The U.S. Court of Appeals for the Federal Circuit has reinstated a gene therapy patent held by RegenxBio Inc. and the University of Pennsylvania, reversing a prior district court decision that had invalidated the patent on grounds of ineligibility under 35 U.S.C. § 101. This decision revives the infringement lawsuit against Sarepta Therapeutics Inc. concerning gene therapies for Duchenne muscular dystrophy.
In January 2024, the U.S. District Court for the District of Delaware had granted summary judgment in favor of Sarepta, ruling that U.S. Patent No. 10,526,617 was directed to ineligible subject matter. The patent pertains to cultured host cells containing recombinant nucleic acid molecules encoding adeno-associated virus (AAV) capsid proteins. The district court’s decision was based on the premise that the patent claims were directed to natural phenomena and thus not patentable.
RegenxBio and the University of Pennsylvania appealed this ruling, arguing that the patented host cells are “markedly different” from naturally occurring entities in both structure and function. They contended that the genetic engineering involved in creating these host cells results in new compositions of matter that do not exist in nature, thereby meeting the criteria for patent eligibility.
The Federal Circuit’s reversal underscores the importance of distinguishing between natural phenomena and human-made inventions in the realm of biotechnology patents. By recognizing the engineered host cells as patent-eligible, the court has provided clarity on the application of Section 101 to genetically modified organisms.
This ruling not only reinstates the ‘617 patent but also allows RegenxBio and the University of Pennsylvania to proceed with their infringement claims against Sarepta. The plaintiffs have indicated their intention to seek substantial damages, potentially exceeding $900 million, should they prove infringement of the reinstated patent.
The case highlights the ongoing complexities in patent law as it applies to biotechnology and gene therapy, areas where innovation often involves modifying natural biological materials to create new therapeutic solutions. The Federal Circuit’s decision may influence future litigation and patent filings in the field, as companies navigate the balance between protecting intellectual property and adhering to legal standards of patent eligibility.
For further details on the Federal Circuit’s decision and its implications, refer to the coverage by Bloomberg Law.