Meril Life Sciences’ patent victory under the safe harbor of 35 U.S.C. 271(e)(1) will continue to stand after the United States Supreme Court on Monday declined to review the case.
The move further solidifies important legal precedents that the safe harbor exemption applies to preparatory activities related to FDA submissions, such as recruiting clinical trial investigators, and that application of the safe harbor does not turn on a party’s subjective intent.
Edwards Lifesciences Corporation sued Meril, a Fenwick client, in 2019, alleging patent infringement after Meril imported two demonstration samples of its Myval transcatheter heart valve to recruit clinical investigators as part of the FDA approval process.
The Northern District of California sided with Meril on summary judgement in 2020, and the U.S. Court of Appeals for the Federal Circuit reaffirmed the judgment and declined Edwards’ request for rehearing en banc last year.
Fenwick’s litigation team was led by partners David Hadden, Melanie Mayer, and Jonathan McMichael.