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Mylan Pharmaceuticals, Inc. v. U.S. Food and Drug Administration

United States Court of Appeals for the Fourth Circuit
454 F.3d 270 (2006)


Facts

Proctor & Gamble Pharmaceuticals, Inc. (“P&G”) developed and patented a pioneer drug to treat urinary tract infections called Macrobid. Mylan Pharmaceuticals, Inc. (“Mylan”) (plaintiff) wanted to develop and market a generic version of Macrobid. Mylan thus filed a Paragraph IV Abbreviated New Drug Application (“ANDA”) with the Food and Drug Administration (“FDA”) (defendant) seeking approval of its generic version, which the FDA approved. When Mylan began selling its generic drug, a third-party company under license from P&G also began selling a competing generic version of Macrobid which significantly impacted Mylan’s revenues. Mylan petitioned the FDA for a ruling under the Federal Food, Drug, and Cosmetic Act (“FFDCA”) that the licensed generic could not be sold until Mylan’s drug had been on the market for 180 days. The FDA denied Mylan’s petition. Mylan then filed suit in the U.S. District Court for the Northern District of West Virginia against the FDA. During the pendency of the Mylan suit, another federal district court held, in a similarly-situated case against the FDA, that the FFDCA did not prohibit a pioneer drug manufacturer from marketing an authorized generic drug via a licensee during the period of exclusivity. The FDA moved to dismiss Mylan’s suit which was granted by the district court and Mylan appealed.

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Holding and Reasoning (Michael, J.)

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  • A “yes” or “no” answer to the question framed in the issue section;
  • A summary of the majority or plurality opinion, using the CREAC method; and
  • The procedural disposition (e.g. reversed and remanded, affirmed, etc.).

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