Amgen, Inc. v. Sanofi

598 U.S. 594, 143 S. Ct. 1243 (2023)

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Amgen, Inc. v. Sanofi

United States Supreme Court
598 U.S. 594, 143 S. Ct. 1243 (2023)

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Facts

High levels of low-density-lipoprotein (LDL) cholesterol in a human can lead to serious health problems. A human protein called PCSK9 inhibits the human body’s ability to remove LDL cholesterol. Amgen, Inc. (plaintiff) developed and patented an antibody that bound to PCSK9 in a manner that blocked its actions and therefore boosted the human body’s ability to naturally remove LDL cholesterol. The same year, Sanofi (defendant) patented a different antibody that performed the same function. Three years later, Amgen obtained two more patents. These patents claimed to cover all antibodies that bound to a specific part of PCSK9 and blocked its harmful actions. The patents identified 26 antibodies that met this description and provided two methods for identifying additional antibodies in the class: roadmap and conservative substitution. Essentially, both methods only directed scientists to test any new or modified antibodies to see if they performed the identified functions. Amgen sued Sanofi for infringing on the new patents. In defense, Sanofi argued that the new patents were invalid. Specifically, Sanofi contended that the new patents did not satisfy patent law’s enablement requirement because they did not enable a skilled person to make and use the potentially millions of antibodies claimed in the patents. The district court ruled that the patents were invalid. The United States Court of Appeals for the Federal Circuit affirmed the ruling. The United States Supreme Court granted certiorari.

Rule of Law

Issue

Holding and Reasoning (Gorsuch, J.)

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