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S. 1496 (104th): A bill to grant certain patent rights for certain non-steroidal anti-inflammatory drugs for a two year period.

The text of the bill below is as of Dec 21, 1995 (Introduced).

S 1496 IS


1st Session

S. 1496

To grant certain patent rights for certain non-steroidal anti-inflammatory drugs for a two-year period.


December 21, 1995

Mr. SIMON (for himself, Mr. HATCH, Mr. BOND, and Mr. ASHCROFT) introduced the following bill; which was read twice and referred to the Committee on the Judiciary


To grant certain patent rights for certain non-steroidal anti-inflammatory drugs for a two-year period.

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


    Congress finds the following:

      (1) The length of the regulatory review process required for approval of new drugs by the Federal Food and Drug Administration (FDA) has varied greatly.

      (2) For virtually all new drugs, this FDA review takes place after the drug has been patented, thereby decreasing the protections that are provided under law as an incentive to those who invest in developing new medications, including the 17- or 20-year prohibition on the use of a patented medication by others.

      (3) In instances of inordinately long periods of review by the FDA, Congress has provided for the restoration of all or a portion of the period consumed by the review.

      (4) In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration (Hatch-Waxman) Act, which was designed in part to provide for the partial and limited restoration of protections lost when drugs are subject to long FDA review.

      (5) Congress has previously recognized, through the passage of legislation, that the added protections provided for by the Hatch-Waxman Act may not adequately address all instances of regulatory delay.

      (6) In 1992, the FDA granted marketing approval for the active agent in the non-steroidal anti-inflammatory drug (NSAID) oxaprozin. The investigational new drug application for oxaprozin had been filed with the FDA in 1971 and the new drug application had been filed with the agency in 1982. Because the FDA approval process lasted 21 years, the entire 17-year patent life of oxaprozin had expired by the time the FDA approved the drug. Oxaprozin was approved by the FDA on the basis of the initial studies submitted with the new drug application filed in 1982.

      (7) At the request of the Committees of the Judiciary in each House of Congress, the General Accounting Office (GAO), during 1992, investigated the FDA review of two other drugs that, like oxaprozin, were NSAIDs. As part of the reviews, the GAO essentially found that, with respect to the entire class of NSAIDs, there was a two-year period of inactivity at the FDA from May 1984 through May 1986. Based in significant part upon this GAO finding, both Houses of Congress subsequently passed legislation to provide additional market protection to certain NSAIDs harmed by this inactivity.

      (8) No class of drugs other than the NSAID class, of which oxaprozin is a part, has been found by the GAO, the relevant Committees and both Houses in previous Congresses, to have incurred such class-wide delays.

      (9) Since the enactment of the Hatch-Waxman Act, no drug other than oxaprozin has had its entire patent life consumed by FDA review.

      (10) In order to redress the unique harm done to oxaprozin, the further restoration of rights for oxaprozin as provided in this bill should be enacted as promptly as possible.


    (a) IN GENERAL- Any owner on the date of enactment of this Act of the right to market a non-steroidal anti-inflammatory drug that--

      (1) contains a previously patented active agent;

      (2) has been reviewed by the Federal Food and Drug Administration for a period of more than 120 months as a new drug application; and

      (3) was approved as safe and effective by the Federal Food and Drug Administration on October 29, 1992,

    shall be entitled, for the 2-year period beginning on October 29, 1997, to exclude others from making, using, offering for sale, selling or importing into the United States such active agent, in accordance with section 154(a)(1) of title 35, United States Code.

    (b) INFRINGEMENT- Section 271 of title 35, United States Code, shall apply to the infringement of the entitlement provided under subsection (a). No application described in section 271(e)(2)(A), regardless of purpose, may be submitted prior to the expiration of the entitlement provided under subsection (a).

    (c) NOTIFICATION- No later than 30 days after the date of the enactment of this Act, any owner granted an entitlement under subsection (a) shall notify the Commissioner of Patents and Trademarks and the Secretary for Health and Human Services of such entitlement. No later than 7 days after receipt of such notice, the Commissioner and the Secretary shall publish appropriate notice thereof.