Federal Circuit IP
Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd.
Fed. Cir. 2022-1877
March 25, 2024
(Lourie, Stoll, Cunningham; Precedential)
Summary: The Federal Circuit affirmed the District Court for the Northern District of California and found that the FDA safe harbor under § 271(e)(1) applied to Meril’s importation of two Myval prosthetic heart valve systems.
Background
- In 2019, Meril imported two Myval prosthetic heart valve systems (“Myval”) to a conference in the U.S.
- At the conference, Meril identified doctors to help with a premarket approval application for the Myval.
- Meril submitted its Myval premarket approval application to the FDA a few months after the conference.
- The imported Myval systems were never removed from the bag or shown to anyone while in the U.S.
Key Issue
- Does the importation of a transcatheter heart valve fall within the safe harbor provision of 35 U.S.C. § 271(e)(1), even if the imported heart valve is not actually used for obtaining FDA approval?
Applicable Rule/Statute
- “It 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).
- “§ 271(e)(1)’s exemption from infringement extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the [FDA].” Merck KGaA v. Integra Lifesciences I, Ltd. 545 U.S. 193, 202 (2005).
- “[T]he [FDA safe harbor] applies ‘as long as there is a reasonable basis for believing’ that the use of the patented invention will produce the types of information that are relevant to an FDA submission.” Amgen Inc. v. Hospira, Inc., 944 F.3d 1327, 1338 (Fed Cir. 2019).
Holding
- The importation of the Myval systems was not an act of infringement because the FDA safe harbor applied.
Reasoning
- The doctors at the conference, the instructions on the bag, the subsequent premarket approval application, and the lack of sales at the conference show that no reasonably minded juror could conclude that the importation was “solely to support commercial sales, rather than to recruit clinical investigators.”
Takeaways
- The FDA safe harbor applies as long as there is a reasonable basis for believing that use is relevant for obtaining FDA approval.
- A party seeking to show that the FDA safe harbor does not apply to a use must show that use’s sole purpose is “wholly unrelated to any FDA submission.”