II

106TH CONGRESS

1ST SESSION S. 1172

To provide a patent term restoration review procedure for certain drug

products.

IN THE SENATE OF THE UNITED STATES

MAY 27, 1999

Mr. TORRICELLI introduced the following bill; which was read twice and

referred to the Committee on the Judiciary

A BILL

To provide a patent term restoration review procedure for

certain drug products.

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

3 SECTION 1. PATENT TERM RESTORATION REVIEW PROCE4 DURE FOR CERTAIN DRUG PRODUCTS.

5 (a) SHORT TITLE.—This Act may be cited as the

6 ‘‘Drug Patent Term Restoration Review Procedure Act of

7 1999’’.

8 (b) PATENT TERM RESTORATION.—
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1 (1) IN GENERAL.—Chapter 14 of title 35,

2 United States Code, is amended by inserting after

3 section 155A the following new section:

4 ‘‘§ 155B. Patent term restoration review procedure

5 for certain drug products

6 ‘‘(a) DEFINITIONS.—For purposes of this section—

7 ‘‘(1) the term ‘Commissioner’ means the Com8 missioner of Patents and Trademarks; and

9 ‘‘(2) the term ‘drug product’ has the meaning

10 given that term under section 156(f)(2)(A), but does

11 not include drugs or products described under sec12 tion 156(f)(2)(B).

13 ‘‘(b) SPECIAL PATENT TERM REVIEW PROCE14 DURE.—

15 ‘‘(1) IN GENERAL.—

16 ‘‘(A) PATENT RESTORED.—The term of

17 any patent described under subparagraph (B)

18 shall be restored under paragraph (3) from the

19 expiration date determined under section 154

20 (including any extension granted under section

21 156), if the Commissioner determines that the

22 standards under paragraph (2) have been met.

23 ‘‘(B) PATENT.—Subparagraph (A) refers

24 to any patent that—
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1 ‘‘(i) has been extended under section

2 156, subject to the 2–year limitation de3 scribed under section 156(g)(6)(c);

4 ‘‘(ii) is in force on—

5 ‘‘(I) September 24, 1984;

6 ‘‘(II) the date of enactment of

7 this section; and

8 ‘‘(III) the date of filing an appli9 cation under this section; and

10 ‘‘(iii) claims a drug product, a method

11 of using a drug product, or a method of

12 manufacturing a drug product.

13 ‘‘(2) STANDARDS.—

14 ‘‘(A) IN GENERAL.—Upon application by

15 the owner of record of the patent or its agent

16 under paragraph (5) and consideration of the

17 application and all materials submitted by par18 ties that would be aggrieved by grant of the

19 restoration of a patent, the term of a patent de20 scribed in paragraph (1) shall be restored if the

21 Commissioner determines that—

22 ‘‘(i) the period set forth in section

23 156(g)(1)(B)(ii) for the drug product ex24 ceeded 60 months;
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1 ‘‘(ii) the owner of record of the patent

2 or its agent has established by clear and

3 convincing evidence that the patent owner

4 acted with due diligence (as such term is

5 defined in section 156(d)(3) and applied in

6 section 156(d)(2)) during the regulatory

7 review period referred to in section

8 156(g)(1)(B); and

9 ‘‘(iii) granting the patent restoration

10 would not be detrimental to the public in11 terest and the interest of fairness, as de12 fined by the factors set forth in paragraph

13 (7).

14 ‘‘(B) DETERMINATION.—

15 ‘‘(i) DEDUCTION OF TIME.—If the

16 Commissioner determines there is substan17 tial evidence that the patent owner did not

18 act with due diligence during a part of the

19 regulatory review period, that part shall be

20 deducted from the total amount of time in

21 the applicable regulatory review period re22 ferred to in section 156(g)(1)(B), and the

23 resulting period, shall be the basis for cal24 culating the patent restoration term under

25 paragraph (3) of this subsection.
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1 ‘‘(ii) FDA CONSULTATION.—The

2 Food and Drug Administration shall be

3 consulted with respect to the Commis4 sioner’s determinations under subpara5 graph (A) (i), (ii), and (iii). If there is a

6 dispute concerning the underlying facts be7 tween the patent owner and the Food and

8 Drug Administration, the Food and Drug

9 Administration shall make the relevant

10 records of the Administration available to

11 the Commissioner.

12 ‘‘(3) RESTORATION TERM.—If the Commis13 sioner determines that the standards in paragraph

14 (2) have been met for a patent, the term of such

15 patent shall be restored for a period equal to the

16 regulatory review period as defined in section

17 156(g)(1)(B) (taking into account any deduction

18 under paragraph (2)(B)(i)), without taking into ac19 count the 2-year limitation described in section

20 156(g)(6)(C), except that—

21 ‘‘(A) the total of the period of the patent

22 term restoration granted under this section and

23 any patent term extension previously granted

24 under section 156 shall be subject to the time
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1 period limitations described in section

2 156(c)(2)–156 (c)(4) and (g)(6)(A); and

3 ‘‘(B) any patent term extension previously

4 granted under section 156 shall be subtracted

5 from the period of the patent term restoration

6 granted under this subsection.

7 ‘‘(4) INFRINGEMENT.—During the period of

8 any restoration granted under this subsection, the

9 rights derived from a patent the term of which is re10 stored shall be determined in accordance with sec11 tions 156(b) and 271.

12 ‘‘(5) PROCEDURE.—

13 ‘‘(A) TIME FOR FILING.—Any application

14 under this section shall be filed with the Com15 missioner within 90 days after the date of en16 actment of this section.

17 ‘‘(B) FILING.—Upon submission of an ap18 plication to the Commissioner by the owner of

19 record of a patent referred to in paragraph (1)

20 or its agent for a determination in accordance

21 with paragraph (3)—

22 ‘‘(i) the Commissioner shall publish

23 within 30 days after the submission in the

24 Federal Register a notice of receipt of an
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1 application and make the application avail2 able to the public upon request;

3 ‘‘(ii) any interested party may submit

4 comments on the application within the 60-

5 day period beginning on the date of publi6 cation of the notice;

7 ‘‘(iii) within 7 days following the expi8 ration of that 60-day period, the Commis9 sioner shall forward a copy of all com10 ments received to the applicant, who shall

11 be entitled to submit a response to such

12 comments to the Commissioner within 45

13 days after receipt of such comments;

14 ‘‘(iv) within 30 days following receipt

15 of the applicant’s response to comments or,

16 if there are no such comments, within 30

17 days following expiration of the 60-day

18 comment period, the Commissioner shall,

19 in writing—

20 ‘‘(I) determine whether to grant

21 the application; and

22 ‘‘(II) make specific findings re23 garding the criteria set forth in para24 graph (2) (including, where appro25 priate, findings regarding the public
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1 interest and fairness factors set forth

2 in paragraph (7)); and

3 ‘‘(v) if the Commissioner determines

4 that the standards set forth in paragraph

5 (2) have been met, the Commissioner

6 shall—

7 ‘‘(I) issue to the applicant a cer8 tificate of restoration, under seal, for

9 the period prescribed under paragraph

10 (3); and

11 ‘‘(II) record the certificate in the

12 official file of the patent, which cer13 tificate shall be in effect from the date

14 it issues and shall be considered a

15 part of the original patent.

16 ‘‘(C) PATENT TERM DURING REVIEW.—If

17 the term of a patent for which an application

18 has been submitted under this section would ex19 pire before a determination to issue a certificate

20 of restoration is made under subparagraph (B),

21 the Commissioner may extend, until such deter22 mination is made (but not to exceed 1 year) the

23 term of the patent if the Commissioner deter24 mines that the patent likely would be eligible

25 for restoration.
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1 ‘‘(D) RECORD AND REVIEW.—The Com2 missioner’s determination under subparagraph

3 (B)(iv) shall be based solely on the record devel4 oped under this subsection. Except as provided

5 in section 141, the Commissioner’s determina6 tion shall not be reviewable in any court.

7 ‘‘(6) APPLICATION FEE.—The applicant shall

8 pay a fee for an application made under this sub9 section which shall be determined in accordance with

10 the same criteria as the fees established under sec11 tion 156(h).

12 ‘‘(7) PUBLIC INTEREST AND FAIRNESS.—When

13 required to make a determination under paragraph

14 (2)(A)(iii), the Commissioner shall consider each of

15 the following factors and shall not rely solely on any

16 single factor:

17 ‘‘(A) Whether grant of the application

18 would result in the public having no other com19 mercially available alternatives to treat the

20 same disease or condition as the drug claimed

21 in the patent that is the subject of the patent

22 term restoration request.

23 ‘‘(B) Whether grant of the application

24 would disserve society’s interest in the avail25 ability of innovative drugs at competitive prices.
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1 ‘‘(C) Whether denial of the application

2 would disserve society’s interest in encouraging

3 and rewarding pharmaceutical research and in4 novation.

5 ‘‘(D) Whether denial of the application

6 would be unfair to the applicant, in comparison

7 to others who have experienced the benefits of

8 a 5-year patent restoration under section 156

9 while experiencing similar regulatory review

10 delays.

11 ‘‘(E) Whether other manufacturers, before

12 the date of enactment of this section, have sub13 mitted applications under sections 505(b)(2) or

14 (j) of the Federal Food, Drug, and Cosmetic

15 Act that are sufficiently complete to permit

16 substantive review and have made substantial

17 investments to manufacture a generic version of

18 the particular drug that is the subject of the

19 patent term restoration application, which

20 would not receive the compensation specified

21 under subsection (e) of the Drug Patent Term

22 Restoration Review Procedure Act of 1999.’’.

23 (2) TECHNICAL AND CONFORMING AMEND24 MENT.—The table of sections for chapter 14 of title
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1 35, United States Code, is amended by inserting

2 after the item relating to section 155A the following:

‘‘155B. Patent term restoration review procedure for certain drug products.’’.

3 (c) APPEAL OF DETERMINATIONS OF THE COMMIS4 SIONER.—Section 141 of title 35, United States Code, is

5 amended by adding at the end the following: ‘‘The appli6 cant under section 155B, or any aggrieved party that

7 made a submission commenting on an application under

8 section 155B, may appeal the determination of the Com9 missioner under such section to the United States Court

10 of Appeals for the Federal Circuit.’’.

11 (d) COURT JURISDICTION.—

12 (1) COURT OF APPEALS FOR THE FEDERAL

13 CIRCUIT.—Section 1295(a)(4) of title 28, United

14 States Code, is amended—

15 (A) in subparagraph (B), by striking ‘‘or’’

16 after the semicolon;

17 (B) in subparagraph (C), by adding ‘‘or’’

18 after the semicolon; and

19 (C) by inserting after subparagraph (C)

20 the following:

21 ‘‘(D) the Commissioner of Patents and

22 Trademarks under section 155B of title 35;’’.

23 (2) JURISDICTION BASED ON INFRINGEMENT

24 OF PATENT.—Section 271(e) of title 35, United
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1 States Code, is amended by adding at the end the

2 following:

3 ‘‘(5) In any action brought under paragraph (2)

4 involving a patent, the term of which has been re5 stored under section 155B, the alleged infringer

6 shall have the right to seek compensation under sub7 section (e) of the Drug Patent Term Restoration Re8 view Procedure Act of 1999.’’.

9 (e) COMPENSATION.—

10 (1) IN GENERAL.—In the event a person has

11 submitted an application described in section

12 505(b)(2) or 505(j) of the Federal Food, Drug, and

13 Cosmetic Act (21 U.S.C. 355(b)(2),(j)) for a drug

14 product covered by a patent for which a patent term

15 restoration was provided under section 155B of title

16 35, United States Code (as added by subsection

17 (a)(1)) and such application has been found by the

18 Food and Drug Administration on or before the date

19 of the enactment of this section to be sufficiently

20 complete to permit substantive review, such person

21 shall be entitled to compensation of $2,000,000 by

22 the patent owner. Any holder of a Type II Drug

23 Master File that has permitted a reference to its

24 Type II Drug Master File to be made in such appli-
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1 cation shall be entitled to compensation of

2 $1,000,000 by the patent owner.

3 (2) LIMITS ON LIABILITY.—A patent owner

4 shall not be required to make under paragraph (1)

5 payments exceeding—

6 (A) $10,000,000 to persons submitting ap7 plications described in such paragraph, or

8 (B) $5,000,000 to holders of Type II Drug

9 Master Files.

10 If the aggregate limits are insufficient to pay the ap11 plicants or holders the full amounts specified in

12 paragraph (1), each such applicant or holder shall be

13 paid its per capita share of the aggregate liability

14 imposed by paragraph (1) upon the patent holder.

15 (f) EFFECT OF FILING OF ABBREVIATED APPLICA16 TIONS.—The fact that 1 or more abbreviated applications

17 have been filed under section 505 (b) or (j) of the Federal

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

19 for approval of a drug product, which is covered by a pat20 ent that is the subject of an application for term restora21 tion under this section, shall not preclude the grant of

22 such term restoration.

23 (g) REPORT TO CONGRESS.—Not later than 1 year

24 after the effective date of this section, the Commissioner

25 of Patents and Trademarks shall—
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1 (1) submit to Congress a report evaluating the

2 patent term restoration review procedure established

3 under this section; and

4 (2) include in such report a recommendation

5 whether Congress should consider establishing such

6 a patent term restoration review procedure for other

7 patents.

8 (h) EFFECTIVE DATE.—This section shall take effect

9 on the date of enactment of this section and an owner

10 of record of a patent referred to under section 155B(b)(1)

11 of title 35, United States Code (as added by this section);

12 or an agent of the owner shall be immediately eligible on

13 such a date to submit an application to the Commissioner

14 for a determination in accordance with subsection (b)(3)

15 of such section.

16 SEC. 2. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND

17 COSMETIC ACT.

18 (a) LIMITATION ON USE OF PATENTS TO PREVENT

19 ANDA APPROVAL.—

20 (1) APPLICATION.—Section 505(b)(2) of the

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

22 355(b)(2)) is amended by adding at the end the fol23 lowing:

24 ‘‘For an approved product claimed in a patent, the term

25 of which has been restored pursuant to section 155B of
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1 title 35, United States Code, the certification required by

2 subparagraph (A) is limited to any patent that claims an

3 active ingredient, including any salt or ester of the active

4 ingredient, of the approved product, alone or in combina5 tion with another active ingredient.’’.

6 (2) ABBREVIATED APPLICATION.—Section

7 505(j)(2)(A) of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 355(j)(2)(A)) is amended by

9 adding at the end the following:

10 ‘‘For an approved product claimed in a patent, the term

11 of which has been restored pursuant to section 155B of

12 title 35, United States Code, the certification required by

13 clause (vii) is limited to any patent that claims an active

14 ingredient, including any salt or ester of the active ingre15 dient, of the approved product, alone or in combination

16 with another active ingredient.’’.

17 (b) EXCLUSIVITY FOR GENERIC DRUG.—Section

18 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic

19 Act (21 U.S.C. 355(j)(5)(B)(iv)) is amended by inserting

20 after ‘‘containing such certification’’ the following: ‘‘and

21 for which an action for infringement of a patent which

22 is the subject of such a certification has been brought be23 fore the expiration of 45 days from the date of the notice

24 provided under paragraph (2)(B)(i) is received’’.

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