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quote out of the report-"delay or neglect occur, and substantial inequity results." And then Congress should intercede only to make the parties as they would have been without regulatory problems.

Prior to 1984, Congress was confronted with an increasing number of private relief bills that were attached to unrelated pieces of legislation. The ad hoc process that was relied upon to consider bills resulted in the enactment of laws that were never considered by a single congressional Subcommittee or exposed, in fact, to any public scrutiny.

In this context, I do not judge harshly my colleagues who may resort to any and all legislative techniques to achieve their political victories. I also cannot criticize members of the other body who proceed under different rules and different pressures.

But I can say that mistakes have been made. One enacted proposal to extend the life of a single patent, on an artificial sweetener, because of its poor drafting has resulted in the extension of at least 31 patents. That was not anticipated or intended by the Congress.

When we extended patent protection in 1984 for two productsoral hypoglycerenic drugs of the sulfonylura class and a method of producing antibodies in milk-we found that the two bills to achieve this end were poorly drafted. In processing the bills, the Subcommittee did make necessary corrections.

To consider private patent and copyright bills, I prefer the system created by the rules of the House. Public hearings, such as this one, receipt of Administration views, open mark-ups, the amendment process, consideration by Subcommittee, Committee and the full House, are all designed to produce a quality work product and promote the highest standards of the public interest. As an aside, I remind my colleagues that this procedure is precisely the same one we developed for bills relating to the geographic organization of the Federal judiciary.

Before introducing our lead-off witness, I would ask unanimous consent to insert the text of H.R. 3074 in the hearing record. I note that identical legislation to H.R. 3074 was passed by the Senate as Title 36 of the Senate amendment to H.R. 3, the Omnibus Trade Bill and Competitiveness Act of 1987.

[The text of H.R. 3074 follows:]

I

100TH CONGRESS 1ST SESSION

H. R. 3074

To amend title 35, United States Code, with respect to patent term restoration, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

AUGUST 3, 1987

Mr. DERRICK (for himself, Mr. GALLO, Mr. BOUCHER, Mr. COBLE, Mr. SLAUGHTER of Virginia, Mrs. MARTIN of Illinois, Mr. SYNar, Mr. Torricelli, Mr. DE WINE, Mr. RINALDO, Mr. LELAND, and Mr. HUGHES) introduced the following bill; which was referred to the Committee on the Judiciary

A BILL

To amend title 35, United States Code, with respect to patent term restoration, and for other purposes.

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Be it enacted by the Senate and House of Representa

2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

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This Act may be cited as the "Lopid Patent Term Ex

5 tension and Fairness Act of 1987”.

6 SEC. 2. PHARMACEUTICAL PATENT.

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(a) Title 35, United States Code, is amended by adding

8 the following new section:

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1 "§ 155B. Patent term restoration

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"(a) Notwithstanding section 154 of this title, the term 3 of a patent which encompasses within its scope a composition

4 of matter which is a new drug shall be extended for a period

5 of five years, and such patent shall have the effect as if origi6 nally issued with such extended term, if—

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"(1) such composition has been subjected to a reg

ulatory review by the Federal Food and Drug Administration pursuant to the Federal Food, Drug, and Cosmetic Act,

"(2) the Federal Food and Drug Administration has approved a new drug application after receipt of a letter from the applicant stating that a phase IV clini

cal study that had been requested as a condition for

approval has been undertaken,

"(3) the phase IV clinical study has covered at least five years with the study term commencing prior to the introduction of the Drug Price Competition and

Patent Term Restoration Act of 1984 and ending subsequent to the enactment of such Act,

"(4) such phase IV clinical study has been completed, and a supplemental new drug application to expand the permitted indications and usage in the la

beling of the new drug based upon such phase IV clini

cal study has been submitted to the Federal Food and

Drug Administration, and

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"(5) the Federal Food and Drug Administration has either approved the supplemental new drug appli

cation, or the original patent term is within ninety days

of expiration and the Federal Food and Drug Adminis

tration has not made a final determination that the

supplemental new drug application is approved or disapproved.

8 If, however, the term of a patent is extended because the 9 Federal Food and Drug Administration has not made a final 10 determination that the supplemental new drug application is 11 approved or disapproved prior to ninety days before the expi12 ration of the patent, such patent extension shall immediately 13 terminate if the Federal Food and Drug Administration 14 makes final determination disapproving the supplemental new 15 drug application.

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"(b)(1) The patentee, his heirs, successors, or assigns 17 shall notify the Commissioner of Patents and Trademarks 18 within thirty days after the date of enactment of this section, 19 or within thirty days after the date of the approval of the 20 supplemental new drug application if such approval does not 21 occur before enactment of this section, or within thirty days 22 after the date which is ninety days from the expiration of the 23 original patent term if the Federal Food and Drug Adminis24 tration has not made a final determination that the supple

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1 mental new drug is approved or disapproved by such date, of

2 the number of the patent to be extended.

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"(2) On receipt of such notice, the Commissioner shall 4 promptly issue to the owner of record of the patent a certifi5 cate of extension, under seal, stating the fact and length of 6 the extension and identifying the composition of matter to 7 which such extension is applicable. Such certificate shall be 8 recorded in the official file of the patent extended and such 9 certificate shall be considered as part of the original patent, 10 and an appropriate notice shall be published in the Official 11 Gazette of the Patent and Trademark Office. If, subsequent 12 to a notification that it is within ninety days of the expiration 13 of the patent and the Federal Food and Drug Administration 14 has not made a final determination that the supplemental 15 new drug application is approved or disapproved, a final de16 termination is made by the Federal Food and Drug Adminis17 tration that the supplemental new drug application is disap18 proved, the patentee, his heirs, successors, or assigns shall, 19 within two days, notify the Commissioner of Patents and 20 Trademarks of such final determination. On receipt of such 21 notice and if the patent has been extended pursuant to the 22 terms hereof, the Commissioner shall promptly issue a certifi23 cate of termination of extension, under seal, stating the fact 24 that the patent is terminated, effective the date of the final 25 determination that the supplemental new drug application is

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