A patent dispute that has reached the United States Supreme Court has the potential to send shockwaves throughout the biopharmaceutical sector. The case has been seen by drugmakers and industry inventors as a critical test of their capacity to obtain, enforce, and defend patents for groundbreaking biological ideas.
The issue pits Amgen against Regeneron and Sanofi over blockbuster monoclonal antibody therapies for heart disease patients. On Friday, November 4, the United States Supreme Court agreed to hear Amgen’s appeal. It will consider the second of Amgen’s appeal petition’s questions:
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).
The Supreme Court is expected to hear arguments in the spring and rule by the end of June 2023. This ruling is expected to have a significant influence on how businesses adopt patent and research strategy. The Court will very certainly decide whether broad functional patent claims, as they presently exist in this business, are permissible, or if patentees will be forced to more clearly define and reach the “full extent” of all conceivable antibodies with the same function in their claims.
The Supreme Court’s decision to hear the Amgen case on the merits is a hopeful indicator that patentees in the biopharma sector may see the pendulum swing back in favour of functional genus claims without the requirement to fulfil a higher threshold to demonstrate patent enablement. However, there is much fear that any change or reset of the present enablement criterion would have a significant impact on the industry and how patents are obtained and enforced.
Industry stakeholders on both sides of this issue will be keeping a close eye on this case in the expectation that the conclusion will lead to more predictability in the outcome of patent acquisition and litigation.