As we previously reported, REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware against Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc., alleging infringement of U.S. Patent No. 11,680,274 by Sarepta's gene therapy product. Sarepta's gene therapy product, SRP-9001, was approved this June under the tradename ELEVIDYS".
Sarepta and Catalent have now filed their answers, denying infringement and asserting that they are "immune or otherwise protected from suit under the Safe Harbor provision of 35 U.S.C. § 271(e)(1)." Defendants also argue that the court lacks subject matter jurisdiction because their activities are allegedly protected under Safe Harbor, and asserted defenses of prosecution history estoppel, prosecution laches, and equitable estoppel, among others. Neither answer asserts any counterclaims.
Stay tuned to Big Molecule Watch for more updates on this litigation.
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