Mead Johnson Pharmaceutical Group, Mead Johnson & Co. v. Bowen, 87-5099

Citation6 USPQ2d 1565,838 F.2d 1332,267 U.S.App.D.C. 382
Decision Date12 February 1988
Docket NumberNo. 87-5099,87-5099
Parties, 6 U.S.P.Q.2d 1565 MEAD JOHNSON PHARMACEUTICAL GROUP, MEAD JOHNSON & COMPANY, Appellant, v. Otis R. BOWEN, Secretary of H.H.S., et al.
CourtUnited States Courts of Appeals. United States Court of Appeals (District of Columbia)

Alan H. Kaplan, with whom Thomas O. Henteleff and Peter R. Mathers, were on the brief, for appellant.

Jacqueline H. Eagle, Atty., Dept. of Justice, with whom Richard K. Willard, Asst. Atty. Gen., Dept. of Justice, Joseph E. diGenova, U.S. Atty., Thomas Scarlett, Chief Counsel, and David G. Adams, Associate Chief Counsel, Food and Drug Admin., and Margaret A. Cotter, Atty., Dept. of Justice, were on the brief, for appellees. Kenneth L. Jost, Atty., Dept. of Justice, also entered an appearance for appellees.

Before EDWARDS, BUCKLEY and SENTELLE, Circuit Judges.

Opinion for the Court filed by Circuit Judge HARRY T. EDWARDS.

HARRY T. EDWARDS, Circuit Judge:

Mead Johnson Pharmaceutical Group ("Mead") appeals from a judgment of the District Court, 655 F.Supp. 53, upholding the Food and Drug Administration's ("FDA") denial of a citizen petition filed by Mead. At issue is whether Mead is entitled to a ten-year period of nonpatent exclusivity for its drug "Desyrel" under the Drug Price Competition and Patent Term Restoration Act. The answer to that question turns solely on whether Mead's New Drug Application ("NDA") for Desyrel was "approved" by the FDA before or after January 1, 1982. There is little dispute about the facts; rather, the case centers on the meaning of the term "approved."

We find the FDA's construction of the statutory term "approved" to be consistent with congressional intent; and, even if the term "approved" might be viewed as ambiguous, it is clear that the FDA's construction was a permissible one. We therefore affirm the judgment of the District Court.

I. BACKGROUND
A. Statutory Background

On September 24, 1984, the President signed into law the Drug Price Competition and Patent Term Restoration Act, Pub.L. No. 98-417, 98 Stat. 1585 (1984), generally known as the "Hatch-Waxman Amendments" to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Sec. 301 et seq. The purpose of this legislation was to increase competition in the drug industry by facilitating the approval of generic copies of drugs. The Amendments notably eliminated the requirement that generic copies of drugs approved after 1962 be supported by independent clinical research data. Rather than complete the full--and very expensive--NDA process, generic copiers could proceed via an "Abbreviated New Drug Application" ("ANDA"), which required merely a reference to the safety and effectiveness data submitted by the "pioneer" drug manufacturer, along with submission of manufacturing and bioequivalence data for the generic copy. See 21 U.S.C. Sec. 355(j) (Supp. II 1984). The result was to make practical the manufacture of generic copies which theretofore had been uneconomical.

In order to compensate drug manufacturers who had invested in new drug development in reliance on the previous rules, as well as to provide continuing incentive for new drug research, the Amendments contained several provisions for varying periods of exclusivity before the FDA could approve ANDAs. One such provision is relevant to this case. As a transitional measure, the Amendments provided for a ten-year period of exclusivity for drugs "approved" by the FDA between January 1, 1982, and the enactment date of the Amendments, September 24, 1984. See 21 U.S.C. Sec. 355(j)(4)(D)(i) (Supp. II 1984). Drugs approved later had shorter periods of exclusivity, while those approved before January 1, 1982, enjoyed no exclusivity at all.

B. The Desyrel NDA Approval

Desyrel is Mead Johnson's trade name for Trazodone HC1, an antidepressant drug. Mead submitted a NDA for Desyrel in October 1978. On December 21, 1981, Dr. Marion Finkel of the FDA transmitted a letter to Mead informing it that review of the NDA was complete. This letter stated that approval would be forthcoming upon Mead's submission of revised printed labeling, in accordance with 4 1/2 pages of detailed FDA comments. Letter from Marion J. Finkel to Mead Johnson and Company (Dec. 21, 1981), Joint Appendix ("J.A.") 150-54. Following several telephone conversations, Mead submitted revised labeling the next day, incorporating the FDA's requested changes. In its accompanying letter, Mead stated its understanding, based on the telephone discussions, that "final approved labeling can be submitted subsequent to the approval of the NDA." Letter from Frank W. Furth to Marion Finkel (Dec. 22, 1981), J.A. 123. More telephone conversations apparently ensued, and on December 24 the FDA sent Mead a letter which stated in relevant part:

We have completed our review of [the Desyrel] 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.

Letter from Marion J. Finkel to Mead Johnson and Company (Dec. 24, 1981) (emphasis added), J.A. 9. There followed five specific requests for minor changes in language under the label's description of adverse reactions (such as changing "memory loss" to "impaired memory"). Id. 1

In the December 1981 supplement to its "Approved Prescription Drug Products" list, the FDA listed Desyrel as approved. J.A. 81, 90. In the December 1981 "FDA Drug and Device Product Approvals" list, the FDA also listed Desyrel with an approval date of December 24, 1981. J.A. 94.

On January 19, 1982, Mead submitted the final printed labeling for Desyrel to the FDA with a cover letter that referenced "Your letter of approval for Desyrel ... dated December 24, 1981." Letter from Robert F. Majewski to Marion Finkel (Jan. 19, 1982), J.A. 157. The FDA processed the final labeling as a "supplemental NDA." On February 1, 1982, in a letter to Mead signed by Dr. Paul Leber, a Division Director, the FDA stated: "We have completed our review and the supplement is approved." Letter from Paul Leber to Mead-Johnson Pharmaceutical Division (Feb. 1, 1982), J.A. 8.

After passage of the Hatch-Waxman Amendments, the FDA began to prepare for implementation by requesting drug manufacturers to submit information on their approved drugs. In response to such a request, Mead informed the FDA on October 22, 1984, that the approval date for Desyrel was December 24, 1981, and that it was not entitled to a period of statutory exclusivity. Letter from Marygayle Ritzert to Thomas J. McGinnis (Oct. 22, 1984), J.A. 129, 130. Six months later, however, on April 19, 1985--just days before its patent on the drug was to expire--Mead wrote to the FDA to inform it that it had "reviewed our NDA file for DESYREL," that it had determined that the proper approval date was February 1, 1982, and that it was therefore entitled to an exclusivity period until February 1, 1992. Letter from Donald G. Harris to Peter H. Rheinstein (Apr. 19, 1985), J.A. 11-12.

C. Proceedings Below

On June 20, 1985, Mead filed a citizen petition with the FDA, requesting that it recognize a ten-year exclusivity period for Desyrel. Citizen Petition of Mead Johnson Pharmaceutical Group, J.A. 3-7. The FDA rejected the petition in a letter issued August 15, 1985. It found that Desyrel had been approved on December 24, 1981. It stated that the December 24 letter had approved the NDA, with the understanding that final labeling would be submitted before the drug was marketed, but that the letter had "neither stated nor implied" that any further approval was necessary before the drug could be marketed. It added that agreement had been reached by telephone on the changes to be made, and that the ten-year exclusivity period depended only on the date of approval, not the date of marketing. The February 1 letter was clearly only an approval of a "labeling supplement" to a previously approved NDA; its author had had no authority to approve Mead submitted a Petition for Reconsideration on October 17, 1985, J.A. 20-43, which the FDA agreed to consider even though it was untimely. In its letter of December 12, 1985, denying the Petition for Reconsideration, Letter from Joseph P. Hile to Alan H. Kaplan (Dec. 12, 1985), J.A. 45-52, the FDA rejected Mead's argument that it had failed to consider provisions of the FDA's letter of December 21, 1981. 3 The agency maintained that the requirements contained in that letter had been modified by the ensuing telephone conversations between Mead and the FDA, as well as by the "approval" letter of December 24. J.A. 46-47. More generally, the FDA stated that, in accordance with 21 C.F.R. Sec. 314.105, 4 its policy had always been that "the date of the approval letter is the date of approval of the application." J.A. 49. In addition, the FDA emphasized that

                a NDA. 2   Letter from Harry M. Meyer to Alan H. Kaplan (Aug. 15, 1985), J.A. 13-15
                

under the provisions of the agency's letter of December 24, 1981 the petitioner could have prepared final printed labeling, incorporating the appropriate changes, and marketed the product without additional agency action at anytime. Thus, contrary to petitioner's allegation Desyrel could have legally been marketed prior to January 19, 1982.

J.A. 50.

Finally, the FDA pointed out that at the time of the passage of the Hatch-Waxman Amendments, it had been a matter of public record (through information contained in FDA publications) that Desyrel had been approved on December 24, 1981. Thus, if Congress had intended Desyrel to enjoy the ten-year exclusivity provision, "it presumably would have selected a...

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