt must warn the declarant 
that willful false statements and the like are punishable by fine or imprisonment, or both 
(18 U.S.C. 1001).
 
 
§ 26.  Effect of defective execution 
 
Any document to be filed in the Patent and Trademark Office and which is required by 
any law, rule, or other regulation to be executed in a specified manner may be 
provisionally accepted by the Director despite a defective execution, provided a properly executed document is submitted within  such time as may be prescribed. 
 
CHAPTER 3. PRACTICE BEFORE PATENT AND TRADEMARK OFFICE 
 
[§ 31.  Repealed] 
 
§ 32.  Suspension or ex clusion from practice 
 
The Director may, after notice and opportunity  for a hearing suspend or exclude, either 
generally or in any particular case, from  further practice before the Patent and 
Trademark Office, any person, agent, or attorney shown to be incompetent or 
disreputable, or guilty of gro ss misconduct, or who does not comply with the regulations 
established under section 2(b)(2)(D) of this titl e, or who shall, by word, circular, letter, 
or advertising, with intent to defraud in an y manner, deceive, misl ead, or threaten any 
applicant or prospective applicant, or othe r person having immediate or prospective 
business before the Office. Th e reasons for any such suspen sion or exclusion shall be 
duly recorded. The Director shall have the di scretion to designate an y attorney who is an 
officer or employee of the United States Pa tent and Trademark Office to conduct the 
hearing required by this section. The United  States District Cour t for the District of 
Columbia, under such conditions and upon such proceedings as it by its rules 
determines, may review the acti on of the Director upon the petition of the person so 
refused recognition or so suspended or excluded. IP/N/1/USA/I/2 
Page 12  
 
  
§ 33.  Unauthorized representation as practitioner 
 
Whoever, not being recognized to practice be fore the Patent and Trademark Office, holds 
himself out or permits himself to be held out as so recognized, or as being qualified to 
prepare or prosecute applications for patent, shall be fined not more than $ 1,000 for each offense. 
 
CHAPTER 4. PATENT FEES; FUNDING; SEARCH SYSTEMS 
 
§ 41.  Patent fees; patent and trademark search systems 
 
(a) The Director shall charge the following fees: 
   (1) 
      (A) On filing each application for an or iginal patent, except in design or plant cases, 
$ 690. 
      (B) In addition, on filing or on presentation at any other time, $ 78 for each claim in 
independent form which is in excess of 3, $ 18 for each claim (whether independent or 
dependent) which is in excess of 20, and $ 260 for each application containing a multiple 
dependent claim. 
      (C) On filing each provisional application for an original patent, $ 150. 
   (2) For issuing each original or reissue patent, except in desi gn or plant cases, $ 
1,210. 
   (3) In design and plant cases--       (A) on filing each design application, $ 310; 
      (B) on filing ea ch plant application, $ 480; 
      (C) on issuing ea ch design patent, $ 430; and 
      (D) on issuing each plant patent, $ 580. 
   (4) (A) On filing each application for the reissue of a patent, $ 690. 
      (B) In addition, on filing or on presentation at any other time, $ 78 for each claim in 
independent form which is in excess of the number of independent claims of the original 
patent, and $ 18 for each claim (whether inde pendent or dependent)  which is in excess 
of 20 and also in excess of the numbe r of claims of the original patent. 
   (5) On filing each disclaimer, $ 110. 
   (6) (A) On filing an appeal from the examiner to the Board of Patent Appeals and 
Interferences, $ 300. 
      (B) In addition, on filing a brief in  support of the appeal, $ 300, and on requesting 
an oral hearing in the appeal before the Bo ard of Patent Appeals and Interferences, $ 
260. 
   (7) On filing each petition for the revival of an unintentionally abandoned application 
for a patent, for the unintentionally delayed payment of the fee for issuing each patent, 
or for an unintentionally dela yed response by the patent owner in any reexamination 
proceeding, $ 1,210, unless the petition is file d under section 133 or 151 of this title, in 
which case the fee shall be $ 110. 
   (8) For petitions for 1-month extensions of time to take actions required by the 
Director in an application-- 
      (A) on filing a first petition, $ 110; 
      (B) on filing a second petition, $ 270; and 
      (C) on filing a third petition or subsequent petition, $ 490. 
   (9) Basic national fee for an internatio nal application where the Patent and Trademark 
Office was the International Preliminary Examining Authority and the International Searching Authority, $ 670. 
   (10) Basic national fee for an international application where the Patent and 
Trademark Office was the International Searching Authority but not the International 
Preliminary Examinin g Authority, $ 690.  IP/N/1/USA/I/2 
 Page 13 
 
 
    (11) Basic national fee for an international application where the Patent and 
Trademark Office was neither the International Searching Authority nor the International 
Preliminary Examinin g Authority, $ 970. 
   (12) Basic national fee for an international application where the international 
preliminary examination fee has been paid to  the Patent and Trademark Office, and the 
international preliminary examination report states that the provisions of Article 33(2), (3), and (4) of the Patent Cooperation Treaty  have been satisfied for all claims in the 
application entering the national stage, $ 96. 
   (13) For filing or later presentation of each independent claim in the national stage of 
an international application in excess of 3, $ 78. 
   (14) For filing or later presentation of each claim (whether independent or dependent) 
in a national stage of an international application in excess of 20, $ 18. 
   (15) For each national stage of an international application containing a multiple 
dependent claim, $ 260. 
  
For the purpose of computing fees, a multiple dependent cl aim referred to in section 112 
of this title or any claim depending therefro m shall be considered as separate dependent 
claims in accordance with the number of clai ms to which reference is made. Errors in 
payment of the additional fees may be rectif ied in accordance with regulations of the 
Director. 
  
(b) The Director shall charge the following fees for maintaining in force all patents based 
on applications filed on or after December 12, 1980: 
   (1) 3 years and 6 months after grant, $ 830. 
   (2) 7 years and 6 months after grant, $ 1,900. 
   (3) 11 years and 6 months after grant, $ 2,910. 
  Unless payment of the applicable maintenance fee is received in the Patent and 
Trademark Office on or before  the date the fee is due or within a grace period of 6 
months thereafter, the patent will expire as of the end of such grace period. The Director 
may require the payment of a surcharge as a condition of accepting within such 6-month 
grace period the payment of an applicable maintenance fee. No fee may be established 
for maintaining a design or  plant patent in force. 
  
(c) (1) The Director may accept the paym ent of any maintenance fee required by 
subsection (b) of this section which is made within twenty-four months after the six-month grace period if the delay is shown to the satisfaction of the Director to have been 
unintentional, or at any time after the six-month grace period if the delay is shown to 
the satisfaction of the Director to have b een unavoidable. The Director may require the 
payment of a surcharge as a condition of accepting payment of any maintenance fee 
after the six-month grace period. If the Dire ctor accepts payment of a maintenance fee 
after the six-month grace period, the patent sh all be considered as not having expired at 
the end of the grace period. 
   (2) A patent, the term of which has been ma intained as a result of the acceptance of a 
payment of a maintenance fee under this subsec tion, shall not abridge or affect the right 
of any person or that person 's successors in business who made, purchased, offered to 
sell, or used anything protected by the pate nt within the United States, or imported 
anything protected by the pate nt into the United States af ter the 6-month grace period 
but prior to the acceptance of a maintenance fee under this subsection, to continue the 
use of, to offer for sale, or to sell to others  to be used, offered for sale, or sold, the 
specific thing so made, purchased, offered fo r sale, used, or imported. The court before 
which such matter is in question may provide for the continued manufacture, use, offer 
for sale, or sale of the thing made, purchased,  offered for sale, or used within the United 
States, or imported into the United States, as sp ecified, or for th e manufacture, use, 
offer for sale, or sale in the United States of which substantial preparation was made IP/N/1/USA/I/2 
Page 14  
 
 after the 6-month grace period but before the acceptance of a maintenance fee under 
this subsection, and the court may also provid e for the continued practice of any process 
that is practiced, or for the practice of wh ich substantial preparation was made, after the 
6-month grace period but before the acce ptance of a maintenance fee under this 
subsection, to the extent and under such terms as the court deems equitable for the 
protection of investments made or busine ss commenced after the 6-month grace period 
but before the acceptance of a main tenance fee under this subsection. 
  
(d) The Director shall establish fees for all other processing, services, or materials 
relating to patents not specified in this sect ion to recover the estimated average cost to 
the Office of such processing , services, or materials, exce pt that the Director shall 
charge the following fees for the following services: 
   (1) For recording a document affecting title, $ 40 per property. 
   (2) For each photocopy, $ .25 per page. 
   (3) For each black and white copy of a patent, $ 3.   
The yearly fee for providing a library specified in section 13 of this title with uncertified 
printed copies of the specifications and drawings for all patents in that year shall be $ 
50. 
  
(e) The Director may waive the payment of any fee for any service or material related to 
patents in connection with an occasional or incidental request made by a department or 
agency of the Government, or any office r thereof. The Director may provide any 
applicant issued a notice under  section 132 of this title [ 35 USCS § 132]
 with a copy of 
the specifications and drawings for all patent s referred to in that notice without charge. 
  
(f) The fees established in subs ections (a) and (b) of this section may be adjusted by the 
Director on October 1, 1992, and every year  thereafter, to reflect any fluctuations 
occurring during the previous 12 months in the Consumer Price Index, as determined by 
the Secretary of Labor. Changes of le ss than 1 per centum may be ignored. 
  
(g) No fee established by the Director under this section shall take effect until at least 30 
days after notice of the fee has been publishe d in the Federal Register  and in the Official 
Gazette of the Patent and Trademark Office. 
  
(h) (1) Fees charged under subsection (a) or  (b) shall be reduced by 50 percent with 
respect to their application to any small bu siness concern as defined under section 3 of 
the Small Business Act, and to any independen t inventor or nonprofit organization as 
defined in regulations i ssued by the Director. 
   (2) With respect to its application to any entity described in paragraph (1), any 
surcharge or fee charged unde r subsection (c) or (d) shall not be higher than the 
surcharge or fee required of any other enti ty under the same or substantially similar 
circumstances. 
  
(i) (1) The Director shall maintain, for use by the public, paper, microform, or electronic 
collections of United States  patents, foreign patent documents, and United States 
trademark registrations arranged to permit se arch for and retrieval of information. The 
Director may not impose fees directly for the use of such collections, or for the use of 
the public patent or trademark search rooms or libraries. 
   (2) The Director shall provide for the fu ll deployment of the automated search systems 
of the Patent and Trademark Office so that  such systems are available for use by the 
public, and shall assure full access by the public to, and dissemination of , patent and 
trademark information, using a variety of automated methods, including electronic 
bulletin boards and remote access by user s to mass storage and retrieval systems. 
   (3) The Director may establish reasonable fees for access by the public to the  IP/N/1/USA/I/2 
 Page 15 
 
 
 automated search systems of  the Patent and Trademark Office. If such fees are 
established, a limited amount of free access shall be made available to users of the 
systems for purposes of education and traini ng. The Director may waive the payment by 
an individual of fees authorized by this subsection upon a showing of need or hardship, 
and if such a waiver is in the public interest. 
   (4) The Director shall submit to the Co ngress an annual report on the automated 
search systems of the Patent and Trademark Office and the access by the public to such 
systems. The Director shall also  publish such report in the Federal Register. The Director 
shall provide an opportunity for the submissi on of comments by interested persons on 
each such report. 
 
§ 42.  Patent and Trademark Office funding 
 
(a) All fees for services performed by or  materials furnished by the Patent and 
Trademark Office will be payable to the Director.   
(b) All fees paid to the Director and all a ppropriations for defraying the costs of the 
activities of the Patent and Trademark Offi ce will be credited to the Patent and 
Trademark Office Appropriation Account in  the Treasury of the United States. 
  
(c) To the extent and in the amounts provided  in advance in appropriations Acts, fees 
authorized in this title or any other Act to be charged or established by the Director shall 
be collected by and shall be available to the Director to carry out the activities of the 
Patent and Trademark Office. All fees availa ble to the Director under section 31 of the 
Trademark Act of 1946 [ 15 USCS § 1113]
 shall be used only for the processing of 
trademark registrations and fo r other activities, services, and materials relating to 
trademarks and to cover a proportionate share of the administrative costs of the Patent 
and Trademark Office. 
  
(d) The Director may refund any fee paid by mistake or any amount paid in excess of 
that required. 
  
(e) The Secretary of Commerce shall, on th e day each year on which the President 
submits the annual budget to  the Congress, provide to the Committees on the Judiciary 
of the Senate and the Ho use of Representatives-- 
   (1) a list of patent and trademark fee co llections by the Patent and Trademark Office 
during the preceding fiscal year; 
   (2) a list of activities of the Patent and Trademark Office during the preceding fiscal 
year which were supported by patent fee ex penditures, trademark fee expenditures, and 
appropriations; 
   (3) budget plans for significant programs, projects, and activities of the Office, 
including out-year funding estimates;    (4) any proposed disposition of  surplus fees by the Office; and 
   (5) such other information as  the committees consider necessary. 
 
 
PART II. PATENTABILITY OF INVE NTIONS AND GRANT OF PATENTS
 
CHAPTER 10. PATENTABILITY OF INVENTIONS 
§ 100.  Definitions 
 
When used in this title [ 35 USCS §§ 1  et seq.] unless the cont ext otherwise indicates-- 
  
 IP/N/1/USA/I/2 
Page 16  
 
 (a) The term "invention" means invention or discovery. 
  
(b) The term "process" means process, art or method, and includes a new use of a 
known process, machine, manufacture, composition of matter, or material. 
  
(c) The terms "United States" and "this country"  mean the United States of America, its 
territories and possessions. 
  
(d) The word "patentee" includes not only the patentee to whom the patent was issued 
but also the successors in title to the patentee. 
  
(e) The term "third-party requester" means a person requesting ex  parte reexamination 
under section 302 or inter partes reexaminat ion under section 311 who is not the patent 
owner. 
 
§ 101.  Inventions patentable 
 
Whoever invents or discovers any new and us eful process, machine, manufacture, or 
composition of matter, or any new and useful  improvement thereof, may obtain a patent 
therefor, subject to the conditions and requirements of this title [ 35 USCS §§ 1  et seq.]. 
 
§ 102.  Conditions for patentability; no velty and loss of right to patent 
 
A person shall be entitled to a patent unless--   
(a) the invention was known or used by others in this country, or patented or described 
in a printed publication in this or a foreign country, before the invention thereof by the 
applicant for patent, or 
  
(b) the invention was patented or described in  a printed publication in this or a foreign 
country or in public use or on sale in this country, more than one year prior to the date 
of the application for patent in the United States, or 
  (c) he has abandoned the invention, or 
  
(d) the invention was first patented or caused to be patented, or was the subject of an 
inventor's certificate, by the applicant or his legal representatives or assigns in a foreign 
country prior to the date of the application for patent in this country on an application for 
patent or inventor's certificate filed more than twelve months before the filing of the 
application in the United States, or 
  
(e) the invention was described in (1) an a pplication for patent, published under section 
122(b), by another filed in the United States before th e invention by the applicant for 
patent or (2) a patent granted on an applicat ion for patent by another filed in the United 
States before the invention by the applicant for patent, except that an international 
application filed under the treaty defined in section 351(a) shall have the effects for the 
purposes of this subsection of an application filed in the United States only if the 
international application designated the United States and was published under Article 
21(2) of such treaty in the English language; or 
  
(f) he did not himself invent the subjec t matter sought to be patented, or 
  
(g) (1) during the course of an interferen ce conducted under section 135 or section 291, 
another inventor involved therein establishes, to the extent permitted in section 104,  IP/N/1/USA/I/2 
 Page 17 
 
 
 that before such person's invention ther eof the invention was made by such other 
inventor and not abandoned, suppressed, or concealed, or (2) before such person's 
invention thereof, the invention was made in  this country by another inventor who had 
not abandoned, suppressed, or concealed it. In determining priority of invention under 
this subsection, there shall be considered not only the respective dates of conception and 
reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to prac tice, from a time prior to conception by the 
other. 
 
§ 103.  Conditions for patentab ility; non-obvious subject matter 
 
(a) A patent may not be obtained though the invention is not identically disclosed or 
described as set forth in section 102 of this title, if the differenc es between the subject 
matter sought to be patented and the prior art are such that the subject matter as a 
whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be 
negatived by the manner in which the invention was made. 
  
(b) (1) Notwithstanding subsection (a), and upon timely election by the applicant for 
patent to proceed under this subsection, a bi otechnological process using or resulting in 
a composition of matter that is novel under section 102 and nonobvious under 
subsection (a) of this section shall be considered nonobvious if-- 
      (A) claims to the process and the co mposition of matter are co ntained in either the 
same application for patent or in separate a pplications having the same effective filing 
date; and 
      (B) the composition of matter, and th e process at the time it was invented, were 
owned by the same person or subject to an obligation of assignment to the same person. 
   (2) A patent issued on a process under paragraph (1)-- 
      (A) shall also contain the claims to the composition of matter used in or made by 
that process, or 
      (B) shall, if such composition of matter is claimed in another patent, be set to expire 
on the same date as such other patent, notwithstanding section 154. 
   (3) For purposes of paragraph (1), th e term "biotechnological process" means-- 
      (A) a process of genetically altering or otherwise inducing a single- or multi-celled 
organism to-- 
         (i) express an exogenous nucleotide sequence, 
         (ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide 
sequence, or 
         (iii) express a specific physiological characteristic not naturally associated with 
said organism; 
      (B) cell fusion procedures yielding a ce ll line that expresses a specific protein, such 
as a monoclonal antibody; and       (C) a method of using a product prod uced by a process defined by subparagraph (A) 
or (B), or a combination of subparagraphs (A) and (B). 
  
(c) Subject matter developed by another person, which qualifies as prior art only under 
one or more of subsections (e), (f), and (g) of  section 102 of this title, shall not preclude 
patentability under this section where the subject matter and the claimed invention 
were, at the time the invention was made, ow ned by the same person or subject to an 
obligation of assignment to the same person. 
 § 104.  Invention made abroad 
 
(a) In general. 
   (1) Proceedings. In proceedings in the Patent and Trademark Office, in the courts, and IP/N/1/USA/I/2 
Page 18  
 
 before any other competent authority, an a pplicant for a patent, or a patentee, may not 
establish a date of invention by reference to knowledge or use thereof, or other activity 
with respect thereto, in a foreign country other than a NAFTA country or a WTO member 
country, except as provided in sections 119 and 365 of this title. 
   (2) Rights. If an invention was made by a person, civil or military-- 
      (A) while domiciled in the United States, and serving in any other country in connection with operations by or on behalf of the United States, 
      (B) while domiciled in a NAFTA country and serving in another country in connection 
with operations by or on behalf of that NAFTA country, or 
      (C) while domiciled in a WTO member country and serving in another country in 
connection with operations by or on behalf of that WTO member country, 
   that person shall be entitled to the same rights of priority in the United States with 
respect to such invention as if such invention had been made in the United States, that 
NAFTA country, or that WTO member country, as the case may be. 
   (3) Use of information. To the extent that any information in a NAFTA country or a WTO member country concerning knowledge, use,  or other activity relevant to proving 
or disproving a date of invention has not b een made available for use in a proceeding in 
the Patent and Trademark Office , a court, or any other competent authority to the same 
extent as such information could be made av ailable in the United States, the Director, 
court, or such other authority shall draw a ppropriate inferences, or take other action 
permitted by statute, rule, or regulation, in favor of the party that requested the 
information in the proceeding. 
  
(b) Definitions. As used in this section--    (1) the term "NAFTA country" has the mean ing given that term in section 2(4) of the 
North American Free Trade Agr eement Implementation Act [ 19 USCS § 3301
(4)]; and 
   (2) the term "WTO member country" has the meaning given that term in section 2(10) 
of the Uruguay Round Agreements Act [ 19 USCS § 3501 (10)]. 
 
§ 105.  Inventions in outer space 
 
(a) Any invention made, used or sold in outer space on a space object or component 
thereof under the jurisdiction or  control of the United States  shall be considered to be 
made, used or sold within the United States for the purposes of this title, except with 
respect to any space object or component ther eof that is specifically identified and 
otherwise provided for by an international agreement to which the United States is a 
party, or with respect to any space object or  component thereof that  is carried on the 
registry of a foreign state in accordance with the Convention  on Registration of Objects 
Launched into Outer Space. 
  
(b) Any invention made, used or sold in outer space on a space object or component 
thereof that is carried on the registry of  a foreign state in accordance with the 
Convention on Registration of  Objects Launched into Outer Sp ace, shall be considered to 
be made, used or sold within th e United States for th e purposes of this ti tle if specifically 
so agreed in an international agreement be tween the United Stat es and the state of 
registry. 
 
CHAPTER 11. APPLICATION FOR PATENT  
§ 111.  Application 
 
(a) In general.    (1) Written application. An application fo r patent shall be made, or authorized to be 
made, by the inventor, except as otherwise provided in this title, in writing to the 
Director.  IP/N/1/USA/I/2 
 Page 19 
 
 
    (2) Contents. Such application shall include-- 
      (A) a specification as pre scribed by section 112 of this title; 
      (B) a drawing as prescribed  by section 113 of this title; and 
      (C) an oath by the applicant as prescribed by section 115 of this title. 
   (3) Fee and oath. The application must be  accompanied by the f ee required by law. 
The fee and oath may be submitted after the specification and any required drawing are 
submitted, within such peri od and under such conditions, including the payment of a 
surcharge, as may be prescribed by the Director. 
   (4) Failure to submit. Upon failure to submit the fee and oath within such prescribed 
period, the application shall be regarded as abandoned, unless it is shown to the 
satisfaction of the Director that the delay in submitting the fee and oath was unavoidable 
or unintentional. The filing date of an application shall be the date on which the 
specification and any required drawing are re ceived in the Patent and Trademark Office. 
  
(b) Provisional application.    (1) Authorization. A provisional applicatio n for patent shall be made or authorized to 
be made by the inventor, except as otherwise provided in this title, in writing to the 
Director. Such application shall include-- 
      (A) a specification as prescribed by the first paragraph of section 112 of this title; 
and 
      (B) a drawing as prescribed by section 113 of this title. 
   (2) Claim. A claim, as re quired by the second through fi fth paragraphs of section 112, 
shall not be required in a provisional application. 
   (3) Fee.       (A) The application must be accompanied by the fee required by law. 
      (B) The fee may be submitted after the specification and any required drawing are 
submitted, within such peri od and under such conditions, including the payment of a 
surcharge, as may be prescribed by the Director. 
      (C) Upon failure to submit the fee with in such prescribed period, the application shall 
be regarded as abandoned, unle ss it is shown to the satisfacti on of the Director that the 
delay in submitting the fee was unavoidable or unintentional. 
   (4) Filing date. The filing date of a provisional application shall be the date on which 
the specification and any required drawing are received in the Patent and Trademark Office. 
   (5) Abandonment. Notwithstanding the abse nce of a claim, upon timely request and as 
prescribed by the Director, a provisional application may be treated as an application 
filed under subsection (a). Subject to section 119(e)(3) of this title, if no such request is 
made, the provisional application shall be regarded as abandoned 12 months after the 
filing date of such applicat ion and shall not be subject to revival after such 12-month 
period. 
   (6) Other basis for provisional applicatio n. Subject to all the conditions in this 
subsection and section 119(e) of this title, and as pre scribed by the Director, an 
application for patent filed under subsection (a) may be treated as a provisional 
application for patent. 
   (7) No right of priority or benefit of earliest filing date. A provisional application shall 
not be entitled to the right of priority of any other application under section 119 or 
365(a) of this title or to the benefit of an earlier filing da te in the United States under 
section 120, 121, or 365(c) of this title. 
   (8) Applicable provisions. The provisions of this title relating to applications for patent 
shall apply to provisional applications for patent, except as otherwise provided, and 
except that provisional applications for patent  shall not be subject to sections 115, 131, 
135, and 157 of this title. 
 
 IP/N/1/USA/I/2 
Page 20  
 
 § 112.  Specification 
 
The specification shall contain a written description of the invention, and of the manner 
and process of making and using it, in such full, clear, concise, and exact terms as to 
enable any person skilled in the art to which it  pertains, or with which it is most nearly 
connected, to make and use the same, and sh all set forth the best mode contemplated 
by the inventor of carrying out his invention. 
  
The specification shall conclude with one or more claims particularly pointing out and 
distinctly claiming the subject matter which the applicant regards as his invention. 
  
A claim may be written in independent or, if the nature of the case admits, in dependent 
or multiple dependent form. 
  
Subject to the following paragraph, a claim in dependent form shall contain a reference 
to a claim previously set forth and then specify a further limitation of the subject matter 
claimed. A claim in dependent form shall be construed to incorporate by reference all the 
limitations of the claim to which it refers. 
  
A claim in multiple dependent form shall contain a reference, in the alternative only, to 
more than one claim previously set forth and then specify a further limitation of the 
subject matter claimed. A multiple dependen t claim shall not serve as a basis for any 
other multiple dependent claim. A multiple dependent claim shall be construed to 
incorporate by reference all the limitations of the particular claim in relation to which it is being considered. 
  
An element in a claim for a combination ma y be expressed as a means or step for 
performing a specified function  without the recital of struct ure, material, or acts in 
support thereof, and such clai m shall be construed to cover the corresponding structure, 
material, or acts described in the sp ecification and equivalents thereof. 
 
§ 113.  Drawings 
 The applicant shall furnish a drawing wher e necessary for the understanding of the 
subject matter sought to be patented. When the nature of such subject matter admits of 
illustration by a drawing and the applicant has not furnished such a drawing, the Director 
may require its submission within a time period of not less than two months from the 
sending of a notice thereof. Drawings submitted after the filing date of the application 
may not be used (i) to overcome any insufficie ncy of the specification due to lack of an 
enabling disclosure or otherwise inadequate disclosure therein,  or (ii) to supplement the 
original disclosure thereof for the purpose of  interpretation of the scope of any claim. 
 § 114.  Models, specimens 
 
The Director may require the applicant to furnish a model of convenient size to exhibit 
advantageously the several parts of his invention. 
  
When the invention relates to a composition of matter, the Director may require the 
applicant to furnish specimens or ingred ients for the purpose of inspection or 
experiment. 
 § 115.  Oath of applicant 
 
The applicant shall make oath that he believes himself to be the original and first 
inventor of the process, machine, manuf acture, or composition of matter, or  IP/N/1/USA/I/2 
 Page 21 
 
 
 improvement thereof, for which he solicits a patent; and shall state of what country he is 
a citizen. Such oath may be made before any person within the Unit ed States authorized 
by law to administer oaths, or, when made in  a foreign country, befo re any diplomatic or 
consular officer of the United States authorized to administer oaths, or before any officer 
having an official seal and authorized to ad minister oaths in the foreign country in which 
the applicant may be, whose authority shall be proved by certificate of a diplomatic or 
consular officer of the United States, or apos tille of an official designated by a foreign 
country which, by treaty or convention, accords like effect to apostilles of designated 
officials in the United States, and such oath is  valid if it complies with the laws of the 
state or country where made. When  the application is made as provided in this title by a 
person other than the inventor, the oath may be  so varied in form that it can be made 
by him. For purposes of this section, a consular officer shall include any United States 
citizen serving overseas, author ized to perform notarial functions pursuant to section 
1750 of the Revised Statutes, as amended (22 U.S.C. 4221).  
 § 116.  Inventors 
 
When an invention is made by two or more persons jointly, they shall apply for patent 
jointly and each make the required oath, exce pt as otherwise provided in this title. 
Inventors may apply for a patent jointly even  though (1) they did not physically work 
together or at the same time, (2) each di d not make the same type or amount of 
contribution, or (3) each did not make a contribution to the subject matter of every 
claim of the patent. 
  If a joint inventor refuses to join in an application for patent or cannot be found or 
reached after diligent effort, the applicatio n may be made by the other inventor on 
behalf of himself and the omi tted inventor. The Director, on proof of the pertinent facts 
and after such notice to the omitted inventor as he prescribes, may grant a patent to the 
inventor making the application, subject to the same rights which the omitted inventor 
would have had if he had been joined. The omitted inventor may subsequently join in 
the application. 
  
Whenever through error a person is named in an application for patent as the inventor, 
or through error an inventor is not named in an application, and such error arose without 
any deceptive intention on his part, the Di rector may permit the application to be 
amended accordingly, under su ch terms as he prescribes. 
 
§ 117.  Death or incapacity of inventor 
 
Legal representatives of deceased inventor s and of those under legal incapacity may 
make application for patent upon compliance with the requirements and on the same 
terms and conditions applicable to the inventor.  
§ 118.  Filing by other than inventor 
 
Whenever an inventor refuses to execute an application for patent, or cannot be found or 
reached after diligent effort, a person to wh om the inventor has assigned or agreed in 
writing to assign the invention or who otherwise shows sufficient proprietary interest in 
the matter justifying such action, may make a pplication for patent on behalf of and as 
agent for the inventor on proof of the pertinent facts and a showing that such action is 
necessary to preserve the rights of the part ies or to prevent irreparable damage; and the 
Director may grant a patent to such inventor  upon such notice to  him as the Director 
deems sufficient, and on compliance with  such regulations as he prescribes. 
 
 IP/N/1/USA/I/2 
Page 22  
 
 § 119.  Benefit of earlier filing date; right of priority 
 
(a) An application for patent for an invention filed in this country by any person who has, 
or whose legal representatives or assigns have , previously regularly filed an application 
for a patent for the same invention in a foreign country which affords similar privileges in 
the case of applications filed in the United Stat es or to citizens of the United States, or in 
a WTO member country, shall have the same e ffect as the same application would have 
if filed in this country on the date on wh ich the application for patent for the same 
invention was first filed in such foreign country,  if the application in this country is filed 
within twelve months from the earliest date on which such foreign application was filed; 
but no patent shall be granted on any applic ation for patent for an invention which had 
been patented or described in a printed pub lication in any country more than one year 
before the date of the actual filing of the app lication in this country, or which had been in 
public use or on sale in this country more than one year prior to such filing. 
  (b) (1) No application for patent shall be entitled to this right of priority unless a claim is 
filed in the Patent and Trademark Office, identifying the foreign application by specifying 
the application number on that foreign applicat ion, the intellectual property authority or 
country in or for which the application was filed,  and the date of filing  the application, at 
such time during the pendency of the a pplication as required by the Director. 
   (2) The Director may consider the failure of the applicant to file a timely claim for 
priority as a waiver of any such claim. Th e Director may establish procedures, including 
the payment of a surcharge, to accept an  unintentionally delayed claim under this 
section.    (3) The Director may require a certified copy of the original foreign application, 
specification, and drawings upon which it is  based, a translation if not in the English 
language, and such other information as th e Director considers necessary. Any such 
certification shall be made by the foreign intellectual property authority in which the 
foreign application was filed and show the date of the application and of the filing of the 
specification and other papers. 
  
(c) In like manner and subjec t to the same conditions and requirements, the right 
provided in this section may be based upon a subsequent regularly filed application in 
the same foreign country instead of the first filed foreign application, provided that any 
foreign application filed prior to such su bsequent application has been withdrawn, 
abandoned, or otherwise disposed  of, without having been laid open to public inspection 
and without leaving any rights outstanding, and has not served, nor thereafter shall 
serve, as a basis for clai ming a right of priority. 
  
(d) Applications for inventors' certificates filed in a foreign country in which applicants 
have a right to apply, at th eir discretion, either for a pa tent or for an inventor's 
certificate shall be treated in this country in the same manner and have the same effect for purpose of the right of prio rity under this section as applications for patents, subject 
to the same conditions and requirements of this section as apply to applications for 
patents, provided such applicants are entitled to the benefits of the Stockholm Revision 
of the Paris Convention at the time of such filing. 
  
(e) (1) An application for patent filed under se ction 111(a) or section 363 of this title for 
an invention disclosed in the manner provided  by the first paragraph of section 112 of 
this title in a provisional application filed under section 111(b) of this title, by an inventor 
or inventors named in the provisional application, shall have the same effect, as to such invention, as though filed on the date of the provisional application filed under section 
111(b) of this title, if the application for patent filed under section 111(a) or section 363 
of this title is filed not later than 12 months after the date on which the provisional 
application was filed and if it contains or is amended to contain a specific reference to  IP/N/1/USA/I/2 
 Page 23 
 
 
 the provisional application. No application sha ll be entitled to the benefit of an earlier 
filed provisional application under this subs ection unless an amendment containing the 
specific reference to the earlier filed provis ional application is submitted at such time 
during the pendency of the application as required by the Direct or. The Director may 
consider the failure to submit such an amendment within that time period as a waiver of 
any benefit under this subsection. The Director may establish procedures, including the payment of a surcharge, to accept an un intentionally delayed submission of an 
amendment under this subs ection during the penden cy of the application. 
   (2) A provisional application filed under se ction 111(b) of this title may not be relied 
upon in any proceeding in the Patent and Tr ademark Office unless the fee set forth in 
subparagraph (A) or (C) of section 41(a)(1) of this title has been paid. 
   (3) If the day that is 12 months after the f iling date of a provisional application falls on 
a Saturday, Sunday, or Federal holiday within the District of Columbia, the period of 
pendency of the provisional application shall be extended to the next succeeding secular 
or business day.   
(f) Applications for plant breeder's rights filed in a WTO member country (or in a foreign 
UPOV Contracting Party) shall have the same effect for the purpose of the right of 
priority under subsections (a) through (c) of this section as applications for patents, 
subject to the same conditions and requirements  of this section as apply to applications 
for patents. 
  
(g) As used in this section-- 
   (1) the term "WTO member country" has the same meaning as the term is defined in 
section 104(b)(2) of this title; and 
   (2) the term "UPOV Contracting Part y" means a member of the International 
Convention for the Protection of New Varieties of Plants. 
 
§ 120.  Benefit of earlier filing  date in the United States 
 
An application for patent for an invention disclosed in the manner provided by the first 
paragraph of section 112 of this title in an application previously filed in the United 
States, or as provided by section 363 of this title, which is filed by an inventor or inventors named in the previously filed application shall have the same effect, as to such 
invention, as though filed on the date of the prior application, if filed before the 
patenting or abandonment of or termination of  proceedings on the first application or on 
an application similarly entitled to the benefit of the filing date of the first application and 
if it contains or is amended to contain a specific reference to the earlier filed application. 
No application shall be entitled to the benefit of an earlier filed application under this 
section unless an amendment co ntaining the specific reference to the earlier filed 
application is submitted at such time during the pendency of the a pplication as required 
by the Director. The Director may consider the failure to submit such an amendment 
within that time period as a waiver of any benefit under this section. The Director may 
establish procedures, including the payment of a surcharge, to accept an unintentionally 
delayed submission of an am endment under this section. 
 
§ 121.  Divisional applications 
 
If two or more independent and distinct inventions are claimed in one application, the 
Director may require the application to be rest ricted to one of the in ventions. If the other 
invention is made the subject of a divisional application which complies with the requirements of section 120 of this title it shal l be entitled to the benefit of the filing date 
of the original application. A patent issuin g on an application with respect to which a 
requirement for restriction under this section has been made, or on an application filed 
as a result of such a requirem ent, shall not be used as a re ference either in the Patent IP/N/1/USA/I/2 
Page 24  
 
 and Trademark Office or in the courts agai nst a divisional application or against the 
original application or any patent issued on ei ther of them, if the divisional application is 
filed before the issuance of the patent on the other application. If a divisional application 
is directed solely to subject matter described and claimed in the original application as 
filed, the Director may dispense with signing and execution by the inventor. The validity 
of a patent shall not be questioned for failure of the Director to require the application to be restricted to one invention. 
 
§ 122.  Confidential status of applicatio ns; publication of patent applications 
 
(a) Confidentiality. Except as provided in subs ection (b), applications for patents shall be 
kept in confidence by the Patent and Trad emark Office and no information concerning 
the same given without authority of the app licant or owner unless necessary to carry out 
the provisions of an Act of Congress or in such special circumstances as may be 
determined by the Director.   
(b) Publication. 
   (1) In general. 
      (A) Subject to paragraph (2), each a pplication for a patent shall be published, in 
accordance with procedures determined by th e Director, promptly af ter the expiration of 
a period of 18 months from the earliest fili ng date for which a benefit is sought under 
this title. At the request of the applicant, an application may be published earlier than 
the end of such 18-month period. 
      (B) No information concerning published patent applications shall be made available to the public except as the Director determines. 
      (C) Notwithstanding any other provision of law, a determination by the Director to 
release or not to release information concerni ng a published patent application shall be 
final and nonreviewable. 
   (2) Exceptions. 
      (A) An application shall not be published if that application is-- 
         (i) no longer pending; 
         (ii) subject to a secrec y order under section 181 of this title; 
         (iii) a provisional application filed under section 111(b)  of this title; or 
         (iv) an application for a design patent filed under chapter 16 of this title [ 35 USCS 
§§ 171  et seq.]. 
      (B) (i) If an applicant makes a request upon filing, certifying that the invention 
disclosed in the application has not and will no t be the subject of an application filed in 
another country, or under a multilateral international agreement, that requires 
publication of applications 18 months after filing, the application shall not be published 
as provided in paragraph (1). 
         (ii) An applicant may rescind a request made under clause (i) at any time. 
         (iii) An applicant who has made a request under clause (i) but who subsequently files, in a foreign country or under a multilateral international agreement specified in 
clause (i), an application directed to the inve ntion disclosed in the application filed in the 
Patent and Trademark Office, shall notify the Director of such filing not later than 45 
days after the date of the filing of such foreign or international application. A failure of 
the applicant to provide such notice within the prescribed period shall result in the 
application being regarded as abandoned, unle ss it is shown to the satisfaction of the 
Director that the delay in submitti ng the notice was unintentional. 
         (iv) If an applicant rescinds a request made under clause  (i) or notifies the 
Director that an application was filed in a foreign country or under a multilateral international agreement specified in clause (i), the application shall be published in 
accordance with the provisions of paragraph (1 ) on or as soon as is practical after the 
date that is specified in clause (i). 
         (v) If an applicant has filed applications in one or more foreign countries, directly  IP/N/1/USA/I/2 
 Page 25 
 
 
 or through a multilateral international agreement, and such foreign filed applications 
corresponding to an application filed in the Patent and Trademark Office or the 
description of the invention in such foreign filed applications is less extensive than the 
application or description of the invention in the application filed in the Patent and 
Trademark Office, the applicant may submit a redacted copy of the application filed in 
the Patent and Trademark Office eliminating any part or description of the invention in such application that is not also contained in  any of the corresponding applications filed 
in a foreign country. The Director may only pu blish the redacted copy of the application 
unless the redacted copy of the application is not received within 16 months after the 
earliest effective filing date for which a benefi t is sought under this title. The provisions 
of section 154(d) shall not apply to a claim if the description of the invention published in 
the redacted application filed under this clause with respect to the claim does not enable 
a person skilled in the art to make an d use the subject ma tter of the claim. 
  
(c) Protest and pre-issuance opposition. The Director shall establish appropriate 
procedures to ensure that no protest or ot her form of pre-issuan ce opposition to the 
grant of a patent on an application may be initiated after publication of the application 
without the express written consent of the applicant. 
  
(d) National security. No application for pa tent shall be published under subsection 
(b)(1) if the publication or disclosure of such invention would be detrimental to the 
national security. The Di rector shall establish appropriate procedures to ensure that such 
applications are promptly identified and the se crecy of such inventions is maintained in 
accordance with chapter 17 of this title [ 35 USCS §§ 181
 et seq.]. 
CHAPTER 12. EXAMINATION OF APPLICATION 
§ 131.  Examination of application 
 
The Director shall cause an ex amination to be made of th e application and the alleged 
new invention; and if on such examination it appears that the applicant is entitled to a 
patent under the law, the Director  shall issue a patent therefor. 
 
§ 132.  Notice of rejection; reexamination 
 (a) Whenever, on examination, any claim for a patent is rejected, or any objection or 
requirement made, the Director shall notify th e applicant thereof, st ating the reasons for 
such rejection, or objection or requiremen t, together with such information and 
references as may be useful in judging of the propriety of continuing the prosecution of 
his application; and if after receiving such notice, the applicant persists in his claim for a 
patent, with or without amendment, the app lication shall be reexamined. No amendment 
shall introduce new matter into the disclosure of the invention. 
  
(b) The Director shall prescribe regulations to provide for the continued examination of applications for patent at the request of the applicant. The Di rector may establish 
appropriate fees for such continued exam ination and shall provide a 50 percent 
reduction in such fees for small entities that qualify for reduced fees under section 
41(h)(1) of this title. 
 
§ 133.  Time for prosecuting application 
 
Upon failure of the applicant to prosecute the application within six months after any 
action therein, of which notice has been given or mailed to the applicant, or within such 
shorter time, not less than thirty days, as fixed by the Director in such action, the 
application shall be regarded as abandoned by  the parties thereto, unless it be shown to IP/N/1/USA/I/2 
Page 26  
 
 the satisfaction of the Director that such delay was unavoidable. 
 
§ 134.  Appeal to the Board of Patent Appeals and Interferences 
 
(a) Patent applicant. An applicant for a pa tent, any of whose cl aims has been twice 
rejected, may appeal from the decision of the primary examin er to the Board of Patent 
Appeals and Interferences, having on ce paid the fee for such appeal. 
  
(b) Patent owner. A patent owner in any r eexamination proceeding may appeal from the 
final rejection of any claim by the primary ex aminer to the Board of Patent Appeals and 
Interferences, having once pa id the fee for such appeal. 
  
(c) Third-party. A third-party requester in an  inter partes proceeding may appeal to the 
Board of Patent Appeals and Interferences from the final decision of the primary 
examiner favorable to the patentability of any original or proposed amended or new claim of a patent, having once paid the fee for such appeal. 
 
§ 135.  Interferences 
 
(a) Whenever an application is made for a pa tent which, in the opinion of the Director, 
would interfere with any pending application, or with any unexpired patent, an 
interference may be declared and the Director shall give notice of su ch declaration to the 
applicants, or applicant and patentee, as th e case may be. The Board of Patent Appeals 
and Interferences shall determine questions of priority of the inventions and may determine questions of patentability. Any final decision, if adverse to the claim of an 
applicant, shall constitute the final refusal by the Patent and Trademark Office of the 
claims involved, and the Director may issue a patent to the applicant who is adjudged 
the prior inventor. A final judgment adverse to  a patentee from which no appeal or other 
review has been or can be taken or had sh all constitute cancellation of the claims 
involved in the patent, and noti ce of such cancellation shall be endorsed on copies of the 
patent distributed after su ch cancellation by the Patent and Trademark Office. 
  
(b) (1) A claim which is the same as, or for the same or substantially the same subject matter as, a claim of an issued patent may no t be made in any application unless such a 
claim is made prior to one year from th e date on which the patent was granted. 
   (2) A claim which is the same as, or for the same or substantially the same subject 
matter as, a claim of an application publishe d under section 122(b) of this title may be 
made in an application filed after the applicat ion is published only if the claim is made 
before 1 year after the date on wh ich the application is published. 
  
(c) Any agreement or understanding between parties to an interference, including any 
collateral agreements referred to therein, made  in connection with or in contemplation of 
the termination of the interference, shall be in writing and a true copy thereof filed in the 
Patent and Trademark Office be fore the termination of the interference as between the 
said parties to the agreement or understanding. If any party filing the same so requests, 
the copy shall be kept separate from the file  of the interference, an d made available only 
to Government agencies on written request,  or to any person on a showing of good 
cause. Failure to file the copy of such  agreement or understanding shall render 
permanently unenforceable such  agreement or understandin g and any patent of such 
parties involved in the interference or any patent subsequently issued on any application 
of such parties so involved. The Director may, however, on  a showing of good cause for 
failure to file within the time prescribed, permit the filing of the agreement or 
understanding during the six-month period subsequent to the termination of the 
interference as between the parties to the agreement or understanding. 
   IP/N/1/USA/I/2 
 Page 27 
 
 
 The Director shall give notice  to the parties or their atto rneys of record, a reasonable 
time prior to said termination, of the filing requirement of this section. If the Director 
gives such notice at a later time, irrespective of the righ t to file such agreement or 
understanding within the six-mon th period on a showing of good cause, the parties may 
file such agreement or underst anding within sixty days of the receipt of such notice. 
  Any discretionary action of th e Director under this subsection shall be reviewable under 
section 10 of the Administ rative Procedure Act. 
  
(d) Parties to a patent interference, within su ch time as may be specified by the Director 
by regulation, may determine such contest or  any aspect thereof by arbitration. Such 
arbitration shall be governed by  the provisions of title 9 [ 9 USCS §§ 1
 et seq.] to the 
extent such title is not inconsistent with this section. The parties shall give notice of any 
arbitration award to the Direct or, and such award shall, as between the parties to the 
arbitration, be dispositive of the issues to wh ich it relates. The arbitration award shall be 
unenforceable until such notice is given. Nothing in this subsection shall preclude the 
Director from determining patentability of the invention involved in the interference. 
 
CHAPTER 13. REVIEW OF PATENT AND TRADEMARK OFFICE  
 
§ 141.  Appeal to Court of A ppeals for the Federal Circuit 
 
An applicant dissatisfied with the decision in an appeal to  the Board of Patent Appeals 
and Interferences under section 134 of this ti tle may appeal the decision to the United 
States Court of Appeals for the Federal Circuit. By filing such an appeal the applicant 
waives his or her right to proceed under sect ion 145 of this title. A patent owner, or a 
third-party requester in an inter partes reexamination proceeding, who is in any 
reexamination proceeding dissatisf ied with the final decision in an appeal to the Board of 
Patent Appeals and Interferences under sect ion 134 may appeal the decision only to the 
United States Court of Appe als for the Federal Circuit. A party to an interference 
dissatisfied with the de cision of the Board of Patent Appeals and Interferences on the 
interference may appeal the decision to th e United States Court of Appeals for the 
Federal Circuit, but such a ppeal shall be dismissed if any adverse party to such 
interference, within twenty days after the appellant has filed notice of appeal in 
accordance with section 142 of this title, files no tice with the Direct or that the party 
elects to have all further proceedings conducted as provided in section 146 of this title. If 
the appellant does not, within thirty days after the filing of such notice by the adverse 
party, file a civil action under section 146, the decision appealed from shall govern the 
further proceedings in the case. 
 
§ 142.  Notice of appeal 
 When an appeal is taken to the United Stat es Court of Appeals for the Federal Circuit, 
the appellant shall file in the Patent and Tr ademark Office a writte n notice of appeal 
directed to the Director, within  such time after the date of the decision from which the 
appeal is taken as the Director prescribes, but in no ca se less than 60 days after that 
date. 
 
§ 143.  Proceedings on appeal 
 
With respect to an appeal de scribed in section 142 of this  title, the Director shall 
transmit to the United States Court of Appeals for the Federal Circuit a certified list of 
the documents comprising the record in the Patent and Trademark Office. The court may 
request that the Director forward the origin al or certified copies of such documents IP/N/1/USA/I/2 
Page 28  
 
 during pendency of the appeal. In an ex parte case or any reexamination case, the 
Director shall submit to the court in writin g the grounds for the de cision of the Patent 
and Trademark Office, addressing  all the issues involved in the appeal. The court shall, 
before hearing an appeal , give notice of the ti me and place of the hearing to the Director 
and the parties in the appeal. 
 § 144.  Decision on appeal 
 
The United States Court of A ppeals for the Federal Circuit sh all review the decision from 
which an appeal is taken on the record befo re the Patent and Trademark Office. Upon its 
determination the court shall issue to the Director its mandate and opinion, which shall 
be entered of record in the Patent and Tr ademark Office and shall govern the further 
proceedings in the case. 
 
§ 145.  Civil action to obtain patent  
An applicant dissatisfied wi th the decision of the Bo ard of Patent Appeals and 
Interferences in an appeal und er section 134(a) of this titl e may, unless appeal has been 
taken to the United States Court of Appeals fo r the Federal Circuit, have remedy by civil 
action against the Director in the United States District Cour t for the District of Columbia 
if commenced within such time after such decision, not less than  sixty days, as the 
Director appoints. The court may adjudge that  such applicant is entitled to receive a 
patent for his invention, as specified in any of his claims involved in the decision of the 
Board of Patent Appeals and Interferences, as  the facts in the case may appear and such 
adjudication shall authorize the Director to  issue such patent on compliance with the 
requirements of law. All the ex penses of the proceedings sha ll be paid by the applicant. 
 
§ 146.  Civil action in case of interference 
 
Any party to an interference di ssatisfied with the decision of  the Board of Patent Appeals 
and Interferences on the inte rference, may have remedy by  civil action, if commenced 
within such time after such de cision, not less than sixty days, as the Director appoints or 
as provided in section 141 of this title, unle ss he has appealed to the United States Court 
of Appeals for the Federal Circ uit, and such appeal  is pending or has been decided. In 
such suits the record in the Patent and Trad emark Office shall be admitted on motion of 
either party upon the terms and conditions as  to costs, expenses, and the further cross-
examination of the witnesses as the court imposes, without prejudice to the right of the 
parties to take further testimony. The testimon y and exhibits of the record in the Patent 
and Trademark Office when admitted shall have the same effect as if originally taken and 
produced in the suit. 
  
Such suit may be instituted against the party in interest as shown by the records of the 
Patent and Trademark Office at  the time of the decision complained of, but any party in 
interest may become a party to the action. If there be adverse pa rties residing in a 
plurality of districts not embrac ed within the same state, or an adverse party residing in 
a foreign country, the United States District Court for the District of Columbia shall have 
jurisdiction and may issue su mmons against the adverse parties directed to the marshal 
of any district in which any adverse part y resides. Summons against adverse parties 
residing in foreign countries may be served by publication or otherwise as the court 
directs. The Director shall not be a necessary party but he shall be notified of the filing of 
the suit by the clerk of the court in which it is filed and shall have the right to intervene. Judgment of the court in favor of the right of an applicant to a patent shall authorize the 
Director to issue such patent  on the filing in the Patent and Trademark Office of a 
certified copy of the judgment and on compliance with the requirements of law.  IP/N/1/USA/I/2 
 Page 29 
 
 
 CHAPTER 14. ISSUE OF PATENT 
§ 151.  Issue of patent 
 
If it appears that applicant is entitled to a patent under the law, a written notice of 
allowance of the application shall be given or mailed to the applicant. The notice shall 
specify a sum, constituting the issue fee or a portion thereof, which shall be paid within three months thereafter. 
  
Upon payment of this sum the patent shall is sue, but if payment is not timely made, the 
application shall be regarded as abandoned. 
  
Any remaining balance of the issue fee shall be paid within three months from the 
sending of a notice thereof and, if not paid, the patent shall lapse at the termination of 
this three-month period. In calculating the amount of a remaining balance, charges for a 
page or less may be disregarded.   
If any payment required by this section is not timely made, but is submitted with the fee 
for delayed payment and the delay in payment is shown to have been unavoidable, it 
may be accepted by the Director as though no abandonment or lapse had ever occurred. 
 
§ 152.  Issue of patent to assignee 
 
Patents may be granted to the assignee of the inventor of record in the Patent and 
Trademark Office, upon the application made  and the specification sworn to by the 
inventor, except as otherwise provided in this title [ 35 USCS §§ 1
 et seq.]. 
 
§ 153.  How issued 
 
Patents shall be issued in the name of the Un ited States of America, under the seal of 
the Patent and Trademark Office, and shall be signed by the Di rector or have his 
signature placed thereon and shall be reco rded in the Patent and Trademark Office. 
 
§ 154.  Contents and term of patent; provisional rights  
(a) In general. 
   (1) Contents. Every patent shall contain a short title of the invention and a grant to 
the patentee, his heirs or assigns, of the right to exclude others from making, using, 
offering for sale, or selling the invention throughout the United States or importing the 
invention into the United States, and, if the invention is a process, of the right to exclude 
others from using, offering for sale or selling throughout the United States, or importing 
into the United States, products  made by that process, referring to the specification for 
the particulars thereof.    (2) Term. Subject to the payment of fees under this title, such grant shall be for a 
term beginning on the date on which the pa tent issues and ending 20 years from the 
date on which the application for the patent was filed in the United States or, if the 
application contains a specific reference to an earlier filed application or applications 
under section 120, 121, or 365(c) of this title,  from the date on wh ich the earliest such 
application was filed. 
   (3) Priority. Priority under  section 119, 365(a), or 365(b) of this title shall not be taken 
into account in determining the term of a patent. 
   (4) Specification and drawing. A copy of the specification and drawing shall be 
annexed to the patent and be a part of such patent. 
  
 IP/N/1/USA/I/2 
Page 30  
 
 (b) Adjustment of patent term 
   (1) Patent term guarantees. 
      (A) Guarantee of prompt patent and trademark office responses. Subject to the 
limitations under paragraph (2), if the issue of an original patent is delayed due to the 
failure of the Patent and Trademark Office to-- 
         (i) provide at least one of the notifications under sectio n 132 of this title or a 
notice of allowance under section 151 of th is title not later than 14 months after-- 
            (I) the date on which an application was filed under section 111(a) of this title; 
or 
            (II) the date on which an international application fulfilled the requirements of 
section 371 of this title; 
         (ii) respond to a reply under sect ion 132, or to an appeal  taken under section 134, 
within 4 months after the date on which the reply was filed or the appeal was taken; 
         (iii) act on an application within 4 months after the date of a decision by the Board 
of Patent Appeals and Interferences under se ction 134 or 135 or a decision by a Federal 
court under section 141, 145, or 146 in a case  in which allowable cl aims remain in the 
application; or 
         (iv) issue a patent within 4 months after the date on which the issue fee was paid 
under section 151 and all outstandin g requirements were satisfied, 
      the term of the patent shall be extended 1 day for each day after the end of the 
period specified in clause (i), (ii), (iii), or (iv), as the case may be, until the action 
described in such clause is taken. 
      (B) Guarantee of no more than 3-year application pendency. Subject to the 
limitations under paragraph (2), if the issue of an original patent is delayed due to the failure of the United States Patent and Tradem ark Office to issue a patent within 3 years 
after the actual filing date of the application in the United States, not including-- 
         (i) any time consumed by continued examination of the application requested by 
the applicant under section 132(b); 
         (ii) any time consumed by a proceeding under section 135( a), any time consumed 
by the imposition of an order under sectio n 181, or any time consumed by appellate 
review by the Board of Patent Appeals and Interferences or by a Federal court; or 
         (iii) any delay in the processing of the application by the United States Patent and 
Trademark Office requested by the applicant except as permitted by paragraph (3)(C), 
      the term of the patent shall be exte nded 1 day for each day after the end of that 3-
year period until the patent is issued. 
      (C) Guarantee or adjustments for dela ys due to interferences, secrecy orders, and 
appeals. Subject to the limitations under paragraph (2), if the issue of an original patent 
is delayed due to-- 
         (i) a proceeding under section 135(a); 
         (ii) the imposition  of an order under section 181; or 
         (iii) appellate review by the Board of Patent Appeals and Interferences or by a 
Federal court in a case in which the patent was issued under a deci sion in the review 
reversing an adverse determination of patentability, 
      the term of the patent shall be exte nded 1 day for each day of the pendency of the 
proceeding, order, or review, as the case may be. 
   (2) Limitations. 
      (A) In general. To the extent that periods of delay attributable to grounds specified 
in paragraph (1) overlap, the period of an y adjustment granted under this subsection 
shall not exceed the actual nu mber of days the issuance of the patent was delayed. 
      (B) Disclaimed term. No patent the term of which has been  disclaimed beyond a 
specified date may be adjusted under this sect ion beyond the expiration date specified in 
the disclaimer. 
      (C) Reduction of period of adjustment. 
         (i) The period of adjustment of the term of a patent under paragraph (1) shall be 
reduced by a period equal to the period of  time during which the applicant failed to  IP/N/1/USA/I/2 
 Page 31 
 
 
 engage in reasonable efforts to conclude prosecution of the application. 
         (ii) With respect to adjustments to patent term made under the authority of 
paragraph (1)(B), an applicant shall be deemed  to have failed to engage in reasonable 
efforts to conclude processing or examination of an application for the cumulative total of 
any periods of time in excess of  3 months that are taken to respond to a notice from the 
Office making any rejection, objection, argument, or other request, measuring such 3-
month period from the date the notice was given or mailed to the applicant. 
         (iii) The Director shall prescribe regulations establishing the circumstances that 
constitute a failure of an applicant to engage in reasonable efforts to conclude processing 
or examination of an application. 
   (3) Procedures for patent term adjustment determination. 
      (A) The Director shall prescribe regulations establishing procedures for the 
application for and determination of patent  term adjustments under this subsection. 
      (B) Under the procedures establishe d under subparagraph (A),  the Director shall-- 
         (i) make a determination of the pe riod of any patent term adjustment under this 
subsection, and shall transmit a notice of th at determination with the written notice of 
allowance of the application under section 151; and 
         (ii) provide the applicant one opportunity to request reconsideration of any patent 
term adjustment determinat ion made by the Director. 
      (C) The Director shall reinstate all or part of the cumulative period of time of an 
adjustment under paragraph (2)(C) if the app licant, prior to the issuance of the patent, 
makes a showing that, in spite of all due care, the applicant was unable to respond 
within the 3-month period, but in no case shall more than three additional months for 
each such response beyond the orig inal 3-month period be reinstated. 
      (D) The Director shall proceed to gran t the patent after completion of the Director's 
determination of a patent term adjustment under the procedures established under this 
subsection, notwithstanding any appeal taken by the applicant of such determination. 
   (4) Appeal of patent term adjustment determination. 
      (A) An applicant dissatisfied with a determination made by the Director under 
paragraph (3) shall have remedy by a civil action against the Director filed in the United 
States District Court for the District of Colu mbia within 180 days after the grant of the 
patent. Chapter 7 of title 5 [ 5 USCS §§ 701  et seq.], shall apply to such action. Any final 
judgment resulting in a change to the period of adjustment of the patent term shall be 
served on the Director, and the Director shall thereafter alter the term of the patent to 
reflect such change. 
      (B) The determination of a patent te rm adjustment under this  subsection shall not 
be subject to appeal or challenge by a th ird party prior to the grant of the patent. 
  
(c) Continuation. 
   (1) Determination. The term of a patent th at is in force on or that results from an 
application filed before the date that is 6 mo nths after the date of the enactment of the 
Uruguay Round Agreements Act shall be the gr eater of the 20-year term as provided in 
subsection (a), or 17 years from grant,  subject to any terminal disclaimers. 
   (2) Remedies. The remedies of sections 283, 284, and 285 of this title shall not apply 
to acts which-- 
      (A) were commenced or for which subs tantial investment was made before the date 
that is 6 months after the date of the enac tment of the Uruguay Round Agreements Act; 
and 
      (B) became infringing by reason of paragraph (1). 
   (3) Remuneration. The acts referred to in paragraph (2) may be continued only upon 
the payment of an equitable remuneration to  the patentee that is  determined in an 
action brought under chapter 28 and chapter 29 (other than those provisions excluded 
by paragraph (2)) of this title. 
  
 IP/N/1/USA/I/2 
Page 32  
 
 (d) Provisional rights. 
   (1) In general. In addition to other rights provided by this section, a patent shall 
include the right to obtain a reasonable roya lty from any person who, during the period 
beginning on the date of publication of th e application for such patent under section 
122(b), or in the case of an international application filed under the treaty defined in 
section 351(a) designating the United States under Article 21(2)(a) of such treaty, the 
date of publication of the application, and ending on the date the patent is issued-- 
      (A) (i) makes, uses, offers for sale, or sells in the United States the invention as 
claimed in the published patent application or imports such an invention into the United 
States; or 
         (ii) if the invention as claimed in the published patent application is a process, 
uses, offers for sale, or sells in the United States or imports into the United States 
products made by that process as claimed in the published patent application; and 
      (B) had actual notice of the published patent application and, in a case in which the 
right arising under this paragraph is based up on an international application designating 
the United States that is published in a language other than English, had a translation of 
the international application into the English language. 
   (2) Right based on substantially identica l inventions. The right under paragraph (1) to 
obtain a reasonable royalty shall not be available under this subsection unless the 
invention as claimed in the patent is substantially identical to the invention as claimed in 
the published patent application. 
   (3) Time limitation on obtaining a reason able royalty. The right under paragraph (1) to 
obtain a reasonable royalty shall be available only in an action brought not later than 6 
years after the patent is issued. The right under paragraph (1) to obtain a reasonable royalty shall not be affected by the duration  of the period described in paragraph (1). 
   (4) Requirements for international applications. 
      (A) Effective date. The right under paragraph (1) to obtain a reasonable royalty 
based upon the publication under the treaty de fined in section 351(a) of an international 
application designating the United States shall commence on the date of publication 
under the treaty of the international applicatio n, or, if the publication under the treaty of 
the international application is in a language  other than English, on the date on which 
the Patent and Trademark Office receives a tr anslation of the publication in the English 
language.       (B) Copies. The Director may requ ire the applicant to provide a copy of the 
international application and a translation thereof. 
 
§ 155.  Patent term extension 
 
Notwithstanding the provisions of section 154,  the term of a patent which encompasses 
within its scope a composition of matter or a process for using such composition shall be 
extended if such composition or process has been subjected to a regulatory review by 
the Federal Food and Drug Administration pursuant to the Federal Food, Drug, and 
Cosmetic Act [ 21 USCS §§ 301
 et seq.] leading to the publication of regulation 
permitting the interstate distribution and sa le of such composition or process and for 
which there has thereafter been a stay of re gulation of approval imposed pursuant to 
section 409 of the Federal Food, Drug, and Cosmetic Act [ 21 USCS § 348]  which stay 
was in effect on January 1, 1981, by a length of time to be measured from the date such 
stay of regulation of approv al was imposed until such proceedings are finally resolved 
and commercial marketing perm itted. The patentee, his he irs, successors or assigns 
shall notify the Director within ninety days  of the date of enactment of this section 
[enacted Jan. 3, 1983] or the date the stay of  regulation of approval has been removed, 
whichever is later, of the number of the pate nt to be extended and the date the stay was 
imposed and the date commercial marketing wa s permitted. On receipt of such notice, 
the Director shall promptly issue to the owne r of record of the patent a certificate of 
extension, under seal, stating the fact and length of the extension and identifying the  IP/N/1/USA/I/2 
 Page 33 
 
 
 composition of matter or process for using su ch composition to which such extension is 
applicable. Such certificate shall be recorded in  the official file of each patent extended 
and such certificate shall be considered as pa rt of the original patent, and an appropriate 
notice shall be published in the Official Gazette of the Patent and Trademark Office. 
 
§ 155A.  Patent term restoration  
(a) Notwithstanding section 154 of this title, the term of each of the following patents 
shall be extended in accordance with this section: 
   (1) Any patent which encompasses within its scope a composition of matter which is a 
new drug product, if during the regulatory review of the product by the Federal Food and 
Drug Administration-- 
      (A) the Federal Food and Drug Admini stration notified the patentee, by letter dated 
February 20, 1976, that such product's new drug application was not approvable under 
section 505(b)(1) of the Federal Food, Drug and Cosmetic Act [ 21 USCS § 355
(b)(1)]; 
      (B) in 1977 the patentee submitted to the Federal Food and Drug Administration the 
results of a health effects test  to evaluate the carcinogenic potential of such product; 
      (C) the Federal Food and Drug Admi nistration approved, by  letter dated December 
18, 1979, the new drug application for such product; and 
      (D) the Federal Food and Drug Admi nistration approved, by  letter dated May 26, 
1981, a supplementary application covering th e facility for the pr oduction of such 
product. 
   (2) Any patent which encompasses wi thin its scope a process for using the 
composition of matter described in paragraph (1).   
(b) The term of any patent described in subs ection (a) shall be extended for a period 
equal to the period beginning February 20,  1976, and ending May 26, 1981, and such 
patent shall have the effect as if originally issued with such extended term. 
  
(c) The patentee of any patent described in subsection (a) of this section shall, within 
ninety days after the date of  enactment of this section [e nacted Oct. 13, 1983], notify 
the Director of the number of any patent so  extended. On receipt of such notice, the 
Director shall conform such exte nsion by placing a notice thereof in the official file of 
such patent and publishing an appropriate notice of such extension in the Official Gazette 
of the Patent and Trademark Office. 
 
§ 156.  Extension of patent term 
 
(a) The term of a patent which claims a pr oduct, a method of using a product, or a 
method of manufacturing a product shall be extended in accordance with this section 
from the original expiration date of the patent, which shall include any patent term 
adjustment granted under section 154(b), if--    (1) the term of the patent has not expi red before an application is submitted under 
subsection (d)(1) for its extension; 
   (2) the term of the patent has never been  extended under subsection (e)(1) of this 
section; 
   (3) an application for extension is submitted by the owner of record of the patent or its 
agent and in accordance with the requirements of paragraphs (1) through (4) of 
subsection (d); 
   (4) the product has been subject to a re gulatory review period before its commercial 
marketing or use;    (5) (A) except as provided in subparagraph (B) or (C), the permission for the 
commercial marketing or use of the product af ter such regulatory review period is the 
first permitted commercial marketing or use of the product under the provision of law 
under which such regulatory  review period occurred; IP/N/1/USA/I/2 
Page 34  
 
       (B) in the case of a patent which claims a method of manufacturing the product 
which primarily uses recombinant DNA technology in the manufacture of the product, the 
permission for the commercial marketing or use of the product af ter such regulatory 
review period is the firs t permitted commercial marketing or use of a product 
manufactured under the process claimed in the patent; or 
      (C) for purposes of subparagraph (A), in the case of a patent which--          (i) claims a new animal drug or a veterinary biological product which (I) is not 
covered by the claims in any other patent which has been extended, and (II) has 
received permission for the commercial marketing or use in non-food-producing animals 
and in food-producing animals, and 
         (ii) was not extended on the basis of the regulatory review period for use in non-
food-producing animals, 
      the permission for the commercial mark eting or use of the drug or product after the 
regulatory review period for use in food -producing animals is the first permitted 
commercial marketing or use of the drug or  product for administration to a food-
producing animal. 
  
The product referred to in paragraphs (4) and (5) is hereinafter in this section referred 
to as the "approved product". 
  
(b) Except as provided in subsection (d)(5)(F), the rights derived from any patent the 
term of which is extended under this section shall during the period during which the 
term of the patent is extended-- 
   (1) in the case of a patent which claims a product, be limited to any use approved for 
the product-- 
      (A) before the expiration of the term of the patent-- 
         (i) under the provision of law under which the applicable regulatory review 
occurred, or 
         (ii) under the provision of law under which any regulatory review described in 
paragraph (1), (4), or (5) of subsection (g) occurred, and 
      (B) on or after the expiration of the regulatory review period upon which the 
extension of the patent was based; 
   (2) in the case of a patent which claims a method of using a product, be limited to any use claimed by the patent and approved for the product-- 
      (A) before the expiration of the term of the patent-- 
         (i) under any provision of law under which an applicable regulatory review 
occurred, and 
         (ii) under the provision of law under which any regulatory review described in 
paragraph (1), (4), or (5) of subsection (g) occurred, and 
      (B) on or after the expiration of the regulatory review period upon which the 
extension of the patent was based; and 
   (3) in the case of a patent which claims a method of manufacturing a product, be limited to the method of manufacturing as used to make-- 
      (A) the approved product, or 
      (B) the product if it has been subjec t to a regulatory review period described in 
paragraph (1), (4), or (5) of subsection (g). 
  
As used in this subsection, the term "p roduct" includes an approved product. 
  
(c) The term of a patent eligible for extension under subsection (a) shall be extended by 
the time equal to the regulatory review period for the approved product which period occurs after the date the pate nt is issued, except that-- 
   (1) each period of the regulatory revi ew period shall be reduced by any period 
determined under subsection (d)(2)(B) duri ng which the applicant for the patent 
extension did not act with due diligence during such period of the regulatory review  IP/N/1/USA/I/2 
 Page 35 
 
 
 period; 
   (2) after any reduction required by paragraph (1), the period of extension shall include 
only one-half of the time remaining in the periods described in paragraphs (1)(B)(i), 
(2)(B)(i), (3)(B)(i), (4)(B)(i), and (5)(B)(i) of subsection (g); 
   (3) if the period remaining in the term of a patent after the date of the approval of the 
approved product under the provision of law under which such regulatory review 
occurred when added to the regulatory review  period as revised under paragraphs (1) 
and (2) exceeds fourteen years,  the period of extension shall be reduced so that the 
total of both such periods does not exceed fourteen years; and 
   (4) in no event shall more than one pate nt be extended under subsection (e)(1) for 
the same regulatory review period for any product. 
  
(d) 
   (1) To obtain an extension of the term of a patent under this section, the owner of 
record of the patent or its agent shall submit an application to the Director. Except as provided in paragraph (5), such an applicat ion may only be submitted within the sixty-
day period beginning on the da te the product received permi ssion under the provision of 
law under which the applicable regulatory  review period occurred for commercial 
marketing or use. The application shall contain-- 
      (A) the identity of the approved  product and the Federal statute under which 
regulatory review occurred; 
      (B) the identity of the patent for which an extension is being sought and the identity 
of each claim of such patent which claims th e approved product or a method of using or 
manufacturing the approved product;       (C) information to enable the Director to determine under subsections (a) and (b) 
the eligibility of a patent for extension and the rights that will be derived from the 
extension and information to enable the Dire ctor and the Secretary of Health and Human 
Services or the Secretary of Agriculture to determine the period of the extension under 
subsection (g); 
      (D) a brief description of the activities undertaken by the applicant during the 
applicable regulatory review period with respect to the approved product and the 
significant dates applicable to such activities; and 
      (E) such patent or other information as the Director may require.    (2) 
      (A) Within 60 days of the submittal of an application for extension of the term of a 
patent under paragraph (1), the Director shall notify-- 
         (i) the Secretary of Agriculture if the patent claims a drug product or a method of 
using or manufacturing a drug product and the drug product is subject to the Virus-
Serum-Toxin Act, and 
         (ii) the Secretary of Health and Human Services if the patent claims any other 
drug product, a medical device, or a food addi tive or color additive or a method of using 
or manufacturing such a product, device, or  additive and if the product, device, and 
additive are subject to the Federa l Food, Drug, and Cosmetic Act, 
      of the extension application and shall submit to the Secretary who is so notified a 
copy of the application. Not later than 30 days after the receipt of an application from 
the Director, the Secretary receiving the application shall review the dates contained in 
the application pursuant to paragraph (1)(C)  and determine the applicable regulatory 
review period, shall notify the Director of the determination, and shall publish in the 
Federal Register a notice of such determination. 
      (B) (i) If a petition is submitted to the Secretary making the determination under 
subparagraph (A), not later than 180 days after the publication of the determination 
under subparagraph (A), upon which it may re asonably be determined  that the applicant 
did not act with due diligence during the applicable regulatory review period, the 
Secretary making the determination shall, in  accordance with re gulations promulgated 
by such Secretary, determine if the applicant acted with due diligence during the IP/N/1/USA/I/2 
Page 36  
 
 applicable regulatory review period. The Secretary making the determination shall make 
such determination not later than 90 days afte r the receipt of such a petition. For a drug 
product, device, or additive subject to the Federal Food, Drug, and Cosmetic Act or the 
Public Health Service Act, the Secretary may not delegate the authority to make the 
determination prescribed by this clause to an  office below the Office of the Director of 
Food and Drugs. For a product subject to th e Virus-Serum-Toxin Ac t, the Secretary of 
Agriculture may not delegate the authority to make the determination prescribed by this 
clause to an office below the Office of  the Assistant Secretary for Marketing and 
Inspection Services. 
         (ii) The Secretary making a determ ination under clause (i) sh all notify the Director 
of the determination and shall publish in the Federal Register a notice of such 
determination together with the factual and legal basis for such determination. Any 
interested person may request,  within the 60-day period begi nning on the publication of 
a determination, the Secretary making the determination to hold an informal hearing on 
the determination. If such a request is made within such period, such Secretary shall hold such hearing not later than 30 days afte r the date of the request, or at the request 
of the person making the request, not later than 60 days after such date. The Secretary 
who is holding the hearing shall provide notice of the hearing to the owner of the patent 
involved and to any interested person and provide the owner and any interested person 
an opportunity to participate in the hearing. Within 30 days after the completion of the 
hearing, such Secretary shall affirm or revi se the determination which was the subject of 
the hearing and shall notify the Director of any revision of the determination and shall 
publish any such revision in the Federal Register. 
   (3) For the purposes of paragraph (2)(B),  the term "due diligence" means that degree 
of attention, continuous directed effort, an d timeliness as may reasonably be expected 
from, and are ordinarily exercised by, a pe rson during a regulatory review period. 
   (4) An application for the extension of the term of a patent is subject to the disclosure 
requirements prescribed by the Director. 
   (5) (A) If the owner of record of the pa tent or its agent reason ably expects that the 
applicable regulatory review period described in paragraph (1)(B)(ii), (2)(B)(ii), 
(3)(B)(ii), (4)(B)(ii), or (5)(B)(ii) of subsection  (g) that began for a product that is the 
subject of such patent may extend beyond th e expiration of the patent term in effect, 
the owner or its agent may submit an application to the Director for an interim extension during the period beginning 6 months, and endi ng 15 days, before such term is due to 
expire. The application shall contain-- 
         (i) the identity of the product su bject to regulatory review  and the Federal statute 
under which such review is occurring; 
         (ii) the identity of the patent for which interim extension is being sought and the 
identity of each claim of such patent which claims the product under regulatory review or 
a method of using or manufacturing the product; 
         (iii) information to enable the Director to determine under subsection (a)(1), (2), 
and (3) the eligibility of a patent for extension;          (iv) a brief description of the activities undertaken by the applicant during the 
applicable regulatory review period to date with respect to the product under review and 
the significant dates applicable to such activities; and 
         (v) such patent or other information as the Director may require. 
      (B) If the Director determines that , except for permission to market or use the 
product commercially, the patent  would be eligible for an extension of the patent term 
under this section, the Director shall publish in the Federal Register a notice of such 
determination, including the identity of the product under regulatory review, and shall 
issue to the applicant a certificate of interim extension for a period of not more than 1 year. 
      (C) The owner of record of a patent, or its agent, for which an interim extension has 
been granted under subparagraph (B), ma y apply for not more than 4 subsequent 
interim extensions under this paragraph, except that, in the case of a patent subject to  IP/N/1/USA/I/2 
 Page 37 
 
 
 subsection (g)(6)(C), the owner of record of the patent, or its agent, may apply for only 
1 subsequent interim extension under this paragraph. Each such subsequent application 
shall be made during the peri od beginning 60 days before, and ending 30 days before, 
the expiration of the prec eding interim extension. 
      (D) Each certificate of interim extension under this paragraph shall be recorded in 
the official file of the patent and shall be  considered part of the original patent. 
      (E) Any interim extension granted under this paragraph shall terminate at the end of 
the 60-day period beginning on the date on which the product involved receives 
permission for commercial marketing or use, except that, if within that 60-day period the 
applicant notifies the Director of such perm ission and submits any additional information 
under paragraph (1) of this subsection not previously contained in the application for 
interim extension, the patent shall be fu rther extended, in accordance with the 
provisions of this section-- 
         (i) for not to exceed 5 years from  the date of expiration of the original patent 
term; or          (ii) if the patent is subject to subsection (g)(6)(C), from the date on which the 
product involved receives approval for commercial marketing or use. 
      (F) The rights derived from any pate nt the term of which is extended under this 
paragraph shall, during the pe riod of interim extension-- 
         (i) in the case of a patent which claims a product, be limited to any use then under 
regulatory review; 
         (ii) in the case of a patent which claims a method of using a product, be limited to 
any use claimed by the patent th en under regulatory review; and 
         (iii) in the case of a patent which claims a method of manufacturing a product, be limited to the method of manufacturing as used to make the product then under 
regulatory review. 
  
(e) 
   (1) A determination that a patent is eligible for extension may be made by the Director 
solely on the basis of the representations contained in the application for the extension. 
If the Director determines that a patent is eligible for extension under subsection (a) and 
that the requirements of paragraphs (1) through (4) of subsection (d) have been 
complied with, the Director sh all issue to the applicant for the extension of the term of 
the patent a certificate of extension, under se al, for the period prescribed by subsection 
(c). Such certificate shall be recorded in the official file of the patent and shall be 
considered as part of the original patent. 
   (2) If the term of a patent for whic h an application has been submitted under 
subsection (d)(1) would expire before a certific ate of extension is issued or denied under 
paragraph (1) respecting the application,  the Director shall extend, until such 
determination is made, the term of the pate nt for periods of up to one year if he 
determines that the patent is eligible for extension. 
  (f) For purposes of this section: 
   (1) The term "product" means: 
      (A) A drug product. 
      (B) Any medical device, food additive, or color additive subjec t to regulation under 
the Federal Food, Drug, and Cosmetic Act. 
   (2) The term "drug product" means the active ingredient of-- 
      (A) a new drug, antibiotic drug, or  human biological product (as those terms are 
used in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act), or 
      (B) a new animal drug or veterinary biological product (as those terms are used in 
the Federal Food, Drug, and Cosmetic Act an d the Virus-Serum-Toxi n Act) which is not 
primarily manufactured using recombinant DNA, recombinant RNA, hybridoma 
technology, or other processes involving site specific genetic manipulation techniques, 
   including any salt or ester of the active in gredient, as a single entity or in combination IP/N/1/USA/I/2 
Page 38  
 
 with another active ingredient. 
   (3) The term "major health or enviro nmental effects test" means a test which is 
reasonably related to the evaluation of the he alth or environmental effects of a product, 
which requires at least six months to conduct, and the data from which is submitted to 
receive permission for commercial marketing or use. Periods of analys is or evaluation of 
test results are not to be included in determining if the conduct of a test required at least six months. 
   (4) (A) Any reference to section 351 is a reference to section 351 of the Public Health 
Service Act [ 42 USCS § 262].
 
      (B) Any reference to section 503, 505, 512, or 515 is a reference to section 503, 
505, 512, or 515 of the Federal Food, Drug, and Cosmetic Act [ 21 USCS § 353,  355, 
360b, or 360e]. 
      (C) Any reference to the Virus-Serum-To xin Act is a reference to the Act of March 4, 
1913 (21 U.S.C. 151 -158). 
   (5) The term "informal hearing" has the meaning prescribed for such term by section 
201(y) of the Federal Food, Drug, and Cosmetic Act. 
   (6) The term "patent" means a patent issued by the United  States Patent and 
Trademark Office. 
   (7) The term "date of enactment" as us ed in this section means September 24, 1984, 
for a human drug product, a medical devi ce, food additive, or color additive. 
   (8) The term "date of enactment" as used  in this section means the date of enactment 
of the Generic Animal Drug and Patent Term Restoration Act for an animal drug or a 
veterinary biological product. 
  (g) For purposes of this section, the term "regulatory review period" has the following 
meanings: 
   (1) 
      (A) In the case of a product which is a new drug, antibiotic drug, or human biological 
product, the term means the period descr ibed in subparagraph (B) to which the 
limitation described in paragraph (6) applies. 
      (B) The regulatory review period for a new drug, antibiotic drug, or human biological 
product is the sum of-- 
         (i) The period beginning on the date an exemption under subsection (i) of section 505 or subsection (d) of section 507 became  effective for the approved product and 
ending on the date an application was init ially submitted for such drug product under 
section 351, 505, or 507, and 
         (ii) the period beginning on the date the application was initially submitted for the 
approved product under section 351 [ 42 USCS § 262],
 subsection (b) of section 505, or 
section 507 [ 21 USCS § 357]  and ending on the date such application was approved 
under such section. 
   (2) (A) In the case of a product which is  a food additive or color additive, the term 
means the period described in subparagraph  (B) to which the limitation described in 
paragraph (6) applies. 
      (B) The regulatory review period fo r a food or color additive is the sum of-- 
         (i) the period beginning on the da te a major health or en vironmental effects test 
on the additive was initiated and ending on the date a petition was initially submitted 
with respect to the product under the Federa l Food, Drug, and Cosmetic Act requesting 
the issuance of a regulation for use of the product, and 
         (ii) the period beginning on the da te a petition was initially submitted with respect 
to the product under the Federal Food, Drug, and Cosmetic Act requesting the issuance 
of a regulation for use of the product, and ending on the date such regulation became 
effective or, if objections were filed to such regulation, ending on the date such 
objections were resolved and commercial marketing was permitted or, if commercial 
marketing was permitted and later revoked pe nding further proceedings as a result of 
such objections, ending on the date su ch proceedings were finally resolved and  IP/N/1/USA/I/2 
 Page 39 
 
 
 commercial marketing was permitted. 
   (3) (A) In the case of a product which is  a medical device, the term means the period 
described in subparagraph (B) to which the lim itation described in paragraph (6) applies. 
      (B) The regulatory review period for a medical device is the sum of-- 
         (i) the period beginning on the date a clinical investigation on humans involving 
the device was begun and ending on the date an application was initially submitted with 
respect to the device under section 515, and 
         (ii) the period beginning on the date an application was initially submitted with 
respect to the device under section 515 and ending on the date such application was 
approved under such Act or the period beginning on the date a notice of completion of a 
product development protocol was initially su bmitted under section 515(f)(5) and ending 
on the date the protocol was declar ed completed under section 515(f)(6). 
   (4) (A) In the case of a product whic h is a new animal drug, the term means the 
period described in subparagraph (B) to wh ich the limitation described in paragraph (6) 
applies.       (B) The regulatory review period for a new animal drug product is the sum of-- 
         (i) the period beginning on the ea rlier of the date a major health or environmental 
effects test on the drug was initiated or th e date an exemption under subsection (j) of 
section 512 became effective for the approved  new animal drug product and ending on 
the date an application was initially subm itted for such animal drug product under 
section 512, and 
         (ii) the period beginning on the date the application was initially submitted for the 
approved animal drug product under subsec tion (b) of section 512 and ending on the 
date such application was approved under such section.    (5) (A) In the case of a product which is a veterinary biological product, the term 
means the period described in subparagraph  (B) to which the limitation described in 
paragraph (6) applies. 
      (B) The regulatory period for a ve terinary biological product is the sum of-- 
         (i) the period beginning on the date the authority to prepare an experimental 
biological product under the Virus-Serum-Toxin Act became effective and ending on the 
date an application for a license was submitted under the Virus-Serum-Toxin Act, and 
         (ii) the period beginning on the date an application for a license was initially 
submitted for approval under the Virus-Seru m-Toxin Act and ending on the date such 
license was issued. 
   (6) A period determined under any of the preceding paragraphs is subject to the 
following limitations: 
      (A) If the patent involved was issued after the date of the enactment of this section, 
the period of extension determined on th e basis of the regula tory review period 
determined under any such paragr aph may not exceed five years. 
      (B) If the patent involved was issu ed before the date of the enactment of this 
section [enacted Sept. 24, 1984] and-- 
         (i) no request for an exempt ion described in paragraph (1)(B) or (4)(B) was 
submitted and no request for the authority de scribed in paragraph (5)(B) was submitted, 
         (ii) no major health or environm ental effects test described in paragraph (2)(B) or 
(4)(B) was initiated and no petition for a re gulation or applicat ion for registration 
described in such paragraph was submitted, or 
         (iii) no clinical investigation described in paragraph (3) was begun or product 
development protocol described in  such paragraph was submitted, 
      before such date for the approved pr oduct the period of extension determined on the 
basis of the regulatory review period de termined under any su ch paragraph may not 
exceed five years.       (C) If the patent involved was issu ed before the date of the enactment of this 
section [enacted Sept. 24, 1984] and if an action described in subparagraph (B) was 
taken before the date of the enactment of this section [enacted  Sept. 24, 1984] with 
respect to the approved product and the comm ercial marketing or use of the product has IP/N/1/USA/I/2 
Page 40  
 
 not been approved before such date, the peri od of extension determined on the basis of 
the regulatory review period determined under such paragraph may not exceed two 
years or in the case of an approved produc t which is a new animal drug or veterinary 
biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act 
or the Virus-Serum-Toxin  Act), three years. 
  (h) The Director may establish such fees as the Director determines appropriate to cover 
the costs to the Office of receiving and acting upon applications under this section. 
 
§ 157.  Statutory inve ntion registration 
 
(a) Notwithstanding any other provision of this title, the Director is authorized to publish 
a statutory invention registration containing the specification and drawings of a regularly 
filed application for a patent without examination if the applicant-- 
   (1) meets the requirements of section 112 of this title; 
   (2) has complied with the requirements for printing, as set forth in regulations of the 
Director; 
   (3) waives the right to receive a patent on the invention within such period as may be 
prescribed by the Director; and 
   (4) pays application, publication, an d other processing fees established by the 
Director. 
  
If an interference is declared with respect to such an application, a statutory invention 
registration may not be published unless the issue of priority of invention is finally determined in favor of the applicant. 
  
(b) The waiver under subsection (a)(3) of this section by an applicant shall take effect 
upon publication of the statutory invention registration. 
  
(c) A statutory invention registration published pursuant to this section shall have all of 
the attributes specified for patents in this title except those specified in section 183 and 
sections 271 through 289 of this title. A st atutory invention registration shall not have 
any of the attributes specified for patents in any other provision of law other than this title. A statutory invention registration published pursuant to this section shall give 
appropriate notice to the public , pursuant to regulations which the Director shall issue, of 
the preceding provisions of this subsecti on. The invention with respect to which a 
statutory invention certificate is published is  not a patented invention for purposes of 
section 292 of this title. 
  
(d) The Director shall report to the Congress annually on the use of statutory invention 
registrations. Such report shall include an assessment of the degree to which agencies of 
the Federal Government are making use of th e statutory invention registration system, 
the degree to which it aids the management of federally developed technology, and an 
assessment of the cost savings to the Fe deral Government of the use of such 
procedures. 
 
CHAPTER 15. PLANT PATENTS  
§ 161.  Patent for plants 
 
Whoever invents or discovers and asexually re produces any distinct and new variety of 
plant, including cultivated sports, mutants,  hybrids, and newly found seedlings, other 
than a tuber propagated plant or a plant foun d in an uncultivated state, may obtain a 
patent therefor, subject to the conditions and requirements of this title [ 35 USCS §§ 1
 et 
seq.].  IP/N/1/USA/I/2 
 Page 41 
 
 
   
The provisions of this title [ 35 USCS §§ 1  et seq.] relating to patents for inventions shall 
apply to patents for plants, except as otherwise provided. 
 
§ 162.  Description, claim 
 No plant patent shall be declared invalid fo r noncompliance with section 112 of this title 
if the description is as complete as is reasonably possible. 
  
The claim in the specification shall be in formal terms to the plant shown and described. 
 
§ 163.  Grant 
 
In the case of a plant patent , the grant shall include the right to exclude others from 
asexually reproducing the plant, and from using,  offering for sale, or selling the plant so 
reproduced, or any of its parts, throughout  the United States, or from importing the 
plant so reproduced, or any parts thereof, into th e United States. 
 
§ 164.  Assistance of De partment of Agriculture 
 
The President may by Executive order direct th e Secretary of Agriculture, in accordance 
with the requests of the Director, for the purpose of carrying into effect the provisions of 
this title with respect to plants (1) to furnish available information of the Department of 
Agriculture, (2) to conduct through the appropriate bureau or division of the Department research upon special problems, or (3) to deta il to the Director officers and employees of 
the Department. 
 
CHAPTER 16. DESIGNS  
§ 171.  Patents for designs 
 
Whoever invents any new, original and orname ntal design for an ar ticle of manufacture 
may obtain a patent therefor, subject to the conditions and requirements of this title [ 35 
USCS §§ 1  et seq.]. 
  
The provisions of this title [ 35 USCS §§ 1  et seq.] relating to patents for inventions shall 
apply to patents for designs, except as otherwise provided. 
 
§ 172.  Right of priority 
 
The right of priority provided for by subs ections (a) through (d) of section 119 and the 
time specified in section 102(d) shall be six months in the ca se of designs. The right of 
priority provided for by section 119(e) of  this title shall not apply to designs. 
 
§ 173.  Term of design patent 
 
Patents for designs shall be granted for the term of fourteen years from the date of 
grant. 
 
CHAPTER 17. SECRECY OF CERTAIN INVE NTIONS AND FILING APPLICATIONS 
IN FOREIGN COUNTRY  
§ 181.  Secrecy of certain invent ions and withholding of patent 
 
Whenever publication or disclosur e by the publication of an a pplication or by the grant of IP/N/1/USA/I/2 
Page 42  
 
 a patent on an invention in which the Government has a property interest might, in the 
opinion of the head of the interested Govern ment agency, be detrimental to the national 
security, the Commissioner of Patents upon being so notified shall order that the 
invention be kept secret and shall withhold the publication of the application or the grant 
of a patent therefor under the conditions set forth hereinafter. 
  Whenever the publication or disclosure of an invention by the publication of an 
application or by the granting of a patent, in which the Government does not have a 
property interest, might, in the opinion of the Commissioner of Patents, be detrimental 
to the national security, he shall make the application for patent in which such invention 
is disclosed available for inspection to th e Atomic Energy Commission, the Secretary of 
Defense, and the chief officer of any other department or agency of the Government 
designated by the President as a de fense agency of the United States. 
  
Each individual to whom the application is disclosed shal l sign a dated acknowledgment 
thereof, which acknowledgment shall be entered in the file of the application. If, in the 
opinion of the Atomic Energy  Commission, the Secretary of a Defense Department, or 
the chief officer of another department or agency so de signated, the publication or 
disclosure of the invention by the publication of an application or by the granting of a 
patent therefor would be detrimental to the national security, the Atomic Energy 
Commission, the Secretary of a Defense Depart ment, or such other chief officer shall 
notify the Commissioner of Patents and the Co mmissioner of Patents shall order that the 
invention be kept secret and shall withhold the publication of the application or the grant 
of a patent for such period as the national interest requires, and notify the applicant thereof. Upon proper showing by the head of the department  or agency who caused the 
secrecy order to be issued that the examin ation of the application might jeopardize the 
national interest, the Commissioner of Patents shall thereupon maintain the application 
in a sealed condition and notify the applican t thereof. The owner of an application which 
has been placed under a secrecy order shall ha ve a right to appeal from the order to the 
Secretary of Commerce under rules prescribed by him. 
  
An invention shall not be ordered kept secret and the publication of an application or the 
grant of a patent withheld for a period of  more than one year. The Commissioner of 
Patents shall renew the order at the end thereo f, or at the end of any renewal period, for 
additional periods of one year  upon notification by the head of the department or the 
chief officer of the agency who caused the order to be issued that an affirmative 
determination has been made that the national interest continues so to require. An order 
in effect, or issued, during a time when the Unit ed States is at war, shall remain in effect 
for the duration of hostilities and one year following cessation of hostilities. An order in 
effect, or issued, during a na tional emergency declared by the President shall remain in 
effect for the duration of the national emergency and six mont hs thereafter. The 
Commissioner of Patents may re scind any order upon notification by the heads of the 
departments and the chief officers of the ag encies who caused the order to be issued 
that the publication or disclosure of the invent ion is no longer deemed detrimental to the 
national security. 
 
§ 182.  Abandonment of invent ion for unauthorized disclosure 
 
The invention disclosed in an application for pa tent subject to an order made pursuant to 
section 181 of this title may be held ab andoned upon its being established by the 
Commissioner of Patents that in violation of said order the invention has been published or disclosed or that an application for a patent therefor has been filed in a foreign 
country by the inventor, his successors, assign s, or legal representatives, or anyone in 
privity with him or them, without the consent of the Commissioner of Patents. The 
abandonment shall be held to have occurred as  of the time of viol ation. The consent of  IP/N/1/USA/I/2 
 Page 43 
 
 
 the Commissioner of Patents sh all not be given without the concurrence of the heads of 
the departments and the chief officers of the agencies who caused the order to be 
issued. A holding of abandonment shall constitute forfeiture by the applicant, his 
successors, assigns, or legal representatives, or anyone in privity with him or them, of 
all claims against the United Stat es based upon such invention. 
 § 183.  Right to compensation 
 
An applicant, his successors, assigns, or lega l representatives, whose patent is withheld 
as herein provided, shall have the right, begi nning at the date the applicant is notified 
that, except for such order, his application is otherwise in condition for allowance, or 
February 1, 1952, whichever is later, and en ding six years after a patent is issued 
thereon, to apply to the head of any depart ment or agency who caused the order to be 
issued for compensation for the damage caused by the order of secrecy and/or for the 
use of the invention by the Government, re sulting from his disclosure. The right to 
compensation for use shall begin on the date  of the first use of the invention by the 
Government. The head of the de partment or agency is author ized, upon the presentation 
of a claim, to enter into an agreement with  the applicant, his successors, assigns, or 
legal representatives, in full settlement fo r the damage and/or use. This settlement 
agreement shall be conclusive for all purpos es notwithstanding any other provision of 
law to the contrary. If full settlement of th e claim cannot be effected, the head of the 
department or agency may award and pay to su ch applicant, his successors, assigns, or 
legal representatives, a sum not exceeding 75 per centum of the sum which the head of 
the department or agency considers just co mpensation for the damage and/or use. A 
claimant may bring suit against the United States in the United States Claims Court 
[United States Court of Federal Claims] or in the District Court of the United States for 
the district in which such claimant is a resident for an amount which when added to the 
award shall constitute just compensation for the damage and/or use of the invention by 
the Government. The owner of an y patent issued upon an application that was subject to 
a secrecy order issued pursuant to sectio n 181 of this title, who did not apply for 
compensation as above provided, shall have the right, after the date of issuance of such 
patent, to bring suit in the United States Claims Court [United States Court of Federal 
Claims] for just compensation for the damage caused by reason of the order of secrecy 
and/or use by the Government of the invention resulting from his disclosure. The right to 
compensation for use shall begin on the date  of the first use of the invention by the 
Government. In a suit under the provisions of this section the United States may avail 
itself of all defenses it may plead in an ac tion under section 1498 of title 28. This section 
shall not confer a right of action on anyo ne or his successors, assigns, or legal 
representatives who, while in the full-time em ployment or service of  the United States, 
discovered, invented, or developed the in vention on which the claim is based. 
 
§ 184.  Filing of application in foreign country  
Except when authorized by a license obtained from the Commissioner of Patents a 
person shall not file or cause or authorize to be filed in any foreign country prior to six 
months after filing in the United States an application for patent or for the registration of 
a utility model, industrial design, or model in respect of an invention made in this 
country. A license shall not be granted with re spect to an invention subject to an order 
issued by the Commissioner of Patents pursuant to section 181 of this title without the 
concurrence of the head of the departments and the chief officers of the agencies who 
caused the order to be issued. The license  may be granted retroactively where an 
application has been filed abroad through error and without deceptive intent and the 
application does not disclose an invention with in the scope of section 181 of this title. 
  
The term "application" when used in this chapter [ 35 USCS §§ 181
 et seq.] includes IP/N/1/USA/I/2 
Page 44  
 
 applications and any modifications, amendmen ts, or supplements thereto, or divisions 
thereof. 
  
The scope of a license shall permit subs equent modifications, amendments, and 
supplements containing additi onal subject matter if the application upon which the 
request for the license is based is not, or was not, required to be made available for 
inspection under section 181 of this title an d if such modificati ons, amendments, and 
supplements do not change the general nature  of the invention in a manner which would 
require such application to be made available for inspection under such section 181. In 
any case in which a license is not, or was not,  required in order to file an application in 
any foreign country, such subsequent modifi cations, amendments, and supplements may 
be made, without a license, to the application filed in the foreign country if the United 
States application was not required to be made available for inspection under section 
181 and if such modifications, amendments, and supplements do  not, or did not, change 
the general nature of the invention in a ma nner which would require the United States 
application to have been made availabl e for inspection under such section 181. 
 
§ 185.  Patent barred for filing without license 
 
Notwithstanding any other provisions of law any person, and his su ccessors, assigns, or 
legal representatives, shall not receive a United States patent for an invention if that 
person, or his successors, assigns, or legal representatives shall, without procuring the 
license prescribed in section 184 of this titl e, have made, or cons ented to or assisted 
another's making, application in a foreign countr y for a patent or for the registration of a 
utility model, industrial design, or model in respect of the invention. A United States 
patent issued to such person, his successors, assigns, or legal representatives shall be 
invalid, unless the failure to procure such license was through error and without 
deceptive intent, and the patent does not disclose subject matter within the scope of 
section 181 of this title. 
 
§ 186.  Penalty 
 
Whoever, during the period or periods of time  an invention has been ordered to be kept 
secret and the grant of a patent thereon with held pursuant to section 181 of this title, 
shall, with knowledge of such order and without due authorization, willfully publish or 
disclose or authorize or cause to be publishe d or disclosed the invention, or material 
information with respect thereto, or whoever willfully, in violation of the provisions of 
section 184 of this title, shall file or cause or authorize to be filed in any foreign country 
an application for patent or for the registration of a utility model, industrial design, or 
model in respect of any invention made in the United States, shall, upon conviction, be 
fined not more than $ 10,000 or imprisoned for not more than two years, or both. 
 § 187.  Nonapplicability to certain persons 
 
The prohibitions and penalties of this chapter [ 35 USCS §§ 181
 et seq.] shall not apply 
to any officer or agent of the United States acting within the scope of his authority, nor 
to any person acting upon his written instru ctions or permission. 
 
§ 188.  Rules and regulation s, delegation of power 
 
The Atomic Energy Commission, the Secretary of a defense department, the chief officer 
of any other department or agency of the Go vernment designated by  the President as a 
defense agency of the United  States, and the Secretary of  Commerce, may separately 
issue rules and regulations to enable the respective departme nt or agency to carry out 
the provisions of this chapter [ 35 USCS §§ 181  et seq.], and may delegate any power  IP/N/1/USA/I/2 
 Page 45 
 
 
 conferred by this chapter [ 35 USCS §§ 181  et seq.]. 
 
CHAPTER 18. PATENT RIGHTS IN INVENTIONS MADE WITH FEDERAL 
ASSISTANCE  
§ 200.  Policy and objective 
 It is the policy and objective of the Congre ss to use the patent system to promote the 
utilization of inventions arising from federally supported research or development; to 
encourage maximum participation of small busi ness firms in federally supported research 
and development efforts; to promote colla boration between commercial concerns and 
nonprofit organizations, including universiti es; to ensure that inventions made by 
nonprofit organizations and sm all business firms are used in a manner to promote free 
competition and enterprise without unduly encumbering future re search and discovery; 
to promote the commercialization and public availability of inventions made in the United 
States by United States industry and labo r; to ensure that the Government obtains 
sufficient rights in federally supported inve ntions to meet the needs of the Government 
and protect the public against nonuse or unreasonable use of inventions; and to 
minimize the costs of  administering policies in this area. 
 
§ 201.  Definitions 
 
As used in this chapter [ 35 USCS §§ 200
 et seq.]-- 
  
(a) The term "Federal agency" means any exec utive agency as defined in section 105 of 
title 5, and the military departments as  defined by section 102 of title 5. 
  
(b) The term "funding agreement" means any contract, grant, or cooperative agreement 
entered into between any Federal agency, ot her than the Tennessee Valley Authority, 
and any contractor for the performance of experimental, developm ental, or research 
work funded in whole or in part by the Federal Government. Such term includes any 
assignment, substitution of pa rties, or subcontract of any type entered into for the 
performance of experimental, developmenta l, or research work under a funding 
agreement as herein defined.   
(c) The term "contractor" means any pe rson, small business firm, or nonprofit 
organization that is a party to a funding agreement. 
  
(d) The term "invention" means any invention or discovery which is or may be 
patentable or otherwise protectable under this title [ 35 USCS §§ 1
 et seq.] or any novel 
variety of plant which is or may be protec table under the Plant Variety Protection Act (7 
U.S.C 2321  et seq.). 
  (e) The term "subject invention" means any invention of the contractor conceived or first 
actually reduced to practice in the perfor mance of work under a funding agreement: 
Provided, That in the case of a variety of pl ant, the date of determination (as defined in 
section 41(d) of the Plant Variety Protection Act (7 U.S.C. 2401
(d))) must also occur 
during the period of contract performance. 
  
(f) The term "practical application" means to manufacture in the case of a composition or 
product, to practice in the case of a proce ss or method, or to operate in the case of a 
machine or system; and, in each case, under such conditions as to establish that the 
invention is being utilized and that its benefits are to the extent permitted by law or 
Government regulations available to the public on reasonable terms. 
  IP/N/1/USA/I/2 
Page 46  
 
 (g) The term "made" when used in relation  to any invention means the conception or 
first actual reduction to practice of such invention. 
  
(h) The term "small business firm" means a sm all business concern as  defined at section 
2 of Public Law 85-536 (15 U.S.C. 632)  and implementing regulations of the 
Administrator of the Smal l Business Administration. 
  
(i) The term "nonprofit organization" means universities and other institutions of higher 
education or an organization of the type described in section 501(c)(3) of the Internal 
Revenue Code  of 1954 (26 U.S.C. 501 (c)) and exempt from taxation under section 
501(a) of the Internal Revenue Code  (26 U.S.C. 501 (a)) or any nonprofit scientific or 
educational organization qualified under a State nonprofit organization statute. 
 
§ 202.  Disposition of rights 
 (a) Each nonprofit organization or small bu siness firm may, within  a reasonable time 
after disclosure as required by paragraph (c)(1) of this section, elect to retain title to any 
subject invention: Provided, however, That a funding agreement may provide otherwise 
(i) when the contractor is not located in the United States or does not have a place of 
business located in the United States or is subject to the control of a foreign 
government, (ii) in exceptional circumstances when it is determined by the agency that 
restriction or elimination of th e right to retain title to any subject invention will better 
promote the policy and objectives of this chapter[,] (iii) when it is determined by a 
Government authority which is authorized by statute or Executive order to conduct 
foreign intelligence or counter-intelligence activities that the restriction or elimination of 
the right to retain title to any subject invent ion is necessary to protect the security of 
such activities or, (iv) when the fundin g agreement includes the operation of a 
Government-owned, contractor-operated facilit y of the Department of Energy primarily 
dedicated to that Department's naval nuclear  propulsion or weapons related programs 
and all funding agreement limitations under this subparagraph on the contractor's right 
to elect title to a subject invention are limited to inventions occurring under the above 
two programs of the Department  of Energy. The rights of th e nonprofit organization or 
small business firm shall be subject to the pro visions of paragraph (c) of this section and 
the other provisions of this chapter [ 35 USCS §§ 200
 et seq.]. 
  
(b)  
   (1) The rights of the Government under subsection (a) shall not be exercised by a 
Federal agency unless it first determines that at least one of the conditions identified in 
clauses (i) through (iv) of subsection (a) exists. Except in the case of subsection (a)(iii), 
the agency shall file with the Secretary of Commerce, within thirty days after the award 
of the applicable funding agreement, a copy of such determination. In the case of a 
determination under subsection (a)(ii), the statement shall include an analysis justifying the determination. In the case of determinations applicable to funding agreements with 
small business firms, copies sh all also be sent to the Chie f Counsel for Advocacy of the 
Small Business Administration. If  the Secretary of Commerce be lieves that any individual 
determination or pattern of determinations is contrary to the policies and objectives of 
this chapter or otherwise not in conformance with this chapter, the Secretary shall so 
advise the head of the agency concerned and the Administrator of the Office of Federal 
Procurement Policy, and reco mmend corrective actions. 
   (2) Whenever the Administrator of th e Office of Federal Procurement Policy has 
determined that one or more Federal agencies are utilizing the authority of clause (i) or (ii) of subsection (a) of this section in a manner that is contrary to the policies and 
objectives of this chapter, the Administrator is authorized to issue regulations describing 
classes of situations in which agencies may not exercise the authorities of those clauses. 
   (3) At least once every five years, the Comptroller General shall transmit a report to  IP/N/1/USA/I/2 
 Page 47 
 
 
 the Committees on the Judiciary of the Sena te and House of Representatives on the 
manner in which this chapter [ 35 USCS §§ 200  et seq.] is being implemented by the 
agencies and on such other aspects of Gove rnment patent policie s and practices with 
respect to federally funded inventions as th e Comptroller General believes appropriate. 
   (4) If the contractor believes that a determination is contrary to the policies and 
objectives of this chapter or constitutes an abuse of discretio n by the agency, the 
determination shall be subject to [the] section 203(b). 
  
(c) Each funding agreement with a small busi ness firm or nonprofit organization shall 
contain appropriate provisions to effectuate the following: 
   (1) That the contractor di sclose each subject invention to  the Federal agency within a 
reasonable time after it becomes known to  contractor personnel responsible for the 
administration of patent matters, and that the Federal Government may receive title to 
any subject invention not disclosed to it within such time. 
   (2) That the contractor make a written el ection within two years after disclosure to the 
Federal agency (or such addi tional time as may be appr oved by the Federal agency) 
whether the contractor will retain title to a subject invention: Provided,That in any case 
where publication, on sale, or public use, has initiated the one year statutory period in 
which valid patent protection can still be ob tained in the United States, the period for 
election may be shortened by the Federal agen cy to a date that is not more than sixty 
days prior to the end of the statutory peri od: And provided further, That the Federal 
Government may receive title to any subject invention in which the contractor does not 
elect to retain rights or fails to elect rights within such times. 
   (3) That a contractor electing rights in  a subject invention agrees to file a patent 
application prior to any statutory bar date that may occur under this title [ 35 USCS §§ 1  
et seq.] due to publication, on sale, or public use, and shall thereafter file corresponding 
patent applications in other countries in which it wishes to retain title within reasonable 
times, and that the Federal Government may receive title to any subject inventions in 
the United States or other countries in which the contractor has not filed patent 
applications on the subject invention within such times. 
   (4) With respect to any invention in which the contractor elects rights, the Federal 
agency shall have a nonexclusive, nontransferrable, irrevocable, paid-up license to 
practice or have practiced fo r or on behalf of the United States any subject invention 
throughout the world: Provided, That th e funding agreement may provide for such 
additional rights, including the right to assign or have assigned foreign patent rights in 
the subject invention, as are determined by  the agency as necessary for meeting the 
obligations of the United States under any treaty, international agreement, arrangement 
of cooperation, memorandum of understand ing, or similar arrangement, including 
military agreement relating to weapons development and production. 
   (5) The right of the Federal agency to require periodic reporting on the utilization or 
efforts at obtaining utilization that are being made by the contractor or his licensees or 
assignees: Provided, That any such information as well as any information on utilization or efforts at obtaining utilization obtained as part of a proceeding under section 203 of 
this chapter shall be treated by the Federal agency as commercial and financial 
information obtained from a person and privileged and confidential and not subject to 
disclosure under sect ion 552 of title 5. 
   (6) An obligation on the part of the co ntractor, in the event a United States patent 
application is filed by or on its behalf or by any assignee of the contractor, to include 
within the specification of such application and any patent issuing thereon, a statement 
specifying that the invention was made with Government support and that the 
Government has certain rights in the invention.    (7) In the case of a nonprofit organization, (A) a prohibition upon the assignment of 
rights to a subject invention in the United States without the approval of the Federal 
agency, except where such assi gnment is made to an organi zation which has as one of 
its primary functions the management of inve ntions (provided that such assignee shall IP/N/1/USA/I/2 
Page 48  
 
 be subject to the same provisions as th e contractor); (B) a requirement that the 
contractor share royalties with the invent or; (C) except with respect to a funding 
agreement for the operation of a Governme nt-owned-contractor-operated facility, a 
requirement that the balance of any royalties or income earned by the contractor with 
respect to subject inventions, after paymen t of expenses (including payments to 
inventors) incidental to the administration of subject inventions, be utilized for the support of scientific research or education; (D) a requirement that, except where it 
proves infeasible after a reasonable inquiry, in  the licensing of subject inventions shall be 
given to small business firm s; and (E) with respect to a funding agreement for the 
operation of a Government-owned-contractor- operated facility, requirements (i) that 
after payment of patenting costs, licensing costs, payments to inventors, and other 
expenses incidental to the administration of subject in ventions, 100 percent of the 
balance of any royalties or income earned and retained by the contractor during any 
fiscal year up to an amount equal to 5 percent of the annual budget of the facility, shall 
be used by the contractor fo r scientific research, developmen t, and education consistent 
with the research and development mission and objectives of the facility, including 
activities that increase the licensing potentia l of other inventions of the facility; provided 
that if said balance exceeds 5 percent of th e annual budget of th e facility, that 75 
percent of such excess shall be paid to th e Treasury of the United States and the 
remaining 25 percent shall be used for the same purposes as described above in this 
clause (D); and (ii) that, to the extent it provides the most effective technology transfer, 
the licensing of subject inventions shall be  administered by cont ractor employees on 
location at the facility. 
   (8) The requirements of sect ions 203 and 204 of this chapter [ 35 USCS §§ 203,
 204]. 
  
(d) If a contractor does not elect to retain ti tle to a subject invention in cases subject to 
this section, the Federal agency may consider  and after consultation with the contractor 
grant requests for retention of rights by the inventor subject to the provisions of this Act 
and regulations promulgated hereunder. 
  
(e) In any case when a Federal employee is a coinventor of any invention made with a 
nonprofit organization, a small business firm , or a non-Federal inventor, the Federal 
agency employing such coinventor may, for the purpose of consolid ating rights in the 
invention and if it finds that it would expedite the development of the invention-- 
   (1) license or assign whatever rights it  may acquire in the su bject invention to the 
nonprofit organization, small business firm, or  non-Federal inventor in accordance with 
the provisions of this chapter [ 35 USCS §§ 200  et seq.]; or 
   (2) acquire any rights in the subject in vention from the nonprofit organization, small 
business firm, or non-Federal inventor, but on ly to the extent the party from whom the 
rights are acquired voluntarily enters into the transaction and no other transaction under 
this chapter [ 35 USCS §§ 200  et seq.] is conditioned on such acquisition. 
  (f)  
   (1) No funding agreement with a small bu siness firm or nonprofit organization shall 
contain a provision allowing a Federal agency to require the licensing to third parties of 
inventions owned by the contractor that are not subject inventions unless such provision 
has been approved by the head of the agency  and a written justification has been signed 
by the head of the agency. An y such provision shall clearly state whether the licensing 
may be required in connection with the prac tice of a subject invention, a specifically 
identified work object, or both. The head of the agency may not delegate the authority 
to approve provisions or sign justific ations required by this paragraph. 
   (2) A Federal agency shall not require the licensing of third parties under any such 
provision unless the head of the agency dete rmines that the use of the invention by 
others is necessary for the practice of a subject invention or for the use of a work object 
of the funding agreement and that such acti on is necessary to achieve the practical  IP/N/1/USA/I/2 
 Page 49 
 
 
 application of the subject invention or work object. Any such determination shall be on 
the record after an opportunity for an agency  hearing. Any action commenced for judicial 
review of such determination sh all be brought within sixty days after notification of such 
determination. 
 
§ 203.  March-in rights  
(a) With respect to any subject invention in which a small business firm or nonprofit 
organization has acquired title under this chapter [ 35 USCS §§ 200
 et seq.], the Federal 
agency under whose funding ag reement the subject inventio n was made shall have the 
right, in accordance with such procedures as are provided in regulations promulgated 
hereunder to require the contractor, an a ssignee or exclusive licensee of a subject 
invention to grant a nonexclusive, partially exclusive, or exclusive license in any field of 
use to a responsible applicant or applicants , upon terms that are reasonable under the 
circumstances, and if the contractor, assi gnee, or exclusive lic ensee refuses such 
request, to grant such a license itself, if the Federal agency determines that such-- 
   (1) action is necessary because the cont ractor or assignee has not taken, or is not 
expected to take within a reasonable time, e ffective steps to achieve practical application 
of the subject invention in such field of use; 
   (2) action is necessary to  alleviate health or safety needs which are not reasonably 
satisfied by the contractor, assignee, or their licensees; 
   (3) action is necessary to meet requirements for public use specified by Federal 
regulations and such requirements are not reasonably satisfied by the contractor, 
assignee, or licensees; or    (4) action is necessary because the agr eement required by section 204 has not been 
obtained or waived or because a licensee of the exclusive right to use or sell any subject 
invention in the United States is in breach of its agreement obtained pursuant to section 
204. 
  
(b) A determination pursuant to this section or section 202(b)(4) shall not be subject to 
the Contract Disputes Act (41 U.S.C. § 601
 et seq.). An admi nistrative appeals 
procedure shall be established by regulation s promulgated in acco rdance with section 
206. Additionally, any contractor, inventor, assignee, or exclusiv e licensee adversely 
affected by a determination under this section may, at any time within sixty days after 
the determination is issued, file a petition in the United States Claims Court [United 
States Court of Federal Claims], which shall have jurisdiction to determine the appeal on 
the record and to affirm, reverse, remand or  modify, as appropriat e, the determination 
of the Federal agency. In cases described in paragraphs (1) and (3) of subsection (a), 
the agency's determination shall be held in abeyance pending the exhaustion of appeals 
or petitions filed under the preceding sentence. 
 
§ 204.  Preference for Un ited States industry 
 
Notwithstanding any other provision of this chapter, [ 35 USCS §§ 200  et seq.], no small 
business firm or nonprofit organization which receives title to any subject invention and 
no assignee of any such small business firm or  nonprofit organization shall grant to any 
person the exclusive right to use or sell any subject inventio n in the United States unless 
such person agrees that any products em bodying the subject invention or produced 
through the use of the subject invention will be manufactured substantially in the United 
States. However, in individu al cases, the requirement fo r such an agreement may be 
waived by the Federal agency  under whose funding agreem ent the invention was made 
upon a showing by the small business firm, nonprofit organization, or assignee that 
reasonable but unsuccessful efforts have been  made to grant licenses on similar terms to 
potential licensees that would be likely to manufacture substantially in the United States 
or that under the circumstances domestic manufacture is not commercially feasible. IP/N/1/USA/I/2 
Page 50  
 
  
§ 205.  Confidentiality 
 
Federal agencies are authorized to withhold  from disclosure to the public information 
disclosing any invention in which the Federal Government owns or may own a right, title, 
or interest (including a nonexclusive license) for a reasonable time in order for a patent application to be filed. Furthermore, Federal agencies shall not be required to release 
copies of any document which is part of an application for patent filed with the United 
States Patent and Tradem ark Office or with any foreign patent office. 
 
§ 206.  Uniform clauses and regulations 
 
The Secretary of Commerce may issue regula tions which may be made applicable to 
Federal agencies implementing the provis ions of sections 202 through 204 of this 
chapter [ 35 USCS §§ 202
-204] and shall establish standard funding agreement 
provisions required under this chapter [ 35 USCS §§ 200  et seq.]. The regulations and 
the standard funding agreem ent shall be subject to public comment before their 
issuance. 
 
§ 207.  Domestic and foreign protecti on of federally owned inventions 
 
(a) Each Federal agency is authorized to-- 
   (1) apply for, obtain, and maintain patent s or other forms of prot ection in the United 
States and in foreign countries on inventions in which the Federal Government owns a right, title, or interest; 
   (2) grant nonexclusive, exclusive, or pa rtially exclusive licenses under federally owned 
inventions, royalty-free or for royalties or other consideration, and on such terms and 
conditions, including the grant to the licensee of the right of enforc ement pursuant to the 
provisions of chapter 29 of this title [ 35 USCS §§ 281
 et seq.] as determined appropriate 
in the public interest; 
   (3) undertake all other suitable and necess ary steps to protect and administer rights to 
federally owned inventions on behalf of th e Federal Government either directly or 
through contract, including acquiring rights for and administering royalties to the Federal Government in any invention, but only to th e extent the party from whom the rights are 
acquired voluntarily enters into the transactio n, to facilitate the licensing of a federally 
owned invention; and 
   (4) transfer custody and administration , in whole or in part, to another Federal 
agency, of the right, title or interest in any federally owned invention. 
  
(b) For the purpose of assuring the effe ctive management of Government-owned 
inventions, the Secretary of Commerce is authorized to-- 
   (1) assist Federal agency efforts to promote the licensing and utilization of Government-owned inventions; 
   (2) assist Federal agencies in seeking protection and maintaining inventions in foreign 
countries, including the payment of fees  and costs connected therewith; and 
   (3) consult with and advise Federal agen cies as to areas of science and technology 
research and development with potential for commercial utilization. 
 
§ 208.  Regulations governing Federal licensing 
 
The Secretary of Commerce is authorized to promulgate regulations specifying the terms 
and conditions upon which any federally owne d invention, other than inventions owned 
by the Tennessee Valley Authority, may be licensed on a nonexclusive, partially 
exclusive, or exclusive basis. 
  IP/N/1/USA/I/2 
 Page 51 
 
 
 § 209.  Licensing federa lly owned inventions 
 
(a) Authority. A Federal agency may grant an exclusive or partially exclusive license on a 
federally owned invention unde r section 207(a)(2) only if-- 
   (1) granting the license is a reasonable and necessary incentive to-- 
      (A) call forth the investment capital and expenditures needed to bring the invention to practical application; or 
      (B) otherwise promote the invention's utilization by the public; 
   (2) the Federal agency find s that the public will be se rved by the granting of the 
license, as indicated by the applicant's intentions, plans, and ability to bring the 
invention to practical application or otherwise promote the invention's utilization by the 
public, and that the proposed scope of ex clusivity is not greater than reasonably 
necessary to provide the incentive for bringing the invention to practical application, as 
proposed by the applicant, or otherwise to promote the invention's utilization by the 
public;    (3) the applicant makes a commitment to achieve practical application of the invention 
within a reasonable time, which time may be extended by the agency upon the 
applicant's request and the applicant's demons tration that the refusal of such extension 
would be unreasonable; 
   (4) granting the license will not tend to substantially lessen competition or create or 
maintain a violation of the Federal antitrust laws; and 
   (5) in the case of an invention covered by a foreign patent application or patent, the 
interests of the Federal Government or United States industry in foreign commerce will 
be enhanced.   
(b) Manufacture in United States. A Federal agency shall normally grant a license under 
section 207(a)(2) to use or sell any federally owned invention in the United States only 
to a licensee who agrees that any produc ts embodying the invention or produced 
through the use of the invention will be manuf actured substantially in the United States. 
  
(c) Small business. First preference for th e granting of any ex clusive or partially 
exclusive licenses under sectio n 207(a)(2) shall be given to  small business firms having 
equal or greater likelihood as other applic ants to bring the invention to practical 
application within a reasonable time. 
  
(d) Terms and conditions. Any licenses gran ted under section 207(a)(2) shall contain 
such terms and conditions as the granting  agency considers a ppropriate, and shall 
include provisions-- 
   (1) retaining a nontransferra ble, irrevocable, paid-up licen se for any Federal agency to 
practice the invention or have the inventio n practiced throughout the world by or on 
behalf of the Government  of the United States; 
   (2) requiring periodic reporting on utilization of the invention, and utilization efforts, by the licensee, but on ly to the extent necessary to enable the Federal agency to 
determine whether the terms of the license are being complied with, except that any 
such report shall be treated by the Fede ral agency as commercial and financial 
information obtained from a person and privileged and confidential and not subject to 
disclosure under sectio n 552 of title 5; and 
   (3) empowering the Federal agency to terminate the license in whole or in part if the 
agency determines that-- 
      (A) the licensee is not executing its commitment to achieve practical application of 
the invention, including commitments contained in any plan submitted in support of its request for a license, and the licensee cannot otherwise demonstrate to the satisfaction 
of the Federal agency that it has taken, or can be expected to take within a reasonable 
time, effective steps to achieve practical application of the invention; 
      (B) the licensee is in breach of  an agreement described in subsection (b); IP/N/1/USA/I/2 
Page 52  
 
       (C) termination is necessary to meet requirements for public use specified by 
Federal regulations issued after the date of  the license, and such requirements are not 
reasonably satisfied by the licensee; or 
      (D) the licensee has been found by a co urt of competent jurisdiction to have violated 
the Federal antitrust laws in connection with its performance under the license 
agreement.   
(e) Public notice. No exclusive or partially exclusive license may be granted under 
section 207(a)(2) unless public notice of the intention to grant an exclusive or partially 
exclusive license on a federally owned invention has been provided in an appropriate 
manner at least 15 days before the license is granted, and the Federal agency has 
considered all comments received before the end of the comment period in response to 
that public notice. This subsection shall not apply to the licensing of inventions made 
under a cooperative research and developmen t agreement entered into under section 12 
of the Stevenson-Wydler Techno logy Innovation Act of 1980 (15 U.S.C. 3710a).
 
  
(f) Plan. No Federal agency shall grant any lic ense under a patent or patent application 
on a federally owned invention unless the pers on requesting the licen se has supplied the 
agency with a plan for development or market ing of the invention, except that any such 
plan shall be treated by the Federal agency as commercial and financial information 
obtained from a person and privileged and confidential and not subject to disclosure 
under section 552 of title 5. 
 
§ 210.  Precedence of chapter  
(a) This chapter [ 35 USCS §§ 200
 et seq.] shall take prec edence over any other Act 
which would require a disposition of rights in subject inventions of small business firms 
or nonprofit organizations contractors in a ma nner that is inconsistent with this chapter 
[35 USCS §§ 200  et seq.], including but not necessarily limited to the following: 
   (1) section 10(a) of the Act of June 29, 1935, as added by title I of the Act of August 
14, 1946 (7 U.S.C. 427i (a); 60 Stat. 1085); 
   (2) section 205(a) of the Act of August 14, 1946 (7 U.S.C. 1624 (a); 60 Stat. 1090); 
   (3) section 501(c) of the Federal Mine Safety and He alth Act of 1977 (30 U.S.C. 
951(c); 83 Stat. 742); 
   (4) section 30168(e) of title 49; 
   (5) section 12 of the National Science Foundation Act of 1950 (42 U.S.C. 1871 (a); 82 
Stat. 360); 
   (6) section 152 of the Atomic Energy Act of 1954 (42 U.S.C. 2182;  68 Stat. 943); 
   (7) section 305 of the National  Aeronautics and Space Act of 1958 (42 U.S.C. 2457);  
   (8) section 6 of the Coal Research Development Act of 1960 (30 U.S.C. 666;  74 Stat. 
337); 
   (9) section 4 of the Helium Act Amendments of 1960 (50 U.S.C. 167b;  74 Stat. 920); 
   (10) section 32 of the Arms Control and Disarmament Act of 1961 (22 U.S.C. 2572;  75 
Stat. 634); 
   (11) section 9 of the Federal Nonnuclear  Energy Research and Development Act of 
1974 (42 U.S.C. 5908;  88 Stat. 1878); 
   (12) section 5(d) of the Consumer Product Safety Act (15 U.S.C. 2054 (d); 86 Stat. 
1211); 
   (13) section 3 of the Act of April 5, 1944 (30 U.S.C. 323;  58 Stat. 191); 
   (14) section 8001(c)(3) of the Solid Waste Disposal Act (42 U.S.C. 6981 (c); 90 Stat. 
2829);    (15) section 219 of the Foreign Assistance Act of 1961 (22 U.S.C. 2179;
 83 Stat. 806); 
   (16) section 427(b) of the Federal Mine Health and Safety Act of 1977 (30 U.S.C. 
937(b); 86 Stat. 155); 
   (17) section 306(d) of the Surfac e Mining and Reclamation Act of 1977 (30 U.S.C.  IP/N/1/USA/I/2 
 Page 53 
 
 
 1226(d); 91 Stat. 455); 
   (18) section 21(d) of the Federal Fire Prevention and Control Act of 1974 (15 U.S.C. 
2218(d); 88 Stat. 1548); 
   (19) section 6(b) of the Solar Phot ovoltaic Energy Research Development and 
Demonstration Act of 1978 (42 U.S.C. 5585 (b); 92 Stat. 2516); 
   (20) section 12 of the Native Latex Co mmercialization and Econ omic Development Act 
of 1978 (7 U.S.C. 178j;  92 Stat. 2533); and 
   (21) section 408 of the Water Re sources and Develo pment Act of 1978 (42 U.S.C. 
7879;  92 Stat. 1360). 
  
The Act creating this chapter shall be constr ued to take precedence over any future Act 
unless that Act specifically cite s this Act and provides that it  shall take precedence over 
this Act. 
  
(b) Nothing in this chapter [ 35 USCS §§ 200  et seq.] is intended to alter the effect of the 
laws cited in paragraph (a) of this section or any other laws with respect to the 
disposition of rights in inventions made in the performance of funding agreements with 
persons other than nonprofit organi zations or small business firms. 
  
(c) Nothing in this chapter [ 35 USCS §§ 200  et seq.] is intended to limit the authority of 
agencies to agree to the disposition of rights  in inventions made in the performance of 
work under funding agreements with persons other than nonprofit organizations or small 
business firms in accordance wi th the Statement of Governme nt Patent Policy issued on 
February 18, 1983, agency regulations, or ot her applicable regulations or to otherwise 
limit the authority of agencies to allow such persons to retain ownership of inventions 
except that all funding agreements, includin g those with other than  small business firms 
and nonprofit organizations, shall include the requirements established in section 
202(c)(4) and section 203 of this title. Any di sposition of rights in  inventions made in 
accordance with the Statement or implementing regulations, including any disposition 
occurring before enactment of this section, are hereby authorized. 
  
(d) Nothing in this chapter [ 35 USCS §§ 200  et seq.] shall be construed to require the 
disclosure of intelligence sources or methods or to otherwise affect the authority granted 
to the Director of Central Intelligence by st atute or Executive order for the protection of 
intelligence sources or methods. 
  
(e) The provisions of the Stevenson-Wydl er Technology Innovation Act of 1980 [ 15 
USCS §§ 3701  et seq.] shall take precedence over  the provisions of this chapter [ 35 
USCS §§ 200  et seq.] to the extent that they permit  or require a disposition of rights in 
subject inventions which is inconsistent with this chapter [ 35 USCS §§ 200  et seq.]. 
 
§ 211.  Relationship to antitrust laws  
Nothing in this chapter [ 35 USCS §§ 200
 et seq.] shall be deemed to convey to any 
person immunity from civil or criminal liabilit y, or to create any defenses to actions, 
under any antitrust law. 
 
§ 212.  Disposition of righ ts in educational awards 
 
No scholarship, fellowship, training grant, or  other funding agreement made by a Federal 
agency primarily to an awardee for educat ional purposes will contain any provision 
giving the Federal agency any rights to inventions made by the awardee. 
 
 IP/N/1/USA/I/2 
Page 54  
 
 PART III. PATENTS AND PROT ECTION OF PATENT RIGHTS  
CHAPTER 25. AMENDMENT AND CORRECTION OF PATENTS 
§ 251.  Reissue of defective patents 
 
Whenever any patent is, thro ugh error without any deceptiv e intention, deemed wholly 
or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, 
the Director shall, on the surrender of such  patent and the payment of the fee required 
by law, reissue the patent for the invention disclosed in the original patent, and in 
accordance with a new and amended applicatio n, for the unexpired part of the term of 
the original patent. No new matter shall be introduced into the application for reissue. 
  
The Director may issue several reissued pate nts for distinct and separate parts of the 
thing patented, upon demand of the applicant,  and upon payment of the required fee for 
a reissue for each of su ch reissued patents. 
  
The provisions of this title relating to app lications for patent shall be applicable to 
applications for reissue of a patent, except that application for reissue may be made and 
sworn to by the assignee of the entire interest if the applicat ion does not seek to enlarge 
the scope of the claims of the original patent. 
  
No reissued patent shall be granted enlarging the scope of the claims of the original 
patent unless applied for with in two years from the grant of the original patent. 
 § 252.  Effect of reissue 
 
The surrender of the original patent shall ta ke effect upon the issue of the reissued 
patent, and every reissued patent shall have the same effect and op eration in law, on 
the trial of actions for causes thereafter ar ising, as if the same had been originally 
granted in such amended form, but in so far as the claims of the original and reissued 
patents are substantially identical, such su rrender shall not affect any action then 
pending nor abate any cause of action then existing, and the rei ssued patent, to the 
extent that its claims are substantially identical with the original patent, shall constitute a continuation thereof and have effect continuo usly from the date of the original patent. 
  
A reissued patent shall not abridge or affect  the right of any person or that person's 
successors in business who, prior to the grant of a reissue, made, purchased, offered to 
sell, or used within the Unit ed States, or imported into the United States, anything 
patented by the reissued patent, to continue the use of, to offer to sell, or to sell to 
others to be used, offered for sale, or so ld, the specific thing so made, purchased, 
offered for sale, used, or imported unless the making, using, offering for sale, or selling 
of such thing infringes a valid claim of the reissued patent which was in the original patent. The court before which such matter is  in question may provide for the continued 
manufacture, use, offer for sale, or sale of the thing made, purchased, offered for sale, 
used, or imported as specified, or for the manu facture, use, offer for sale, or sale in the 
United States of which substantial preparatio n was made before the grant of the reissue, 
and the court may also provide for the continue d practice of any process patented by the 
reissue that is practiced, or for the practice of which substantial preparation was made, 
before the grant of the reissue, to the exte nt and under such terms as the court deems 
equitable for the protection of investments made or bu siness commenced before the 
grant of the reissue.  
  IP/N/1/USA/I/2 
 Page 55 
 
 
 § 253.  Disclaimer 
 
Whenever, without any deceptive intention, a claim of a patent is invalid the remaining 
claims shall not thereby be rendered invalid. A patentee, whether of the whole or any 
sectional interest therein, may, on payment of the fee required by law, make disclaimer 
of any complete claim, stating therein the ex tent of his interest in such patent. Such 
disclaimer shall be in writing, and recorded in the Patent and Trademark Office; and it 
shall thereafter be considered as part of the original patent to the extent of the interest 
possessed by the disclaimant and by those claiming under him. 
  
In like manner any patentee or applicant may disclaim or dedicate to the public the 
entire term, or any terminal part of the term , of the patent granted or to be granted. 
 
§ 254.  Certificate of correction of Patent and Trademar k Office mistake 
 Whenever a mistake in a pate nt, incurred through the fault of the Patent and Trademark 
Office, is clearly di sclosed by the records of the O ffice, the Director may issue a 
certificate of correction statin g the fact and nature of such  mistake, under seal, without 
charge, to be recorded in the records of pate nts. A printed copy thereof shall be attached 
to each printed copy of the patent, and such ce rtificate shall be considered as part of the 
original patent. Every such patent, together with such certificate, shall have the same 
effect and operation in law on the trial of ac tions for causes thereafter arising as if the 
same had been originally issued in such  corrected form. The Director may issue a 
corrected patent without charge in lieu of and with like effect as a certificate of correction. 
 
§ 255.  Certificate of correct ion of applicant's mistake 
 
Whenever a mistake of a clerical or typographical nature , or of minor character, which 
was not the fault of the Patent and Trademar k Office, appears in a patent and a showing 
has been made that such mi stake occurred in good faith,  the Director may, upon 
payment of the required fee, issue a certificate of correctio n, if the correction does not 
involve such changes in the patent as woul d constitute new matter or would require re-
examination. Such patent, together with the certificate, shall have  the same effect and 
operation in law on the trial of actions for ca uses thereafter arising as if the same had 
been originally issued in such corrected form. 
 
§ 256.  Correction of named inventor 
 
Whenever through error a person is named in  an issued patent as the inventor, or 
through error an inventor is not named in an  issued patent and such error arose without 
any deceptive intention on his part, the Director may, on application of all the parties and assignees, with proof of the facts and su ch other requirements as may be imposed, 
issue a certificate co rrecting such error. 
  
The error of omitting invent ors or naming persons who are not inventors shall not 
invalidate the patent in which such error occurred if it can be corrected as provided in 
this section. The court before which such matter is called in question may order 
correction of the patent on notice and hearin g of all parties concerned and the Director 
shall issue a certif icate accordingly. 
  
 IP/N/1/USA/I/2 
Page 56  
 
 CHAPTER 26. OWNERSHIP AND ASSIGNMENT  
§ 261.  Ownership; assignment 
 
Subject to the provisions of this title [ 35 USCS §§ 1  et seq.], patents shall have the 
attributes of personal property. 
  Applications for patent, patents, or any interest therein, shall be assignable in law by an 
instrument in writing. The applicant, patentee, or his assigns or legal representatives 
may in like manner grant and convey an exclusive right under his application for patent, 
or patents, to the whole or any sp ecified part of the United States. 
  
A certificate of acknowledgment under the hand and official se al of a person authorized 
to administer oaths within the United States, or, in a foreign country, of a diplomatic or 
consular officer of the United States or an officer authorized to administer oaths whose 
authority is proved by a certificate of a di plomatic or consular officer of the United 
States, or apostille of an official designated by a foreign country which, by treaty or 
convention, accords like effect to apostilles of  designated officials in the United States, 
shall be prima facie evidence of the executio n of an assignment, grant or conveyance of 
a patent or application for patent. 
  
An assignment, grant or conveyance shall be  void as against any subsequent purchaser 
or mortgagee for a valuable consideration, without notice, unless it is recorded in the 
Patent and Trademark Office wi thin three months from its date or prior to the date of 
such subsequent purchase or mortgage.  
§ 262.  Joint owners 
 
In the absence of any agreement to the contra ry, each of the joint owners of a patent 
may make, use, offer to sell, or sell the pate nted invention within the United States, or 
import the patented invention into the United States, without the consent of and without 
accounting to the other owners. 
 
CHAPTER 27. GOVERNMENT INTERESTS IN PATENTS 
 
[§ 266.  Repealed] 
 
§ 267.  Time for taking action  in Government applications 
 
Notwithstanding the provisions of sections 133 and 151 of this title, the Director may 
extend the time for taking any action to th ree years, when an application has become 
the property of the United St ates and the head of the appr opriate department or agency 
of the Government has certified to the Direct or that the invention disclosed therein is 
important to the armament or defense of the United States. 
 
CHAPTER 28. INFRINGEMENT OF PATENTS 
 
§ 271.  Infringement of patent 
 
(a) Except as otherwise provided in this title [ 35 USCS §§ 1
 et seq.], whoever without 
authority makes, uses, offers to sell, or sells  any patented invention, within the United 
States or imports into the Un ited States any patented inve ntion during the term of the 
patent therefor, infringes the patent. 
  
  IP/N/1/USA/I/2 
 Page 57 
 
 
 (b) Whoever actively induces infringement of a patent shall be liable as an infringer. 
  
(c) Whoever offers to sell or sells within the United States or imports into the United 
States a component of a patented machine,  manufacture, combination or composition, 
or a material or apparatus for use in prac ticing a patented process, constituting a 
material part of the invention, knowing the same to be especially made or especially adapted for use in an infringement of such patent, and not a staple article or commodity 
of commerce suitable for substantial noninfringing use, shall be liable as a contributory 
infringer. 
  
(d) No patent owner otherwise entitled to relief for infringement or contributory 
infringement of a patent shall be denied relief or deemed guilty of misuse or illegal 
extension of the patent right by reason of his having done one or more of the following: 
(1) derived revenue from acts which if perf ormed by another without his consent would 
constitute contributory infringement of the patent; (2) licensed or authorized another to 
perform acts which if performed without his consent would constitute contributory 
infringement of the patent; (3) sought to en force his patent rights against infringement 
or contributory infringement; (4) refused to license or use any rights to the patent; or 
(5) conditioned the license of any rights to the patent or the sale of the patented product 
on the acquisition of a license to rights in another patent or purchase of a separate 
product, unless, in view of the circumstances, the patent owner has market power in the 
relevant market for the patent or patented product on which the license or sale is 
conditioned. 
  (e) (1) It shall not be an act of infringement to make, use, offer to sell, or sell within the 
United States or import into the United St ates a patented invention (other than a new 
animal drug or veterinary bi ological product (as those terms are used in the Federal 
Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily 
manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or 
other processes involving site specific genetic manipulation techniques) solely for uses 
reasonably related to the development and submission of information under a Federal 
law which regulates the manufacture, use, or sale of drugs or ve terinary biological 
products.    (2) It shall be an act of infringement to submit-- 
      (A) an application under section 505(j)  of the Federal Food, Drug, and Cosmetic Act 
[21 USCS § 355
(j)] or described in section 505(b)(2) of such Act [ 21 USCS § 355 (b)(2)] 
for a drug claimed in a patent or the us e of which is claimed in a patent, or 
      (B) an application under section 512 of such Act [ 21 USCS § 360b]  or under the Act 
of March 4, 1913 (21 U.S.C. 151 -158) for a drug or veterinary  biological product which is 
not primarily manufactured using recombinant DNA, recombinant RNA, hybridoma 
technology, or other processes involving site specific genetic manipulation techniques 
and which is claimed in a patent or the use of which is claimed in a patent,    if the purpose of such submission is to obtain approval under such Act to engage in the 
commercial manufacture, use, or sale of a drug  or veterinary biolog ical product claimed 
in a patent or the use of which is claimed in a patent before the expiration of such 
patent. 
   (3) In any action for patent infringement brought under this section, no injunctive or 
other relief may be granted which would prohibit the making, using, offering to sell, or 
selling within the United States or importing into the United States of a patented 
invention under paragraph (1). 
   (4) For an act of infringement described in paragraph (2)--       (A) the court shall order the effective date of any approval of the drug or veterinary 
biological product involved in the infringement  to be a date which is not earlier than the 
date of the expiration of the pa tent which has been infringed, 
      (B) injunctive relief may be granted against an infringer to prevent the commercial IP/N/1/USA/I/2 
Page 58  
 
 manufacture, use, offer to sell, or sale within the United States or importation into the 
United States of an approved drug or  veterinary biological product, and 
      (C) damages or other monetary relief may be awarded against an infringer only if 
there has been commercial manufacture, use, o ffer to sell, or sale within the United 
States or importation into the United States of  an approved drug or veterinary biological 
product.    The remedies prescribed by subparagraph s (A), (B), and (C) are the only remedies 
which may be granted by a court for an act of  infringement described in paragraph (2), 
except that a court may award a ttorney fees under section 285. 
  
(f) (1) Whoever without authority supplies or causes to be supplied in or from the United 
States all or a substantial portion of the components of a patented invention, where such 
components are uncombined in whole or in part, in such manner as to actively induce 
the combination of such components outside of the United States in a manner that would 
infringe the patent if such combination occurred within the United States, shall be liable as an infringer. 
   (2) Whoever without authority supplies or causes to be supplied in or from the United 
States any component of a patented invention that is especially made or especially 
adapted for use in the invention and not a staple article or commodity of commerce 
suitable for substantial noninfringing use, where such component is uncombined in whole 
or in part, knowing that such component is so made or adapted and intending that such 
component will be combined outs ide of the United States in a manner that would infringe 
the patent if such combination occurred within the United States, shall be liable as an 
infringer.   
(g) Whoever without authority imports into the United States or offers to sell, sells, or 
uses within the United  States a product which is made  by a process patented in the 
United States shall be liable as an infringer, if the importation, offer to sell, sale, or use 
of the product occurs during  the term of such process patent. In an action for 
infringement of a process patent, no reme dy may be granted for infringement on 
account of the noncommercial use or retail sa le of a product unless there is no adequate 
remedy under this title for infringement on ac count of the importation or other use, offer 
to sell, or sale of that product. A product which is made by a patented process will, for purposes of this title, not be considered to be so made after-- 
   (1) it is materially change d by subsequent processes; or 
   (2) it becomes a trivial and none ssential component of another product. 
  
(h) As used in this section, the term "who ever" includes any Stat e, any instrumentality 
of a State, and any officer or employee of a St ate or instrumentality of a State acting in 
his official capaci ty. Any State, and any such instrument ality, officer, or employee, shall 
be subject to the provisions of this title in the same manner and to the same extent as 
any nongovernmental entity.   
(i) As used in this section, an "offer for sale " or an "offer to sell" by a person other than 
the patentee, or any designee of the patentee, is that in which the sale will occur before 
the expiration of the term of the patent. 
 
§ 272.  Temporary presence in the United States 
 
The use of any invention in any vessel, aircraft or vehicle of any country which affords 
similar privileges to vessels, aircraft or vehicl es of the United States , entering the United 
States temporarily or accidenta lly, shall not constitute infringement of any patent, if the 
invention is used exclusively for the needs of the vessel, ai rcraft or vehicle and is not 
offered for sale or sold in or used for the manufacture of anything to be sold in or 
exported from the United States.  IP/N/1/USA/I/2 
 Page 59 
 
 
  
§ 273.  Defense to infringement  based on earlier inventor 
 
(a) Definitions. For purposes of this section-- 
   (1) the terms "commercially used" and "commercial use" mean use of a method in the 
United States, so long as such use is in conn ection with an internal commercial use or an 
actual arm's-length sale or other arm's-length  commercial transfer of a useful end result, 
whether or not the subject matter at issue is  accessible to or otherwise known to the 
public, except that the subjec t matter for which commercial marketing or use is subject 
to a premarketing regulatory review period during which the safety or efficacy of the 
subject matter is established,  including any period specifie d in section 156(g), shall be 
deemed "commercially used" and in "commerc ial use" during such  regulatory review 
period; 
   (2) in the case of activities performed by  a nonprofit research la boratory, or nonprofit 
entity such as a university, research center, or hospital, a use for which the public is the 
intended beneficiary shall be considered to be a use describ ed in paragraph (1), except 
that the use-- 
      (A) may be asserted as a defense unde r this section only for continued use by and in 
the laboratory or nonprofit entity; and 
      (B) may not be asserted as a defense with respect to any subsequent 
commercialization or use outside such laboratory or nonprofit entity; 
   (3) the term "method" means a method  of doing or conducting business; and 
   (4) the "effective filing date" of a patent is the earlier of the actual filing date of the 
application for the patent or the filing date of any earlier United States, foreign, or international application to which the subject matter at issue is entitled under section 
119, 120, or 365 of this title. 
  
(b) Defense to infringement. 
   (1) In general. It shall be a defense to an action for infringement under section 271 of 
this title with respect to any subject matter that would otherwise infringe one or more 
claims for a method in the patent being asse rted against a person, if such person had, 
acting in good faith, actually reduced the subject matter to practice at least 1 year 
before the effective filing date of such patent, and commercially used the subject matter before the effective filing date of such patent. 
   (2) Exhaustion of right. The sale or other disposition of  a useful end product produced 
by a patented method, by a person entitled to assert a defense under this section with 
respect to that useful end result shall exhaust the patent owner's rights under the patent 
to the extent such rights would have been exhausted had such sale or other disposition 
been made by the patent owner. 
   (3) Limitations and qualifications of defe nse. The defense to infringement under this 
section is subject to the following: 
      (A) Patent. A person may not asse rt the defense under this section unless the 
invention for which the defense is asserted is for a method. 
      (B) Derivation. A person may not assert  the defense under this section if the subject 
matter on which the defense is based was derived from the patentee or persons in 
privity with the patentee. 
      (C) Not a general license. The defense asserted by a person under this section is not 
a general license under all claims  of the patent at issue, but extends only to the specific 
subject matter claimed in the patent with respect to which the person can assert a 
defense under this chapter, exce pt that the defense shall also extend to variations in the 
quantity or volume of use of the claimed subject matter, and to improvements in the claimed subject matter that do not infringe a dditional specifically claimed subject matter 
of the patent. 
   (4) Burden of proof. A person asserting the defense under this section shall have the 
burden of establishing the defense by clear and convincing evidence. IP/N/1/USA/I/2 
Page 60  
 
    (5) Abandonment of use. A person who has abandoned commercial use of subject 
matter may not rely on activities performed before the date of such abandonment in 
establishing a defense under this section with  respect to actions taken after the date of 
such abandonment. 
   (6) Personal defense. The defense under this section may be asserted only by the 
person who performed the acts necessary to establish the defense and, except for any 
transfer to the patent owner, the right to assert the defense shall not be licensed or 
assigned or transferred to anot her person except as an ancillary and subordinate part of 
a good faith assignment or transfer for other reasons of the entire enterprise or line of 
business to which the defense relates. 
   (7) Limitation on sites. A defense under this section, when acquired as part of a good 
faith assignment or transfer of an entire en terprise or line of business to which the 
defense relates, may only be asserted for uses at sites where the subject matter that 
would otherwise infringe one or more of the claims is in use before the later of the 
effective filing date of the patent or the da te of the assignment or transfer of such 
enterprise or line of business. 
   (8) Unsuccessful assertion of defense. If the defense under this section is pleaded by a 
person who is found to infringe the patent and who subsequently fails to demonstrate a 
reasonable basis for asserting the defense, th e court shall find the case exceptional for 
the purpose of awarding attorney f ees under section 285 of this title. 
   (9) Invalidity. A patent shall not be d eemed to be invalid under section 102 or 103 of 
this title solely because a defense is ra ised or established under this section. 
 
CHAPTER 29. REMEDIES FOR INFRINGEMENT OF PATENT, AND OTHER ACTIONS  
 
§ 281.  Remedy for infringement of patent 
 
A patentee shall have remedy by civil action for infringement of his patent. 
 
§ 282.  Presumption of validity; defenses 
 
A patent shall be presumed valid. Each clai m of a patent (whether in independent, 
dependent, or multiple dependent form) sha ll be presumed valid independently of the 
validity of other claims; dependent or multiple dependent claims shall be presumed valid 
even though dependent upon an invalid claim. Notwithstanding the preceding sentence, 
if a claim to a composition of matter is held invalid and that claim was the basis of a 
determination of nonobviousness under section 103(b)(1), the process shall no longer be 
considered nonobvious solely on the ba sis of section 103(b)(1). The burden of 
establishing invalidity of a patent or any claim thereof shall rest on the party asserting 
such invalidity. 
  
The following shall be defenses in any action involving the validity or infringement of a patent and shall be pleaded: 
   (1) Noninfringement, absence of liabili ty for infringement or unenforceability, 
   (2) Invalidity of the patent or any claim in suit on any ground specified in part II of 
this title [ 35 USCS §§ 100
 et seq.] as a condition for patentability, 
   (3) Invalidity of the patent or any claim in suit for failure to comply with any 
requirement of sections 112 or 251 of this title. 
   (4) Any other fact or act made a defense by this title. 
  
In actions involving the validity or infringement of a patent the party asserting invalidity or noninfringement shall give notice in the pleadings or otherwise in writing to the 
adverse party at least thirty days before the trial, of the country, number, date, and 
name of the patentee of any patent, the title,  date, and page numbers of any publication 
to be relied upon as anticipation of the patent in suit or, except in actions in the United  IP/N/1/USA/I/2 
 Page 61 
 
 
 States Claims Court [United St ates Court of Federal Claims],  as showing the state of the 
art, and the name and address of any pers on who may be relied upon as the prior 
inventor or as having prior knowledge of or as  having previously used or offered for sale 
the invention of the patent in suit. In the absence of such notice proof of the said 
matters may not be made at the trial exce pt on such terms as the court requires. 
Invalidity of the extension of a patent term or any portion thereof under section 154(b) 
or 156 of this title becaus e of the material failure-- 
   (1) by the applicant for the extension, or 
   (2) by the Director, 
  
to comply with the requirements of such section shall be a defense in any action 
involving the infringement of a patent during the period of the extension of its term and 
shall be pleaded. A due dilige nce determination under sectio n 156(d)(2) is not subject to 
review in such an action. 
 § 283.  Injunction 
 
The several courts having jurisdic tion of cases under this title [ 35 USCS §§ 1
 et seq.] 
may grant injunctions in accordance with the pr inciples of equity to prevent the violation 
of any right secured by patent, on such  terms as the court deems reasonable. 
 
§ 284.  Damages 
 
Upon finding for the claimant the court sha ll award the claimant damages adequate to 
compensate for the infringement, but in no event less than a reasonable royalty for the 
use made of the invention by the infringer, together with interest and costs as fixed by 
the court. 
  
When the damages are not foun d by a jury, the court shall assess them. In either event 
the court may increase the damages up to three times the amount found or assessed. 
Increased damages under this paragraph sha ll not apply to provisional rights under 
section 154(d) of this title. 
  The court may receive expert testimony as an aid to the determination of damages or of 
what royalty would be reasonab le under the circumstances. 
 
§ 285.  Attorney fees 
 
The court in exceptional cases may award reas onable attorney fees to the prevailing 
party. 
 
§ 286.  Time limitation on damages  
Except as otherwise provided by law, no recovery shall be had for any infringement 
committed more than six years prior to the filing of the complaint or counterclaim for 
infringement in the action. 
  
In the case of claims against the United States Government for use of a patented 
invention, the period before bringing suit, up to six years, between the date of receipt of 
a written claim for compensati on by the department or agency of the Government 
having authority to settle such claim, and the date of mailing by the Government of a notice to the claimant that hi s claim has been denied shall no t be counted as part of the 
period referred to in the preceding paragraph. 
 
 IP/N/1/USA/I/2 
Page 62  
 
 § 287.  Limitation on damages and other remedies; marking and notice 
 
(a) Patentees, and persons making, offering for sale, or selling within the United States 
any patented article for or under them, or importing any patented article into the United 
States, may give notice to the public that th e same is patented, either by fixing thereon 
the word "patent" or the abbrev iation "pat.", together with the number of the patent, or 
when, from the character of the article, this can not be done, by fixing to it, or to the 
package wherein one or more of them is contained, a label containing a like notice. In 
the event of failure so to mark, no damage s shall be recovered by the patentee in any 
action for infringement, except on proof that the infringer was notified of the 
infringement and continued to infringe thereafter, in which event damages may be 
recovered only for infringement occurring after such notice. Filing of an action for 
infringement shall constitute such notice. 
  
(b) (1) An infringer under section 271(g) shall be  subject to all the provisions of this title 
relating to damages and injunctions except to  the extent those remedies are modified by 
this subsection or section 9006 of the Pr ocess Patent Amendments Act of 1988 [ 35 USCS 
§ 271  note]. The modifications of remedies provided in this subsection shall not be 
available to any person who-- 
      (A) practiced the patented process; 
      (B) owns or controls, or is owned or controlled by, the person who practiced the 
patented process; or 
      (C) had knowledge before the infrin gement that a patented process was used to 
make the product the importation, use, offer for sale, or sale of which constitutes the 
infringement. 
   (2) No remedies for infrin gement under section 271(g) of this title shall be available 
with respect to any product in the possession of, or in transit to, the person subject to 
liability under such section befo re that person had notice of infringement with respect to 
that product. The person subject to liability  shall bear the burden  of proving any such 
possession or transit. 
   (3) (A) In making a determination with re spect to the remedy in an action brought for 
infringement under section 271( g), the court shall consider-- 
         (i) the good faith demonstrated by the defendant with respect to a request for disclosure, 
         (ii) the good faith demonstrated by the plaintiff with respect to a request for 
disclosure, and 
         (iii) the need to restore the exclusive rights secured by the patent. 
      (B) For purposes of subparagraph (A), the following are evidence of good faith: 
         (i) a request for disclosure made by the defendant; 
         (ii) a response within a reasonab le time by the person receiving the request for 
disclosure; and 
         (iii) the submission of the response by the defendant to the manufacturer, or if the manufacturer is not known, to the supplier, of the product to be purchased by the 
defendant, together with a request for a wr itten statement that the process claimed in 
any patent disclosed in the response is  not used to produce such product. 
   The failure to perform any acts described  in the preceding sentence is evidence of 
absence of good faith unless there are mitigating circumst ances. Mitigating 
circumstances include the case in which, due to  the nature of the product, the number of 
sources for the product, or like commercial ci rcumstances, a request for disclosure is not 
necessary or practicable to avoid infringement. 
   (4) (A) For purposes of this subsection , a "request for disclos ure" means a written 
request made to a person then engaged in the manufacture of a product to identify all 
process patents owned by or licensed to that pe rson, as of the time of the request, that 
the person then reasonably believes could be asserted to be infringed under section 
271(g) if that product were imported into, or sold, offered for sale, or used in, the United  IP/N/1/USA/I/2 
 Page 63 
 
 
 States by an unauthorized person. A requ est for disclosure is further limited to a 
request-- 
         (i) which is made by a person regularly engaged in the United States in the sale of 
the same type of products as those manufactured by the person to whom the request is 
directed, or which includes facts showing th at the person making the request plans to 
engage in the sale of such pr oducts in the United States; 
         (ii) which is made by such person before the person's first importation, use, offer 
for sale, or sale of units of the product produced by an infringing process and before the 
person had notice of infringement with respect to the product; and 
         (iii) which includes a representati on by the person making the request that such 
person will promptly submit the patents identified pursuant to the request to the 
manufacturer, or if the manufacturer is not kn own, to the supplier, of the product to be 
purchased by the person making  the request, and will reques t from that manufacturer or 
supplier a written statement that none of the processes claimed in those patents is used 
in the manufacture of the product.       (B) In the case of a request for disclos ure received by a person to whom a patent is 
licensed, that person shall either identify the patent or promptly noti fy the licensor of the 
request for disclosure. 
      (C) A person who has marked, in th e manner prescribed by subsection (a), the 
number of the process patent on all products  made by the patented process which have 
been offered for sale or sold by that person in the United States, or imported by the 
person into the United States, before a request for disclosure is received is not required 
to respond to the request for disclosure. Fo r purposes of the preceding sentence, the 
term "all products" does not include products  made before the effective date of the 
Process Patent Amendments Act of 1988. 
   (5) (A) For purposes of this subsection, notice of infringement means actual 
knowledge, or receipt by a person of a writte n notification, or a combination thereof, of 
information sufficient to persuade a reasonable  person that it is likely that a product was 
made by a process patented in the United States. 
      (B) A written notification from the pate nt holder charging a person with infringement 
shall specify the patented process alleged to have been used and the reasons for a good 
faith belief that such process was used. The patent holder shall include in the notification 
such information as is reasonably necessary to explain fairly the patent holder's belief, except that the patent holder is not requir ed to disclose any trade secret information. 
      (C) A person who receives a written no tification described in subparagraph (B) or a 
written response to a request for disclosure described in paragraph (4) shall be deemed 
to have notice of infringement with respec t to any patent referred to in such written 
notification or response unless that person, absent mitigating ci rcumstances-- 
         (i) promptly transmits the written notification or response to the manufacturer or, 
if the manufacturer is not known, to the supplier, of the product purchased or to be 
purchased by that person; and 
         (ii) receives a written statemen t from the manufacturer or supplier which on its 
face sets forth a well grounded factual basis for a belief that the identified patents are 
not infringed. 
      (D) For purposes of this subsecti on, a person who obtains a product made by a 
process patented in the United States in a quantity which is abnormally large in relation 
to the volume of business of such person or an efficient inventory level shall be 
rebuttably presumed to have actual knowle dge that the product was made by such 
patented process. 
   (6) A person who receives a response to a request for disclosure under this subsection 
shall pay to the person to whom the request was made a reasonable fee to cover actual costs incurred in complying with the reques t, which may not exceed the cost of a 
commercially available automated patent search  of the matter involved, but in no case 
more than $ 500. 
  IP/N/1/USA/I/2 
Page 64  
 
 (c) (1) With respect to a medical practitioner 's performance of a medical activity that 
constitutes an infringement under section 271(a) or (b) of this title, the provisions of 
sections 281, 283, 284, and 285 of this ti tle shall not apply against the medical 
practitioner or against a related health care entity with respect to such medical activity. 
   (2) For the purposes of this subsection: 
      (A) the term "medical activity" me ans the performance of a medical or surgical 
procedure on a body, but shall not includ e (i) the use of a patented machine, 
manufacture, or composition of matter in violation of such patent, (ii) the practice of a 
patented use of a composition of matter in violation of such patent, or (iii) the practice of 
a process in violation of  a biotechnology patent. 
      (B) the term "medical practitioner" means any natural person who is licensed by a 
State to provide the medical activity describ ed in subsection (c)(1) or who is acting 
under the direction of such person in the performance of the medical activity. 
      (C) the term "related health care en tity" shall mean an entity with which a medical 
practitioner has a professional  affiliation under which the medical practitioner performs 
the medical activity, including but not limited to a nursing home, hospital, university, 
medical school, health maintenance organizati on, group medical practice, or a medical 
clinic. 
      (D) the term "professional affiliati on" shall mean staff pr ivileges, medical staff 
membership, employment or contractual relati onship, partnership or ownership interest, 
academic appointment, or other affiliation under which a medical practitioner provides 
the medical activity on behalf of, or in association with, the health care entity. 
      (E) the term "body" shall mean a human body, organ or cadaver, or a nonhuman 
animal used in medical research or instruction directly relating to the treatment of humans. 
      (F) the term "patented use of a composition of matter" does not include a claim for a 
method of performing a medical or surgical pr ocedure on a body that  recites the use of a 
composition of matter where the use of that co mposition of matter does not directly 
contribute to achievement of the objective of the claimed method. 
      (G) the term "State" shall mean any state or territory of the United States, the 
District of Columbia, and the Commonwealth of Puerto Rico. 
   (3) This subsection does not apply to the activities of any person, or employee or 
agent of such person (regardl ess of whether such person is  a tax exempt organization 
under section 501(c) of the Internal Revenue Code
 [26 USCS § 501 (c)]), who is engaged 
in the commercial development, manufacture, sale, importation, or distribution of a 
machine, manufacture, or composition of matter or the provision of pharmacy or clinical 
laboratory services (other than clinical la boratory services provided in a physician's 
office), where such  activities are: 
      (A) directly related to the commercial development, manufacture, sale, importation, 
or distribution of a machine,  manufacture, or composition of matter or the provision of 
pharmacy or clinical laboratory services (other  than clinical laboratory services provided 
in a physician's office), and       (B) regulated under the Federal Food , Drug, and Cosmetic Act, the Public Health 
Service Act, or the Clinical Laboratories Improvement Act. 
   (4) This subsection shall not apply to an y patent issued based on an application the 
earliest effective filing date of which is prior to September 30, 1996. 
 
§ 288.  Action for infringement of a patent containing an invalid claim 
 
Whenever, without deceptive intention, a claim of a patent is invalid, an action may be 
maintained for the infringement of a claim of the patent which may be valid. The patentee shall recover no costs unless a disclai mer of the invalid claim has been entered 
at the Patent and Trademark Office before the commencement of the suit. 
 
  IP/N/1/USA/I/2 
 Page 65 
 
 
 § 289.  Additional remedy for in fringement of design patent 
 
Whoever during the term of a patent for a design, without license  of the owner, (1) 
applies the patented design, or any colora ble imitation thereof, to any article of 
manufacture for the purpose of sale, or (2) sells or exposes for sale any article of 
manufacture to which such design or colorable imitation has been applied shall be liable to the owner to the extent of his total prof it, but not less than $ 250, recoverable in any 
United States district court havi ng jurisdiction of the parties. 
  
Nothing in this section shall prevent, lessen, or impeach any other remedy which an 
owner of an infringed patent has under the provisions of this title [ 35 USCS §§ 1
 et 
seq.], but he shall not twice recover the profit made from the infringement. 
 
§ 290.  Notice of patent suits 
 The clerks of the courts of the United States, within one month after the filing of an 
action under this title shall give notice thereo f in writing to the Director, setting forth so 
far as known the names and addresses of th e parties, name of the inventor, and the 
designating number of the patent upon which the action has been brought. If any other 
patent is subsequently included in the action he shall give like notice thereof. Within one 
month after the decision is rendered or a judgment issued the cler k of the court shall 
give notice thereof to the Dire ctor. The Director shall, on re ceipt of such notices, enter 
the same in the file of such patent. 
 § 291.  Interfering patents 
 
The owner of an interfering patent may have relief against the owner of another by civil 
action, and the court may adjudge the question of the validity of any of the interfering 
patents, in whole or in part. The provisions  of the second paragraph of section 146 of 
this title shall apply to actions brought under this section. 
 
§ 292.  False marking 
 (a) Whoever, without the consent of the patent ee, marks upon, or affixes to, or uses in 
advertising in connection with anything made, used, offered for sale, or sold by such 
person within the United Stat es, or imported by the person  into the Unit ed States, the 
name or any imitation of the name of the patentee, the patent number, or the words 
"patent," "patentee," or the like, with the intent of counterfeiting or imitating the mark 
of the patentee, or of deceiv ing the public and inducing th em to believe that the thing 
was made, offered for sale, sold, or imported  into the United Stat es by or with the 
consent of the patentee; or 
  Whoever marks upon, or affixes to, or uses in advertising in connection with any 
unpatented article, the word "patent" or any word or number importing that the same is 
patented, for the purpose of  deceiving the public; or 
  
Whoever marks upon, or affixes to, or uses in advertising in connection with any article, 
the words "patent applied for," "patent pe nding," or any word importing that an 
application for patent has been made, when no  application for patent has been made, or 
if made, is not pending, for the purpose of deceiving the public-- 
  Shall be fined not more than $ 500 for every such offense. 
  
(b) Any person may sue for the penalty, in which event one-half shall go to the person 
suing and the other to the use of the United States. IP/N/1/USA/I/2 
Page 66  
 
  
§ 293.  Nonresident patentee; service and notice 
 
Every patentee not residing in the United St ates may file in the Patent and Trademark 
Office a written design ation stating the name and address of a person residing within the 
United States on whom may be served proc ess or notice of proceedings affecting the 
patent or rights thereunder. If the person designated cann ot be found at the address 
given in the last designation, or if no pe rson has been designat ed, the United States 
District Court for the District  of Columbia shall have jurisdiction and summons shall be 
served by publication or otherwise as the co urt directs. The court shall have the same 
jurisdiction to take any action respecting th e patent or rights thereunder that it would 
have if the patentee were personally within the jurisdiction of the court. 
 
§ 294.  Voluntary arbitration 
 (a) A contract involving a patent or any ri ght under a patent may contain a provision 
requiring arbitration of any dispute relating to patent validity or infringement arising 
under the contract. In the absence of such a provision, the parties to an existing patent 
validity or infringement dispute may agree in writing to settle such dispute by 
arbitration. Any such provision or agreement sh all be valid, irrevoca ble, and enforceable, 
except for any grounds that exist at law or  in equity for revocation of a contract. 
  
(b) Arbitration of such disputes, awards by arbitrators and confirmation of awards shall 
be governed by title 9, to the extent such ti tle is not inconsistent with this section. In 
any such arbitration proceeding,  the defenses provided for un der section 282 of this title 
shall be considered by the arbitrator if  raised by any party to the proceeding. 
  
(c) An award by an arbitrator shall be fi nal and binding between  the parties to the 
arbitration but shall have no force or effe ct on any other person. The parties to an 
arbitration may agree that in the event a patent which is the subject matter of an award 
is subsequently determined to be invalid or unenforceable in a judgment rendered by a 
court of competent jurisdiction from which no  appeal can or has been taken, such award 
may be modified by any court of competent jurisdiction upon application by any party to 
the arbitration. Any such modification shall govern the rights and obligations between 
such parties from the date  of such modification. 
  
(d) When an award is made by an arbitrator , the patentee, his assignee or licensee shall 
give notice thereof in writing to the Director . There shall be a separate notice prepared 
for each patent involved in such proceeding.  Such notice shall set forth the names and 
addresses of the parties, the name of the inventor , and the name of the patent owner, 
shall designate the number of the patent, and shall contain a copy of the award. If an 
award is modified by a court, the party reques ting such modification shall give notice of 
such modification to th e Director. The Director shall, upon  receipt of either notice, enter 
the same in the record of the prosecution of such patent. If the required notice is not 
filed with the Director, any party to the pr oceeding may provide such notice to the 
Director. 
  
(e) The award shall be unenforceable until the notice required by subsection (d) is 
received by the Director. 
 
§ 295.  Presumption: Product made by patented process  
In actions alleging infringement of a process patent based on the importation, sale, offer 
for sale, or use of a product which is made fr om a process patented in the United States, 
if the court finds--  IP/N/1/USA/I/2 
 Page 67 
 
 
    (1) that a substantial likelihood exists that the product was made by the patented 
process, and 
   (2) that the plaintiff has made a reasonable effort to determine the process actually 
used in the production of the prod uct and was unable to so determine, 
  
the product shall be presumed to have been  so made, and the burden of establishing 
that the product was not made by the process shall be on the party asserting that it was 
not so made. 
 
§ 296.  Liability of States, inst rumentalities of States, and St ate officials for infringement 
of patents 
 
(a) In general. Any State, any instrumentalit y of a State, and any officer or employee of 
a State or instrumentality of a State acting in his official capacity, shall not be immune, 
under the eleventh amendment of the Constitution of the United States or under any 
other doctrine of sovereign immunity, from su it in Federal court by any person, including 
any governmental or nongovernmental entity, for infringement of a patent under section 
271, or for any other viol ation under this title. 
  
(b) Remedies. In a suit described in subsec tion (a) for a violation described in that 
subsection, remedies (including  remedies both at law and in equity) are available for the 
violation to the same extent as such remedies  are available for such a violation in a suit 
against any private entity. Such  remedies include damages, interest, costs, and treble 
damages under section 284, attorney fees und er section 285, and th e additional remedy 
for infringement of design  patents under section 289. 
 
§ 297.  Improper and deceptive invention promotion 
 
(a) In general. An invention promoter shall have a duty to disclose the following 
information to a customer in writing, prior to entering into a contract for invention 
promotion services: 
   (1) the total number of inventions evalua ted by the invention promoter for commercial 
potential in the past 5 years, as well as th e number of those inve ntions that received 
positive evaluations, and the number of those inventions that received negative 
evaluations; 
   (2) the total number of customers who have  contracted with the invention promoter in 
the past 5 years, not including customers who have purchased trade show services, 
research, advertising, or other nonmarketing  services from the invention promoter, or 
who have defaulted in their payment to the invention promoter; 
   (3) the total number of customers known by  the invention promoter to have received a 
net financial profit as a direct result of the invention promotion services provided by such 
invention promoter;    (4) the total number of customers known by  the invention promoter to have received 
license agreements for their inventions as a direct result of the invention promotion 
services provided by such invention promoter; and 
   (5) the names and addresses of all previous invention promotion companies with 
which the invention promoter or its officers have collectively or individually been 
affiliated in the previous 10 years. 
  
(b) Civil action. 
   (1) Any customer who enters into a contract with an invention promoter and who is found by a court to have been injured by any material false or fraudulent statement or 
representation, or any omission  of material fact, by that invention promoter (or any 
agent, employee, director, offi cer, partner, or independent contractor of such invention 
promoter), or by the failure of that invent ion promoter to disclose such information as IP/N/1/USA/I/2 
Page 68  
 
 required under subsection (a), may recover in a civil action against the invention 
promoter (or the officers, direct ors, or partners of such inve ntion promoter), in addition 
to reasonable costs and attorneys' fees-- 
      (A) the amount of actual damages incurred by the customer; or 
      (B) at the election of the customer at any time before final judgment is rendered, 
statutory damages in a sum of not more th an $ 5,000, as the court considers just. 
   (2) Notwithstanding paragraph (1), in a case where the customer  sustains the burden 
of proof, and the court finds, that the invent ion promoter intentionally misrepresented or 
omitted a material fact to such customer, or willfully failed to disclose such information 
as required under subsection (a), with the purpose of dece iving that customer, the court 
may increase damages to not more than thr ee times the amount awarded, taking into 
account past complaints made against the invention promoter that resulted in regulatory 
sanctions or other corrective actions ba sed on those records compiled by the 
Commissioner of Patents under subsection (d). 
  (c) Definitions. For purposes of this section-- 
   (1) a "contract for invention promotio n services" means a contract by which an 
invention promoter undertakes invention promotion services for a customer; 
   (2) a "customer" is any individual who enters into a contract with an invention 
promoter for invention promotion services; 
   (3) the term "invention promoter" means any person, firm, partnership, corporation, 
or other entity who offers to perform or perf orms invention promotion services for, or on 
behalf of, a customer, and who holds itself out through advertising in any mass media as 
providing such services, but does not include--       (A) any department or agency of th e Federal Government or of a State or local 
government; 
      (B) any nonprofit, charitable, scientific, or educational organization, qualified under 
applicable State law or described under section 170(b)(1)(A) of the Internal Revenue 
Code of 1986 [ 26 USCS § 170 (b)(1)(A)]; 
      (C) any person or entity involved in the evaluation to determine commercial 
potential of, or offering to license or sell, a utility patent or a previously filed 
nonprovisional utility patent application; 
      (D) any party participating in a transaction involving the sale of the stock or assets of a business; or 
      (E) any party who directly engages in the business of retail sa les of products or the 
distribution of products; and 
   (4) the term "invention promotion se rvices" means the procurement or attempted 
procurement for a customer of a firm, corporat ion, or other entity to develop and market 
products or services that includ e the invention of the customer. 
  
(d) Records of complaints. 
   (1) Release of complaints. The Commissioner of Patents shall make all complaints received by the Patent and Trademark Office involving invention promoters publicly 
available, together with any response of the invention promoters. The Commissioner of 
Patents shall notify the invention promoter of a complaint and provide a reasonable 
opportunity to reply prior to making such complaint publicly available. 
   (2) Request for complaints. The Commissioner of Patents may request complaints 
relating to invention promotion services from any Federal or State agency and include 
such complaints in the records maintained  under paragraph (1), together with any 
response of the invention promoters. 
  
 
 
  IP/N/1/USA/I/2 
 Page 69 
 
 
 CHAPTER 30. PRIOR ART CITATION S TO OFFICE AND EX PARTE 
REEXAMINATION OF PATENTS 
 
§ 301.  Citation of prior art 
 
Any person at any time may cite to the Office in writing prior art consisting of patents or 
printed publications which that person believes to have a bearing on the patentability of 
any claim of a particular pate nt. If the person explains in writing the pertinency and 
manner of applying such prior art to at least one claim of the patent, the citation of such 
prior art and the explanation thereof will become a part of the official file of the patent. 
At the written request of the person citing the prior art, his or her identity will be 
excluded from the patent file and kept confidential. 
 
§ 302.  Request for reexamination 
 Any person at any time may file a request for reexamination by the O ffice of any claim of 
a patent on the basis of any prior art cited under the provisions of section 301 of this 
title. The request must be in writing an d must be accompanied by payment of a 
reexamination fee established by the Director pursuant to the provisions of section 41 of 
this title. The request must set forth the pertinency and manner of applying cited prior 
art to every claim for which reexamination is requested. Unless the requesting person is 
the owner of the patent, the Director promptly will send a copy of the request to the 
owner of record of the patent. 
 § 303.  Determination of issue by Director 
 
(a) Within three months following the filing of a request for reexamination under the 
provisions of section 302 of this title, the Director will determine whether a substantial 
new question of patentability affecting any clai m of the patent concerned is raised by the 
request, with or without consideration of other patents or printed publications. On his 
own initiative, and any time, the Director may determine whether a substantial new 
question of patentability is raised by patents and publications discovered by him or cited 
under the provisions of section 301 of this title. The existence of a substantial new question of patentability is not precluded by th e fact that a patent or printed publication 
was previously cited by or to the Office or considered by the Office. 
  
(b) A record of the Director's determination un der subsection (a) of this section will be 
placed in the official file of the patent, and a copy promptly will be given or mailed to the 
owner of record of the patent and to the person requesting reexamination, if any. 
  
(c) A determination by the Director pursuant to subsection (a) of this section that no 
substantial new question of patentability has been raised will be final and nonappealable. Upon such a determination, the Director may refund a portion of the reexamination fee 
required under section 302 of this title. 
 
§ 304.  Reexamination order by Director 
 
If, in a determination made under the provisio ns of subsection 303(a)  of this title, the 
Director finds that a substantial new question of patentability affecting any claim of a 
patent is raised, the determination will include an order for reexamination of the patent 
for resolution of the question. The patent owner will be given a reasonable period, not less than two months from the date a copy of the determination is given or mailed to 
him, within which he may file a statement on such question, including any amendment 
to his patent and new claim or claims he may wish to propose, for consideration in the 
reexamination. If the patent owner files such a statement, he promptly will serve a copy IP/N/1/USA/I/2 
Page 70  
 
 of it on the person who has requested reex amination under the provisions of section 302 
of this title. Within a period of two months fr om the date of service, that person may file 
and have considered in the reexamination a reply to any statement filed by the patent 
owner. That person promptly will serve on the patent owner a copy of any reply filed. 
 
§ 305.  Conduct of reexamination proceedings  
After the times for filing the st atement and reply provided for by section 304 of this title 
have expired, reexamination will be conducted according to the procedures established 
for initial examination under th e provisions of sections 132 and 133 of this title. In any 
reexamination proceeding under this chapter [ 35 USCS §§ 301
 et seq.], the patent 
owner will be permi tted to propose any amendment to his patent and a new claim or 
claims thereto, in order to distinguish the invention as claimed from the prior art cited 
under the provisions of section 301 of this titl e, or in response to a decision adverse to 
the patentability of a claim of a patent. No  proposed amended or new claim enlarging 
the scope of a claim of the patent will be permitted in a reexamination proceeding under 
this chapter [ 35 USCS §§ 301  et seq.]. All reexamination proceedings under this section, 
including any appeal to the Bo ard of Patent Appeals and Inte rferences, will be conducted 
with special dispatch  within the Office. 
 
§ 306.  Appeal 
 
The patent owner involved in a reexamination proceeding under this chapter [ 35 USCS 
§§ 301  et seq.] may appeal under the provisions  of section 134 of this title, and may 
seek court review under the provisions of sect ions 141 to 145 of this title, with respect 
to any decision adverse to the patentability of any original or proposed amended or new 
claim of the patent. 
 
§ 307.  Certificate of patentability, unp atentability, and claim cancellation 
 
(a) In a reexamination proceeding under this chapter [ 35 USCS §§ 301  et seq.], when 
the time for appeal has expi red or any appeal proceeding has terminated, the Director 
will issue and publish a certificate canceling any claim of the patent finally determined to be unpatentable, confirming any claim of th e patent determined to be patentable, and 
incorporating in the patent any proposed amended or new claim determined to be 
patentable. 
  
(b) Any proposed amended or new claim determ ined to be patentable and incorporated 
into a patent following a reexamination proceeding will have the same effect as that 
specified in section 252 of this title for reissued patents on the right of any person who 
made, purchased, or used with in the United States, or imported in to the United States, 
anything patented by such proposed amende d or new claim, or who made substantial 
preparation for the same, prior to issuance of a certificate under the provisions of 
subsection (a) of this section. 
 
CHAPTER 31. OPTIONAL INTER PARTES REEXAMINATION PROCEDURES 
 
§ 311.  Request for inter partes reexamination 
 
(a) In general. Any third-party requester at any time may file a request for inter partes 
reexamination by the Office of a patent on  the basis of any prior art cited under the 
provisions of section 301. 
  
(b) Requirements. The request shall-- 
   (1) be in writing, include the identity of the real party in interest, and be accompanied  IP/N/1/USA/I/2 
 Page 71 
 
 
 by payment of an inter partes reexaminat ion fee established by the Director under 
section 41; and 
   (2) set forth the pertinency and manner of applying cited prior art to every claim for 
which reexamination is requested. 
  
(c) Copy. The Director promptly shall send a copy of the request to the owner of record 
of the patent. 
 
§ 312.  Determination of issue by Director 
 
(a) Reexamination. Not later than 3 months after the filing of a request for inter partes 
reexamination under section 311,  the Director shall determin e whether a substantial new 
question of patentability affecting any claim of the patent concerned is raised by the 
request, with or without consideration of other patents or printed publications. The 
existence of a substantial new question of patentability is not precluded by the fact that a patent or printed publication was previously cited by or to the Office or considered by 
the Office. 
  
(b) Record. A record of the Director's determ ination under subsection (a) shall be placed 
in the official file of the patent, and a copy  shall be promptly given or mailed to the 
owner of record of the patent an d to the third-party requester. 
  
(c) Final decision. A determination by the Dire ctor under subsection (a) shall be final and 
non-appealable. Upon a determin ation that no substantial new question of patentability 
has been raised, the Director may refund a portion of the in ter partes reexamination fee 
required under section 311. 
 
§ 313.  Inter partes reexamination order by Director 
 
If, in a determination made under section 312( a), the Director find s that a substantial 
new question of patentability affecting a claim of a patent is raised, the determination 
shall include an order for inter partes reexam ination of the patent for resolution of the 
question. The order may be accompanied by  the initial action of the Patent and 
Trademark Office on the merits of the inter partes reexamination conducted in 
accordance with section 314. 
 
§ 314.  Conduct of inter part es reexamination proceedings 
 
(a) In general. Except as otherwise provided in this section, reexamination shall be 
conducted according to the procedures esta blished for initial examination under the 
provisions of sections 132 and 133. In any inter partes reexamination proceeding under 
this chapter [ 35 USCS §§ 311
 et seq.], the patent owner shall be permitted to propose 
any amendment to the patent and a new clai m or claims, except that no proposed 
amended or new claim enlarging the scope of the claims of the patent shall be 
permitted. 
  
(b) Response. 
   (1) With the exception of the inter part es reexamination reques t, any document filed 
by either the patent owner or the third-pa rty requester shall be served on the other 
party. In addition, the Office shall send to the third-party requester a copy of any 
communication sent by the Offi ce to the patent owner concerning the patent subject to 
the inter partes reex amination proceeding. 
   (2) Each time that the patent owner files a response to an action on the merits from 
the Patent and Trademark Office, the third-pa rty requester shall have  one opportunity to 
file written comments addr essing issues raised by the action of the Office or the patent IP/N/1/USA/I/2 
Page 72  
 
 owner's response thereto, if th ose written comments are receiv ed by the Office within 30 
days after the date of service of the patent owner's response. 
   (3) [Redesignated] 
  
(c) Special dispatch. Unless otherwise provided by the Director for good cause, all inter 
partes reexamination proceedings under this section, including any appeal to the Board of Patent Appeals and Interferences, shall be  conducted with special dispatch within the 
Office. 
 
§ 315.  Appeal 
 
(a) Patent owner. The patent owner involved in an inter partes reexamination proceeding 
under this chapter [ 35 USCS §§ 311
 et seq.]-- 
   (1) may appeal under the provisions  of section 134 and may appeal under the 
provisions of sections 141 through 144, with  respect to any decision adverse to the 
patentability of any original or proposed amended or new claim of the patent; and 
   (2) may be a party to any appeal taken by a third-party reques ter under subsection 
(b). 
  
(b) Third-party requester. A third-party requester-- 
   (1) may appeal under the provisions of section 134, and may appeal under the 
provisions of sections 141 through 144, with respect to any final de cision favorable to 
the patentability of any original or propos ed amended or new claim of the patent; and 
   (2) may, subject to subsection (c), be a party to any appeal taken by the patent owner 
under the provisions of section 134 or sections 141 through 144. 
  
(c) Civil action. A third-party requester whos e request for an inter partes reexamination 
results in an order under section 313 is estopped from asserting at a later time, in any 
civil action arising in whole or  in part under section 1338 of title 28, the invalidity of any 
claim finally determined to be valid and patentable on any ground which the third-party 
requester raised or could have raised during  the inter partes reex amination proceedings. 
This subsection does not prevent the assert ion of invalidity based on newly discovered 
prior art unavailable to the third-party reques ter and the Patent and Trademark Office at 
the time of the inter partes  reexamination proceedings. 
 
§ 316.  Certificate of patentability, unp atentability, and claim cancellation 
 
(a) In general. In an inter partes reexamination proceeding under this chapter [ 35 USCS 
§§ 311  et seq.], when the time for appeal has expired or any appeal proceeding has 
terminated, the Director shall issue and publish a certificate canceling any claim of the 
patent finally determined to  be unpatentable, confirming any claim of the patent 
determined to be patentable, and incorporat ing in the patent any proposed amended or 
new claim determined to be patentable. 
  
(b) Amended or new claim. Any proposed amended or new claim determined to be 
patentable and incorporated into a patent following an inter partes reexamination 
proceeding shall have the same effect as that specified in section 252 of this title for 
reissued patents on the right of any person  who made, purchased, or used within the 
United States, or imported into the United States, anything patented by such proposed 
amended or new claim, or who made substant ial preparation therefor, prior to issuance 
of a certificate under the provisions of subsection (a) of this section.  
 
 
  IP/N/1/USA/I/2 
 Page 73 
 
 
 § 317.  Inter partes r eexamination prohibited 
 
(a) Order for reexamination. Notwithstanding any provision of this chapter [ 35 USCS §§ 
311 et seq.], once an order fo r inter partes reexamination of  a patent has been issued 
under section 313, neither the third-party requester nor its privies[,] may file a 
subsequent request for inter partes reexamin ation of the patent until an inter partes 
reexamination certificate is i ssued and published under sect ion 316, unless authorized by 
the Director. 
  
(b) Final decision. Once a final decision has been entered agai nst a party in a civil action 
arising in whole or in part  under section 1338 of title 28, that the party has not 
sustained its burden of proving the invalidity of any patent claim in suit or if a final 
decision in an inter partes reexamination pr oceeding instituted by a third-party requester 
is favorable to the patentability of any original or proposed amended or new claim of the 
patent, then neither that party nor its privies may thereafter request an inter partes reexamination of any such patent claim on th e basis of issues which that party or its 
privies raised or could have raised in such civil action or inter partes reexamination 
proceeding, and an inter partes  reexamination requested by that party or its privies on 
the basis of such issues may not thereafter be maintained by the Office, notwithstanding 
any other provision of this chapter [ 35 USCS §§ 311
 et seq.]. This subsection does not 
prevent the assertion of invalidity based on newly discovered prior art unavailable to the 
third-party requester and the Patent and Tradem ark Office at the time of the inter partes 
reexamination proceedings. 
 § 318.  Stay of litigation 
 
Once an order for inter partes reexamination of a patent has been issued under section 
313, the patent owner may obtain a stay of any pending litigation which involves an 
issue of patentability of any claims of the pa tent which are the subjec t of the inter partes 
reexamination order, unless the court before which such litigation is pending determines 
that a stay would not serve the interests of justice. 
 
PART IV. PATENT COOPERATION TREATY
 
 
CHAPTER 35. DEFINITIONS 
 
§ 351.  Definitions 
 
When used in this part [ 35 USCS §§ 351  et seq.] unless the context otherwise indicates-
- 
  
(a) The term "treaty" means the Patent Cooper ation Treaty done at Washington, on June 
19, 1970. 
  
(b) The term "Regulations", when capitalized, means the Regulations under the treaty, 
done at Washington on the same date as th e treaty. The term "regulations", when not 
capitalized, means the regulations established by the Director under this title. 
  
(c) The term "international application" means an application filed under the treaty. 
  
(d) The term "international application originating in the United States" means an international application filed in the Patent and Trademark Office when it is acting as a 
Receiving Office under the trea ty, irrespective of whether or not the United States has 
been designated in that international application. 
  IP/N/1/USA/I/2 
Page 74  
 
 (e) The term "international application designating the United  States" means an 
international application specifying the United  States as a country in which a patent is 
sought, regardless where such international application is filed. 
  
(f) The term "Receiving Offi ce" means a national patent office or intergovernmental 
organization which receives and processes inte rnational applications as prescribed by the 
treaty and the Regulations. 
  
(g) The terms "International Searching Au thority" and "International Preliminary 
Examining Authority" mean a national patent office or intergovernm ental organization as 
appointed under the treaty which processes in ternational applications as prescribed by 
the treaty and the Regulations. 
  
(h) The term "International Bureau" means the international intergovernmental 
organization which is recognized as the coordinating body under the treaty and the Regulations. 
  
(i) Terms and expressions not defined in this part are to be taken in the sense indicated 
by the treaty and the Regulations. 
 
CHAPTER 36. INTERNATIONAL STAGE  
 
§ 361.  Receiving Office 
 (a) The Patent and Trademark Office shall ac t as a Receiving Office for international 
applications filed by nationals or residents of  the United States. In  accordance with any 
agreement made between the United Stat es and another country, the Patent and 
Trademark Office may also act as a Receiving Office for international applications filed by 
residents or nationals of such country who are entitled to file international applications. 
  
(b) The Patent and Trademark Office shall pe rform all acts connected  with the discharge 
of duties required of a Receiving Office, including the collection of international fees and 
their transmittal to the International Bureau.   
(c) International applications filed in the Patent and Trademark Office shall be in the 
English language. 
  
(d) The international fee, and the transmitta l and search fees prescribed under section 
376(a) of this part, shall either be paid on f iling of an intern ational application or within 
such later time as may be fixed by the Director. 
 
§ 362.  International Search ing Authority and Internatio nal Preliminary Examining 
Authority 
 
(a) The Patent and Trademark Office may ac t as an International Searching Authority 
and International Preliminary Examining Authority with respect to international 
applications in accordance with the terms an d conditions of an agreement which may be 
concluded with the International Bureau, and may discharge all duties required of such 
Authorities, including the collection of handling fees and their transmittal to the 
International Bureau. 
  (b) The handling fee, preliminary examinatio n fee, and any additional fees due for 
international preliminary examination shall be paid within such time as may be fixed by 
the Director. 
  IP/N/1/USA/I/2 
 Page 75 
 
 
 § 363.  International application desi gnating the United States: Effect 
 
An international application designating the United States shall have the effect, from its 
international filing date under article 11 of th e treaty, of a national application for patent 
regularly filed in the Patent and Trademark Office except as otherwise provided in 
section 102(e) of this title.  
§ 364.  International stage: Procedure 
 
(a) International applications shall be proc essed by the Patent and Trademark Office 
when acting as a Receiving Office, International Searching Authority, or International 
Preliminary Examining Authority in accordance  with the applicable provisions of the 
treaty, the Regulations, and this title. 
  
(b) An applicant's failure to act within pr escribed time limits in connection with 
requirements pertaining to a pending international application may be excused upon a 
showing satisfactory to the Dire ctor of unavoidable delay, to the extent not precluded by 
the treaty and the Regulations,  and provided the conditions imposed by the treaty and 
the Regulations regarding th e excuse of such failure to act are complied with. 
 
§ 365.  Right of priority; benefit of the filing date of a prior application 
 
(a) In accordance with the conditions and requirements of subsections (a) through (d) of 
section 119 of this title, a national application shall be entitled to the right of priority based on a prior filed international application which designated at least one country 
other than the United States. 
  
(b) In accordance with the conditions and re quirement of section 119( a) of this title and 
the treaty and the Regulations, an international application designating the United States 
shall be entitled to the right of priority ba sed on a prior foreign application, or a prior 
international application designating at least one country other than the United States. 
  
(c) In accordance with the conditions and requ irements of section 120 of this title, an 
international application designating the United States shall be entitled to the benefit of 
the filing date of a prior national application or a prior international application 
designating the United States, and a national application shall be entitled to the benefit 
of the filing date of a prior international application designating the United States. If any 
claim for the benefit of an earlier filing date is based on a prior international application 
which designated but did not or iginate in the United States, the Director may require the 
filing in the Patent and Trademark Office of a certified copy of such application together 
with a translation thereof into the English language, if it was filed in another language. 
 § 366.  Withdrawn international application 
 
Subject to section 367 of this part [ 35 USCS § 367],
 if an international application 
designating the United States is withdrawn or  considered withdrawn,  either generally or 
as to the United States, unde r the conditions of the treaty  and the Regulations, before 
the applicant has complied with  the applicable requirements prescribed by section 371(c) 
of this part [ 35 USCS § 371 (c)], the designation of the United States shall have no effect 
after the date of withdrawal, and shall be co nsidered as not having been made, unless a 
claim for the benefit of a prior filing da te under section 365(c) of this part [ 35 USCS § 
365(c)] was made in a national application, or an international application designating 
the United States, filed before the date of  such withdrawal. However, such withdrawn 
international application may serve as the basis for a claim of priority under section 
365(a) and (b) of this part [ 35 USCS § 365 (a), (b)], if it designated a country other than IP/N/1/USA/I/2 
Page 76  
 
 the United States. 
 
§ 367.  Actions of other authorities: Review 
 
(a) Where a Receiving Office ot her than the Patent and Trad emark Office has refused to 
accord an international filing date to an international application designating the United States or where it has held such application to  be withdrawn either generally or as to the 
United States, the applicant may request review of the matter by the Director, on 
compliance with the requirements  of and within the time limits specified by the treaty 
and the Regulations. Such review may result in a determination that such application be 
considered as pending in the national stage. 
  
(b) The review under subsection (a) of this section, subject to the same requirements 
and conditions, may also be requested in those instances where an international 
application designating the United States is considered withdrawn due to a finding by the 
International Bureau under ar ticle 12(3) of the treaty. 
 
§ 368.  Secrecy of certain inventions; filing in ternational applications in foreign countries 
 
(a) International applications filed in the Patent and Trademark Office shall be subject to 
the provisions of chapter 17 of this title [ 35 USCS §§ 181
 et seq.]. 
  
(b) In accordance with article 27(8) of the treaty, the filing of an international 
application in a country other than the United States on the invention made in this country shall be considered to constitute the filing of an application in a foreign country 
within the meaning of chapter 17 of this title [ 35 USCS §§ 181
 et seq.], whether or not 
the United States is designated in that international application. 
  
(c) If a license to file in a foreign country is  refused or if an international application is 
ordered to be kept secret and a permit refu sed, the Patent and Trademark Office when 
acting as a Receiving Office, International Searching Authority, or International 
Preliminary Examining Authority, may not disclose the contents of such application to 
anyone not authorized to receive such disclosure. 
 
CHAPTER 37. NATIONAL STAGE  
 
§ 371.  National stage: Commencement 
 
(a) Receipt from the International Bureau of copies of international applications with any 
amendments to the claims, international search reports, and international preliminary 
examination reports including any annexes thereto may be required in the case of 
international applications designating or electing the United States.   
(b) Subject to subsection (f) of this sectio n, the national stage shall commence with the 
expiration of the applicable time limit under article 22(1) or (2), or under article 39(1)(a) 
of the treaty[.] 
  
(c) The applicant shall file in the Patent and Trademark Office-- 
   (1) the national fee provided in section 41(a) of this title; 
   (2) a copy of the international application, unless not required under subsection (a) of 
this section or already communicated by the International Bureau, and a translation into 
the English language of the international application, if it was filed in another language; 
   (3) amendments, if any, to the claims in the international application, made under 
article 19 of the treaty, unless such amendmen ts have been communicated to the Patent 
and Trademark Office by the International Bureau, and a translation into the English  IP/N/1/USA/I/2 
 Page 77 
 
 
 language if such amendments were made in another language; 
   (4) an oath or declaration of the invent or (or other person authorized under chapter 
11 of this title) complying wi th the requirements of sectio n 115 of this title and with 
regulations prescribed for oaths or declarations of applicants; 
   (5) a translation into the English language of any annexes to the international 
preliminary examination report, if such annexes were made in another language.   
(d) The requirements with respect to the nati onal fee referred to in subsection (c)(1), 
the translation referred to in subsection (c)(2) , and the oath or declaration referred to in 
subsection (c)(4) of this section shall be complied with by the date of the 
commencement of the national stage or by such later time as may be fixed by the 
Director. The copy of the international application referred to in subsection (c)(2) shall 
be submitted by the date of the commencement of the national stage. Failure to comply 
with these requirements sha ll be regarded as abandonment of the application by the 
parties thereof, unless it be sh own to the satisfaction of the Director that such failure to 
comply was unavoidable. The payment of a surc harge may be required as a condition of 
accepting the national fee referred to in subs ection (c)(1) or the oath or declaration 
referred to in subsection (c)(4) of this sect ion if these requiremen ts are not met by the 
date of the commencement of the national st age. The requirements of subsection (c)(3) 
of this section shall be complied with by the date of the commenc ement of the national 
stage, and failure to do so shall be regarded  as a cancellation of the amendments to the 
claim in the international application made under article 19 of the treaty. The 
requirement of subsection (c)(5) shall be compli ed with at such time as may be fixed by 
the Director and failure to do so shall be regarded as cancellati on of the amendments 
made under article 34(2)(b) of the treaty. 
  
(e) After an international application has ente red the national stage, no patent may be 
granted or refused thereon before  the expiration of the applicable time limit under article 
28 or article 41 of the treaty, except with the express consent of the applicant. The 
applicant may present amendments to the sp ecification, claims, and drawings of the 
application after the national stage has commenced. 
  
(f) At the express request of the applicant,  the national stage of  processing may be 
commenced at any time at which the applicat ion is in order for such purpose and the 
applicable requirements of subsection (c) of this section have been complied with. 
 
§ 372.  National stage: Requirements and procedure 
 
(a) All questions of substance and, within th e scope of the requirements of the treaty 
and Regulations, procedure in an international application designating the United States 
shall be determined as in the case of national applications regularly filed in the Patent 
and Trademark Office.   
(b) In case of international applications designating but not originating in, the United 
States-- 
   (1) the Director may cause to be reexamin ed questions relating to form and contents 
of the application in accordance  with the requirements of th e treaty and the Regulations; 
   (2) the Director may cause the question of  unity of invention to be reexamined under 
section 121 of this title, within the scope of the requirements of the treaty and the 
Regulations; and 
   (3) the Director may require a verificati on of the translation of the international 
application or any other document pertaining to the application if the application or other 
document was filed in a language other than English. 
 
 IP/N/1/USA/I/2 
Page 78  
 
 § 373.  Improper applicant 
 
An international application designating the United States, shall not be accepted by the 
Patent and Trademark Office for the national stage if it was filed by anyone not qualified 
under chapter 11 of this title [ 35 USCS §§ 111  et seq.] to be an applicant for the 
purpose of filing a national application in the United States. Such international applications shall not serve as the basis for the benefit of an earlier filing date under 
section 120 of this title in a subsequently filed application, but may serve as the basis for 
a claim of the right of priority under subsec tions (a) through (d) of section 119 of this 
title, if the United States was not the sole country designated in such international 
application. 
 
§ 374.  Publication of in ternational application 
 
The publication under the treaty defined in sect ion 351(a) of this title, of an international 
application designating the United States sh all be deemed a publication under section 
122(b), except as provided in sectio ns 102(e) and 154(d) of this title. 
 
§ 375.  Patent issued on inte rnational application: Effect 
 
(a) A patent may be issued by the Direct or based on an international application 
designating the United St ates, in accordance with the provisions of this title. Subject to 
section 102(e) of this title, such patent shall have the force and effect of a patent issued 
on a national application filed under the provisions of chapter 11 of this title [ 35 USCS 
§§ 111  et seq.]. 
  
(b) Where due to an incorre ct translation the scope of a patent granted on an 
international application designating the United States, which was not originally filed in 
the English language, exceeds the scope of th e international application in its original 
language, a court of competent jurisdiction  may retroactively limit the scope of the 
patent, by declaring it unenforceable to th e extent that it exceeds the scope of the 
international application in its original language. 
 § 376.  Fees 
 
(a) The required payment of the international fee and the handling fee, which amounts 
are specified in the Regulations, shall be paid in United States currency. The Patent and 
Trademark Office shall charge a national fee as provided in section 41(a), and may also 
charge the following fees: 
   (1) A transmittal fee (see section 361(d)). 
   (2) A search fee (see section 361(d)). 
   (3) A supplemental search fee (to be paid when required).    (4) A preliminary examination fee and any additional fees (see section 362(b)). 
   (5) Such other fees as established by the Director. 
  
(b) The amounts of fees spec ified in subsection (a) of this section, except the 
international fee, and the handling fee shall be prescribed by the Director. He may 
refund any sum paid by mistake or in excess of the fees so specified, or if required under 
the treaty and the Regulations. The Director may also refund any part of the search fee, 
the national fee, the prelim inary examination fee, and an y additional fees, where he 
determines such refund to be warranted.  
 
 
  IP/N/1/USA/I/2 
 Page 79 
 
 
 CHAPTER 38. PATENT RIGHTS IN INVENTIONS MADE WITH FEDERAL 
ASSISTANCE [REDESIGNATED] 
 
__________