SCOTUS Takes on the Enablement Clause in Amgen Sanofi Dispute
The United States Supreme Court recently agreed to review Section 112 of the Patent Act for the second time in history.[1] Section 112 of the Patent Act includes the “enablement requirement.”[2] The language in the Patent Act requires “a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.”[3]
The Supreme Court will address whether the requirement is to enable those skilled in the art to ”make and use” the invention or enable those “to reach the full scope of the claimed embodiments.”[4]
Specifically, the Court has decided to hear the dispute between pharmaceutical companies Amgen Inc. and Sanofi, and Regeneron.[5] Amgen and Sanofi have been through years of litigation disputing Amgen’s anti-cholesterol drug, Repatha, and Sanofi’s competitor drug, Praluent.[6] Repatha functions using monoclonal antibodies.[7] These antibodies help decrease low-density lipoprotein (LDL) levels, also known as “bad” cholesterol.[8] The antibody binds to the PCSK9 protein and prevents it from binding to LDL receptors, decreasing LDL levels.[9] Amgen’s patent claims, directed to these antibodies, are known as functional genus claims.[10] These claims describe a category of things using examples of their function.[11] Here, Amgen’s claims are broad enough to include all monoclonal antibodies that bind to PCSK9.[12]
Amgen sued Sanofi for patent infringement; Sanofi stipulated infringement but challenged the patent’s enablement. Sanofi argues that these genus claims are too broad and require undue experimentation with trial and error.[13] In contrast, Amgen argues that screening techniques can be used to narrow the breadth of the claim.[14] Sanofi additionally argued that Amgen’s patent claims could potentially include millions of antibodies, therefore not allowing a person of skill in the art to emulate the full scope of the claim.[15] Two juries upheld Amgen’s patent claims.[16] However, the Federal Circuit disagreed and found them invalid for lack of enablement.[17] The Federal Circuit reasoned that Amgen’s claims only listed some representative antibodies and sought broad protection for all possible antibodies that function the same.[18] Generally, a patent claim with a structural description of the antibody (the amino acid sequence) is preferable.[19] But instead, here we have a functional description.[20] The Federal Circuit reasoned that Amgen must specify all potential antibodies to receive protection.[21]
The Supreme Court requested the input of the Solicitor General for feedback on this case.[22] She reasoned that they should not grant certiorari because the facts of the case were narrow.[23] Although the Court usually relies heavily on the Solicitor General’s guidance, they ultimately granted certiorari, making this the second time this year that they went against her advice.[24]
Amgen released a statement claiming that they were “encouraged” by the Court’s grant of certiorari.[25] Amgen stands behind the validity of its patents and believes that finding its patent valid is crucial to the biotechnology and pharmaceutical industry to help encourage investment into therapeutics.[26] The Court’s interpretation of the enablement requirement could invalidate many pharmaceutical patents or, alternatively, open pharmaceutical companies to invest further in experimental therapies.[27]
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