Biologics & Biosimilars – Section 112 at the Supreme Court
Kramer Levin or by Zoom. Written description and enablement of biotech inventions is currently a hotbed of controversy and has divided the biopharma industry. The industry is divided on two fronts: whether there is a separate written description requirement and whether the full scope of the claimed invention has to be described and enabled. The Supreme Court declined to hear the dispute regarding written description in Juno v. Kite. But the Court has taken up enablement of functionally-defined antibody claims in Amgen v. Sanofi, and is set to address whether the full scope of functional genus claims, i.e., claims to all therapies to a particular biological target, has to be enabled.Both the Amgen and Juno cases have garnered significant attention from patent professionals and various amici regarding the scope of disclosure required for claims to a genus of biological materials defined by their function, not the structure or sequence of the materials. Some argue that it is not possible to describe or enable the full scope of functionally-defined biological materials and that the standard for enablement has to be lowered in order to allow return on investment by allowing control of a therapeutic target based on limited disclosure of biological materials with the requisite function. Others argue that functionally-defined biological materials have to be described and enabled across their scope and that functional genus claims suppress rather than promote innovation.
In this installment of NYIPLA’s Biologics & Biosimilars program, we will discuss the current state of the law, the industry divide, the issues before the Supreme Court and potential impact on innovation of biologics and on biosimilar litigation.