May 2023

In a unanimous decision published on May 18, 2023, the U.S. Supreme Court invalidated two of Amgen’s patents for its cholesterol drug, Repatha, making it more difficult for patentees to obtain broadly worded patents.[1]  The case – Amgen Inc. v. Sanofi – involves a dispute between the two pharmaceutical companies over the “enablement” requirement of 35 U.S.C. Section 112,[2] specifically how much a patent must disclose in order to “enable” a skilled person to make and use the claimed invention without undue trial and error.  The Supreme Court held that Amgen failed to provide enough detail to recreate the full scope of its claimed invention, and that if a patent claims an entire class of processes, machines, manufactures or compositions of matter then the patent must include sufficient information that enables a person skilled in the art to make and use the entire class.

The U.S. Supreme Court affirmed the judgment of the Second Circuit in the case of Andy Warhol Found. for Visual Arts, Inc. v. Goldsmith in a 7-2 decision issued May 18, 2023, authored by Justice Sotomayor.  The Court held that the first factor of the copyright fair use test favored respondent photographer, Lynn Goldsmith, rather than petitioner, Andy Warhol Foundation for the Visual Arts (“AWF”).  The decision was limited to AWF’s commercial licensing of a silkscreen image of Prince, based on Goldsmith’s underlying photograph, to Condé Nast.  Below, we have highlighted the key factual background in the case and some takeaways from the Court’s decision. For more information, please see Cleary Gottlieb’s client alert.

What You Need To Know

  1. From 1 June 2023, a new EU unitary patent system (UPS) will become fully effective. A unitary patent (UP) is a European patent granted by the European Patent Office (EPO) to which, at the patent owner’s request, unitary effect is given for the territory of the EU Member States that have ratified the Unified Patent Court Agreement – currently, 17 EU Member States. UPs give patent owners uniform protection across participating EU Member States, removing the need for national validation procedures as well as individual national enforcement in each EU Member State.