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Caraco Pharmaceutical Labs, Ltd. v. Novo Nordisk A/S

566 U.S. 399, 102 U.S.P.Q.2d 1345 (2012)

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Caraco Pharmaceutical Labs, Ltd. v. Novo Nordisk A/S

United States Supreme Court

566 U.S. 399, 102 U.S.P.Q.2d 1345 (2012)

Facts

The United States Food and Drug Administration (FDA) reviewed Abbreviated New Drug Applications (ANDAs) to determine whether to grant approval to market new generic drugs. The ANDA process aimed to expedite the release of new generic medications. Because the FDA considered patent infringement in deciding whether to approve an ANDA, brand manufacturers were required to submit use codes describing the scope of their patents. As a policy, the FDA assumed use codes were accurate in deciding whether to approve ANDAs. Novo Nordisk A/S (Novo) (defendant) held a patent claiming the approved use of combining repaglinide with metformin, but the patent did not claim the approved uses of using repaglinide alone or in conjunction with thiazolidinediones. Caraco Pharmaceutical Labs, Ltd. (Caraco) (plaintiff) filed an ANDA seeking to market a generic version of repaglinide to use alone and with thiazolidinediones. Novo filed a patent-infringement claim in federal court against Caraco. While Caraco’s ANDA was pending, Novo amended its use code to state all three approved uses were covered under Novo’s patent. Caraco filed a counterclaim against Novo. The district court granted summary judgment in favor of Caraco, and the Federal Circuit reversed. Caraco appealed.

Rule of Law

Issue

Holding and Reasoning (Kagan, J.)

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