FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FTC Says Hatch-Waxman Patent Infringement Suits Are Not Antitrust Proof

June 12, 2018

The Federal Trade Commission filed an amicus brief in the case of Takeda v. Zydus, urging the U.S. District Court of New Jersey to reject the notion that patent infringement suits brought under a law governing generic drugs are exempt from antitrust scrutiny.

Takeda launched the suit after Zydus submitted an abbreviated new drug application for a generic version of the Japanese drugmaker’s Prevacid SoluTab, claiming the Zydus product infringed on multiple claims of several patents.

 “Within the maze of Hatch-Waxman, if a patent-holder’s actions unlawfully maintain otherwise lawful monopoly power or use a lawful patent to manipulate the ANDA process, such actions could lead to anticompetitive effects in the relevant market,” the FTC said.

While the Hatch-Waxman Act may encourage early resolution of patent disputes, it does not encourage filing sham patent suits, the FTC argued.

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