I

106TH CONGRESS

1ST SESSION H. R. 1598

To provide a patent term restoration review procedure for certain drug

products.

IN THE HOUSE OF REPRESENTATIVES

APRIL 28, 1999

Mr. BRYANT (for himself, Mr. MCDERMOTT, Mrs. BONO, Mr. DUNCAN, Mr.

WICKER, Mr. JENKINS, Mr. FRANKS of New Jersey, Mr. FORD, Mr.

BLUNT, Mr. WAMP, Mr. HOYER, Mr. ROTHMAN, Mr. MENENDEZ, Mr.

GORDON, Mrs. TAUSCHER, Mr. DELAHUNT, Ms. JACKSON-LEE of Texas,

Ms. ESHOO, Mr. PASTOR, Mr. CONYERS, Mr. SMITH of Texas, Mr.

PAYNE, Mrs. EMERSON, Mr. HILLEARY, and Mr. FRELINGHUYSEN) introduced the following bill; which was 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. SHORT TITLE.

4 This Act may be cited as the ‘‘Patent Fairness Act

5 of 1999’’.
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1 SEC. 2. PATENT TERM RESTORATION REVIEW PROCEDURE

2 FOR CERTAIN DRUG PRODUCTS.

3 (a) PATENT TERM RESTORATION.—

4 (1) IN GENERAL.—Chapter 14 of title 35,

5 United States Code, is amended by inserting after

6 section 155A the following new section:

7 ‘‘§ 155B. Patent term restoration review procedure

8 for certain drug products

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

10 ‘‘(1) the term ‘Commissioner’ means the Com11 missioner of Patents and Trademarks; and

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

13 given such term under section 156(f)(2)(A).

14 ‘‘(b) SPECIAL PATENT TERM REVIEW PROCE15 DURE.—

16 ‘‘(1) IN GENERAL.—The term of any patent, in

17 force on September 24, 1984, and on the date of the

18 filing of an application under this section, that

19 claims—

20 ‘‘(A) a drug product,

21 ‘‘(B) a method of using a drug product, or

22 ‘‘(C) a method of manufacturing a drug

23 product,

24 shall be restored under paragraph (4) from the expi25 ration date of the patent term determined under sec26 tion 154 (including any extension granted under sec-
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1 tion 156) if the Commissioner determines that the

2 standards under paragraph (2) have been met.

3 ‘‘(2) STANDARDS.—Upon application, filed

4 under paragraph (6), by the owner of record of a

5 patent described in paragraph (1) or its agent and

6 consideration of the application and all materials

7 submitted by parties that would be aggrieved by

8 grant of the restoration of the term of such patent,

9 the term of such patent shall be restored if the Com10 missioner determines that—

11 ‘‘(A) the period set forth in section

12 156(g)(1)(B)(ii) for the drug product exceeded

13 60 months; and

14 ‘‘(B) there is no substantial evidence over15 coming the rebuttable presumption that the ap16 plicant for patent term restoration for the drug

17 product acted with due diligence (as such term

18 is defined in section 156(d)(3)) during the pe19 riod referred to in section 156(g)(1)(B)(ii).

20 If the Commissioner determines there is substantial

21 evidence that the applicant for patent term restora22 tion did not act with due diligence during a part of

23 the period referred to in section 156(g)(1)(B)(ii)

24 that part shall be deducted from the total amount
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1 of time in such period for purposes of paragraph

2 (4).

3 ‘‘(3) RECORDS.—The Commissioner may re4 quest and obtain relevant records from the Food and

5 Drug Administration to verify the facts underlying

6 the Commissioner’s determinations under paragraph

7 (2). Such records shall be afforded the same protec8 tions against public disclosure that apply to such

9 records when in the possession of the Food and

10 Drug Administration.

11 ‘‘(4) RESTORATION TERM.—If the Commis12 sioner determines that the standards in paragraph

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

14 patent shall be restored for a restoration period

15 equal to the period set forth in section

16 156(g)(1)(B)(ii) for the drug product that is the

17 subject of an application under paragraph (6), ex18 cept that—

19 ‘‘(A) the restoration period shall be re20 duced by any deduction made pursuant to para21 graph (2);

22 ‘‘(B) if the sum of—

23 ‘‘(i) the remaining term of such pat24 ent after the date of the approval of the

25 drug product covered by the patent under
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1 the provision of law under which the regu2 latory review occurred, and

3 ‘‘(ii) the restoration period as revised

4 under subparagraph (A),

5 exceeds 14 years, the restoration period shall be re6 duced so that the total of such periods does not ex7 ceed 14 years; and

8 ‘‘(C) the restoration period, after any ad9 justment required by subparagraph (A) or (B)

10 plus any previous extension of the patent term

11 under section 156(c), shall not exceed 5 years.

12 ‘‘(5) INFRINGEMENT.—During the period of

13 any restoration granted under this subsection, the

14 rights derived from a patent the term of which is re15 stored shall be determined in accordance with sec16 tions 156(b) and 271.

17 ‘‘(6) PROCEDURE.—

18 ‘‘(A) TIME FOR FILING.—An application

19 under this section shall be filed with the Com20 missioner within 90 days after the date of the

21 enactment of this section.

22 ‘‘(B) FILING AND DETERMINATION.—Upon

23 the filing of an application to the Commissioner

24 under this section—
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1 ‘‘(i) the Commissioner shall publish

2 within 30 days of its filing a notice in the

3 Federal Register of receipt of the applica4 tion;

5 ‘‘(ii) any party who would be ag6 grieved by the granting of a patent term

7 restoration under the application may sub8 mit comments on the application within

9 the 30-day period beginning on the date of

10 publication of the notice under clause (i);

11 ‘‘(iii) within 7 days following the expi12 ration of the 30-day comment period, the

13 Commissioner shall forward a copy of all

14 comments received to the applicant who

15 shall be entitled to submit a response to

16 such comments to the Commissioner within

17 30 days after receipt of the comments

18 from the Commissioner;

19 ‘‘(iv) within 30 days following the re20 ceipt of the applicant’s response to com21 ments or, if there are no such comments,

22 within 30 days following expiration of the

23 30-day comment period, the Commissioner

24 shall, in writing—
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1 ‘‘(I) determine whether to grant

2 the patent term restoration for which

3 the application was filed; and

4 ‘‘(II) make specific findings re5 garding the criteria set forth in para6 graph (2); and

7 ‘‘(V) if the Commissioner grants such

8 patent term restoration, on the same date

9 that the Commissioner makes the deter10 mination under clause (iv) the Commis11 sioner shall—

12 ‘‘(I) issue to the applicant a cer13 tificate of patent term restoration,

14 under seal, for the period prescribed

15 under paragraph (4); and

16 ‘‘(II) record the certificate in the

17 official file of the patent, which cer18 tificate shall be in effect from such

19 date and shall be considered a part of

20 the original patent.

21 ‘‘(C) INTERIM RESTORATION.—If the term

22 of a patent that is the subject of an application

23 filed under this section would otherwise expire

24 before a determination under subparagraph
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1 (B)(iv) is made, the Commissioner shall extend

2 the term of such patent until—

3 ‘‘(i) a determination is made under

4 such subparagraph to restore the term of

5 such patent, or

6 ‘‘(ii) 60 days after a determination is

7 made under such subparagraph to not re8 store the patent term,

9 as applicable. If the Commissioner determines

10 not to restore the patent term, then during the

11 60-day period described in clause (ii), an appli12 cant may apply to the United States Court of

13 Appeals for the Federal Circuit for an order di14 recting the Commissioner to extend the patent

15 pending judicial review and subsequent Com16 missioner action following that review.

17 ‘‘(D) RECORD.—The Commissioner’s de18 termination under subparagraph (B)(iv) shall

19 be based solely on the record developed under

20 this subsection.

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

22 pay a fee for an application made under paragraph

23 (6) which shall be established in accordance with the

24 same criteria applicable to fees required under sec25 tion 156(h). If no such fee has been established at
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1 the time of the application, the applicant may pro2 vide the Commissioner with an undertaking, satis3 factory to the Commissioner, to pay the subse4 quently established fee.’’.

5 (2) TECHNICAL AND CONFORMING AMEND6 MENT.—The table of sections for chapter 14 of title

7 35, United States Code, is amended by inserting

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

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

9 (b) APPEAL OF DETERMINATIONS OF THE COMMIS10 SIONER.—Section 141 of the title 35, United States Code,

11 is amended by adding at the end the following: ‘‘The appli12 cant under section 155B or any aggrieved party that made

13 a submission commenting on an application made under

14 such section may appeal the determination of the Commis15 sioner with respect to the application involved under such

16 section only to the United States Court of Appeals for the

17 Federal Circuit.’’.

18 (c) COURT JURISDICTION.—Section 1295(a)(4) of

19 title 28, United States Code, is amended—

20 (1) in subparagraph (B), by striking ‘‘or’’ after

21 the semicolon;

22 (2) in subparagraph (C), by adding ‘‘or’’ after

23 the semicolon; and

24 (3) by inserting after subparagraph (C) the fol25 lowing:
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1 ‘‘(D) the Commissioner of Patents and

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

3 (d) COMPENSATION.—

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

5 submitted an application described in section

6 505(b)(2) or 505(j) of the Federal Food, Drug, and

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

8 product covered by a patent for which a patent term

9 restoration was provided under section 155B of title

10 35, United States Code (as added by subsection

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

12 Food and Drug Administration on or before the date

13 of the enactment of this section to be sufficiently

14 complete to permit substantive review, such person

15 shall be entitled to compensation of $1,000,000 by

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

17 Master File that has permitted a reference to its

18 Type II Drug Master File to be made in such appli19 cation shall be entitled to compensation of $500,000

20 by the patent owner.

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

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

23 payments exceeding—

24 (A) $5,000,000 to persons submitting ap25 plications described in such paragraph, or
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1 (B) $2,500,000 to holders of Type II Drug

2 Master Files.

3 If the aggregate limits are insufficient to pay the ap4 plicants or holders the full amounts specified in

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

6 paid its per capita share of the aggregate liability

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

8 (e) EFFECT OF FILING OF ABBREVIATED APPLICA9 TIONS.—The fact that one or more applications have been

10 filed under section 505(b)(2) or 505(j) of the Federal

11 Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(2),(j))

12 for approval of a drug or a method of using a drug which

13 is claimed by a patent that is the subject of an application

14 under section 155B of title 35, United States Code, for

15 restoration of the patent term shall not affect the grant

16 of such patent term restoration.

17 (f) REPORT.—Not later than 1 year after the date

18 of the enactment of this section, the Commissioner of Pat19 ents and Trademarks shall submit to Congress a report

20 evaluating the patent term restoration review procedure

21 established under section 155B of title 35, United States

22 Code, and shall include in such report a recommendation

23 whether Congress should consider establishing such a pat24 ent term review procedure for patents not covered by such

25 section.
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1 (g) EFFECTIVE DATE.—The owner of record of a

2 patent referred to in section 155B(b)(1) of title 35, United

3 States Code (as added by subsection (a)(1)) or an agent

4 of the owner shall be immediately eligible on the date of

5 the enactment of this section to submit an application to

6 the Commissioner of Patents and Trademarks for a deter7 mination in accordance with section 155B(b)(6) of such

8 title.

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