Teva Pharmaceuticals USA, Inc. v. Sebelius

MEMORANDUM OPINION

ROSEMARY M. COLLYER, District Judge.

Teva Pharmaceuticals USA, Inc. (“Teva”), a manufacturer of generic drugs, seeks a preliminary injunction to invalidate a “Delisting Rule” instituted by the Food and Drug Administration (“FDA”). The FDA contends that there is no such “Delisting Rule.” Instead, in informal adjudications regarding other drugs, the FDA has held that a name brand manufacturer’s withdrawal of a patent as a basis for its drug(s) (ie., a request that the patent be “delisted”) triggers a forfeiture provision excising the generic company’s eligibility for a 180-day…