Mylan Pharmaceuticals, Inc. v. Henney
United States District Court for the District of Columbia
94 F. Supp. 2d 36 (2000)

- Written by Mary Phelan D'Isa, JD
Facts
In August 1985, Imperial Chemicals Industries, PLC was given a patent for brand-name drug tamoxifen, which was exclusively produced by its subsidiary, Zeneca, Inc. In December 1985, Barr Laboratories submitted an abbreviated new drug application (ANDA) with the Food and Drug Administration (FDA) to market its generic tamoxifen. Barr later amended its ANDA to challenge the validity of Imperial’s patent and to change its paragraph III certification to a paragraph IV certification, which would make it eligible for the marketing exclusivity incentive in the Federal Food, Drug, and Cosmetic Act, (FDCA), which would be triggered upon the earlier of (1) Barr’s first commercial marketing of its generic drug, or (2) the date of a final decision of a court holding that Imperial’s patent is invalid. Thereafter, Imperial sued Barr for patent infringement, and a federal district court held that Imperial’s patent was invalid. While an appeal was pending, the case settled with Barr withdrawing its patent-invalidity claim and amending its ANDA back to a paragraph III certification. The appellate court granted the parties’ request to vacate the district-court decision. Within a year of that vacatur, generic tamoxifen drug manufacturers—Pharmachemie, B.V. and Mylan Pharmaceuticals, Inc (plaintiffs)—filed ANDAs with paragraph IV certifications, and Zeneca sued each for patent infringement. Before the expiration of Pharmachemie and Mylan’s statutory stays, Barr filed a petition with the FDA to continue to credit Barr with the marketing exclusivity incentive and to not approve any ANDA for generic tamoxifen. The FDA, ignoring the district court’s decision invalidating Imperial’s patent, approved Barr’s petition after concluding that Barr’s 180-day exclusivity period had not yet been triggered because there had not been a court decision nor commercial marketing of Barr’s generic tamoxifen. Pharmachemie and Mylan sued the FDA, alleging that its decision was arbitrary and capricious and in violation of FDA regulations because Barr was no longer entitled to the exclusivity period.
Rule of Law
Issue
Holding and Reasoning (Urbina, J.)
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