Amgen Inc. v. Sanofi

Welcome to Supreme Court Opinions. In this episode, you’ll hear the Court’s opinion in Amgen Inc. v Sanofi. In this case, the court considered this issue: Do Amgen’s two patents satisfy the Patent Act’s enablement clause—that is, describing the invention with sufficient particularity that would enable a “skilled artisan” to “make and use” the claimed invention? The case was decided on May 18, 2023. The Supreme Court held that Amgen’s two patent applications—purporting to cover all antibodies that bind and block the PCSK9 receptor involved in LDL cholesterol metabolism—fail to satisfy the Patent Act’s enablement clause. Justice Neil Gorsuch authored the unanimous opinion of the Court affirming the judgment below. It is well established that the enablement requirement means that if a patent claims an entire class of process, machines, manufactures, or compositions of matter, its specification must enable a person skilled in the art to make and use the entire class. While the specification may call for a reasonable amount of experimentation to make and use a claimed invention, it must not be too broad. Amgen’s specification fails to enable all that it has claimed, even allowing for a reasonable degree of experimentation. It described 26 antibodies by their amino acid sequences, but it claims to monopolize an entire class of antibodies not described. Thus, its claim is too broad. The opinion is presented here in its entirety, but with citations omitted. If you appreciate this episode, please subscribe. Thank you.