The U.S. Court of Appeals for the Federal Circuit (CAFC) today held in a precedential split decision authored by Judge Stoll that the safe harbor provision of 35 U.S.C.§ 271(e)(1) applied to Meril Life Sciences’ importation of two demonstration samples of its transcatheter heart valves to a medical conference. Judge Lourie dissented, explaining that both the district court and the Federal Circuit have erred in interpreting the statute, specifically by failing to adequately consider the word “solely,” under which interpretation it could be reasonably held that Meril “at least partially” imported the valves for commercial reasons.
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