The Supreme Court recently granted Amgen’s petition for certiorari against the advice of the U.S. government, taking up Amgen’s challenge to the Federal Circuit’s enablement review of its PCSK9 antibody patents covering evolocumab (Repatha®). In its petition, Amgen asserts that the Federal Circuit has gone too far in invalidating its PCSK9 antibody patents by imposing a disclosure burden beyond the requirements of 35 U.S.C. § 112. Notably, the Supreme Court, albeit with a different composition, recently declined to hear several other similar cases raising issues with the Federal Circuit’s enablement review.

Claimed Embodiments

At issue in the Supreme Court’s review is Amgen’s patents that include genus claims. These patents claim a genetically engineered monoclonal antibody having an amino acid sequence and functional characteristics such as binding to a particular target, i.e., proprotein convertase subtilisin/kexin type 9 (PCSK9). Amgen’s patent claims additionally include a number of embodiments of the claimed invention.

Federal Circuit Enablement Review

The Supreme Court’s decision in Amgen vs. Sanofi could have a major impact on how the federal circuit reviews patent claims for enablement under 35 U.S.C. § 112. In particular, the Supreme Court will consider whether the Federal Circuit was correct to require an inventor to disclose claimed embodiments within a genus claim—i.e to cumulatively identify all possible embodiments of the claimed invention—or whether a patentee only needs to satisfy the statutory requirement that its specifications teach those skilled in the art how to use the claimed invention without undue experimentation.

The district court found “there does not appear to be a genuine dispute between the parties” that “millions” of antibodies “would need to be tested to determine whether they fell within the claims.” Thus, “’substantial time and effort’ would be required to reach the full scope of the claimed embodiments.” The Federal Circuit affirmed, holding that undue experimentation would be required as “no reasonable factfinder could conclude that there was adequate guidance beyond the narrow scope of the working examples[.]” The Federal Circuit further highlighted the “quantity of experimentation” is important in an enablement inquiry.

The Supreme Court’s decision could also have implications for whether a patentee must disclose exact terms, such as amino acid sequence, in order to meet the enablement inquiry. At issue is whether a patentee can reach the full scope of its claims without disclosing specific embodiments or must it cumulatively identify all possible embodiments before it can do so?

The Supreme Court’s decision could also provide guidance on how much effort must be made by a person skilled in the art to use the claimed invention without undue experimentation. The Supreme Court will consider whether a patentee must, as the Federal Circuit held in Amgen v Sanofi, show that it is possible to reach the full scope of its claims with only “a substantial time and effort.”

Supreme Court’s Decision

At the Supreme Court, Amgen and its amici curiae will argue in favor of giving patentees a more relaxed standard for enablement under 35 U.S.C. § 112. They will focus on Supreme Court precedent (McKeesport Light & Water Co v Westinghouse Electric Corp) which held that “patent validity does not require that the specification necessarily teach those skilled in the art to make other embodiments or variations of the invention.”

The Supreme Court’s decision could have a major impact on how patentees draft their claims moving forward. With its writ filed, we will soon see how the Supreme Court emphasizes person skilled in the art and whether it will govern the enablement review by the statutory requirements or by a more relaxed standard. Whatever the Supreme Court decides, its decision could have major implications for the patent landscape in terms of disclosure and enablement.

Implications for Patent Law

The Supreme Court’s decision in Amgen v Sanofi will have a major impact on how patentees draft their claims moving forward. The Supreme Court will consider whether the Federal Circuit was correct to require an inventor to disclose claimed embodiments within a genus claim or only needs to satisfy the statutory requirement that its specifications teach those skilled in the art how to use the claimed invention without undue experimentation. The Supreme Court’s decision could also have implications for whether a patentee must disclose exact terms, such as amino acid sequence, in order to meet the enablement inquiry.

The Supreme Court’s decision could have major implications for the patent landscape in terms of disclosure and enablement. It could induce changes in the way patent applications are drafted, and how patents are interpreted. It could also have a major impact on how much effort must be made by a person skilled in the art to use the claimed invention without undue experimentation.