REGENXBIO to appeal decision after court rules on patent case

ROCKVILLE, Md. – Biotechnology firm REGENXBIO Inc. (NASDAQ:RGNX) announced today its intention to appeal a recent U.S. District Court decision. The court ruled in favor of Sarepta Therapeutics, Inc. (NASDAQ:) on a patent invalidity claim, part of an ongoing infringement suit concerning technology used in a Duchenne muscular dystrophy treatment.

The patent in question, U.S. Patent No. 10,526,617, exclusively licensed by REGENXBIO from the University of Pennsylvania, was deemed invalid by the court, which could have implications for the manufacture and use of SRP-9001, known commercially as ELEVIDYS. Despite the ruling, the company clarified that the decision does not affect its current licenses or therapeutic pipeline.

REGENXBIO’s Chief Legal Officer, Patrick J. Christmas, expressed the company’s disappointment and resolve to appeal, stating, “We will continue to take appropriate steps to vigorously defend our patent rights.” Kenneth T. Mills, President and CEO, reiterated the importance of patent protections in the U.S. for the development of new medicines and the biotech industry’s growth.

The company is also involved in a separate action against Sarepta concerning another patent, U.S. Patent No. 11,680,274, which covers gene therapy vector products including ELEVIDYS. This lawsuit, filed in June 2023, is still pending, with REGENXBIO seeking damages for alleged infringement.

REGENXBIO, a clinical-stage company, focuses on gene therapy treatments using its NAV Technology Platform, which includes exclusive rights to over 100 novel adeno-associated virus vectors. The company has a strategic goal to bring five AAV therapeutics to pivotal-stage or commercial status by 2025.

The information for this article is based on a press release statement. The court’s decision does not impact REGENXBIO’s financial outlook or its commitment to advancing gene therapy treatments. The company’s appeal will seek to overturn the court’s ruling on the patent’s validity.

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