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May 18, 2023: In Amgen Inc. v. Sanofi , the Supreme Court unanimously held that Sanofi's “genus” patents – patents directed to broad patents cholesterol-lowering monoclonal antibodies but directed to a specific antibodies – were invalid for lacking an enabling disclosure. Stated the court: “If a patent claims an entire class of processes, machines, manufactures, or compositions of matter . . . the patent's specification must enable a person skilled in the art to make and use the entire class.” Because the c

This ruling is consistent with prior Federal Circuit holdings that the entire scope of a claimed invention must be enabled. See, e.g., Liebel-Flarsheim v. Medrad 1) discussed here . However, in their Yale Law Journal article, "The Antibody Patent Paradox" 2) the authors Lemley and Sherkow argue that the written description requirement is inconsistent with the science of antibody research. As we can now learn more about the molecular structure through DNA sequencing, the requirements for satisfying the writt

A set of proposed rules for IPR discretionary denials was published by the USPTO to “build on and codify existing precedent and guidance on Director’s discretion to determine whether to institute [IPRs].” In summary the rules would:

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