When a patent owner relies on FDA drug-distribution regulations to withhold samples of a branded product to a would-be generic manufacturer, resulting in that generic manufacturer’s inability to conduct bioequivalence testing required for an Abbreviated New Drug Application under the Hatch-Waxman Act, does it amount to an antitrust violation?
In broader terms, is a prior course of dealing between the parties a prerequisite to asserting a Sherman Act claim for refusal to deal? A case raising these questions is currently pending before Judge Esther Salas in the U.S. District Court for the District of New Jersey (Mylan Pharmaceuticals v. Celgene Corp., case no. 2:14-cv-02094). The U.S. Court of Appeals for the Third Circuit declined to weigh in on the issue, by way of denial of a petition for an interlocutory appeal of the District Court’s denial of Celgene’s motion to dismiss. (Appeal No. 15-8017, March 5, 2015, Order.)
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