Edwards Lifesciences argues that the Federal Circuit's decision significantly broadened safe harbor protections under Section 271(e)(1), impacting the regulatory use of patented inventions.
The U.S. Supreme Court's refusal to hear the appeal upholds a Federal Circuit ruling that allows for expanded safe harbor protections under the Hatch-Waxman Act, despite dissenting opinions.
Judge Lourie's dissent emphasized that the majority overlooked Meril's commercial intent, arguing that the safe harbor should not apply to uses that include commercial speech at industry conferences.
Edwards Lifesciences initiated legal action against Meril Life Sciences after the latter's participation in a significant medical conference, questioning both their intent and compliance with patent laws.
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