Edwards Lifesciences Corporation v. Meril Life Sciences Pvt. Ltd.


Question(s) Presented

“Under the Hatch-Waxman Act, Congress declared that ‘[i]t shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . 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.’ 35 U.S.C. 271(e)(1).”

“In these proceedings, a panel of this Court split 2-1 over the proper scope of this critical provision. The majority held Section 271(e)(1)’s safe harbor applies whenever a fact-finder identifies any use reasonably related to obtaining FDA approval, even if a party also engages in ‘alternative uses’ unrelated to the regulatory process. The dissent reached the opposite conclusion: ‘our case law has incorrectly given short shrift to the word “solely” in the statute,’ which cabins the safe harbor to infringing acts solely related to the regulatory process—any non-protected ‘alternative uses’ (often commercial in nature) are disqualifying.”

“Accordingly, based on my professional judgment, I believe this appeal requires an answer to the following precedent-setting question of exceptional importance:”

“Whether, under 35 U.S.C. 271(e)(1), identifying any regulatory use also immunizes all other uses, whether they relate to the federal regulatory process or not, under the Act’s safe harbor—which excuses infringing activities ‘solely for uses reasonably related’ to the federal regulatory process.”

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Selected Proceedings and Orders