By: Noah Pollio*
Abstract
Therapeutic antibodies treat many serious medical conditions and represent an industry worth over $160 billion. Acquiring intellectual property protection is paramount for drug researchers producing therapeutic antibodies. Early on, antibody inventors received broad patent protection from the United States Patent and Trademark Office through a patenting strategy called functional genus claiming, whereby antibody patents claimed groups of antibodies that bind to a common epitope.
Over the past 20 years, the Federal Circuit has routinely invalidated antibody patents with functional genus claims. The court has held that such patents fail to meet the Patent Act’s “enablement requirement,” which requires a patent’s specifications to contain enough information so it enables a person of skill in the art to make and use the patented invention without resorting to undue experimentation.
Recently, the United States Supreme Court heard Amgen v. Sanofi, where the Court considered whether an antibody patent with functional claims met the enablement requirement. In a unanimous opinion, the Court held that it did not. However, the Court explicitly did not foreclose validity on all patents with functional genus claims. The Court’s decision has highlighted polarizing views regarding judicial standards for enforcing the Patent Act’s enablement requirement.
This Comment analyzes the jurisprudential and scientific inroads underlying the Court’s decision in Amgen. An analysis of this progression reveals that the Supreme Court attempted to put the issue of enabling antibody patents to rest. Instead, the decision opened the door to future jurisprudential shifts, leaving the Federal Circuit responsible to establish clarity in the future. Finally, this Comment recommends that the Federal Circuit should make any future changes to its enablement jurisprudence for antibodies with an eye toward the establishment of specific, bright-line standards to promote certainty across the industry.
* J.D. Candidate, The Pennsylvania State University, Penn State Law, 2025. I thank Adam Cook, Erik Blasic, Abigail Roos, Arthur Benne, and Drew Weglarz for their guidance in writing this Comment. I also thank the PSLR Vol. 129 Editorial Board for their efforts throughout the year. Finally, I thank my family and friends for their unwavering support.