Murky FDA Device Guidance Kills Sanofi Antitrust Suit

Law360, New York (January 11, 2018, 3:37 PM EST) -- Sanofi reasonably filed a patent for its insulin injector in the FDA's Orange Book, since the agency wasn't clear about whether it should, and rationally defended that patent against possible infringement, a Massachusetts federal magistrate judge said Wednesday when dismissing an antitrust suit over the conduct.

A proposed class of direct purchasers had claimed Sanofi-Aventis US LLC knew the patents didn't belong in the U.S. Food and Drug Administration database and that the company then brought sham infringement litigation against Eli Lilly & Co. But U.S. Magistrate Judge Judith G. Dein said Sanofi acted under its best understanding of the law,...

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