REGENXBIO Inc. (Nasdaq: RGNX) today announced the U.S. District Court for the District of Delaware granted Sarepta Therapeutics, Inc. (Sarepta) summary judgment on invalidity in a patent infringement suit arising from Sarepta's manufacture and use of cultured host cell technology covered by a University of Pennsylvania (Penn) patent that Sarepta uses to make clinical and commercial supplies of SRP-9001 (also known as ELEVIDYS in the U.S.), for itself and Roche, for the treatment of Duchenne muscular dystrophy. REGENXBIO intends to file an immediate appeal.
REGENXBIO exclusively licensed the patent, U.S. Patent No. 10,526,617 ('617), from Penn, which is a joint plaintiff in the lawsuit. The lawsuit was filed September 30, 2020, and a trial was scheduled for the end of January 2024. The ruling on this expired patent does not impact REGENXBIO's current licenses or therapeutic pipeline.
"We are disappointed by the decision and believe the court got it wrong. We will appeal," said Patrick J. Christmas, J.D., Chief Legal Officer of REGENXBIO. "REGENXBIO will continue to take appropriate steps to vigorously defend our patent rights."
"The strong patent protections in the U.S. have enabled the robust development of new medicines and spurred growth in the biotechnology industry," said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. "We are proud of the impact our NAV® Technology Platform has had on the gene therapy field and the thousands of patients that have been treated with AAV gene therapies built on our patented technology. We are not attempting to halt development or production of gene therapies; we are seeking fair and reasonable compensation for deliberate infringement."
A separate patent infringement action on a different Penn patent brought by REGENXBIO and Penn against Sarepta in June 2023 is also pending. This second infringement action concerns Sarepta's commercial launch of products covered by U.S. Patent No. 11,680,274 ('274), which covers Sarepta's AAVrh74-based gene therapy vector products, including ELEVIDYS, and that are partnered with Roche outside the U.S. The term of the '274 patent extends to October 2027 and damages are being sought to compensate REGENXBIO and its licensor, Penn.
