We previously reported on the ongoing dispute between Amgen and Sanofi regarding enablement of genus claims here, here, here, here, and here.  But, the case is nearing a final decision. On January 31, the Supreme Court set arguments to address Question 2 presented by the petition for cert: Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation-i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “’time and effort.’”  In other words, can the requirement of “enablement to the full scope” continue to render genus claims to biotechnology inventions invalid?    

More than 30 amicus briefs were filed by numerous entities, including the Intellectual Property Owners Association, the New York Intellectual Property Law Association, the Intellectual Property Law Association of Chicago, intellectual property professors, and various biopharma companies.  The briefs were roughly split in their support of Amgen versus Sanofi.  For example, fourteen professors jointly argued that the Federal Circuit’s recent approach to enablement of genus claims exceeds the statutory requirement and is unnecessarily harsh in the analysis of chemical and biotechnology fields, whereas Eli Lilly argued that the Supreme Court should decide that claims with only functional limitations should be invalid. 

In April 2022, the Court invited the Solicitor General to file a brief in the case expressing the views of the United States, but the Solicitor General recommended the Court decline to hear the case.  Despite the government’s recommendation, in November 2022, the Court granted cert on Question 2 of Amgen’s petition.  On February 10, the United States filed an amicus brief, and moved to participate in the oral argument.  On February 21, the Court granted the Solicitor General’s motion for leave to participate in oral argument as amicus curiae, for divided argument, and for enlargement of time for oral argument.  The Court, however, denied leave for the Chemistry and the Law Division of the American Chemical Society to participate in the oral argument.  

At the March 27 oral argument, Amgen will have 35 minutes to present its argument, Sanofi will have 20 minutes, and the United States will have 15 minutes.  The audio recordings will be posted on the Court’s website later that day.  Because the stakes could not be higher to biopharma companies and industry stakeholders, it will be fascinating to determine what can be gleaned from the Court’s questions and comments during oral argument.  A decision is expected to be handed down before the Court recesses for the summer.  We will undoubtedly provide more posts as the case proceeds as the Supreme Court decision will have substantial ramifications regarding genus claims and functional terms.

April Abele Isaacson is a partner in the San Francisco, CA office and Tina Williams McKeon is a partner in the Atlanta, GA office of Kilpatrick Townsend & Stockton, LLP.

The opinions expressed are those of the author(s) and do not necessarily reflect the views of Kilpatrick Townsend, its clients, or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.