Federal Circuit Debates Scope of 271(e)(1) Safe Harbor and the Meaning of “Solely”

by Dennis Crouch

The Federal Circuit's recent 2-1 decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd. highlights tensions in the court's interpretation of the patent infringement safe harbor under 35 U.S.C. § 271(e)(1). A forceful dissent by Judge Lourie argues that the majority's approach, while following precedent, improperly reads the word "solely" out of the statute and unduly expands the safe harbor exemption.  Lourie ends his opinion with a call for en banc rehearing.


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