[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 1496 Introduced in Senate (IS)]

  1st Session
                                S. 1496

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           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

_______________________________________________________________________

                                 A BILL


 
     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,

SECTION 1. FINDINGS.

    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.

SEC. 2. GRANTING CERTAIN PATENT RIGHTS RELATING TO CERTAIN DRUGS.

    (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.
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