In REGENXBIO Inc. v. Sarepta Therapeutics, Inc., Regenxbio, company developing gene therapy, sued Sarepta for infringement of claims of U.S. Pat. No. 105526417.
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Federal Circuit Reiterates That an Alleged Infringer's Intent Is Irrelevant in a Hatch-Waxman Safe Harbor Analysis | Fish & Richardson jdsupra.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from jdsupra.com Daily Mail and Mail on Sunday newspapers.
The Federal Circuit handed down an opinion last week that invalidated several asserted claims and found infringement under 35 U.S.C. § 271(e)(2) of the claims, while refusing to modify.
A divided panel of the Federal Circuit affirmed a district court's grant of summary judgment of noninfringement, holding that importation of two product samples into the U.S. was reasonably related to obtaining FDA approval based on the particular facts of this case.