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Pharmaceuticals / Regulatory Affairs

Judge Throws Out Teva Lawsuit Against FDA Generic Exclusivity Policy

March 7, 2019

A federal judge ruled Teva can’t challenge the FDA’s new policy on generic exclusivity because the drugmaker has not proved a danger of imminent injury.

Under the ruling in the District Court for the District of Columbia, Teva cannot challenge the FDA’s reading of first-to-file rights until after the agency has acted on any of various pending applications for generic Restasis. Under the first-to-file system, the first generic applicant to challenge a branded drug’s patent is eligible for six months’ exclusivity, which Teva estimates is worth more than $50 million.

Teva initially brought the lawsuit last October, saying the FDA had thrown out its traditional interpretation in a July 2018 decision letter, which said ANDA applicants can qualify for the exclusivity period regardless of whether they provide a patent certification under the Drug Price Competition and Patent Term Restoration Act of 1984 — also known as the Hatch-Waxman Amendments.

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