United States Recommends Denial of Writ of Certiorari on Reverse Payments Question in Tamoxifen Patent Litigation

On May 23, the Solicitor General submitted an amicus brief recommending that the Supreme Court deny the pending Petition for a Writ of Certiorari in the Joblove, et al. v. Barr Laboratories, Inc. et al (tamoxifen) patent litigation. The question presented is “whether the federal antitrust laws prohibit a brand name drug patent holder and a prospective generic competitor from settling patent infringement litigation by agreeing that the generic manufacturer will not challenge the validity of the patent or market its own version of the drug until the expiration of the patent, in exchange for a substantial payment from the patent holder.” Recognizing that “the petition presents an important and difficult question, and that the court of appeals adopted an incorrect standard,” the Solicitor General concluded that “this case does not appear to be a good vehicle for resolving the questions presented.” (Br. p. 1.)

In or around 1987, Barr Laboratories (Barr) filed an ANDA to market a generic version of tamoxifen, a breast cancer drug marketed by AstraZeneca. AstraZeneca sued Barr for patent infringement, and in 1992 the district court held that AstraZeneca’s patent, the ‘516 patent, was invalid and unenforceable. AstraZeneca appealed the decision to the Federal Circuit. While the appeal was pending, AstraZeneca and Barr entered into a settlement agreement conditioned on vacatur of the judgment invalidating the ‘516 patent. The settlement provided that Barr would receive a cash payment of $21 million from AstraZeneca, withdraw its paragraph IV certification and its challenge to the validity of the patent, and enter into a license with AstraZeneca for the duration of the patent term, under which Barr would be allowed to market tamoxifen supplied by AstraZeneca. As agreed, AstraZeneca dismissed its appeal and AstraZeneca and Barr successfully moved to vacate the district court’s decision.

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