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February 5, 1986

OTIS R. BOWEN, et al., Defendants

Norma Holloway Johnson, United States District Judge.

The opinion of the court was delivered by: JOHNSON


 Plaintiff brings this action seeking a declaration that its drug product Desyrel, trazadone HCL, was approved for marketing by the Food and Drug Administration (FDA) in 1982 and not on December 24, 1981, the date of the FDA approval letter. Plaintiff seeks such a determination to qualify its product for a ten-year period of non-patent marketing exclusivity provided by the 1984 Amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. § 321, et seq. Plaintiff also requests injunctive relief prohibiting FDA from granting approval of generic copies of Desyrel within the ten-year period. This action is presently before the Court on the motion of plaintiff for a preliminary injunction. After consideration of the motion, the opposition, supporting and opposing memoranda, the evidence, and the argument of counsel, the Court concludes that plaintiff has failed to make a showing sufficient to entitle it to the extraordinary relief requested.

 On October 10, 1978, plaintiff filed a new drug application (NDA) under 21 U.S.C. § 355 for FDA approval of Desyrel. On December 21, 1981, FDA advised plaintiff that its review of the Desyrel NDA was completed but certain revisions in the draft labeling would be required before final approval. Three days later, on December 24, 1981, FDA notified plaintiff by letter and telephone that the Desyrel NDA was approved. Significantly, the following language was contained in the letter:

We have completed our review of this application as submitted with revised draft labeling on December 22, 1981, and have concluded the drug is safe and effective for use as recommended in the labeling. Accordingly, the application is approved.
As agreed to over the phone, this approval is granted with the understanding that any remaining issues regarding validation will be promptly and satisfactorily resolved and that final printed labeling will be promptly submitted and revised as follows before the drug is marketed.

 On January 19, 1982, plaintiff submitted final printed labeling to FDA which approved it on February 1, 1982.

 The Drug Price Competition and Patent Term Restoration Act became law on September 24, 1984. This amendment to the FFDCA provided for the approval of generic copies of drugs marketed after 1962. The purpose of the Act was to facilitate FDA approval of generic copies of pioneer drugs by permitting the submission of Abbreviated New Drug Applications (ANDAs). The ANDAs need not contain full reports of investigations to prove the safety and effectiveness of the drug but include only adequate manufacturing and bioequivalence data. The basic safety and effectiveness of the generic drug could be demonstrated by simple reference to the pioneer drug product the generic manufacturer seeks to copy.

 The Act provides a limited period of protection from competition through its "exclusivity" provisions under which FDA may not make immediate approval of ANDAs for certain previously approved pioneer drugs. Specifically, section 505(j) of the Act provides in relevant part:

If an application . . . submitted under section 355(b) for a drug . . . was approved during the period beginning January 1, 1982, and ending on the date of the enactment of this subsection, the Secretary may not make the approval of an [abbreviated new drug application] . . . before the expiration of ten years from the date of approval of the application under subsection (b).

 Following the passage of the Act, FDA sought information from plaintiff with respect to its NDAs. Plaintiff, as it had consistently done, advised FDA on October 24, 1984, that Desyrel was approved on December 24, 1981, and claimed no entitlement to the exclusivity provisions. However, shortly before the patent on Desyrel was to expire on April 19, 1985, plaintiff challenged, for the first time, the December 1981 approval date.

 On June 20, 1985, plaintiff filed a citizen petition with FDA alleging that Desyrel was not approved until after January 1, 1982. The petition was denied on August 15, 1985, and the petition for ...

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