I 

108TH CONGRESS 

1ST SESSION H. R. 2640

To provide greater access to affordable pharmaceuticals, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 26, 2003

Mr. KENNEDY of Rhode Island (for himself, Mr. FROST, and Ms. NORTON) 

introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and 

Means, 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 provide greater access to affordable pharmaceuticals, and 

for other purposes.

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 ‘‘Prescription Afford5 ability and Medicine Safety Act of 2003’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds as follows: 
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1 (1) Although prescription drugs represent one 

2 of the increasingly used medical care interventions in 

3 treating common acute and chronic diseases, many 

4 Americans, especially the elderly and other vulner5 able populations, are often unable to afford their 

6 medication because of excessive and persistent drug 

7 price inflation. 

8 (2) In 1999, the top 5 pharmaceutical compa9 nies allocated a higher proportion of their revenue to 

10 their income than to research and development. 

(3) In 2000, over 1 11 ⁄3 of the most frequently pre12 scribed drugs for seniors rose in price at a rate that 

13 was 3 times the rate of inflation. 

14 (4) Prescription drug manufacturers continue 

15 to make enormous profits on the backs of Ameri16 cans. 

17 (5) Because of the limited availability of private 

18 or public prescription drug coverage for the elderly, 

19 prescription drugs represent the highest out-of-pock20 et medical care cost for 3 of 4 elderly patients, sur21 passed only by the cost of long-term care services. 

22 (6) Ninety percent of Americans who are 60 

23 years of age or older take 1 or more medications 

24 daily. 
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1 (7) According to a recent study, around 60 per2 cent of doctors say that patients somewhat often 

3 talk with them about specific disease or treatment 

4 they heard about from prescription drug advertise5 ments. 

6 (8) The National Institutes of Health, the Gov7 ernment’s most important health research arm, has 

8 helped develop almost all of the 50 top-selling drugs 

9 from 1992 through 1997 for a cost of over 

10 $175,000,000. 

11 (9) The pharmaceutical industry makes large 

12 profits off the sale of drugs produced from the ben13 efit of research paid for by the United States and, 

14 aside from royalties, none of such profits are reim15 bursed to United States taxpayers. 

16 (10) Only 24 percent of people over age 45 al17 ways ask their pharmacist about drug side effects. 

18 (11) Only 31 percent of people over age 45 al19 ways ask their pharmacists about cost-saving generic 

20 equivalents for new prescriptions. 

21 SEC. 3. GENERIC DRUG APPLICATION REVIEW. 

22 For the purpose of enabling the Food and Drug Ad23 ministration to employ additional staff for the Office of 

24 Generic Drugs to review abbreviated applications for the 

25 approval of new drugs under section 505(j) of the Federal 
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1 Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)), and 

2 for the purpose of otherwise providing for accelerated re3 views of such applications, there is authorized to be appro4 priated $5,000,000 for each fiscal year, in addition to 

5 other authorizations of appropriations that are available 

6 for such purposes. 

7 SEC. 4. GENERIC DRUG EDUCATION. 

8 For the purpose of enabling the Food and Drug Ad9 ministration, through the Office of Generic Drugs, to con10 tinue the education program started in fiscal year 2001 

11 on the use and therapeutic equivalency of drugs approved 

12 under section 505(j) of the Federal Food, Drug, and Cos13 metic Act (21 U.S.C. 355(j)), there is authorized to be 

14 appropriated $1,000,000 for each fiscal year, in addition 

15 to other authorizations of appropriations that are available 

16 for such purpose. 

17 SEC. 5. PRESCRIPTION DRUG ASSISTANCE PROGRAM; 

18 PROFITS FROM RESEARCH. 

19 The Public Health Service Act (42 U.S.C. 201 et 

20 seq.) is amended by adding at the end the following:

21 ‘‘TITLE XXIX—PHARMACY 

22 ASSISTANCE 

23 ‘‘SEC. 2901. GRANTS. 

24 ‘‘(a) AUTHORIZATION.—From amounts available 

25 from the revolving fund established under section 2903, 
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1 the Secretary may make grants to States for the purpose 

2 of providing pharmacy assistance as described in sub3 section (b). 

4 ‘‘(b) USE OF FUNDS.—A grant may be made under 

5 subsection (a) only if the State involved agrees that funds 

6 received under the grant will be used—

7 ‘‘(1) to provide outreach services and education 

8 regarding an existing State pharmacy benefit assist9 ance program; or 

10 ‘‘(2) to establish or expand such a program. 

11 ‘‘(c) APPLICATION.—To seek a grant under this sec12 tion, a State shall submit an application to the Secretary 

13 at such time, in such manner, and accompanied by such 

14 information as the Secretary may reasonably require. 

15 ‘‘(d) STATE DEFINED.—For purposes of this section, 

16 the term ‘State’ means any of the several States, the Dis17 trict of Columbia, the Commonwealth of Puerto Rico, the 

18 Commonwealth of the Northern Mariana Islands, Amer19 ican Samoa, Guam, the Virgin Islands, or any other terri20 tory or possession of the United States.

21 ‘‘SEC. 2902. PROFITS FROM RESEARCH. 

22 ‘‘(a) IN GENERAL.—Subject to subsection (b), the 

23 Secretary shall not approve any covered application for the 

24 approval of a biological product under section 351 of this 

25 Act or of a drug under section 505 of the Federal Food, 
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1 Drug, and Cosmetic Act unless the manufacturer submit2 ting the application enters into an agreement with the Sec3 retary that—

4 ‘‘(1) requires the manufacturer to pay the Sec5 retary 7 percent of the gross amount received by the 

6 manufacturer from sales of such biological product 

7 or drug; and 

8 ‘‘(2) specifies the manner in which such gross 

9 amount will be determined. 

10 ‘‘(b) EXCEPTION.—The Secretary may waive the ap11 plication of subsection (a) to a manufacturer of a biologi12 cal product or drug when the Secretary determines that 

13 it would be in the public interest to exempt such manufac14 turer. 

15 ‘‘(c) COVERED APPLICATION.—For purposes of this 

16 section, the term ‘covered application’ means an applica17 tion that includes the results of research carried out—

18 ‘‘(1) by an entity of the National Institutes of 

19 Health; or 

20 ‘‘(2) under an agreement under section 12 of 

21 the Stevenson-Wydler Technology Innovation Act of 

22 1980. 

23 ‘‘SEC. 2903. REVOLVING FUND. 

24 ‘‘(a) ESTABLISHMENT.—There is hereby established 

25 in the Treasury a revolving fund which shall consist of 
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1 the amounts deposited by the Secretary under subsection 

2 (b). 

3 ‘‘(b) DEPOSIT OF FUNDS.—The Secretary shall de4 posit in the fund established under this section all pay5 ments made to the Secretary under an agreement pursu6 ant to section 2902(a)(1). 

7 ‘‘(c) USE OF AMOUNTS IN FUND.—To the extent or 

8 in the amounts made available in advance in appropria9 tions Acts, amounts in the fund established under this sec10 tion shall be available to the Secretary to make grants 

11 under section 2901.’’. 

12 SEC. 6. LIMITATION ON DEDUCTIONS FOR ADVERTISING BY 

13 PRESCRIPTION DRUG MANUFACTURERS. 

14 (a) IN GENERAL.—Part IX of subchapter B of chap15 ter 1 of subtitle A of the Internal Revenue Code of 1986 

16 (relating to items not deductible) is amended by adding 

17 at the end the following: 

18 ‘‘SEC. 280I. LIMITATION ON DEDUCTIONS FOR ADVER19 TISING BY PRESCRIPTION DRUG MANUFAC20 TURERS. 

21 ‘‘(a) IN GENERAL.—No deduction shall be allowed 

22 under this chapter for any taxable year for any expendi23 ture relating to the advertising, promoting, or marketing 

24 (in any medium) of any prescription drug manufactured 

25 by the taxpayer to the extent the aggregate amount of 
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1 such expenditures exceeds 50 percent of the taxpayer’s ag2 gregate research and development expenditures for such 

3 taxable year. 

4 ‘‘(b) DEFINITIONS AND SPECIAL RULES.—For pur5 poses of this section: 

6 ‘‘(1) PRESCRIPTION DRUGS.—The term ‘pre7 scription drug’ means any drug subject to section 

8 503(b)(1) of the Federal Food, Drug, and Cosmetic 

9 Act. 

10 ‘‘(2) RESEARCH AND DEVELOPMENT EXPENDI11 TURES.—The term ‘research and development ex12 penditures’ means any expenditures that may be 

13 treated as expenses under section 174. 

14 ‘‘(3) AGGREGATION RULES.—All members of 

15 the same controlled group of corporations (within 

16 the meaning of section 52(a)) and all persons under 

17 common control (within the meaning of section 

18 52(b)) shall be treated as 1 person.’’. 

19 (b) CLERICAL AMENDMENT.—The table of sections 

20 for such part IX is amended by adding after the item re21 lating to section 280H the following:

‘‘Sec. 280I. Limitation on deductions for advertising by prescription drug manufacturers.’’.

22 (c) EFFECTIVE DATE.—The amendments made by 

23 this section shall apply to taxable years beginning after 

24 December 31, 2002. 
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1 (d) TRANSFER TO THE FEDERAL HOSPITAL INSUR2 ANCE TRUST FUND OF RESULTING BUDGETARY SAV3 INGS.—There are authorized to be appropriated to the 

4 Federal Hospital Insurance Trust Fund established under 

5 section 1817 of the Social Security Act amounts equal to 

6 the increase in Federal revenues resulting from the 

7 amendment made by subsection (a). Such appropriated 

8 amounts may be transferred from the general fund of the 

9 Treasury on the basis of estimates of such revenues made 

10 by the Secretary of the Treasury. 

11 SEC. 7. LIMITATION OF 30-MONTH STAY TO CERTAIN PAT12 ENTS. 

13 (a) ABBREVIATED NEW DRUG APPLICATIONS.—

14 (1) IN GENERAL.—Clause (iii) of section 

15 505(j)(5)(B) of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 355(j)(5)(B)) is amended to 

17 read as follows: 

18 ‘‘(iii) If the applicant made a certification de19 scribed in subclause (IV) of paragraph (2)(A)(vii): 

20 ‘‘(I) If such certification concerns a patent 

21 (other than a patent that claims a process for 

22 manufacturing the listed drug) for which patent 

23 information was submitted under subsection 

24 (b), the approval shall be made effective imme25 diately unless an action is brought for infringe-
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1 ment of a patent which is the subject of the cer2 tification before the expiration of 45 days from 

3 the date the notice provided under paragraph 

4 (2)(B)(i) is received. If such an action is 

5 brought before the expiration of such days, the 

6 approval shall be made effective upon the expi7 ration of the 30-month period beginning on the 

8 date of the receipt of the notice provided under 

9 paragraph (2)(B)(i) or such shorter or longer 

10 period as the court may order because either 

11 party to the action failed to reasonably cooper12 ate in expediting the action, except that—

13 ‘‘(aa) if before the expiration of such 

14 period the court decides that such patent is 

15 invalid or not infringed, the approval shall 

16 be made effective on the date of the court 

17 decision;

18 ‘‘(bb) if before the expiration of such 

19 period the court decides that such patent 

20 has been infringed, the approval shall be 

21 made effective on such date as the court 

22 orders under section 271(e)(4)(A) of title 

23 35, United States Code; or 

24 ‘‘(cc) if before the expiration of such 

25 period the court grants a preliminary in-
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1 junction prohibiting the applicant from en2 gaging in the commercial manufacture or 

3 sale of the drug until the court decides the 

4 issues of patent validity and infringement 

5 and if the court decides that such patent 

6 is invalid or not infringed, the approval 

7 shall be made effective on the date of such 

8 court decision. 

9 ‘‘In such an action, each of the parties shall 

10 reasonably cooperate in expediting the action. 

11 Until the expiration of 45 days from the date 

12 the notice made under paragraph (2)(B)(i) is 

13 received, no action may be brought under sec14 tion 2201 of title 28, United States Code, for 

15 a declaratory judgment with respect to the pat16 ent. Any action brought under such section 

17 2201 shall be brought in the judicial district 

18 where the defendant has its principal place of 

19 business or a regular and established place of 

20 business. The 30-month period provided under 

21 the second sentence of this clause shall not 

22 apply to a certification under paragraph 

23 (2)(A)(vii)(IV) made with respect to a patent 

24 for which patent information was submitted 

25 under subsection (c)(2).
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1 ‘‘(II) If the certification referred to at the 

2 beginning of this clause concerns a patent 

3 (other than a patent that claims a process for 

4 manufacturing the listed drug) for which patent 

5 information was submitted under subsection 

6 (c)(2), the approval shall be made effective on 

7 the date that is 45 days after the date on which 

8 the notice provided under paragraph (2)(B) is 

9 received, unless a civil action for infringement 

10 of the patent, accompanied by a motion for pre11 liminary injunction to enjoin the applicant from 

12 engaging in the commercial manufacture or sale 

13 of the drug, is filed on or before such date, in 

14 which case the approval shall be made effec15 tive— 

16 ‘‘(aa) on the date of a court action de17 clining to grant a preliminary injunction; 

18 or 

19 ‘‘(bb) if the court has granted a pre20 liminary injunction prohibiting the appli21 cant from engaging in the commercial 

22 manufacture or sale of the drug— 

23 ‘‘(AA) on issuance by a court of 

24 a determination that the patent is in25 valid or is not infringed; 
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1 ‘‘(BB) on issuance by a court of 

2 an order revoking the preliminary in3 junction or permitting the applicant to 

4 engage in the commercial manufac5 ture or sale of the drug; or 

6 ‘‘(CC) on the date specified in a 

7 court order under section 

8 271(e)(4)(A) of title 35, United 

9 States Code, if the court determines 

10 that the patent is infringed. 

11 ‘‘Each of the parties shall reasonably cooperate 

12 in expediting a civil action under this subclause. 

13 If the notice under paragraph (2)(B) contains 

14 an address for the receipt of expedited notifica15 tion of a civil action under this subclause, the 

16 plaintiff shall, on the date on which the com17 plaint is filed, simultaneously cause a notifica18 tion of the civil action to be delivered to that 

19 address by the next business day.’’. 

20 (2) FAILURE TO BRING INFRINGEMENT AC21 TION.—Paragraph (5) of section 505(j) of the Fed22 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

23 355(j)) is amended by adding at the end the fol24 lowing: 
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1 ‘‘(E) If, in connection with an application under this 

2 subsection, the applicant provides an owner of a patent 

3 notice under paragraph (2)(B) with respect to the patent, 

4 and the owner of the patent fails to bring a civil action 

5 against the applicant for infringement of the patent on 

6 or before the date that is 45 days after the date on which 

7 the notice is received, the owner of the patent shall be 

8 barred from bringing a civil action for infringement of the 

9 patent in connection with the development, manufacture, 

10 use, offer to sell, or sale of the drug for which the applica11 tion was filed or approved under this subsection.’’. 

12 (b) OTHER APPLICATIONS.—

13 (1) IN GENERAL.—Subparagraph (C) of section 

14 505(c)(3) of the Federal Food, Drug, and Cosmetic 

15 Act (21 U.S.C. 355(c)(3)) is amended to read as fol16 lows: 

17 ‘‘(C) If the applicant made a certification de18 scribed in subsection (b)(2)(A)(iv): 

19 ‘‘(i) If such certification concerns a patent 

20 (other than a patent that claims a process for 

21 manufacturing the listed drug) for which patent 

22 information was submitted under subsection 

23 (b), the approval shall be made effective imme24 diately unless an action is brought for infringe25 ment of a patent which is the subject of the cer-
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1 tification before the expiration of 45 days from 

2 the date the notice provided under subsection 

3 (b)(3)(A) is received. If such an action is 

4 brought before the expiration of such days, the 

5 approval may be made effective upon the expi6 ration of the 30-month period beginning on the 

7 date of the receipt of the notice provided under 

8 subsection (b)(3)(A) or such shorter or longer 

9 period as the court may order because either 

10 party to the action failed to reasonably cooper11 ate in expediting the action, except that—

12 ‘‘(I) if before the expiration of such 

13 period the court decides that such patent is 

14 invalid or not infringed, the approval shall 

15 be made effective on the date of the court 

16 decision;

17 ‘‘(II) if, before the expiration of such 

18 period, the court decides that such patent 

19 has been infringed, the approval shall be 

20 made effective on such date as the court 

21 orders under section 271(e)(4)(A) of title 

22 35, United States Code; or 

23 ‘‘(III) if before the expiration of such 

24 period the court grants a preliminary in25 junction prohibiting the applicant from en-
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1 gaging in the commercial manufacture or 

2 sale of the drug until the court decides the 

3 issues of patent validity and infringement 

4 and if the court decides that such patent 

5 is invalid or not infringed, the approval 

6 shall be made effective on the date of such 

7 court decision. 

8 ‘‘In such an action, each of the parties shall 

9 reasonably cooperate in expediting the action. 

10 Until the expiration of 45 days from the date 

11 the notice made under subsection (b)(3)(A) is 

12 received, no action may be brought under sec13 tion 2201 of title 28, United States Code, for 

14 a declaratory judgment with respect to the pat15 ent. Any action brought under such section 

16 2201 shall be brought in the judicial district 

17 where the defendant has its principal place of 

18 business or a regular and established place of 

19 business. The 30-month period provided under 

20 the second sentence of this subparagraph shall 

21 not apply to a certification under subsection 

22 (b)(2)(A)(iv) made with respect to a patent for 

23 which patent information was submitted under 

24 subsection (c)(2).
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1 ‘‘(ii) If the certification referred to at the 

2 beginning of this subparagraph concerns a pat3 ent (other than a patent that claims a process 

4 for manufacturing the listed drug) for which 

5 patent information was submitted under sub6 section (c)(2), the approval shall be made effec7 tive on the date that is 45 days after the date 

8 on which the notice provided under subsection 

9 (b)(3) is received, unless a civil action for in10 fringement of the patent, accompanied by a mo11 tion for preliminary injunction to enjoin the ap12 plicant from engaging in the commercial manu13 facture or sale of the drug, is filed on or before 

14 such date, in which case the approval shall be 

15 made effective— 

16 ‘‘(I) on the date of a court action de17 clining to grant a preliminary injunction; 

18 or 

19 ‘‘(II) if the court has granted a pre20 liminary injunction prohibiting the appli21 cant from engaging in the commercial 

22 manufacture or sale of the drug— 

23 ‘‘(aa) on issuance by a court of a 

24 determination that the patent is in25 valid or is not infringed; 
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1 ‘‘(bb) on issuance by a court of 

2 an order revoking the preliminary in3 junction or permitting the applicant to 

4 engage in the commercial manufac5 ture or sale of the drug; or 

6 ‘‘(cc) on the date specified in a 

7 court order under section 

8 271(e)(4)(A) of title 35, United 

9 States Code, if the court determines 

10 that the patent is infringed. 

11 ‘‘Each of the parties shall reasonably cooperate 

12 in expediting a civil action under this clause. If 

13 the notice under subsection (b)(3) contains an 

14 address for the receipt of expedited notification 

15 of a civil action under this clause, the plaintiff 

16 shall, on the date on which the complaint is 

17 filed, simultaneously cause a notification of the 

18 civil action to be delivered to that address by 

19 the next business day.’’. 

20 (2) FAILURE TO BRING INFRINGEMENT AC21 TION.—Subsection (c) of section 505 of the Federal 

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

23 355(c)(3)) is amended by adding at the end the fol24 lowing: 
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1 ‘‘(5) If, in connection with an application under sub2 section (b)(2), the applicant provides an owner of a patent 

3 notice under subsection (b)(3) with respect to the patent, 

4 and the owner of the patent fails to bring a civil action 

5 against the applicant for infringement of the patent on 

6 or before the date that is 45 days after the date on which 

7 the notice is received, the owner of the patent shall be 

8 barred from bringing a civil action for infringement of the 

9 patent in connection with the development, manufacture, 

10 use, offer to sell, or sale of the drug for which the applica11 tion was filed or approved under subsection (b)(2).’’. 

12 (c) EFFECTIVE DATE.—The amendments made by 

13 subsections (a) and (b) shall be effective with respect to 

14 any certification under subsection (b)(2)(A)(iv) or 

15 (j)(2)(A)(vii)(IV) of section 505 of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 355) made after the 

17 date of enactment of this Act in an application filed under 

18 subsection (b)(2) or (j) of that section, including with re19 spect to patent information that was submitted to the Sec20 retary before such date under subsection (c)(2) of such 

21 Act. 
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1 SEC. 8. EXCLUSIVITY FOR ACCELERATED GENERIC DRUG 

2 APPLICANTS. 

3 (a) IN GENERAL.—Section 505(j)(5) of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) is 

5 amended—

6 (1) in subparagraph (B)(iv)—

7 (A) in the text preceding subclause (I), by 

8 inserting ‘‘the earlier of—’’ after ‘‘not earlier 

9 than one hundred and eighty days after’’; 

10 (B) by striking ‘‘or’’ at the end of sub11 clause (I); 

12 (C) by striking subclause (II) and all that 

13 follows through the end; and 

14 (D) by adding after subclause (I) the fol15 lowing: 

16 ‘‘(II) the date of a final decision of a court 

17 (from which no appeal has been or can be 

18 taken, other than a petition to the Supreme 

19 Court for a writ of certiorari) holding that the

20 patent that is the subject of the certification is 

21 invalid or not infringed, or 

22 ‘‘(III) the date of a settlement order or 

23 consent decree signed by a Federal judge that 

24 enters a final judgment and includes a finding 

25 that the patent that is the subject of the certifi26 cation is invalid or not infringed.’’; and 
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1 (2) by inserting after subparagraph (D) the fol2 lowing: 

3 ‘‘(E) FORFEITURE OF 180-DAY PERIOD.—

4 ‘‘(i) IN GENERAL.—Except as provided in 

5 clause (ii), if a forfeiture event occurs with respect 

6 to a first application—

7 ‘‘(I) the 180-day period under subpara8 graph (B)(iv) shall be forfeited by the first ap9 plicant; and 

10 ‘‘(II) any subsequent application shall be11 come effective as provided under clause (i), (ii), 

12 or (iii) of subparagraph (B), and clause (iv) of 

13 subparagraph (B) shall not apply to the subse14 quent application. 

15 ‘‘(ii) FORFEITURE TO FIRST SUBSEQUENT AP16 PLICANT.—If the subsequent application that is the 

17 first to be made effective under clause (i) was the 

18 first among a number of subsequent applications to 

19 be filed—

20 ‘‘(I) that first subsequent application shall 

21 be treated as the first application under this 

22 subparagraph (including clause (i)) and as the 

23 previous application under subparagraph 

24 (B)(iv); and
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1 ‘‘(II) any other subsequent applications 

2 shall become effective as provided under clause 

3 (i), (ii), or (iii) of subparagraph (B), but clause 

4 (iv) of subparagraph (B) shall apply to any 

5 such subsequent application. 

6 ‘‘(iii) AVAILABILITY.—The 180-day period 

7 under subparagraph (B)(iv) shall be available to a 

8 first applicant submitting an application for a drug 

9 with respect to any patent without regard to whether 

10 an application has been submitted for the drug 

11 under this subsection containing such a certification 

12 with respect to a different patent. 

13 ‘‘(iv) APPLICABILITY.—The 180-day period de14 scribed in subparagraph (B)(iv) shall apply to an ap15 plication only if a civil action is brought against the 

16 applicant for infringement of a patent that is the 

17 subject of the certification. 

18 ‘‘(v) DEFINITIONS.—In this subparagraph: 

19 ‘‘(I) APPLICATION.—The term ‘application’ 

20 means an application for approval of a drug 

21 under this subsection containing a certification 

22 under paragraph (2)(A)(vii)(IV) with respect to 

23 a patent. 
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1 ‘‘(II) FIRST APPLICATION.—The term 

2 ‘first application’ means the first application to 

3 be filed for approval of the drug. 

4 ‘‘(III) FORFEITURE EVENT.—The term 

5 ‘forfeiture event’, with respect to an application 

6 under this subsection, means the occurrence of 

7 any of the following: 

8 ‘‘(aa) FAILURE TO MARKET.—The ap9 plicant fails to market the drug by the 

10 later of—

11 ‘‘(AA) the date that is 60 days 

12 after the date on which the approval 

13 of the application for the drug is 

14 made effective under clause (iii) of 

15 subparagraph (B) (unless the Sec16 retary extends the date because of ex17 traordinary or unusual cir18 cumstances); or 

19 ‘‘(BB) if 1 or more civil actions 

20 have been brought against the appli21 cant for infringement of a patent sub22 ject to a certification under paragraph 

23 (2)(A)(vii)(IV) or 1 or more civil ac24 tions have been brought by the appli25 cant for a declaratory judgment that 
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1 such a patent is invalid or not in2 fringed, the date that is 60 days after 

3 the date of a final decision (from 

4 which no appeal has been or can be 

5 taken, other than a petition to the Su6 preme Court for a writ of certiorari) 

7 in the last of those civil actions to be 

8 decided (unless the Secretary extends 

9 the date because of extraordinary or 

10 unusual circumstances). 

11 ‘‘(bb) WITHDRAWAL OF APPLICA12 TION.—The applicant withdraws the appli13 cation. 

14 ‘‘(cc) AMENDMENT OF CERTIFI15 CATION.—The applicant, voluntarily or as 

16 a result of a settlement or defeat in patent 

17 litigation, amends the certification from a 

18 certification under paragraph 

19 (2)(A)(vii)(IV) to a certification under 

20 paragraph (2)(A)(vii)(III). 

21 ‘‘(dd) FAILURE TO OBTAIN AP22 PROVAL.—The applicant fails to obtain 

23 tentative approval of an application within 

24 30 months after the date on which the ap-
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1 plication is filed, unless the failure is 

2 caused by—

3 ‘‘(AA) a change in the require4 ments for approval of the application 

5 imposed after the date on which the 

6 application is filed; or 

7 ‘‘(BB) other extraordinary cir8 cumstances warranting an exception, 

9 as determined by the Secretary. 

10 ‘‘(ee) FAILURE TO CHALLENGE PAT11 ENT.—In a case in which, after the date 

12 on which the applicant submitted the ap13 plication, new patent information is sub14 mitted under subsection (c)(2) for the list15 ed drug for a patent for which certification 

16 is required under paragraph (2)(A), the 

17 applicant fails to submit, not later than the 

18 date that is 60 days after the date on 

19 which the Secretary publishes the new pat20 ent information under paragraph 

21 (7)(A)(iii) (unless the Secretary extends

22 the date because of extraordinary or un23 usual circumstances)—

24 ‘‘(AA) a certification described in 

25 paragraph (2)(A)(vii)(IV) with respect 
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1 to the patent to which the new patent 

2 information relates; or 

3 ‘‘(BB) a statement that any 

4 method of use claim of that patent 

5 does not claim a use for which the ap6 plicant is seeking approval under this 

7 subsection in accordance with para8 graph (2)(A)(viii). 

9 ‘‘(ff) UNLAWFUL CONDUCT.—The 

10 Federal Trade Commission determines 

11 that the applicant engaged in unlawful 

12 conduct with respect to the application in 

13 violation of section 1 of the Sherman Act. 

14 ‘‘(IV) SUBSEQUENT APPLICATION.—The 

15 term ‘subsequent application’ means an applica16 tion for approval of a drug that is filed subse17 quent to the filing of a first application for ap18 proval of that drug.’’. 

19 (b) APPLICABILITY.—The amendment made by sub20 section (a) shall apply only with respect to an application 

21 filed under section 505(j) of the Federal Food, Drug, and 

22 Cosmetic Act (21 U.S.C. 355(j)) after the date of enact23 ment of this Act for a listed drug for which no certification 

24 under section 505(j)(2)(A)(vii)(IV) of that Act was made 

25 before the date of enactment of this Act, except that if 
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1 a forfeiture event described in section 

2 505(j)(5)(E)(v)(III)(ff) of that Act (as amended by this 

3 section) occurs in the case of an applicant, the applicant 

4 shall forfeit the 180-day period under section 

5 505(j)(5)(B)(iv) of that Act without regard to when the 

6 applicant made a certification under section 

7 505(j)(2)(A)(vii)(IV) of that Act. 

8 SEC. 9. BIOEQUIVALENCE. 

9 (a) IN GENERAL.—The amendments to part 320 of 

10 title 21, Code of Federal Regulations, promulgated by the 

11 Commissioner of Food and Drugs on July 17, 1991 (57 

12 Fed. Reg. 17997 (April 28, 1992)), shall continue in effect 

13 as an exercise of authorities under sections 501, 502, 505, 

14 and 701 of the Federal Food, Drug, and Cosmetic Act 

15 (21 U.S.C. 351, 352, 355, 371). 

16 (b) EFFECT.—Subsection (a) does not affect the au17 thority of the Commissioner of Food and Drugs to amend 

18 part 320 of title 21, Code of Federal Regulations. 

19 (c) EFFECT OF SECTION.—This section shall not be 

20 construed to alter the authority of the Secretary of Health 

21 and Human Services to regulate biological products under 

22 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 

23 et seq.). Any such authority shall be exercised under that 

24 Act as in effect on the day before the date of enactment 

25 of this Act. 
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1 SEC. 10. FILING OF PATENT INFORMATION WITH THE FOOD 

2 AND DRUG ADMINISTRATION. 

3 (a) FILING AFTER APPROVAL OF AN APPLICA4 TION.—

5 (1) IN GENERAL.—Section 505 of the Federal 

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

7 amended by section 9(a)(2)(B)(ii)) is amended in 

8 subsection (c) by striking paragraph (2) and insert9 ing the following: 

10 ‘‘(2) PATENT INFORMATION.—

11 ‘‘(A) IN GENERAL.—Not later than the 

12 date that is 30 days after the date of an order 

13 approving an application under subsection (b) 

14 (unless the Secretary extends the date because 

15 of extraordinary or unusual circumstances), the 

16 holder of the application shall file with the Sec17 retary the patent information described in sub18 paragraph (C) with respect to any patent—

19 ‘‘(i)(I) that claims the drug for which 

20 the application was approved; or 

21 ‘‘(II) that claims an approved method 

22 of using the drug; and 

23 ‘‘(ii) with respect to which a claim of 

24 patent infringement could reasonably be 

25 asserted if a person not licensed by the 
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1 owner engaged in the manufacture, use, or 

2 sale of the drug. 

3 ‘‘(B) SUBSEQUENTLY ISSUED PATENTS.—

4 In a case in which a patent described in sub5 paragraph (A) is issued after the date of an 

6 order approving an application under subsection 

7 (b), the holder of the application shall file with 

8 the Secretary the patent information described 

9 in subparagraph (C) not later than the date 

10 that is 30 days after the date on which the pat11 ent is issued (unless the Secretary extends the 

12 date because of extraordinary or unusual cir13 cumstances). 

14 ‘‘(C) PATENT INFORMATION.—The patent 

15 information required to be filed under subpara16 graph (A) or (B) includes—

17 ‘‘(i) the patent number; 

18 ‘‘(ii) the expiration date of the patent; 

19 ‘‘(iii) with respect to each claim of the 

20 patent—

21 ‘‘(I) whether the patent claims 

22 the drug or claims a method of using 

23 the drug; and 

24 ‘‘(II) whether the claim covers—

25 ‘‘(aa) a drug substance; 
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1 ‘‘(bb) a drug formulation; 

2 ‘‘(cc) a drug composition; or 

3 ‘‘(dd) a method of use; 

4 ‘‘(iv) if the patent claims a method of 

5 use, the approved use covered by the claim; 

6 ‘‘(v) the identity of the owner of the 

7 patent (including the identity of any agent 

8 of the patent owner); and 

9 ‘‘(vi) a declaration that the applicant, 

10 as of the date of the filing, has provided 

11 complete and accurate patent information 

12 for all patents described in subparagraph 

13 (A). 

14 ‘‘(D) PUBLICATION.—On filing of patent 

15 information required under subparagraph (A) 

16 or (B), the Secretary shall—

17 ‘‘(i) immediately publish the informa18 tion described in clauses (i) through (iv) of 

19 subparagraph (C); and

20 ‘‘(ii) make the information described 

21 in clauses (v) and (vi) of subparagraph (C) 

22 available to the public on request. 

23 ‘‘(E) CIVIL ACTION FOR CORRECTION OR

24 DELETION OF PATENT INFORMATION.—
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1 ‘‘(i) IN GENERAL.—A person that has 

2 filed an application under subsection (b)(2) 

3 or (j) for a drug may bring a civil action 

4 against the holder of the approved applica5 tion for the drug seeking an order requir6 ing that the holder of the application 

7 amend the application—

8 ‘‘(I) to correct patent information 

9 filed under subparagraph (A); or 

10 ‘‘(II) to delete the patent infor11 mation in its entirety for the reason 

12 that—

13 ‘‘(aa) the patent does not 

14 claim the drug for which the ap15 plication was approved; or 

16 ‘‘(bb) the patent does not 

17 claim an approved method of 

18 using the drug. 

19 ‘‘(ii) LIMITATIONS.—Clause (i) does 

20 not authorize—

21 ‘‘(I) a civil action to correct pat22 ent information filed under subpara23 graph (B); or 

24 ‘‘(II) an award of damages in a 

25 civil action under clause (i).
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1 ‘‘(F) NO CLAIM FOR PATENT INFRINGE2 MENT.—An owner of a patent with respect to 

3 which a holder of an application fails to file in4 formation on or before the date required under 

5 subparagraph (A) or (B) shall be barred from 

6 bringing a civil action for infringement of the 

7 patent against a person that—

8 ‘‘(i) has filed an application under 

9 subsection (b)(2) or (j); or 

10 ‘‘(ii) manufactures, uses, offers to sell, 

11 or sells a drug approved under an applica12 tion under subsection (b)(2) or (j).’’. 

13 (2) TRANSITION PROVISION.—

14 (A) FILING OF PATENT INFORMATION.—

15 Each holder of an application for approval of a 

16 new drug under section 505(b) of the Federal 

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

18 355(b)) that has been approved before the date 

19 of enactment of this Act shall amend the appli20 cation to include the patent information re21 quired under the amendment made by para22 graph (1) not later than the date that is 30 

23 days after the date of enactment of this Act 

24 (unless the Secretary of Health and Human 
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1 Services extends the date because of extraor2 dinary or unusual circumstances). 

3 (B) NO CLAIM FOR PATENT INFRINGE4 MENT.—An owner of a patent with respect to 

5 which a holder of an application under sub6 section (b) of section 505 of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 355) fails 

8 to file information on or before the date re9 quired under subparagraph (A) shall be barred 

10 from bringing a civil action for infringement of 

11 the patent against a person that—

12 (i) has filed an application under sub13 section (b)(2) or (j) of that section; or 

14 (ii) manufactures, uses, offers to sell, 

15 or sells a drug approved under an applica16 tion under subsection (b)(2) or (j) of that 

17 section. 

18 (b) FILING WITH AN APPLICATION.—Section 505 of 

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

20 355) is amended—

21 (1) in subsection (b)(2)—

22 (A) in subparagraph (A), by striking 

23 ‘‘and’’ at the end; 

24 (B) in subparagraph (B), by striking the 

25 period at the end and inserting ‘‘; and’’; and 
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1 (C) by adding at the end the following: 

2 ‘‘(C) with respect to a patent that claims 

3 both the drug and a method of using the drug 

4 or claims more than 1 method of using the drug 

5 for which the application is filed—

6 ‘‘(i) a certification under subpara7 graph (A)(iv) on a claim-by-claim basis; 

8 and 

9 ‘‘(ii) a statement under subparagraph 

10 (B) regarding the method of use claim.’’; 

11 and 

12 (2) in subsection (j)(2)(A), by inserting after 

13 clause (viii) the following: 

14 ‘‘With respect to a patent that claims both the drug and 

15 a method of using the drug or claims more than 1 method 

16 of using the drug for which the application is filed, the 

17 application shall contain a certification under clause 

18 (vii)(IV) on a claim-by-claim basis and a statement under 

19 clause (viii) regarding the method of use claim.’’.

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