The U.S. Court of Appeals for the Federal Circuit reversed a lower court ruling Feb. 20 that had invalidated key gene therapy patents, delivering a victory to REGENXBIO Inc. and the Trustees of the University of Pennsylvania in their high-stakes intellectual property dispute with Sarepta Therapeutics.
The Federal Circuit held that claims in U.S. Patent No. 10,526,617 are not directed to a natural phenomenon and therefore remain patent-eligible under 35 U.S.C. § 101. Circuit Judge Kathleen M. Stoll wrote the opinion for a three-judge panel that also included Circuit Judges Timothy B. Dyk and Jimmie V. Reyna.
The case stems from a 2020 patent infringement lawsuit filed by REGENXBIO and the University of Pennsylvania trustees against Sarepta Therapeutics, Inc. and its subsidiary Sarepta Therapeutics Three, LLC in the U.S. District Court for the District of Delaware. The plaintiffs alleged that Sarepta infringed multiple claims of their gene therapy patent, specifically claims 1-9, 12, 15, and 18-25.
Both sides moved for summary judgment on the critical question of patent eligibility under Section 101 of the Patent Act, which excludes laws of nature, natural phenomena, and abstract ideas from patent protection. The district court, presided over by Judge Richard G. Andrews, granted Sarepta's motion and ruled that the patent claims were ineligible because they were directed to a natural phenomenon.
The Federal Circuit's reversal represents a significant development in biotechnology patent law, where the boundaries of patent eligibility have been heavily litigated in recent years. Gene therapy patents often face Section 101 challenges because they can involve naturally occurring biological processes or phenomena.
REGENXBIO, a clinical-stage biotechnology company focused on gene therapy treatments, has built its business model around adeno-associated virus (AAV) gene delivery technology. The University of Pennsylvania has been a pioneer in gene therapy research and holds foundational patents in the field through its licensing arrangements with biotechnology companies.
Sarepta Therapeutics is a commercial-stage biopharmaceutical company that develops precision genetic medicine for rare diseases, particularly focusing on treatments for Duchenne muscular dystrophy and other neuromuscular conditions. The company has several approved gene therapy products on the market.
The patent dispute highlights the competitive landscape in gene therapy, where intellectual property rights play a crucial role in determining market position and commercial viability. Companies in this space often engage in patent litigation to protect their technological advantages and clear potential obstacles to product development.
Susan E. Morrison of Fish & Richardson PC argued for the plaintiffs-appellants before the Federal Circuit, with additional representation by Deanna Jean Reichel of Minneapolis for REGENXBIO. The University of Pennsylvania was represented by Julie S. Goldemberg of Morgan, Lewis & Bockius LLP, along with Amy M. Dudash of the firm's Wilmington office.
Sarepta was represented by Robert B. Wilson of Quinn Emanuel Urquhart & Sullivan, LLP, along with James Baker and Anastasia M. Fernands from the same firm.
The Federal Circuit's decision to reverse and remand means the case will return to the Delaware district court for further proceedings on the merits of the patent infringement claims. With the Section 101 eligibility hurdle now cleared, the litigation will likely focus on questions of infringement, validity under other sections of the Patent Act, and potential damages.
This ruling could have broader implications for gene therapy patent litigation, as it provides guidance on how courts should analyze patent eligibility in this rapidly evolving field. The decision may encourage other patent holders to pursue enforcement actions that might previously have been deterred by Section 101 concerns.
The gene therapy market has experienced significant growth in recent years, with multiple products receiving FDA approval and substantial investment flowing into the sector. Patent protection remains essential for companies seeking to recoup research and development investments and maintain competitive advantages in this highly technical field.
For REGENXBIO and the University of Pennsylvania, the Federal Circuit's reversal preserves valuable intellectual property rights that could generate licensing revenue and provide leverage in future business negotiations. The ruling validates their position that their gene therapy innovations represent more than mere natural phenomena and deserve patent protection.
Sarepta now faces the prospect of continued litigation on the underlying infringement claims, potentially including significant financial exposure if the patents are ultimately found to be valid and infringed. The company will likely need to reassess its freedom to operate in areas covered by the disputed patents and consider potential licensing arrangements or design-around strategies.