by Dennis Crouch
The Federal Circuit's divided ruling in Edwards Lifesciences Corp. v. Meril Life Sciences is now before the U.S. Supreme Court -- focusing on the scope of the Hatch-Waxman Act's safe harbor provision. At issue is whether 35 U.S.C. § 271(e)(1)'s regulatory development shield extends to activities conducted for both regulatory and commercial purposes. The statutory text excuses certain acts that would otherwise be considered patent infringement if conducted "solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products." While Congress intended to ensure competitors could efficiently prepare for post-patent market entry through necessary regulatory compliance work, an expansive reading arguably erodes patent rights by immunizing activities far beyond pure regulatory preparation. The safe harbor thus sits with the uncomfortable tension of promoting timely competition and protecting innovation incentives.
The case is currently proceeding through the Supreme Court's certiorari process, with Edwards having filed its petition in October 2024. As is common in Supreme Court practice, respondent Meril waived its right to respond to the petition, and the case has been distributed for the Justices' conference on December 6, 2024, where they will consider whether to grant review. This is a case where I expect
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