The U.S. Supreme Court recently issued a unanimous ruling that could have major implications for a wide range of patents, particularly those in the chemical and life sciences sectors. The case, Amgen v. Sanofi, involved a patent infringement dispute between two pharmaceutical companies over cholesterol drugs and hinged on the appropriate legal standard for the enablement requirement under 35 U.S.C. Section 112. Amgen asserted functional genus claims of monoclonal antibodies, claiming that its patents anticipate and encompass the antibodies of Sanofi’s Praluent. The Supreme Court found Amgen’s patent claims invalid, stating that they do not contain enough information to enable someone with expertise in the field to make and use the invention.

Our firm authored an article in The Legal Intelligencer examining the implications of this decision. We provide an overview of functional genus claims and the legal controversy surrounding them. We also describe how the Supreme Court decision addresses the necessary balance between incentivizing inventors who make groundbreaking discoveries and encouraging further independent research among the public.

We note that the decision may result in a narrowing of the scope of functional genus claims, as patent holders may be called to describe how to make and use every embodiment within a claimed class. He urges those pursuing patents to keep these issues in mind when determining the breadth of their claims.

Read the full article here: “Is Change Coming? Enablement Requirement of Functional Genus Claims After ‘Sanofi’” (Subscription is required.)