This week, I had two ideas for a column, one of which I had to set aside to focus on a recent precedential Federal Circuit decision in a medical device case involving the safe harbor provision of 35 U.S. Code § 271(e)(1). The case centered around the import of a single word in the statute, offering insight into the Federal Circuit’s approach to statutory construction in the context of district court infringement decisions.
In this case, Meril was seeking FDA approval to sell its Myval-branded transcatheter heart valves. After obtaining approval in India and the EU, Meril needed FDA approval for the U.S. market. As part of this process, Meril attended a conference in San Francisco to recruit clinical trial partners for an FDA submission. Despite bringing two samples of their product to the conference, Meril did not make any sales or offers for sale, staying focused on recruiting investigators for the clinical trial.
Despite this, Meril was sued for patent infringement by Edwards Lifesciences but won on summary judgment of noninfringement based on the safe harbor of 35 U.S.C. § 271(e)(1). The majority of the Federal Circuit upheld this decision, emphasizing Meril’s efforts to secure FDA approval and recruit clinical trial partners. However, Judge Lourie dissented, arguing that the majority misapplied precedent and the word “solely” in the statute.
While it is uncertain if the full Federal Circuit will revisit this decision, the interpretation of the safe harbor provision in patent law remains a topic of debate. The implications for the pharmaceutical industry are significant, and any further developments in this case are worth monitoring. Ultimately, Meril avoided a finding of infringement, showcasing the complexities of patent law in a global market.
For comments or questions, contact me at [email protected] or on Twitter: @gkroub. Your feedback and topic suggestions are welcome.
Gaston Kroub is a founding partner of Kroub, Silbersher & Kolmykov PLLC, an intellectual property litigation boutique, and Markman Advisors LLC, a leading consultancy on patent issues for the investment community. Gaston’s practice focuses on intellectual property litigation with a strong emphasis on patent matters. Contact him at [email protected] or follow him on Twitter: @gkroub.