Most of the community involved in life science litigation and pharmaceutical companies, thought they saw the end of the long-fought battle between Amgen and Sanofi in 2021 with the CAFC decision. As a result, at the time, it was said that the attorney representing Amgen in the appeal, Jeffrey A. Lamken of MoloLamken LLP, would take it further before the Supreme Court. A Petition for Writ of Certiorari with two questions was presented before SCOTUS, which has rarely considered patent loss cases. However, in a move that came as a surprise to many and again will grab the attention of all stakeholders in life science litigation, the Supreme Court granted the petition on November 4th, limited only to the second question, which states:

“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,'" Pet.App. 14a (emphasis added).”

This means that by the end of June 2023, it’s expected that the Supreme Court will finally decide on a case that started back in 2014. At that time, both companies were developing new biologic drugs that aimed to fight high cholesterol and applied to get FDA approval. Amgen filed a lawsuit arguing that Sanofi infringed two of its patents, U.S. Patent 8,829,165 and U.S. Patent 8,859,741. In a healthy organism, LDL receptors act and remove LDL cholesterol from the blood, thus decreasing the amount of it circulating. The proprotein PCSK9 is mainly produced in the liver, kidney, and small intestine. It binds to the LDL receptors depending on the amount of LDL cholesterol in the blood, which regulates the cholesterol levels and keeps them at a normal level. For patients with high cholesterol, the above Amgen patents cover the production of antibodies that bind to the PCSK9 protein and prevent them from binding with the LDL receptors, which continue their work and reduce the cholesterol.

Several lawsuits were filed from both sides in district courts, where Amgen managed to get a victory and an order to hold on to the release of Sanofi’s drug. In another district court case, they lost some claims to the patents; however, the case that seemed to have ended everything was the appeal before CAFC. The whole dispute consists of the concept of patent invalidation by lack of enablement. Both patents are considered as broad as they define the antibodies by their function rather than their formula or way of production. Amgen is asking the courts to support the broad patents on drugs such as Repatha as, without the protection, other pharma companies may make minor changes to the compositions and come up with similar drugs without investing in research and development. On the other side, Sanofi argues that such protections prevent other companies from creating an entire class of drugs, fearing patent infringement.

The decision, in this case, will not only affect the sales and the future of these two drugs but will also become a precedent for patents with broad claims. Repatah, during 2021, maintained its status as a global leader in the PCSK9 inhibitor class of drugs. The latest sale data camefrom 2020, when Repatha generated $887 million last year, increasing by 34% from 2019, while Praulent generated $359 million for Sanofi.

How do you think the Supreme Court will decide on this matter?