I 

113TH CONGRESS 

1ST SESSION H. R. 3091 

To promote the development of meaningful treatments for patients. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 12, 2013 

Mr. LANCE (for himself, Mr. ROSKAM, Mr. GUTHRIE, Mr. PAULSEN, Mr. 

RANGEL, Mr. RUNYAN, Ms. SCHWARTZ, Mr. KING of New York, Mr. 

MCCAUL, Mr. WALDEN, Mr. TIBERI, Mr. LOEBSACK, Mr. BEN RAY

LUJA ́N of New Mexico, Mr. ELLISON, Mr. JONES, and Mr. LONG) introduced the following bill; which was referred to the Committee on Energy 

and Commerce, and in addition to the Committees on Ways and Means 

and the Judiciary, for a period to be subsequently determined by the 

Speaker, in each case for consideration of such provisions as fall within 

the jurisdiction of the committee concerned 

A BILL 

To promote the development of meaningful treatments for 

patients. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Modernizing Our Drug 

5 & Diagnostics Evaluation and Regulatory Network Cures 

6 Act of 2013’’ or the ‘‘MODDERN Cures Act of 2013’’. 


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1 SEC. 2. TABLE OF CONTENTS. 

2 The table of contents for this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents. 

Sec. 3. Findings. 

Sec. 4. Definitions. 

TITLE I—ADVANCING DIAGNOSTICS FOR PATIENTS 

Sec. 101. Developing a common lexicon to facilitate progress on diagnostics. 

Sec. 102. Creating incentives for innovative diagnostics. 

Sec. 103. Promoting the development of innovative diagnostics. 

TITLE II—CAPTURING LOST OPPORTUNITIES FOR PATIENTS 

Sec. 201. Dormant therapies. 

Sec. 202. Study regarding new indications for existing therapies. 

3 SEC. 3. FINDINGS. 

4 The Congress makes the following findings: 

5 (1) More than 133 million Americans, or 45 

6 percent of the population, have at least one chronic 

7 condition. A quarter of Americans have multiple 

8 chronic conditions. 

9 (2) Chronic diseases have become the leading 

10 cause of death and disability in the United States. 

11 Seven out of every 10 deaths are attributable to 

12 chronic disease. Chronic diseases also compromise 

13 the quality of life of millions of Americans. 

14 (3) Despite $80 billion spent annually on re15 search and development, many diseases and condi16 tions lack effective treatments. 

17 (4) Many commonly used drugs are effective in 

18 only 50 to 75 percent of the patient population, 

19 which can lead to devastating long-term side effects, 


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1 resulting in the potential risks outweighing the bene2 fits for some patients. 

3 (5) Advanced and innovative diagnostic tests 

4 have the potential to dramatically increase the effi5 cacy and safety of drugs by better predicting how 

6 patients will respond to a given therapy. 

7 (6) Despite their promise, many drugs and 

8 diagnostics may go undeveloped due to uncertain 

9 regulatory and reimbursement processes, among 

10 other reasons. 

11 (7) In addition, there is reason to believe that 

12 potential treatments with tremendous value to pa13 tients are never developed or are discontinued during 

14 research and development due to insufficiencies in 

15 the intellectual property system. 

16 (8) It is in the public interest to address the 

17 hurdles that may be precluding new treatments from 

18 reaching patients and to remove the disincentives for 

19 the development of therapies for these unmet needs. 

20 SEC. 4. DEFINITIONS. 

21 In this Act: 

22 (1) The term ‘‘biological product’’ has the 

23 meaning given to that term in section 351 of the 

24 Public Health Service Act (42 U.S.C. 262). 


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1 (2) The term ‘‘drug’’ has the meaning given to 

2 that term in section 201 of the Federal Food, Drug, 

3 and Cosmetic Act (21 U.S.C. 321). 

4 (3) The term ‘‘medicine’’ means a biological 

5 product or a drug. 

6 (4) The term ‘‘Secretary’’ means the Secretary 

7 of Health and Human Services. 

8 TITLE I—ADVANCING 

9 DIAGNOSTICS FOR PATIENTS 

10 SEC. 101. DEVELOPING A COMMON LEXICON TO FACILI11 TATE PROGRESS ON DIAGNOSTICS. 

12 (a) IN GENERAL.—Not later than 180 days after the 

13 date of enactment of this Act, the Secretary shall establish 

14 within the Department of Health and Human Services the 

15 Advanced Diagnostics Education Council (in this section 

16 referred to as the ‘‘Council’’). 

17 (b) DUTIES.— 

18 (1) IN GENERAL.—The Council shall promote 

19 an improved understanding of key concepts related 

20 to innovative diagnostics by recommending standard 

21 terms and definitions for use by patients, physicians, 

22 health care providers, payers, and policymakers. 

23 (2) GUIDE.—The Secretary shall publish and 

24 disseminate a guide regarding such recommended 


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1 terms and definitions for patients, physicians, health 

2 care providers, payers, and policymakers. 

3 (3) REPORT.—Not later than 12 months after 

4 the establishment of the Council, the Secretary shall 

5 prepare and submit a report to the Congress and to 

6 the public on the Council’s deliberations, activities, 

7 and determinations with respect to meeting its du8 ties described in paragraphs (1) and (2). 

9 (c) CHAIRPERSON.—The Secretary, or the Sec10 retary’s designee, shall serve as chairperson of the Coun11 cil. 

12 (d) MEMBERS.—In addition to the Secretary, the 

13 Council shall consist of the following: 

14 (1) The head of each the following agencies (or 

15 a designee thereof): 

16 (A) The National Institutes of Health. 

17 (B) The Centers for Disease Control and 

18 Prevention. 

19 (C) The Food and Drug Administration. 

20 (D) The Agency for Healthcare Research 

21 and Quality. 

22 (E) The Centers for Medicare & Medicaid 

23 Services. 

24 (F) The Department of Defense. 

25 (G) The Department of Veterans Affairs. 


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1 (H) The Health Resources and Services 

2 Administration. 

3 (I) The Substance Abuse and Mental 

4 Health Services Administration. 

5 (J) The Indian Health Service. 

6 (2) Seven members appointed by the Secretary 

7 from among individuals who collectively— 

8 (A) represent a broad range of perspec9 tives; and 

10 (B) have expertise in— 

11 (i) basic and translational research, 

12 including with respect to molecular biology 

13 and genetics; 

14 (ii) bioinformatics; 

15 (iii) the discovery, development, and 

16 commercialization of in vitro diagnostics; 

17 and 

18 (iv) law and ethics. 

19 (3) Four members appointed by the Secretary 

20 who are each a chief medical or scientific officer of 

21 a patient advocacy organization. 

22 (e) PUBLIC INPUT.—In carrying out its duties, the 

23 Council shall solicit input from relevant stakeholders and 

24 the public. 


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1 (f) TERMINATION.—The Council shall terminate 

2 after publishing the guide required by subsection (b)(2) 

3 and submitting the report required by subsection (b)(3), 

4 or later at the discretion of the Secretary. 

5 SEC. 102. CREATING INCENTIVES FOR INNOVATIVE 

6 DIAGNOSTICS. 

7 (a) IMPROVEMENTS TO PROCESS FOR DETERMINING

8 FEE SCHEDULE AMOUNTS FOR NEW TESTS.— 

9 (1) CLARIFYING FACTORS FOR RATE-SET10 TING.— 

11 (A) IN GENERAL.—In determining the pay12 ment amount under gapfilling procedures (as 

13 described in section 414.508(b) of title 42, 

14 Code of Federal Regulations, or any successor 

15 regulation to such section) for new clinical diag16 nostic laboratory tests under section 1833(h)(8) 

17 of the Social Security Act (42 U.S.C. 

18 1395l(h)(8)), the Secretary shall take into ac19 count, as applicable and available, the following 

20 factors with respect to such a new test: 

21 (i) IMPACT ON PATIENT CARE.—The 

22 impact of the new test on patient care, pa23 tient management, or patient treatment. 

24 (ii) TECHNICAL CHARACTERISTICS.— 

25 The technical characteristics of the new 


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1 test, and the resources required to develop, 

2 validate, and perform the new test. 

3 (iii) CLAIMS DATA.—Data from claims 

4 for which payment is made under part B 

5 of title XVIII of the Social Security Act. 

6 (iv) LABORATORY CHARGES.— 

7 Amounts charged by laboratories to self8 pay patients for the new test. 

9 (v) PRIVATE INSURANCE RATES.— 

10 Amounts paid to laboratories for such new 

11 test under private health insurance cov12 erage offered in the group market and the 

13 individual market. 

14 (vi) ADVISORY PANEL RECOMMENDA15 TIONS.—The findings and recommenda16 tions of the independent advisory panel 

17 convened under paragraph (2) with respect 

18 to that new test and any comments re19 ceived during the open meeting of the advi20 sory panel. 

21 (vii) ADDITIONAL FACTORS.—Such 

22 other factors as the Secretary may specify. 

23 (2) INPUT FROM PATIENTS, CLINICIANS, AND

24 TECHNICAL EXPERTS.— 


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1 (A) REQUIREMENT FOR INDEPENDENT AD2 VISORY PANEL.—The Secretary shall convene 

3 an independent advisory panel from which the 

4 Secretary shall request information and rec5 ommendations regarding any new test (as re6 ferred to under subparagraph (A) of section 

7 1833(h)(8) of the Social Security Act (42 

8 U.S.C. 1395l(h)(8))) for which payment is 

9 made under such section, including technical, 

10 clinical, and quality information. 

11 (B) COMPOSITION OF INDEPENDENT ADVI12 SORY PANEL.—The independent advisory panel 

13 shall be comprised of 19 members, including— 

14 (i) 4 individuals with expertise and ex15 perience with advanced clinical diagnostic 

16 laboratory tests, including expertise in the 

17 technical characteristics of the new test; 

18 (ii) 3 representatives of patients, in19 cluding a patient representative for rare 

20 disorders; 

21 (iii) 3 clinicians who use results of the 

22 new test in patient care; 

23 (iv) 3 individuals with expertise in the 

24 requirements to develop, validate, and per25 form the new test; 


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1 (v) 2 laboratorians; 

2 (vi) 2 experts in the area of 

3 pharmacoeconomics or health technology 

4 assessment; and 

5 (vii) 2 individuals with expertise on 

6 the impact of new tests on quality of pa7 tient care, including genetic counselors. 

8 (C) TERMS.—A member of the panel shall 

9 be appointed to serve a term of 6 years, except 

10 with respect to the members first appointed, 

11 whose terms of appointment shall be staggered 

12 evenly over 2-year increments. 

13 (D) EXPERT CONSULTANTS.—The Sec14 retary may include to serve temporarily on the 

15 panel individuals who have expertise pertaining 

16 to the new test involved. 

17 (E) OPEN MEETINGS.—The Secretary shall 

18 receive or review the findings and recommenda19 tions of the independent advisory panel with re20 spect to the new tests described in subpara21 graph (A) involved during a meeting open to 

22 the public and provide opportunity for public 

23 comment. 

24 (F) CLARIFICATION OF AUTHORITY OF

25 SECRETARY TO CONSULT CARRIERS.—Nothing 


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1 in this section shall be construed as affecting 

2 the authority of the Secretary to consult with 

3 appropriate Medicare administrative contrac4 tors. 

5 (b) PROCESS FOR ASSIGNMENT OF TEMPORARY

6 CODES FOR DIAGNOSTIC TESTS.—The Secretary shall es7 tablish a process for application for the assignment of a 

8 temporary national HCPCS code to uniquely identify a di9 agnostic test until a permanent national HCPCS code is 

10 available for assignment to that test. Assignments of a 

11 temporary national HCPCS code shall occur on a quar12 terly basis. The Secretary shall provide public notice 

13 through the Centers for Medicare & Medicaid Services 

14 website of applications made for such temporary national 

15 HCPCS codes. Upon assignment of a temporary code 

16 under this process, the Secretary shall treat such test as 

17 a new test for purposes of section 1833(h)(8) of the Social 

18 Security Act. 

19 (c) DEVELOPMENT OF FURTHER IMPROVEMENTS IN

20 RATE-SETTING PROCESSES.—The Secretary shall analyze 

21 the process used for the gapfilling procedure used in deter22 mining payment amounts for new clinical diagnostic lab23 oratory tests under section 1833(h)(8) of the Social Secu24 rity Act. Taking into account the changes made by this 

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1 prove the accuracy and appropriateness of resulting rates 

2 and the openness, transparency, and predictability of the 

3 process. The Secretary shall examine what and how many 

4 entities should perform gapfilling, under contract or other5 wise, and how to ensure that the process is informed by 

6 appropriate expertise and proceeds in a transparent and 

7 accountable manner. The Secretary shall implement im8 provements in the process, insofar as these are possible 

9 under the law through regulations, after public notice and 

10 opportunity for comment. For changes the Secretary de11 termines would require a change in law, the Secretary 

12 shall transmit recommendations to the Speaker of the 

13 House of Representatives and the President of the Senate 

14 not later than July 1, 2015. 

15 (d) DEFINITIONS.—For purposes of this section: 

16 (1) NEW CLINICAL DIAGNOSTIC LABORATORY

17 TESTS.—The term ‘‘new clinical diagnostic labora18 tory test’’ means a clinical diagnostic laboratory 

19 test— 

20 (A) that is assigned a new or substantially 

21 revised code on or after January 1, 2015; or 

22 (B) for which an application for a tem23 porary national HCPCS code is made under 

24 subsection (b) on or after January 1, 2015. 


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1 (2) SELF-PAY PATIENT.—The term ‘‘self-pay 

2 patient’’ means, with respect to a health care item 

3 or service, an individual who pays out of pocket for 

4 such item or service and who does not have health 

5 insurance coverage for such item or service. 

6 (e) EFFECTIVE DATE.—This section shall take effect 

7 on the date of enactment of this Act, and shall apply with 

8 respect to new clinical diagnostic laboratory tests. 

9 SEC. 103. PROMOTING THE DEVELOPMENT OF INNOVATIVE 

10 DIAGNOSTICS. 

11 (a) DETERMINATION.— 

12 (1) REQUEST.—The manufacturer or sponsor 

13 of a medicine may request the Secretary to deter14 mine that— 

15 (A) a diagnostic test has been developed 

16 by, or with the participation of, the manufac17 turer or sponsor of the medicine; and 

18 (B) use of the diagnostic test, as dem19 onstrated through valid scientific information 

20 such as peer-reviewed literature— 

21 (i) provides for or improves the identi22 fication of a patient population for which 

23 the medicine will or will not be used in ac24 cordance with its approved indications; 


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1 (ii) provides for or improves the deter2 mination of the most appropriate treat3 ment option for a patient population with 

4 the medicine in accordance with its ap5 proved indications; or 

6 (iii) provides for the detection of a 

7 qualifying pathogen (as defined in section 

8 505E(f) of the Federal Food, Drug, and 

9 Cosmetic Act (21 U.S.C. 355(f)). 

10 (2) RESPONSE BY SECRETARY.—Not later than 

11 30 days after the submission of a request under 

12 paragraph (1), the Secretary, shall— 

13 (A) make the requested determination and 

14 publish a notice of such determination and any 

15 extension under this section resulting from such 

16 determination; or 

17 (B) provide an explanation to the manufac18 turer or sponsor submitting the request of why 

19 the determination is not warranted. 

20 (b) APPLICABLE EXTENSION PERIOD.—For purposes 

21 of subsections (c) and (d), the applicable extension period 

22 is— 

23 (1) with respect to a diagnostic test developed 

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1 neously with the development of the medicine in2 volved, 12 months; and 

3 (2) with respect to a diagnostic test developed 

4 otherwise, 6 months. 

5 (c) EXTENSION FOR DRUGS.—If, at the request of 

6 the manufacturer or sponsor of a drug, the Secretary 

7 makes the determination described in subsection (a)(1) 

8 with respect to such drug and a diagnostic test, then— 

9 (1) the four- and five-year periods described in 

10 subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 

11 505 of the Federal Food, Drug, and Cosmetic Act 

12 (21 U.S.C. 355), the three-year periods described in 

13 clauses (iii) and (iv) of subsection (c)(3)(E) and 

14 clauses (iii) and (iv) of subsection (j)(5)(F) of such 

15 section 505, or the seven-year period described in 

16 section 527 of the Federal Food, Drug, and Cos17 metic Act (21 U.S.C. 360cc), as applicable, shall be 

18 extended by the applicable extension period; 

19 (2) if the drug is the subject of— 

20 (A) a listed patent for which a certification 

21 has been submitted under subsection 

22 (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of such section 

23 505; or 

24 (B) a listed patent for which a certification 

25 has been submitted under subsection 


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1 (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of such sec2 tion 505, 

3 then the period during which an application may not 

4 be approved under subsection (c)(3) or (j)(5)(B) of 

5 such section 505 shall be extended by the applicable 

6 extension period after the date the patent expires 

7 (including any patent extensions); and 

8 (3) if the drug is the subject of a listed patent 

9 for which a certification has been submitted under 

10 subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of such 

11 section 505, and in the patent infringement litiga12 tion resulting from the certification the court deter13 mines that the patent is valid and would be in14 fringed, the period during which an application may 

15 not be approved under subsection (c)(3) or (j)(5)(B) 

16 of such section 505 shall be extended by the applica17 ble extension period after the date the patent expires 

18 (including any patent extension). 

19 (d) EXTENSION FOR BIOLOGICAL PRODUCTS.—If, at 

20 the request of the manufacturer or sponsor of a biological 

21 product, the Secretary makes the determination described 

22 in subsection (a)(1) with respect to such biological product 

23 and a diagnostic test, then the 12-year period described 

24 in subsection (k)(7)(A) of section 351 of the Public Health 

25 Service Act (42 U.S.C. 262), the 4-year period described 


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1 in subsection (k)(7)(B) of such section 351, and the 7- 

2 year period described in section 527 of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 360cc), as applicable, 

4 shall be extended by the applicable extension period. 

5 (e) RELATION TO PEDIATRIC EXCLUSIVITY.—Any 

6 extension under subsection (c) or (d) of a period shall be 

7 in addition to any extension of the period under section 

8 505A of the Federal Food, Drug, and Cosmetic Act (21 

9 U.S.C. 355a) with respect to the medicine. 

10 (f) LIMITATIONS.—Extensions under this section 

11 may apply— 

12 (1) not more than twice with respect to the 

13 same medicine; and 

14 (2) not more than once with respect to the 

15 same indication to be treated by the same medicine. 

16 TITLE II—CAPTURING LOST 

17 OPPORTUNITIES FOR PATIENTS 

18 SEC. 201. DORMANT THERAPIES. 

19 (a) DESIGNATION AS DORMANT THERAPY.—The 

20 Secretary shall designate a medicine as a dormant therapy 

21 if— 

22 (1) the sponsor of the medicine submits a re23 quest for such designation meeting the requirements 

24 under subsection (b), and the request has not been 

25 withdrawn under subsection (d)(1); and 


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1 (2) the Secretary determines that— 

2 (A) the medicine is being investigated or is 

3 intended to be investigated for an indication to 

4 address one or more unmet medical needs; 

5 (B) a suitable clinical plan for such inves6 tigations of the medicine has been developed by 

7 the sponsor; 

8 (C) the sponsor intends to file an applica9 tion pursuant to section 505(b) of the Federal 

10 Food, Drug, and Cosmetic Act (21 U.S.C. 

11 355(b)) or section 351(a) of the Public Health 

12 Service Act (42 U.S.C. 262(a)) for approval or 

13 licensing of the medicine for an indication de14 scribed in subparagraph (A); and 

15 (D) the request for designation was made 

16 on or before the date of submission of any ap17 plication under section 505 of the Federal 

18 Food, Drug, and Cosmetic Act (21 U.S.C. 355) 

19 or section 351 of the Public Health Service Act 

20 (42 U.S.C. 262) for the approval or licensure of 

21 commercial marketing or use of a medicine that 

22 in the case of a drug shares an active moiety 

23 that is the same as, and in the case of a bio24 logic contains an active moiety that is highly 


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1 similar to, an active moiety in the medicine for 

2 which designation is being requested. 

3 (b) REQUIREMENTS FOR REQUEST FOR DESIGNA4 TION AS DORMANT THERAPY.—A request under sub5 section (a)(1) with respect to a medicine may only be made 

6 by the sponsor of the medicine and shall contain each of 

7 the following: 

8 (1) A listing of all patents and applications for 

9 patents under which the sponsor has rights and that 

10 may be reasonably construed to provide protection 

11 for the medicine. 

12 (2) A waiver of patent rights to the extent re13 quired under subsection (c) to take effect, if at all, 

14 as provided under subsection (c)(3). 

15 (3) Such additional information as the Sec16 retary may require by regulation in order to deter17 mine eligibility for designation under subsection (a). 

18 (c) WAIVER OF PATENT RIGHTS EXPIRING AFTER

19 THE PROTECTION PERIOD ENDS.— 

20 (1) PATENT WAIVER.— 

21 (A) IN GENERAL.—Subject to subpara22 graph (B), the request under this subsection 

23 shall include a waiver of the right to enforce or 

24 otherwise assert any patent described in sub25 section (b)(1) (or any patent issued on the basis 


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1 of an application described in subsection 

2 (b)(1)), which may expire after the end of the 

3 protection period for the dormant therapy, 

4 against any applicable product described in 

5 paragraph (2). The waiver shall be made by the 

6 owner of the patent or application for patent, 

7 as the case may be. 

8 (B) LIMITATIONS ON PATENT WAIVER.— 

9 Any patent waiver provided pursuant to this 

10 section, should it become effective— 

11 (i) shall have no effect during the pro12 tection period for the medicine to which 

13 the waiver relates; and 

14 (ii) shall have no effect with respect to 

15 the subject matter of a claimed invention 

16 in a patent that does not provide any pro17 tection for such medicine with respect to 

18 an applicable product described in para19 graph (2). 

20 (2) APPLICABLE PRODUCTS DESCRIBED.—An 

21 applicable product is described in this paragraph 

22 only if— 

23 (A) it is approved or licensed pursuant to 

24 an application that— 


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1 (i) is filed under section 505(b)(2) or 

2 505(j) of the Federal Food, Drug, and 

3 Cosmetic Act (21 U.S.C. 355(b)(2), (j)) or 

4 section 351(k) of the Public Health Service 

5 Act (42 U.S.C. 262(k)); and 

6 (ii) references or otherwise relies upon 

7 the approval or licensure of the dormant 

8 therapy to which the waiver relates; and 

9 (B) the approval of the product occurs 

10 after the expiration of the protection period ap11 plicable to the medicine to which the request 

12 under subsection (a)(1) relates. 

13 (3) EFFECTIVE DATE OF WAIVER.—A waiver 

14 under subsection (b)(2) with respect to a patent 

15 shall take effect, if at all, on the date the Director 

16 publishes the notice required under subsection 

17 (e)(2)(F) relating to the patent. 

18 (d) WITHDRAWAL OF REQUEST FOR DESIGNATION, 

19 REVOCATION BY THE SECRETARY.— 

20 (1) IN GENERAL.—The sponsor of a medicine 

21 may withdraw a request for designation under sub22 section (a)(1) with respect to a medicine unless the 

23 medicine has been approved or licensed under sec24 tion 505 of the Federal Food, Drug, and Cosmetic 

25 Act (21 U.S.C. 355) or section 351 of the Public 


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1 Health Service Act (42 U.S.C. 262). The Secretary 

2 shall deny a designation request or revoke any des3 ignation granted if at any time the Secretary finds 

4 that the sponsor is not in compliance with sub5 sections (c)(1) and (g)(1). 

6 (2) EFFECTS OF WITHDRAWAL OF REQUEST OR

7 REVOCATION OF DESIGNATION.—If the sponsor of a 

8 medicine withdraws a request under subsection (b) 

9 or the Secretary denies a designation request or re10 vokes a designation with respect to the medicine— 

11 (A) any patent waiver submitted under 

12 this section with respect to the medicine, but 

13 not yet effective, is canceled and deemed a nul14 lity; 

15 (B) any patent waiver that has taken ef16 fect under this section with respect to the medi17 cine shall remain in effect; 

18 (C) any patent term extension granted by 

19 the Director under subsection (e)(2) with re20 spect to the medicine shall be canceled, except 

21 that the Director shall maintain the patent 

22 term extension for one patent, to be selected by 

23 the sponsor of the medicine, for the period of 

24 extension that would have been applicable under 

25 section 156 of title 35, United States Code; and 


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1 (D) the designation, if made, otherwise 

2 shall be treated as never having been requested 

3 or made or having effect. 

4 (3) BASIS FOR REVOCATION.—The Secretary 

5 may revoke a designation made under subsection 

6 (a), but only based upon a finding by the Secretary 

7 under paragraph (1). 

8 (e) GUARANTEED PROTECTIONS FOR DORMANT

9 THERAPIES.— 

10 (1) APPLICATIONS FILED DURING THE PROTEC11 TION PERIOD.—During the protection period for a 

12 dormant therapy, notwithstanding any other provi13 sion of the Federal Food, Drug, and Cosmetic Act 

14 (21 U.S.C. 301 et seq.) or the Public Health Service 

15 Act (42 U.S.C. 201 et seq.)— 

16 (A) absent a right of reference from the 

17 holder of such approved application for the dor18 mant therapy, the Secretary shall not approve 

19 an application filed pursuant to section 

20 505(b)(2) or section 505(j) of the Federal 

21 Food, Drug, and Cosmetic Act (21 U.S.C. 

22 355(b)(2), (j)) or section 351(k) of the Public 

23 Health Service Act (42 U.S.C. 262(k)) ref24 erencing or otherwise relying on the approval or 

25 licensure of the dormant therapy; 


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1 (B) the Secretary shall not approve— 

2 (i) an application filed pursuant to 

3 such section 505(b)(2) or 505(j) that ref4 erences or otherwise relies on the approval 

5 or licensure of a medicine that is not the 

6 dormant therapy, was approved subsequent 

7 to the approval of the dormant therapy, 

8 and contains the same active moiety as the 

9 active moiety in the dormant therapy (or if 

10 the dormant therapy contains more than 

11 one active moiety, all of the active moieties 

12 are the same); or 

13 (ii) an application filed pursuant to 

14 such section 351(k) that references or oth15 erwise relies on the approval or licensure of 

16 a medicine that is not the dormant ther17 apy, was approved subsequent to the ap18 proval or licensure of the dormant therapy, 

19 and contains an active moiety that is high20 ly similar to the active moiety in the dor21 mant therapy (or if the dormant therapy 

22 contains more than one active moiety, all 

23 of the active moieties are highly similar); 

24 and 


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1 (C) the Secretary shall not approve an ap2 plication filed pursuant to section 505(b)(1) of 

3 the Federal Food, Drug, and Cosmetic Act (21 

4 U.S.C. 355(b)(1)) for a drug that contains the 

5 same active moiety as the active moiety in the 

6 dormant therapy (or if the dormant therapy 

7 contains more than one active moiety, all of the 

8 active moieties are the same), or an application 

9 filed pursuant to section 351(a) of the Public 

10 Health Service Act (42 U.S.C. 262(a)) for a bi11 ological product that contains an active moiety 

12 that is highly similar to the active moiety in the 

13 dormant therapy (or if the dormant therapy 

14 contains more than one active moiety, all of the 

15 active moieties are highly similar), unless— 

16 (i) the information provided to sup17 port approval of such application is com18 parable in scope and extent, including with 

19 respect to design and extent of preclinical 

20 and clinical testing, to the information pro21 vided to support approval of the applica22 tion for the dormant therapy under section 

23 505(b) of the Federal Food, Drug and 

24 Cosmetic Act (21 U.S.C. 355(b)) or secVerDate Mar 15 2010 00:56 Sep 14, 2013 Jkt 029200 PO 00000 Frm 00025 Fmt 6652 Sfmt 6201 E:\BILLS\H3091.IH H3091

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1 tion 351(a) of the Public Health Service 

2 Act (42 U.S.C. 262(a)); and 

3 (ii) if such clinical testing had not 

4 commenced before the approval of the ap5 plication for the dormant therapy, the clin6 ical testing establishes clinical superiority 

7 in the form of a significant therapeutic ad8 vantage over and above that provided by 

9 the dormant therapy in one or more of the 

10 following ways: 

11 (I) Greater effectiveness on a 

12 clinically meaningful endpoint. 

13 (II) Greater safety in a substan14 tial portion of the target populations. 

15 (III) Where neither greater safe16 ty nor greater effectiveness has been 

17 shown, a demonstration that the drug 

18 otherwise makes a major contribution 

19 to patient care. 

20 (2) PATENT TERM ALIGNMENT WITH DATA

21 PACKAGE PROTECTION PERIOD.— 

22 (A) IN GENERAL.—Notwithstanding any 

23 provision of title 35, United States Code, a 

24 sponsor of a medicine designated as a dormant 

25 therapy under subsection (a)(1), upon the apVerDate Mar 15 2010 00:56 Sep 14, 2013 Jkt 029200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6201 E:\BILLS\H3091.IH H3091

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1 proval or licensure thereof under section 505 of 

2 the Federal Food, Drug, and Cosmetic Act (21 

3 U.S.C. 355) or section 351 of the Public Health 

4 Service Act (42 U.S.C. 262), and in lieu of fil5 ing a patent term extension application under 

6 section 156(d) of such title 35, shall be entitled 

7 to patent term extensions in accordance with 

8 this paragraph. 

9 (B) SUBMISSION OF FINAL LISTING OF

10 PATENTS AND APPLICATIONS FOR PATENTS

11 FOLLOWING APPROVAL.— 

12 (i) SUBMISSION.—The sponsor of the 

13 dormant therapy, within a period to be set 

14 by the Director of not less than 2 months 

15 beginning on the date the Secretary ap16 proves or licenses the dormant therapy, 

17 shall submit to the Director— 

18 (I) the listing of patents and ap19 plications for patents provided to the 

20 Secretary under subsection (b)(1); 

21 (II) any revisions to such listing 

22 as may be required for compliance 

23 with subsection (b)(1); and 

24 (III) any documentation the Di25 rector may require from the patentee 


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1 or patent applicant (as the case may 

2 be) of the waiver of patent rights re3 quired under subsection (b)(2). 

4 (ii) FAILURE TO PROVIDE SUFFICIENT

5 DOCUMENTATION OF WAIVER.—If the Di6 rector determines that the sponsor has not 

7 complied with the waiver requirements 

8 under subsection (c), after providing the 

9 sponsor the opportunity to remedy any in10 sufficiency, the Director shall so notify the 

11 Secretary that the patent waiver require12 ments for designation have not been satis13 fied. 

14 (C) EXTENSION OF PATENTS.— 

15 (i) IN GENERAL.—Unless the Director 

16 has notified the Secretary of a determina17 tion under subparagraph (B)(ii), for each 

18 patent identified in a submission pursuant 

19 to subparagraph (B)(i), and for each pat20 ent issuing based upon an application for 

21 patent so identified, the Director shall, 

22 within the 3-month period beginning on 

23 the date of the submission, extend the pat24 ent to expire at the end of the protection 

25 period for the dormant therapy, if the patVerDate Mar 15 2010 00:56 Sep 14, 2013 Jkt 029200 PO 00000 Frm 00028 Fmt 6652 Sfmt 6201 E:\BILLS\H3091.IH H3091

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1 ent would otherwise expire before the end 

2 of the protection period. If the Director 

3 has so notified the Secretary under sub4 paragraph (B)(ii), the Director shall ex5 tend one such patent, selected by the spon6 sor, for the period that would have been 

7 applicable had an application for extension 

8 been filed under section 156 of title 35, 

9 United States Code, with respect to such 

10 patent. 

11 (ii) APPLICATION OF CERTAIN PROVI12 SIONS.—During the period of an extension 

13 under clause (i)— 

14 (I) the rights under the patent 

15 shall be limited in the manner pro16 vided under section 156(b) of title 35, 

17 United States Code; and 

18 (II) the terms ‘‘product’’ and 

19 ‘‘approved product’’ in such section 

20 156(b) shall be deemed to include 

21 forms of the active moiety of the dor22 mant therapy and highly similar ac23 tive moieties that might be approved 

24 by the Secretary based upon an appli25 cation filed under section 505(b)(2) or 


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1 505(j) of the Federal Food, Drug, 

2 and Cosmetic Act (21 U.S.C. 

3 355(b)(2), (j)) or under section 

4 351(k) of the Public Health Service 

5 Act (42 U.S.C. 262(k)) that ref6 erences or otherwise relies upon the 

7 dormant therapy. 

8 (D) INTERIM PATENT EXTENSIONS.—Not9 withstanding any provision of title 35, United 

10 States Code, with respect to any patent listed 

11 (or patent issuing on an application listed) 

12 under subsection (b)(1) that would otherwise 

13 expire before the sponsor could make a submis14 sion under subparagraph (B), the Director, 

15 upon application of the patentee, shall grant to 

16 the patentee an interim extension of such pat17 ent, subject to the limitations in section 

18 156(d)(5)(F) of such title 35, for such period 

19 as may be necessary to permit the sponsor to 

20 submit the listing under subparagraph (B) and, 

21 if the patent is therein listed, to extend the pat22 ent as provided under subparagraph (C). The 

23 Director may require, for any patent extended 

24 under this subparagraph, that the sponsor of 

25 the dormant therapy to which the patent relates 


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1 provide periodic certifications that development 

2 of the dormant therapy is continuing. The Di3 rector may terminate any interim extension for 

4 which a required certification has not been 

5 made. 

6 (E) NOTICE OF EXTENSION.—For each 

7 patent that is extended under this paragraph, 

8 the Director shall publish a notice of such ex9 tension and issue a certificate of extension de10 scribed in section 156(e)(1) of title 35, United 

11 States Code. 

12 (F) NOTICE OF WAIVER.—For each patent 

13 identified in a submission under subparagraph 

14 (B)(i), and each patent issuing based upon an 

15 application for patent so identified, that expires 

16 after the end of the protection period for the 

17 dormant therapy, the Director shall publish a 

18 notice that the patent is subject to the limited 

19 waiver of the right to enforce described in sub20 section (c)(1). 

21 (f) CERTAIN FDA PROTECTIONS INAPPLICABLE.—If 

22 a medicine has been designated as a dormant therapy 

23 under subsection (a), the protections otherwise applicable 

24 with respect to such medicine under sections 505A, 505E, 

25 and 527 of the Federal Food, Drug, and Cosmetic Act 


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1 (21 U.S.C. 355a, 355f, 360cc) shall not apply. The pre2 ceding sentence shall not be construed to affect any pro3 tections applicable with respect to a drug, including a drug 

4 designated under section 526 of such Act (21 U.S.C. 

5 360bb) for a rare disease or condition, under provisions 

6 other than such sections 505A, 505E, and 527. 

7 (g) DEVELOPMENT CERTIFICATIONS.— 

8 (1) IN GENERAL.—The Secretary shall require 

9 that the sponsor of a dormant therapy provide peri10 odic certifications that development of the dormant 

11 therapy to address one or more unmet medical needs 

12 is continuing. 

13 (2) DETERMINATION OF NONCOMPLIANCE.—If 

14 the Secretary concludes that the sponsor has not 

15 complied with paragraph (1), after providing the 

16 sponsor the opportunity to remedy any insufficiency, 

17 the Secretary shall, for purposes of subsection 

18 (d)(1), determine that the sponsor is not in compli19 ance with the certification requirement under para20 graph (1). 

21 (h) COLLABORATION.—Nothing in this section shall 

22 be construed as preventing a sponsor from collaborating 

23 with other entities in developing a dormant therapy or ap24 plying for a dormant therapy designation. 

25 (i) DEFINITIONS.—For purposes of this section: 


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1 (1) The term ‘‘address one or more unmet med2 ical needs’’ refers to— 

3 (A) addressing a need for medicines for 

4 the treatment of one or more life-threatening or 

5 other serious diseases or conditions for which 

6 no therapy exists; or 

7 (B) if one or more therapies are available 

8 for the treatment of such a disease or condition, 

9 demonstrating through clinical investigations— 

10 (i) one or more improved effects on 

11 serious outcomes of the disease or condi12 tion that are affected by alternative thera13 pies, such as superiority of the medicine 

14 used alone or in combination with other 

15 therapies in an active controlled trial as16 sessing an endpoint reflecting serious mor17 bidity; 

18 (ii) one or more effects on serious out19 comes of the disease or condition not 

20 known to be affected by alternative thera21 pies, such as progressive disability in mul22 tiple sclerosis when alternative therapies 

23 have shown an effect on exacerbations but 

24 have not shown an effect on progressive 

25 disability; 


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1 (iii) an ability— 

2 (I) to provide one or more bene3 fits in patients who are unable to tol4 erate or are unresponsive to alter5 native therapies, such as an 

6 antipsychotic agent that is effective in 

7 people failing standard therapy; or 

8 (II) to be used effectively in com9 bination with other critical agents 

10 that cannot be combined with alter11 native therapies; 

12 (iv) an ability to provide one or more 

13 benefits similar to those of alternative 

14 therapies while— 

15 (I) avoiding serious toxicity that 

16 is present in alternative therapies; or 

17 (II) avoiding less serious toxicity 

18 that is common in alternative thera19 pies and causes discontinuation of 

20 treatment of a life-threatening or seri21 ous disease; or 

22 (v) an ability to provide one or more 

23 benefits similar to those of alternative 

24 therapies but with improvement in some 

25 factor, such as compliance or convenience, 


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1 that is shown to lead to improved effects 

2 on serious outcomes. 

3 (2) The term ‘‘Director’’ means the Under Sec4 retary of Commerce for Intellectual Property and 

5 Director of the United States Patent and Trade6 mark Office. 

7 (3) The term ‘‘dormant therapy’’ means a med8 icine designated as a dormant therapy under sub9 section (a). 

10 (4) The term ‘‘protection period’’ for a dormant 

11 therapy means the period that— 

12 (A) begins on the date on which the Sec13 retary first approves an application under sec14 tion 505(b) of the Federal Food, Drug, and 

15 Cosmetic Act (21 U.S.C. 355(b)) or section 

16 351(a) of the Public Health Service Act (42 

17 U.S.C. 262(a)) for the dormant therapy for any 

18 indication; and 

19 (B) ends on the date that is 15 years after 

20 the date of such approval. 

21 (5) The term ‘‘sponsor’’ for a dormant therapy 

22 is the person who takes responsibility for the des23 ignation and development of the dormant therapy. 

24 The sponsor may be a single entity or an entity col25 laborating with one or more other entities. 


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1 SEC. 202. STUDY REGARDING NEW INDICATIONS FOR EX2 ISTING THERAPIES. 

3 Not later than one year after the date of the enact4 ment of this Act, the Secretary shall enter into an ar5 rangement with the Institute of Medicine (or, if the Insti6 tute declines, another appropriate entity)— 

7 (1) to conduct a study on intellectual property 

8 laws and their impact on therapy and diagnostic de9 velopment in order to formulate recommendations on 

10 how to facilitate the clinical evaluation and develop11 ment of therapies currently available on the market 

12 for new potential indications; and 

13 (2) not later than 18 months after such date of 

14 the enactment, to submit a report to the Secretary 

15 and the Congress containing the results of such 

16 study. 

Æ 


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