[Congressional Record Volume 141, Number 203 (Monday, December 18, 1995)]
[Senate]
[Page S18826]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                             GENERIC ZANTAC

 Mr. FAIRCLOTH. Mr. President, during the debate on an 
amendment offered by my colleague from Arkansas, Senator Pryor, with 
regard to GATT patent extensions, there were representations made about 
the availability of a generic form of Zantac. The Senate has expressed 
its support for Judiciary Committee hearings on this important issue. 
The chairman of that committee has committed to hold a hearing on 
February 27, 1996.
  Some supporters of the generic drug companies claim that the hearings 
will delay marketing of generic Zantac. This is not true. In fact, due 
to other outstanding patent issues with regard to Zantac, it is unclear 
when a generic form of Zantac will be available, but it will be at 
least several months and likely to be after September 1996. Therefore, 
hearings held in early 1996 will permit more than sufficient time to 
resolve this question well before September 1996.
  Mr. President, I ask to have printed in the Record a detailed 
background paper on the patent issues relating to Zantac.
  The material follows:

    Background on the Impact of GATT Patent Extensions on Potential 
  Availability of Generic Zantac (ranitidine hydrochloride)

       Even if the U.S. had not implemented the General Agreement 
     on Tariffs and Trade (GATT), based on the generic 
     applications submitted to date, no generic form of Zantac 
     could have been legally marketed on December 5, when the 
     basic patent was scheduled to expire prior to the 
     implementation of GATT. Because of other outstanding patent 
     issues with regard to Zantac, it is unclear when a generic 
     form of Zantac will be available, but it will be at least 
     several months and is likely to be after September 1996.
       Glaxo Wellcome has two product patents with respect to 
     ranitidine hydrochloride, which exists in two form:, referred 
     to as form 1 and Form 2. All of the Zantac sold by Glaxo 
     Wellcome worldwide has been Form 2. The Form 2 product patent 
     expires on June 4, 2002. It bars the marketing of generic 
     versions of Form 2 or any product that contains Form 2. In 
     September 1993, the validity of the Form 2 patent was upheld 
     in federal district court against a challenge by a generic 
     company. That decision was affirmed on appeal.
       The basic patent was scheduled to expire on December 5, 
     1995, but was changed by the GATT implementing law to July 
     25, 1997. The basic patent bars the marketing of generic 
     versions of both Form 1 and Form 2. For various reasons it 
     may be more difficult to manufacture Form 1 ranitidine in a 
     pure form in commercial quantities over time. Even when the 
     basic patent expires, before a company can market a generic 
     form 1 ranitidine, they must demonstrate that their Form 1 
     product is bioequivalent to Zantac and does not violate the 
     remaining Form 2 patent.
       The Drug Price Competition and Patent Term Restoration Act 
     of 1984 (Hatch/Waxman Act) provides expedited procedures for 
     generic drugs to enter the market and for the resolution of 
     outstanding patent issues. Under these procedures, a company 
     seeking approval for a generic drug may file an Abbreviated 
     New Drug Application (ANDA) with the FDA. The ANDA must 
     contain one of the following certifications with respect to 
     each relevant patent on the pioneer drug: (I) patent 
     information has not been filed with the FDA, (II) the patent 
     has expired, (III) the patent will expire on a date 
     specified, or (IV) the patent is invalid or won't be 
     infringed.
       If the ANDA contains a paragraph III certification listing 
     the patent expiration date, the FDA is precluded from making 
     the ANDA effective prior to that date. If the generic company 
     seeks to market a drug before the expiration of any relevant 
     patents, the ANDA must contain a paragraph IV certification 
     that the patents are invalid or won't be infringed, and the 
     generic company must notify the patent owner. Unless the 
     patent owner sues for infringement within 45 days of being 
     notified, the FDA can approve the ANDA.
       If the patent owner does sue within 45 days, FDA cannot 
     make the ANDA effective immediately. To protect generics from 
     undue delay during litigation, the Act provides that the FDA 
     can make the ANDA effective after 30 months from the date the 
     patent holder is notified of the ANDA filing or when there is 
     a final court ruling that the patent is invalid or not 
     infringed, whichever is earlier.
       All ANDA applicants seeking to market generic ranitidine 
     hydrochloride prior to 2002 have lawsuits pending against 
     them asserting violations of one or more patents. Because of 
     the 30 month provision, the pending litigation affects the 
     earliest date that generic ranitidine hydrochloride could be 
     marketed by any of these companies.
       Even if the FDA were not precluded by the Hatch/Waxman Act 
     from making ANDAs effective prior to the expiration of the 
     full patent term for brand name drugs, September 1996 is the 
     earliest date under the Hatch/Waxman Act procedures that Form 
     1 generic ranitidine hydrochloride could be marketed by any 
     of these companies unless there is a final court ruling 
     earlier that the basic patent is invalid or that the generic 
     product does not infringe any Glaxo Wellcome patents.
       Because a trial court decision is not considered final if 
     an appeal is taken, it is unlikely that a final court ruling 
     will occur prior to September 1996. In a prior patent 
     infringement case against Novopharm with respect to the 
     validity of the Form 2 patent, the trial court ruled in Glaxo 
     Wellcome's favor in September 1993. Novopharm appealed the 
     same month, but the appeal was not decided for 19 months, in 
     April 1995. The appeals court upheld the earlier decision in 
     favor of Glaxo Wellcome.

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