II 

113TH CONGRESS 

2D SESSION S. 3004 

To promote the development of meaningful treatments for patients. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 11, 2014 

Mr. HATCH (for himself and Mr. BENNET) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

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 ‘‘Dormant Therapies 

5 Act of 2014’’. 

6 SEC. 2. TABLE OF CONTENTS. 

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

Sec. 1. Short title. 

Sec. 2. Table of contents. 

Sec. 3. Definitions. 

Sec. 4. Capturing lost opportunities and creating new cures for patients. 

Sec. 5. Implementation and effect. 


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1 SEC. 3. DEFINITIONS. 

2 In this Act: 

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

4 meaning given to that term in section 351 of the 

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

6 (2) The term ‘‘Director’’ means the Under Sec7 retary of Commerce for Intellectual Property and 

8 Director of the United States Patent and Trade9 mark Office. 

10 (3) The term ‘‘dormant therapy’’ means a med11 icine designated as a dormant therapy under section 

12 4(a). 

13 (4) The term ‘‘drug’’ has the meaning given to 

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

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

16 (5) The term ‘‘medicine’’ means a biological 

17 product or a drug. 

18 (6) The term ‘‘protection period’’, with respect 

19 to a dormant therapy, means the period that— 

20 (A) begins on the date on which the Sec21 retary first approves an application under sec22 tion 505(b) of the Federal Food, Drug, and 

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

24 351(a) of the Public Health Service Act (42 

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

26 indication; and 


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

2 the date of such approval. 

3 (7) The term ‘‘Secretary’’ means the Secretary 

4 of Health and Human Services. 

5 (8) The term ‘‘sponsor’’, with respect to a dor6 mant therapy, is the person who takes responsibility 

7 for the designation and development of the dormant 

8 therapy. The sponsor may be a single entity or an 

9 entity collaborating with one or more other entities. 

10 SEC. 4. CAPTURING LOST OPPORTUNITIES AND CREATING 

11 NEW CURES FOR PATIENTS. 

12 (a) DESIGNATION AS A 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) at the time the request for designation 

9 is made, the medicine for which designation is 

10 being requested contains, in the case of a drug 

11 an active moiety that is not the same as, and 

12 in the case of a biological product an active 

13 moiety that is not highly similar to, an active 

14 moiety in a medicine for which an application 

15 under section 505 of the Federal Food, Drug, 

16 and Cosmetic Act (21 U.S.C. 355) or section 

17 351 of the Public Health Service Act (42 

18 U.S.C. 262) has been submitted. 

19 (b) REQUIREMENTS FOR REQUEST FOR DESIGNA20 TION AS DORMANT THERAPY.—A request under sub21 section (a)(1) with respect to a medicine may be made only 

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

23 the following: 

24 (1) A listing of all United States patents and 

25 applications for patents under which the sponsor has 


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1 rights and that may be reasonably construed to pro2 vide protection for the medicine. 

3 (2) A waiver of patent rights to the extent re4 quired under subsection (c) to take effect, if at all, 

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

6 (3) Such additional information as the Sec7 retary may require by regulation in order to deter8 mine eligibility for designation under subsection (a). 

9 (c) WAIVER OF PATENT RIGHTS EXPIRING AFTER

10 THE PROTECTION PERIOD ENDS.— 

11 (1) PATENT WAIVER.— 

12 (A) IN GENERAL.—Subject to subpara13 graph (B), the request under this subsection 

14 shall include a waiver of the right to enforce or 

15 otherwise assert any patent described in sub16 section (b)(1) (or any patent issued on the basis 

17 of an application described in subsection 

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

19 protection period for the dormant therapy, 

20 against any applicable product described in 

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

22 owner of the patent or application for patent, 

23 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 or licensure of the prod2 uct occurs after the expiration of the protection 

3 period applicable to the medicine to which the 

4 request 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 subsection 

22 (c)(1) or (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 of 

18 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 of a medicine that is not the dormant ther24 apy, was approved subsequent to the ap25 proval of the dormant therapy, and conVerDate Sep 11 2014 19:40 Dec 16, 2014 Jkt 049200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S3004.IS S3004

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1 tains the same active moiety as the active 

2 moiety in the dormant therapy (or if the 

3 dormant therapy contains more than one 

4 active moiety, all of the active moieties are 

5 the same); or 

6 (ii) an application filed pursuant to 

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

9 that is not the dormant therapy, was li10 censed subsequent to the licensure of the 

11 dormant therapy, and contains an active 

12 moiety that is highly similar to the active 

13 moiety in the dormant therapy (or if the 

14 dormant therapy contains more than one 

15 active moiety, all of the active moieties are 

16 highly similar); and 

17 (C) the Secretary shall not approve an ap18 plication filed pursuant to section 505(b)(1) of 

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

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

21 same active moiety as the active moiety in the 

22 qualifying medicine (or if the qualifying medi23 cine contains more than one active moiety, all 

24 of the active moieties are the same), or an ap25 plication filed pursuant to section 351(a) of the 


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

2 for a biological product that contains an active 

3 moiety that is highly similar to the active moi4 ety in the qualifying medicine (or if the quali5 fying medicine contains more than one active 

6 moiety, all of the active moieties are highly 

7 similar), unless the information provided to 

8 support approval of such application is com9 parable in scope and extent, including with re10 spect to design and extent of preclinical and 

11 clinical testing, to the information provided to 

12 support approval of the application for the 

13 qualifying medicine under section 505(b) of the 

14 Federal Food, Drug, and Cosmetic Act (21 

15 U.S.C. 355(b)) or section 351(a) of the Public 

16 Health Service Act (42 U.S.C. 262(a)). 

17 (2) PATENT TERM ALIGNMENT WITH DATA

18 PACKAGE PROTECTION PERIOD.— 

19 (A) IN GENERAL.—Notwithstanding any 

20 provision of title 35, United States Code, a 

21 sponsor of a medicine designated as a dormant 

22 therapy under subsection (a)(1), upon the ap23 proval or licensure thereof under section 505 of 

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

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


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1 Service Act (42 U.S.C. 262), and in lieu of fil2 ing a patent term extension application under 

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

4 to patent term extensions in accordance with 

5 this paragraph. 

6 (B) SUBMISSION OF FINAL LISTING OF

7 PATENTS AND APPLICATIONS FOR PATENTS

8 FOLLOWING APPROVAL OR LICENSURE.— 

9 (i) SUBMISSION.—The sponsor of the 

10 dormant therapy, within a period to be set 

11 by the Director of not less than 2 months 

12 beginning on the date the Secretary ap13 proves or licenses the dormant therapy, 

14 shall submit to the Director— 

15 (I) the listing of patents and ap16 plications for patents provided to the 

17 Secretary under subsection (b)(1); 

18 (II) any revisions to such listing 

19 as may be required for compliance 

20 with subsection (b)(1); and 

21 (III) any documentation the Di22 rector may require from the patentee 

23 or patent applicant (as the case may 

24 be) of the waiver of patent rights re25 quired under subsection (b)(2). 


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1 (ii) FAILURE TO PROVIDE SUFFICIENT

2 DOCUMENTATION OF WAIVER.—If the Di3 rector determines that the sponsor has not 

4 complied with the waiver requirements 

5 under subsection (c), after providing the 

6 sponsor the opportunity to remedy any in7 sufficiency, the Director shall so notify the 

8 Secretary that the patent waiver require9 ments for designation have not been satis10 fied. 

11 (C) EXTENSION OF PATENTS.— 

12 (i) IN GENERAL.—Unless the Director 

13 has notified the Secretary of a determina14 tion under subparagraph (B)(ii), for each 

15 patent identified in a submission pursuant 

16 to subparagraph (B)(i), and for each pat17 ent issuing based upon an application for 

18 patent so identified, the Director shall, 

19 within the 3-month period beginning on 

20 the date of the submission, extend the pat21 ent to expire at the end of the protection 

22 period for the dormant therapy, if the pat23 ent would otherwise expire before the end 

24 of the protection period. If the Director 

25 has so notified the Secretary under subVerDate Sep 11 2014 19:40 Dec 16, 2014 Jkt 049200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S3004.IS S3004

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1 paragraph (B)(ii), the Director shall ex2 tend one such patent, selected by the spon3 sor, for the period that would have been 

4 applicable had an application for extension 

5 been filed under section 156 of title 35, 

6 United States Code, with respect to such 

7 patent. 

8 (ii) APPLICATION OF CERTAIN PROVI9 SIONS.—During the period of an extension 

10 under clause (i)— 

11 (I) the rights under the patent 

12 shall be limited in the manner pro13 vided under section 156(b) of title 35, 

14 United States Code; and 

15 (II) the terms ‘‘product’’ and 

16 ‘‘approved product’’ in such section 

17 156(b) shall be deemed to include 

18 forms of the active moiety of the dor19 mant therapy and highly similar ac20 tive moieties that might be approved 

21 or licensed by the Secretary based 

22 upon an application filed under sec23 tion 505(b)(2) or 505(j) of the Fed24 eral Food, Drug, and Cosmetic Act 

25 (21 U.S.C. 355(b)(2), (j)) or under 


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1 section 351(k) of the Public Health 

2 Service Act (42 U.S.C. 262(k)) that 

3 references or otherwise relies upon the 

4 dormant therapy. 

5 (D) INTERIM PATENT EXTENSIONS.—Not6 withstanding any provision of title 35, United 

7 States Code, with respect to any patent listed 

8 (or patent issuing on an application listed) 

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

10 expire before the sponsor could make a submis11 sion under subparagraph (B), the Director, 

12 upon application of the patentee, shall grant to 

13 the patentee an interim extension of such pat14 ent, subject to the limitations in section 

15 156(d)(5)(F) of such title 35, for such period 

16 as may be necessary to permit the sponsor to 

17 submit the listing under subparagraph (B) and, 

18 if the patent is therein listed, to extend the pat19 ent as provided under subparagraph (C). The 

20 Director may require, for any patent extended 

21 under this subparagraph, that the sponsor of 

22 the dormant therapy to which the patent relates 

23 provide periodic certifications that development 

24 of the dormant therapy is continuing. The Di25 rector may terminate any interim extension for 


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1 which a required certification has not been 

2 made. 

3 (E) NOTICE OF EXTENSION.—For each 

4 patent that is extended under this paragraph, 

5 the Director shall publish a notice of such ex6 tension and issue a certificate of extension de7 scribed in section 156(e)(1) of title 35, United 

8 States Code. 

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

10 identified in a submission under subparagraph 

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

12 application for patent so identified, that expires 

13 after the end of the protection period for the 

14 dormant therapy, the Director shall publish a 

15 notice that the patent is subject to the limited 

16 waiver of the right to enforce described in sub17 section (c)(1). 

18 (f) CERTAIN FDA PROTECTIONS INAPPLICABLE.—If 

19 a medicine has been designated as a dormant therapy 

20 under subsection (a), the protections otherwise applicable 

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

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

23 (21 U.S.C. 355a, 355f, 360cc) shall not apply. The pre24 ceding sentence shall not be construed to affect any pro25 tections applicable with respect to a medicine, including 


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1 a medicine designated under section 526 of such Act (21 

2 U.S.C. 360bb) for a rare disease or condition, under provi3 sions other than such sections 505A, 505E, and 527. 

4 (g) DEVELOPMENT CERTIFICATIONS.— 

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

6 that the sponsor of a dormant therapy provide a cer7 tification that the clinical plan under subsection 

8 (a)(2)(B) has been completed, and, that the initial 

9 marketing approval or licensure for the qualifying 

10 medicine was based on the investigations set forth in 

11 such clinical plan (including modifications to the ini12 tial plan approved by the Food and Drug Adminis13 tration). Prior to receiving such certifications, the 

14 Secretary shall require periodic certifications that 

15 the clinical plan under subsection (a)(2)(B) is con16 tinuing. 

17 (2) DETERMINATION OF NONCOMPLIANCE.—If 

18 the Secretary concludes that the sponsor has not 

19 complied with paragraph (1), after providing the 

20 sponsor the opportunity to remedy any insufficiency, 

21 the Secretary shall, for purposes of subsection 

22 (d)(1), determine that the sponsor is not in compli23 ance with the certification requirement under para24 graph (1). 


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

2 be construed as preventing a sponsor from collaborating 

3 with other entities in developing a dormant therapy or ap4 plying for a dormant therapy designation. 

5 SEC. 5. IMPLEMENTATION AND EFFECT. 

6 (a) EFFECTIVE DATE.—Subject to the provisions of 

7 this section, this Act shall take effect on the date of enact8 ment. 

9 (b) IMPLEMENTING REGULATIONS.—The Secretary, 

10 in consultation with the Secretary of Commerce, shall pro11 mulgate such regulations and finalize such guidance as 

12 necessary to implement the provisions of section 4. Such 

13 regulations or guidance shall take effect 18 months after 

14 the date of enactment of this Act. 

15 (c) LIMITATION ON DETERMINATIONS AND DESIGNA16 TIONS.—Notwithstanding any provision of section 4, the 

17 Secretary may not make a determination on a request for 

18 designation by a manufacturer or sponsor under section 

19 4(a) prior to the effective date of the regulations under 

20 subsection (b) or 30 months after the date of enactment 

21 of this Act, whichever occurs first, and the Secretary may 

22 not designate a medicine under section 4(a) unless the re23 quirement under section 4(a)(2)(D) is met for such medi24 cine as of the effective date of the regulations under subVerDate Sep 11 2014 19:40 Dec 16, 2014 Jkt 049200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6201 E:\BILLS\S3004.IS S3004

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1 section (b) or 30 months after the date of enactment of 

2 this Act, whichever occurs first. 

Æ 


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