Mead Johnson Pharmaceutical Group v. Bowen, Civ. A. No. 85-3971.

• Decision Date: 05 February 1986
• Docket Number: Civ. A. No. 85-3971.
• Citation: 655 F. Supp. 53
• Court: U.S. District Court — District of Columbia
• Parties: MEAD JOHNSON PHARMACEUTICAL GROUP, Mead Johnson & Company, a Delaware Corporation, Plaintiff, v. Otis R. BOWEN, et al., Defendants.

655 F. Supp. 53

MEAD JOHNSON PHARMACEUTICAL GROUP, Mead Johnson & Company, a Delaware Corporation, Plaintiff, v. Otis R. BOWEN, et al., Defendants.

Civ. A. No. 85-3971.

United States District Court, District of Columbia.

February 5, 1986.

Alan H. Kaplan, Washington, D.C., for plaintiff.

Kenneth L. Jost, Office of Consumer Litigation, Civil Div., U.S. Dept. of Justice, Washington, D.C., for defendants.

MEMORANDUM OPINION

NORMA HOLLOWAY JOHNSON, District Judge.

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.

BACKGROUND

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 reconsideration was likewise denied on December 12, 1985.

DISCUSSION

The criteria governing the issuance of preliminary injunctive relief in the District of Columbia Circuit are well established. In order to prevail on a motion seeking this extraordinary relief, plaintiff must demonstrate: 1) that it is likely to succeed on the ultimate merits of the claim; 2) that it will be irreparably harmed if the preliminary relief is denied; 3) that the issuance of relief will not significantly harm other interested parties; and 4) that the public interest favors the issuance of a preliminary injunction. Washington Metropolitan Area Transit Commission v. Holiday Tours, Inc., 559 F.2d 841, 843 (D.C.Cir. 1977); Virginia Petroleum Jobbers Association v. Federal Power Commission, 259 F.2d 921, 925 (D.C.Cir.1958).

A. Likelihood of Success on the Merits

The gravamen of plaintiff's complaint is that the December 24, 1981, letter from FDA did not constitute approval of the Desyrel NDA. To support its claim that it is likely to succeed on the merits, plaintiff contends that the letter was merely an "approvable letter" as it set forth labeling requirements which had to be complied with before the product could be marketed. Thus, plaintiff contends that the Desyrel NDA could not have been approved before either January 19, 1982, the date on which the final printed labeling was submitted to FDA, or February 1, 1982, the date of approval. Since plaintiff views approval of the labeling as a condition precedent to the approval of the drug, it argues that the earliest date of approval could not have been before January or February 1982. Based on either date, plaintiff argues that because the Desyrel NDA was approved after January 1, 1982, it is entitled to the benefit of the ten-year exclusivity provision of the FFDCA. Plaintiff also asserts in further support of its position that Desyrel was not marketed until March 1982. Notwithstanding its legal contention, plaintiff has failed to cite any statutory provisions or case law to support its position that FDA may not approve an NDA before a manufacturer submits final printed labeling.

In opposition, defendants argue that the letter of December 24, 1981, was not an approvable letter but was an approval letter. To support their position, defendants refer to that portion of the letter which states in clear language that the Desyrel NDA "is approved." In further support, defendants maintain that the language of that letter which plaintiff characterizes as imposing a condition precedent to approval merely recounts an understanding between plaintiff and FDA, reached in discussions on December 22 and 23, 1981, that the final labeling would contain a certain agreed upon revision. Furthermore, defendants contend that plai...