Am. Bioscience, Inc. v. Thompson

Am. Bioscience, Inc. v. Thompson

Opinion

 [*1078]  SILBERMAN, Senior Circuit Judge: American Bioscience, Inc., appeals from the district court's denial of its request for preliminary injunctive relief. Appellant argues [**2]  that the Food and Drug Administration's decision to approve intervenor-defendant Baker Norton Pharmaceutical's Abbreviated New Drug Application (ANDA) for a generic version of the cancer treatment Taxol was arbitrary and capricious. We agree and vacate that approval.

This case is here for the second time. See  American Bioscience, Inc. v. Thompson, 345 U.S. App. D.C. 243, 243 F.3d 579 (D.C. Cir. 2001). American Bioscience is a pharmaceutical research firm that has developed a patented process for delivering safer and more effective dosage forms of Taxol. Bristol-Myers Squibb Company holds the patent on and FDA approval of Taxol itself, a drug that has generated billions of dollars in sales. Bristol-Myers intervened in the district court proceeding for the limited purpose of providing information. Appellees Baker Norton Pharmaceuticals, Inc. (BNP) and Zenith Goldline Pharmaceuticals, Inc., who are corporate affiliates and  [*1079]  hold ANDAs for generic versions of Taxol, intervened as defendants.

This dispute arises out of the complex relationship between the FDA's approval process for generic drugs and patent law. A company wishing to market a new (or "pioneer") drug must seek FDA approval,  [**3]  usually by completing a New Drug Application. The NDA is expensive and time-consuming, requiring data from tests showing the drug's safety and effectiveness. Prior to 1984, a firm that wished to make a generic version of an approved drug was required to file a new NDA, complete with new safety and effectiveness studies. In 1984, Congress enacted ] the Hatch-Waxman Amendments, ² which introduced the Abbreviated NDA and allowed a generic drug ANDA to rely on the pioneer NDA's safety and effectiveness studies. These amendments also provide that a competitor may use and manufacture an approved and patented drug, for the purpose of developing a generic version, without infringing that patent.

The Hatch-Waxman Amendments also sought to afford an NDA holder some patent protection, to lower the risk to innovation posed by the simplified ANDA process. ] NDAs are required to contain a list of any patents which [**4]  claim the drug or which claim a method of using such a drug and with respect to which a claim of patent infringement could reasonably be asserted--but that includes patents held by those other than the NDA holder. The FDA publishes all patent listings in the Approved Drug Products With Therapeutic Equivalence (the "Orange Book"). For "each patent which claims" the pioneer drug, an ANDA must certify: (1) that no patent has been filed with the FDA; (2) that the patent has expired; (3) that the patent has not expired, but will expire on a particular date; or (4) that the patent is either invalid or the generic drug will not infringe it (a "Paragraph IV certification"). ] When an ANDA applicant files a Paragraph IV certification, it must also certify to the FDA that it will give notice to the patent holder. That notice must include a detailed statement of the factual and legal basis of the applicant's opinion that the patent is not valid or will not be infringed and must be given at the same time the certification is submitted to the FDA. Filing a Paragraph IV certification can constitute patent infringement. Upon receipt of notice of a Paragraph IV certification, the patent holder has [**5]  45 days in which to file an infringement suit. If the patent holder does not file within that time period, the FDA may immediately approve an otherwise conforming ANDA. If, on the other hand, the patent holder does sue within 45 days, the FDA may not approve the ANDA for 30 months, or until the patent dispute has been resolved, whichever is sooner. The first ANDA filed and approved gets a 180-day period of market exclusivity.

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