St. Louis-based Kisuk Lee authored an article published on June 13, 2023, in Law360. Within, Lee provides commentary surrounding the impact on biologic patents in the wake of the Supreme Court ruling in Amgen v. Sanofi. Specifically, he calls the Amgen decision devastating news for innovator companies because the ruling makes it harder to obtain broad genus claims.

“Innovators often focus on discovery of a new principle such as identifying a protein target leading to new therapy. The discovery of such a new principle is more worthy of protection than screening antibodies, but a genus claim covering the principle itself would not be patentable according to this decision.”

Lee goes on to say that the ultimate outcome of the Amgen decision will be, in short, higher patent costs and more competition. Innovators need to prepare a voluminous patent application or pursue a multiple application strategy. They also will likely receive more enablement rejections during examination and face more difficult invalidity challenges from competitors.

However, Lee does mention that now a floodgate for follow-on inventors just opened. “Innovators’ patents only cover what they actually disclose in a specification, and competitors, using the original inventor’s work as a roadmap, may be able to obtain a patent on other products in the same class. Also, competitors can practice their inventions more actively since a patent infringement threat based upon a broad genus claim would be reduced drastically.”

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