I 

113TH CONGRESS 

1ST SESSION H. R. 3116 

To promote the development of meaningful treatments for patients. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 17, 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 of the following agencies 

15 (or 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.—In determining the payment amount under 

11 gapfilling procedures (as described in section 

12 414.508(b) of title 42, Code of Federal Regulations, 

13 or any successor regulation to such section) for new 

14 clinical diagnostic laboratory tests under section 

15 1833(h)(8) of the Social Security Act (42 U.S.C. 

16 1395l(h)(8)), the Secretary of Health and Human 

17 Services (in this section referred to as the ‘‘Sec18 retary’’) shall take into account, as applicable and 

19 available, the following factors with respect to such 

20 a new test: 

21 (A) IMPACT ON PATIENT CARE.—The im22 pact of the new test on patient care, patient 

23 management, or patient treatment. 

24 (B) TECHNICAL CHARACTERISTICS.—The 

25 technical characteristics of the new test, and 


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1 the resources required to develop, validate, and 

2 perform the new test. 

3 (C) CLAIMS DATA.—Data from claims for 

4 which payment is made under part B of title 

5 XVIII of the Social Security Act. 

6 (D) LABORATORY CHARGES.—Amounts 

7 charged by laboratories to self-pay patients for 

8 the new test. 

9 (E) PRIVATE INSURANCE RATES.— 

10 Amounts paid to laboratories for such new test 

11 under private health insurance coverage offered 

12 in the group market and the individual market. 

13 (F) ADVISORY PANEL RECOMMENDA14 TIONS.—The findings and recommendations of 

15 the independent advisory panel convened under 

16 paragraph (2) with respect to that new test and 

17 any comments received during the open meeting 

18 of the advisory panel. 

19 (G) ADDITIONAL FACTORS.—Such other 

20 factors as the Secretary may specify. 

21 (2) INPUT FROM PATIENTS, CLINICIANS, AND

22 TECHNICAL EXPERTS.— 

23 (A) REQUIREMENT FOR INDEPENDENT AD24 VISORY PANEL.—The Secretary shall convene 

25 an independent advisory panel from which the 


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1 Secretary shall request information and rec2 ommendations regarding any new test (as re3 ferred to under subparagraph (A) of section 

4 1833(h)(8) of the Social Security Act (42 

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

6 made under such section, including technical, 

7 clinical, and quality information. 

8 (B) COMPOSITION OF INDEPENDENT ADVI9 SORY PANEL.—Subject to subparagraph (D), 

10 the independent advisory panel shall be com11 prised of 19 members, including— 

12 (i) 7 individuals with expertise and ex13 perience with clinical diagnostic laboratory 

14 tests including expertise in the technical 

15 characteristics of the new test as well as 

16 expertise in the requirements to develop, 

17 validate, and perform 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) 2 laboratorians; 


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1 (v) 2 individuals with expertise in the 

2 area of pharmacoeconomics or health tech3 nology assessment; and 

4 (vi) 2 individuals with expertise on the 

5 impact of new tests on quality of patient 

6 care, including genetic counselors. 

7 (C) TERMS.—Subject to subparagraph 

8 (D), a member of the panel shall be appointed 

9 to serve a term of 6 years, except with respect 

10 to the members first appointed, whose terms of 

11 appointment shall be staggered evenly over 2- 

12 year increments. 

13 (D) TEMPORARY APPOINTMENT OF EX14 PERTS.—Insofar as the Secretary determines 

15 with respect to a new test that there are an in16 sufficient number of members of the panel with 

17 expertise with respect to that specific test, the 

18 Secretary may appoint individuals who have ex19 pertise pertaining to the new test involved to 

20 serve on the panel. 

21 (E) OPEN MEETINGS.—The Secretary shall 

22 receive or review the findings and recommenda23 tions of the independent advisory panel with re24 spect to the new tests described in subpara25 graph (A) involved during a meeting open to 


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1 the public and provide opportunity for public 

2 comment. 

3 (F) CLARIFICATION OF AUTHORITY OF

4 SECRETARY TO CONSULT CARRIERS.—Nothing 

5 in this section shall be construed as affecting 

6 the authority of the Secretary to consult with 

7 appropriate Medicare administrative contrac8 tors. 

9 (3) JUSTIFICATION FOR PAYMENT DETERMINA10 TIONS.— 

11 (A) INITIAL JUSTIFICATION.—With respect 

12 to decisions regarding payments made under 

13 the clinical laboratory fee schedule for new clin14 ical diagnostic laboratory tests, the Secretary 

15 shall publicly provide a justification for the pay16 ment basis and payment rate determination, in17 cluding a detailed summary of the information 

18 submitted to, or obtained by, the Secretary re19 garding the factors specified in paragraph (1), 

20 such that interested stakeholders can readily 

21 understand the Secretary’s rationale for the 

22 payment basis and rate determinations. 

23 (B) RECONSIDERATION PERIOD.—After 

24 providing such justification for a payment basis 

25 and payment rate determination, the Secretary 


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1 shall provide for a reasonable period of recon2 sideration to receive any appeal of the deter3 mination and to evaluate any additional infor4 mation received regarding the justification and 

5 the factors specified in paragraph (1). 

6 (C) FINAL DETERMINATION.—After the 

7 period of reconsideration the Secretary shall 

8 make a final payment basis and payment rate 

9 determination and provide a justification for 

10 such final determination explaining what addi11 tional information was evaluated during the re12 consideration and how such information was 

13 taken into account with respect to the final de14 termination. Nothing in this paragraph shall be 

15 construed as authorizing the Secretary to reveal 

16 proprietary information which is otherwise pro17 hibited from disclosure under law. 

18 (b) PROCESS FOR ASSIGNMENT OF TEMPORARY

19 CODES FOR DIAGNOSTIC TESTS.—The Secretary shall es20 tablish a process for application for the assignment of a 

21 temporary national HCPCS code to uniquely identify a di22 agnostic test until a permanent national HCPCS code is 

23 available for assignment to that test. Assignments of a 

24 temporary national HCPCS code shall occur on a quar25 terly basis. The Secretary shall provide public notice 


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1 through the Centers for Medicare & Medicaid Services 

2 Web site of applications made for such temporary national 

3 HCPCS codes. Upon assignment of a temporary code 

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

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

6 Security Act. 

7 (c) DEVELOPMENT OF FURTHER IMPROVEMENTS IN

8 RATE-SETTING PROCESSES.—The Secretary shall analyze 

9 the process used for the gapfilling procedure used in deter10 mining payment amounts for new clinical diagnostic lab11 oratory tests under section 1833(h)(8) of the Social Secu12 rity Act. Taking into account the changes made by this 

13 section, the Secretary shall identify further changes to im14 prove the accuracy and appropriateness of resulting rates 

15 and the openness, transparency, and predictability of the 

16 process. The Secretary shall examine what and how many 

17 entities should perform gapfilling, under contract or other18 wise, and how to ensure that the process is informed by 

19 appropriate expertise and proceeds in a transparent and 

20 accountable manner. The Secretary shall implement im21 provements in the process, insofar as these are possible 

22 under the law through regulations, after public notice and 

23 opportunity for comment. For changes the Secretary de24 termines would require a change in law, the Secretary 

25 shall transmit recommendations to the Speaker of the 


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1 House and the President of the Senate not later than July 

2 1, 2014. 

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

4 (1) NEW CLINICAL DIAGNOSTIC LABORATORY

5 TESTS.—The term ‘‘new clinical diagnostic labora6 tory test’’ means a clinical diagnostic laboratory 

7 test— 

8 (A) that is assigned a new or substantially 

9 revised code on or after January 1, 2013; or 

10 (B) for which a temporary national 

11 HCPCS code is granted under subsection (b) on 

12 or after January 1, 2014. 

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

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

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

16 such item or service and who does not have health 

17 insurance coverage for such item or service. 

18 (e) EFFECTIVE DATE.— 

19 (1) IN GENERAL.—Subject to paragraph (2), 

20 this section shall take effect on the date of enact21 ment of this Act and shall apply with respect to new 

22 clinical diagnostic laboratory tests. 

23 (2) APPLICATION OF JUSTIFICATIONS TO CUR24 RENT RATE DETERMINATIONS.—Subsection (a)(3) 


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1 shall apply to payment basis and payment rate de2 terminations made on or after January 1, 2013. 

3 SEC. 103. PROMOTING THE DEVELOPMENT OF INNOVATIVE 

4 DIAGNOSTICS. 

5 (a) DETERMINATION.— 

6 (1) REQUEST.—The manufacturer or sponsor 

7 of a medicine may request the Secretary to deter8 mine that— 

9 (A) a diagnostic test has been developed 

10 by, or with the participation of, the manufac11 turer or sponsor of the medicine; and 

12 (B) use of the diagnostic test, as dem13 onstrated through valid scientific information 

14 such as peer-reviewed literature— 

15 (i) provides for or improves the identi16 fication of a patient population for which 

17 the medicine will or will not be used in ac18 cordance with its approved indications; 

19 (ii) provides for or improves the deter20 mination of the most appropriate treat21 ment option for a patient population with 

22 the medicine in accordance with its ap23 proved indications; or 

24 (iii) provides for the detection of a 

25 qualifying pathogen (as defined in section 


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1 505E(f) of the Federal Food, Drug, and 

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

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

4 30 days after the submission of a request under 

5 paragraph (1), the Secretary, shall— 

6 (A) make the requested determination and 

7 publish a notice of such determination and any 

8 extension under this section resulting from such 

9 determination; or 

10 (B) provide an explanation to the manufac11 turer or sponsor submitting the request of why 

12 the determination is not warranted. 

13 (b) APPLICABLE EXTENSION PERIOD.—For purposes 

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

15 is— 

16 (1) with respect to a diagnostic test developed 

17 (as described in subsection (a)(1)(A)) contempora18 neously with the development of the medicine in19 volved, 12 months; and 

20 (2) with respect to a diagnostic test developed 

21 otherwise, 6 months. 

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

23 the manufacturer or sponsor of a drug, the Secretary 

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

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


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

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

3 505 of the Federal Food, Drug, and Cosmetic Act 

4 (21 U.S.C. 355), the three-year periods described in 

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

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

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

8 section 527 of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 360cc), as applicable, shall be 

10 extended by the applicable extension period; 

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

12 (A) a listed patent for which a certification 

13 has been submitted under subsection 

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

15 505; or 

16 (B) a listed patent for which a certification 

17 has been submitted under subsection 

18 (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of such sec19 tion 505, 

20 then the period during which an application may not 

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

22 such section 505 shall be extended by the applicable 

23 extension period after the date the patent expires 

24 (including any patent extensions); and 


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

2 for which a certification has been submitted under 

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

4 section 505, and in the patent infringement litiga5 tion resulting from the certification the court deter6 mines that the patent is valid and would be in7 fringed, the period during which an application may 

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

9 of such section 505 shall be extended by the applica10 ble extension period after the date the patent expires 

11 (including any patent extension). 

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

13 the request of the manufacturer or sponsor of a biological 

14 product, the Secretary makes the determination described 

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

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

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

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

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

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

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

22 shall be extended by the applicable extension period. 

23 (e) RELATION TO PEDIATRIC EXCLUSIVITY.—Any 

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

25 in addition to any extension of the period under section 


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1 505A of the Federal Food, Drug, and Cosmetic Act (21 

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

3 (f) LIMITATIONS.—Extensions under this section 

4 may apply— 

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

6 same medicine; and 

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

8 same indication to be treated by the same medicine. 

9 TITLE II—CAPTURING LOST 

10 OPPORTUNITIES FOR PATIENTS 

11 SEC. 201. DORMANT THERAPIES. 

12 (a) DESIGNATION AS DORMANT THERAPY.—The 

13 Secretary shall designate a medicine as a dormant therapy 

14 if— 

15 (1) the sponsor of the medicine submits a re16 quest for such designation meeting the requirements 

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

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

19 (2) the Secretary determines that— 

20 (A) the medicine is being investigated or is 

21 intended to be investigated for an indication to 

22 address one or more unmet medical needs; 

23 (B) a suitable clinical plan for such inves24 tigations of the medicine has been developed by 

25 the sponsor; 


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1 (C) the sponsor intends to file an applica2 tion pursuant to section 505(b) of the Federal 

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

4 355(b)) or section 351(a) of the Public Health 

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

6 licensing of the medicine for an indication de7 scribed in subparagraph (A); and 

8 (D) the request for designation was made 

9 on or before the date of submission of any ap10 plication under section 505 of the Federal 

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

12 or section 351 of the Public Health Service Act 

13 (42 U.S.C. 262) for the approval or licensure of 

14 commercial marketing or use of a medicine that 

15 in the case of a drug shares an active moiety 

16 that is the same as, and in the case of a bio17 logic contains an active moiety that is highly 

18 similar to, an active moiety in the medicine for 

19 which designation is being requested. 

20 (b) REQUIREMENTS FOR REQUEST FOR DESIGNA21 TION AS DORMANT THERAPY.—A request under sub22 section (a)(1) with respect to a medicine may only be made 

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

24 the following: 


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

2 patents under which the sponsor has rights and that 

3 may be reasonably construed to provide protection 

4 for the medicine. 

5 (2) A waiver of patent rights to the extent re6 quired under subsection (c) to take effect, if at all, 

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

8 (3) Such additional information as the Sec9 retary may require by regulation in order to deter10 mine eligibility for designation under subsection (a). 

11 (c) WAIVER OF PATENT RIGHTS EXPIRING AFTER

12 THE PROTECTION PERIOD ENDS.— 

13 (1) PATENT WAIVER.— 

14 (A) IN GENERAL.—Subject to subpara15 graph (B), the request under this subsection 

16 shall include a waiver of the right to enforce or 

17 otherwise assert any patent described in sub18 section (b)(1) (or any patent issued on the basis 

19 of an application described in subsection 

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

21 protection period for the dormant therapy, 

22 against any applicable product described in 

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

24 owner of the patent or application for patent, 

25 as the case may be. 


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1 (B) LIMITATIONS ON PATENT WAIVER.— 

2 Any patent waiver provided pursuant to this 

3 section, should it become effective— 

4 (i) shall have no effect during the pro5 tection period for the medicine to which 

6 the waiver relates; and 

7 (ii) shall have no effect with respect to 

8 the subject matter of a claimed invention 

9 in a patent that does not provide any pro10 tection for such medicine with respect to 

11 an applicable product described in para12 graph (2). 

13 (2) APPLICABLE PRODUCTS DESCRIBED.—An 

14 applicable product is described in this paragraph 

15 only if— 

16 (A) it is approved or licensed pursuant to 

17 an application that— 

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

19 505(j) of the Federal Food, Drug, and 

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

21 section 351(k) of the Public Health Service 

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

23 (ii) references or otherwise relies upon 

24 the approval or licensure of the dormant 

25 therapy to which the waiver relates; and 


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1 (B) the approval of the product occurs 

2 after the expiration of the protection period ap3 plicable to the medicine to which the request 

4 under subsection (a)(1) relates. 

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

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

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

8 publishes the notice required under subsection 

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

10 (d) WITHDRAWAL OF REQUEST FOR DESIGNATION, 

11 REVOCATION BY THE SECRETARY.— 

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

13 may withdraw a request for designation under sub14 section (a)(1) with respect to a medicine unless the 

15 medicine has been approved or licensed under sec16 tion 505 of the Federal Food, Drug, and Cosmetic 

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

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

19 shall deny a designation request or revoke any des20 ignation granted if at any time the Secretary finds 

21 that the sponsor is not in compliance with sub22 sections (c)(1) and (g)(1). 

23 (2) EFFECTS OF WITHDRAWAL OF REQUEST OR

24 REVOCATION OF DESIGNATION.—If the sponsor of a 

25 medicine withdraws a request under subsection (b) 


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1 or the Secretary denies a designation request or re2 vokes a designation with respect to the medicine— 

3 (A) any patent waiver submitted under 

4 this section with respect to the medicine, but 

5 not yet effective, is canceled and deemed a nul6 lity; 

7 (B) any patent waiver that has taken ef8 fect under this section with respect to the medi9 cine shall remain in effect; 

10 (C) any patent term extension granted by 

11 the Director under subsection (e)(2) with re12 spect to the medicine shall be canceled, except 

13 that the Director shall maintain the patent 

14 term extension for one patent, to be selected by 

15 the sponsor of the medicine, for the period of 

16 extension that would have been applicable under 

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

18 (D) the designation, if made, otherwise 

19 shall be treated as never having been requested 

20 or made or having effect. 

21 (3) BASIS FOR REVOCATION.—The Secretary 

22 may revoke a designation made under subsection 

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

24 under paragraph (1). 


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1 (e) GUARANTEED PROTECTIONS FOR DORMANT

2 THERAPIES.— 

3 (1) APPLICATIONS FILED DURING THE PROTEC4 TION PERIOD.—During the protection period for a 

5 dormant therapy, notwithstanding any other provi6 sion of the Federal Food, Drug, and Cosmetic Act 

7 (21 U.S.C. 301 et seq.) or the Public Health Service 

8 Act (42 U.S.C. 201 et seq.)— 

9 (A) absent a right of reference from the 

10 holder of such approved application for the dor11 mant therapy, the Secretary shall not approve 

12 an application filed pursuant to section 

13 505(b)(2) or section 505(j) of the Federal 

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

15 355(b)(2), (j)) or section 351(k) of the Public 

16 Health Service Act (42 U.S.C. 262(k)) ref17 erencing or otherwise relying on the approval or 

18 licensure of the dormant therapy; 

19 (B) the Secretary shall not approve— 

20 (i) an application filed pursuant to 

21 such section 505(b)(2) or 505(j) that ref22 erences or otherwise relies on the approval 

23 or licensure of a medicine that is not the 

24 dormant therapy, was approved subsequent 

25 to the approval of the dormant therapy, 


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1 and contains the same active moiety as the 

2 active moiety in the dormant therapy (or if 

3 the dormant therapy contains more than 

4 one active moiety, all of the active moieties 

5 are the same); or 

6 (ii) an application filed pursuant to 

7 such section 351(k) that references or oth8 erwise relies on the approval or licensure of 

9 a medicine that is not the dormant ther10 apy, was approved subsequent to the ap11 proval or licensure of the dormant therapy, 

12 and contains an active moiety that is high13 ly similar to the active moiety in the dor14 mant therapy (or if the dormant therapy 

15 contains more than one active moiety, all 

16 of the active moieties are highly similar); 

17 and 

18 (C) the Secretary shall not approve an ap19 plication filed pursuant to section 505(b)(1) of 

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

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

22 same active moiety as the active moiety in the 

23 dormant therapy (or if the dormant therapy 

24 contains more than one active moiety, all of the 

25 active moieties are the same), or an application 


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

2 Health Service Act (42 U.S.C. 262(a)) for a bi3 ological product that contains an active moiety 

4 that is highly similar to the active moiety in the 

5 dormant therapy (or if the dormant therapy 

6 contains more than one active moiety, all of the 

7 active moieties are highly similar), unless— 

8 (i) the information provided to sup9 port approval of such application is com10 parable in scope and extent, including with 

11 respect to design and extent of preclinical 

12 and clinical testing, to the information pro13 vided to support approval of the applica14 tion for the dormant therapy under section 

15 505(b) of the Federal Food, Drug and 

16 Cosmetic Act (21 U.S.C. 355(b)) or sec17 tion 351(a) of the Public Health Service 

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

19 (ii) if such clinical testing had not 

20 commenced before the approval of the ap21 plication for the dormant therapy, the clin22 ical testing establishes clinical superiority 

23 in the form of a significant therapeutic ad24 vantage over and above that provided by 


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1 the dormant therapy in one or more of the 

2 following ways: 

3 (I) Greater effectiveness on a 

4 clinically meaningful endpoint. 

5 (II) Greater safety in a substan6 tial portion of the target populations. 

7 (III) Where neither greater safe8 ty nor greater effectiveness has been 

9 shown, a demonstration that the drug 

10 otherwise makes a major contribution 

11 to patient care. 

12 (2) PATENT TERM ALIGNMENT WITH DATA

13 PACKAGE PROTECTION PERIOD.— 

14 (A) IN GENERAL.—Notwithstanding any 

15 provision of title 35, United States Code, a 

16 sponsor of a medicine designated as a dormant 

17 therapy under subsection (a)(1), upon the ap18 proval or licensure thereof under section 505 of 

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

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

21 Service Act (42 U.S.C. 262), and in lieu of fil22 ing a patent term extension application under 

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

24 to patent term extensions in accordance with 

25 this paragraph. 


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1 (B) SUBMISSION OF FINAL LISTING OF

2 PATENTS AND APPLICATIONS FOR PATENTS

3 FOLLOWING APPROVAL.— 

4 (i) SUBMISSION.—The sponsor of the 

5 dormant therapy, within a period to be set 

6 by the Director of not less than 2 months 

7 beginning on the date the Secretary ap8 proves or licenses the dormant therapy, 

9 shall submit to the Director— 

10 (I) the listing of patents and ap11 plications for patents provided to the 

12 Secretary under subsection (b)(1); 

13 (II) any revisions to such listing 

14 as may be required for compliance 

15 with subsection (b)(1); and 

16 (III) any documentation the Di17 rector may require from the patentee 

18 or patent applicant (as the case may 

19 be) of the waiver of patent rights re20 quired under subsection (b)(2). 

21 (ii) FAILURE TO PROVIDE SUFFICIENT

22 DOCUMENTATION OF WAIVER.—If the Di23 rector determines that the sponsor has not 

24 complied with the waiver requirements 

25 under subsection (c), after providing the 


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1 sponsor the opportunity to remedy any in2 sufficiency, the Director shall so notify the 

3 Secretary that the patent waiver require4 ments for designation have not been satis5 fied. 

6 (C) EXTENSION OF PATENTS.— 

7 (i) IN GENERAL.—Unless the Director 

8 has notified the Secretary of a determina9 tion under subparagraph (B)(ii), for each 

10 patent identified in a submission pursuant 

11 to subparagraph (B)(i), and for each pat12 ent issuing based upon an application for 

13 patent so identified, the Director shall, 

14 within the 3-month period beginning on 

15 the date of the submission, extend the pat16 ent to expire at the end of the protection 

17 period for the dormant therapy, if the pat18 ent would otherwise expire before the end 

19 of the protection period. If the Director 

20 has so notified the Secretary under sub21 paragraph (B)(ii), the Director shall ex22 tend one such patent, selected by the spon23 sor, for the period that would have been 

24 applicable had an application for extension 

25 been filed under section 156 of title 35, 


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1 United States Code, with respect to such 

2 patent. 

3 (ii) APPLICATION OF CERTAIN PROVI4 SIONS.—During the period of an extension 

5 under clause (i)— 

6 (I) the rights under the patent 

7 shall be limited in the manner pro8 vided under section 156(b) of title 35, 

9 United States Code; and 

10 (II) the terms ‘‘product’’ and 

11 ‘‘approved product’’ in such section 

12 156(b) shall be deemed to include 

13 forms of the active moiety of the dor14 mant therapy and highly similar ac15 tive moieties that might be approved 

16 by the Secretary based upon an appli17 cation filed under section 505(b)(2) or 

18 505(j) of the Federal Food, Drug, 

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

20 355(b)(2), (j)) or under section 

21 351(k) of the Public Health Service 

22 Act (42 U.S.C. 262(k)) that ref23 erences or otherwise relies upon the 

24 dormant therapy. 


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1 (D) INTERIM PATENT EXTENSIONS.—Not2 withstanding any provision of title 35, United 

3 States Code, with respect to any patent listed 

4 (or patent issuing on an application listed) 

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

6 expire before the sponsor could make a submis7 sion under subparagraph (B), the Director, 

8 upon application of the patentee, shall grant to 

9 the patentee an interim extension of such pat10 ent, subject to the limitations in section 

11 156(d)(5)(F) of such title 35, for such period 

12 as may be necessary to permit the sponsor to 

13 submit the listing under subparagraph (B) and, 

14 if the patent is therein listed, to extend the pat15 ent as provided under subparagraph (C). The 

16 Director may require, for any patent extended 

17 under this subparagraph, that the sponsor of 

18 the dormant therapy to which the patent relates 

19 provide periodic certifications that development 

20 of the dormant therapy is continuing. The Di21 rector may terminate any interim extension for 

22 which a required certification has not been 

23 made. 

24 (E) NOTICE OF EXTENSION.—For each 

25 patent that is extended under this paragraph, 


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1 the Director shall publish a notice of such ex2 tension and issue a certificate of extension de3 scribed in section 156(e)(1) of title 35, United 

4 States Code. 

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

6 identified in a submission under subparagraph 

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

8 application for patent so identified, that expires 

9 after the end of the protection period for the 

10 dormant therapy, the Director shall publish a 

11 notice that the patent is subject to the limited 

12 waiver of the right to enforce described in sub13 section (c)(1). 

14 (f) CERTAIN FDA PROTECTIONS INAPPLICABLE.—If 

15 a medicine has been designated as a dormant therapy 

16 under subsection (a), the protections otherwise applicable 

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

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

19 (21 U.S.C. 355a, 355f, 360cc) shall not apply. The pre20 ceding sentence shall not be construed to affect any pro21 tections applicable with respect to a drug, including a drug 

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

23 360bb) for a rare disease or condition, under provisions 

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

25 (g) DEVELOPMENT CERTIFICATIONS.— 


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

2 that the sponsor of a dormant therapy provide peri3 odic certifications that development of the dormant 

4 therapy to address one or more unmet medical needs 

5 is continuing. 

6 (2) DETERMINATION OF NONCOMPLIANCE.—If 

7 the Secretary concludes that the sponsor has not 

8 complied with paragraph (1), after providing the 

9 sponsor the opportunity to remedy any insufficiency, 

10 the Secretary shall, for purposes of subsection 

11 (d)(1), determine that the sponsor is not in compli12 ance with the certification requirement under para13 graph (1). 

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

15 be construed as preventing a sponsor from collaborating 

16 with other entities in developing a dormant therapy or ap17 plying for a dormant therapy designation. 

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

19 (1) The term ‘‘address one or more unmet med20 ical needs’’ refers to— 

21 (A) addressing a need for medicines for 

22 the treatment of one or more life-threatening or 

23 other serious diseases or conditions for which 

24 no therapy exists; or 


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1 (B) if one or more therapies are available 

2 for the treatment of such a disease or condition, 

3 demonstrating through clinical investigations— 

4 (i) one or more improved effects on 

5 serious outcomes of the disease or condi6 tion that are affected by alternative thera7 pies, such as superiority of the medicine 

8 used alone or in combination with other 

9 therapies in an active controlled trial as10 sessing an endpoint reflecting serious mor11 bidity; 

12 (ii) one or more effects on serious out13 comes of the disease or condition not 

14 known to be affected by alternative thera15 pies, such as progressive disability in mul16 tiple sclerosis when alternative therapies 

17 have shown an effect on exacerbations but 

18 have not shown an effect on progressive 

19 disability; 

20 (iii) an ability— 

21 (I) to provide one or more bene22 fits in patients who are unable to tol23 erate or are unresponsive to alter24 native therapies, such as an 


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1 antipsychotic agent that is effective in 

2 people failing standard therapy; or 

3 (II) to be used effectively in com4 bination with other critical agents 

5 that cannot be combined with alter6 native therapies; 

7 (iv) an ability to provide one or more 

8 benefits similar to those of alternative 

9 therapies while— 

10 (I) avoiding serious toxicity that 

11 is present in alternative therapies; or 

12 (II) avoiding less serious toxicity 

13 that is common in alternative thera14 pies and causes discontinuation of 

15 treatment of a life-threatening or seri16 ous disease; or 

17 (v) an ability to provide one or more 

18 benefits similar to those of alternative 

19 therapies but with improvement in some 

20 factor, such as compliance or convenience, 

21 that is shown to lead to improved effects 

22 on serious outcomes. 

23 (2) The term ‘‘Director’’ means the Under Sec24 retary of Commerce for Intellectual Property and 


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1 Director of the United States Patent and Trade2 mark Office. 

3 (3) The term ‘‘dormant therapy’’ means a med4 icine designated as a dormant therapy under sub5 section (a). 

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

7 therapy means the period that— 

8 (A) begins on the date on which the Sec9 retary first approves an application under sec10 tion 505(b) of the Federal Food, Drug, and 

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

12 351(a) of the Public Health Service Act (42 

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

14 indication; and 

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

16 the date of such approval. 

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

18 is the person who takes responsibility for the des19 ignation and development of the dormant therapy. 

20 The sponsor may be a single entity or an entity col21 laborating with one or more other entities. 

22 SEC. 202. STUDY REGARDING NEW INDICATIONS FOR EX23 ISTING THERAPIES. 

24 Not later than one year after the date of the enact25 ment of this Act, the Secretary shall enter into an arVerDate Mar 15 2010 00:27 Sep 19, 2013 Jkt 029200 PO 00000 Frm 00037 Fmt 6652 Sfmt 6201 E:\BILLS\H3116.IH H3116

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1 rangement with the Institute of Medicine (or, if the Insti2 tute declines, another appropriate entity)— 

3 (1) to conduct a study on intellectual property 

4 laws and their impact on therapy and diagnostic de5 velopment in order to formulate recommendations on 

6 how to facilitate the clinical evaluation and develop7 ment of therapies currently available on the market 

8 for new potential indications; and 

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

10 the enactment, to submit a report to the Secretary 

11 and the Congress containing the results of such 

12 study. 

Æ 


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