Takeda v Zydus: FTC intervenes in sham lawsuit claims

The US Federal Trade Commission ( FTC) has filed an amicus brief urging a district court to reject Takeda’s claim that its patent infringement lawsuit brought under the Hatch-Waxman Act cannot be a sham.

On February 12, Takeda filed a lawsuit alleging that Zydus Pharmaceuticals infringed four of its patents relating to Prevacid SoluTab (lansoprazole), used in the treatment of duodenal ulcer disease.

Takeda filed the claim at the US District Court for the District of New Jersey.

The lawsuit was filed under the Hatch-Waxman Act, which permits brand drug manufacturers to sue generic companies for patent infringement before the generic drug’s entry into the market.

Takeda alleged that Zydus filed an Abbreviated New Drug Application at the US Food and Drug Administration (FDA) seeking to market lansoprazole as a disintegrating oral tablet.

Zydus filed a counterclaim alleging that Takeda’s suit constitutes “anticompetitive sham litigation”.

In response, Takeda sought to dismiss Zydus’s antitrust counterclaim, alleging that the lawsuit cannot be a sham because Takeda has a statutory right to file a patent infringement suit under the Hatch-Waxman Act.

The FTC’s amicus brief requests that the court dismiss Takeda’s counterclaim.

In a press release, the FTC said that neither the language of the Hatch-Waxman Act, the case law, nor FDA regulations exempt Hatch-Waxman suits from antitrust scrutiny as potential shams.

“Takeda’s position incorrectly suggests that patent infringement suits brought under the provisions of the Hatch-Waxman Act can never satisfy the test for sham litigation,” the FTC said.

“But the Hatch-Waxman framework does not create any special protection from antitrust liability. Such infringement suits are subject to the same case-specific inquiry that applies to any other litigation alleged to be a sham.”

The FTC vote approving the amicus brief filing was 5-0.

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