The Supreme Court handed down its decision in Amgen v. Sanofi today. In Justice Gorsuch’s unanimous opinion, the Court held that the scope of the claims at issue were much broader than the 26 expressly disclosed antibodies. The Court sees these claims as being like (“bear more than a passing resemblance”) the claims held to be invalid in O’Reilly v. Morse, 15 How. 62, The Incandescent Lamp Patent, 159 U. S. 465, and Holland Furniture Co. v. Perkins Glue Co., 277 U. S. 245. The Court understands Amgen’s claims to attempt to “monopolize an entire class of things defined by their function” even though that class was much broader (“a vast number” of antibodies). Nor was Amgen’s disclosure of a “roadmap” for obtaining other antibodies or reference to “conservative substitutions” persuasive, the Court considering these to “amount to little more than two research assignments.”
While there are many potential consequences of the Court’s opinion in favor of Sanofi, here are three initial takeaways:
There’s more to unpack here, but for innovators in the life sciences, this ruling means their claim scope will be more limited and the extent of the disclosure will need to be greater. The potentially greatest impact will be on the assumption that claims (and disclosure without explicit support) relying on conservative amino acid substitutions will not be upheld unless there is some disclosure showing which amino acids at what positions can be substituted and the amino acids they can be substituted for. That is the type of disclosure that may delay pursuing patent protection (until supporting experiments can be performed) or reduce the scope of claims pursued, resulting in a smaller scope of exclusivity and permitting competition from compounds not significantly different from the innovator’s compound. In view of the costs of bringing complex biologic molecules including antibodies to market the decision could have the consequences warned about by Amgen and its amici in reducing innovation in the form of new therapeutic antibody products.
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