Actual Use in FDA Approval Process Not Required for Section 271 Safe Harbor Protection: Federal Circuit | Practical Law

Actual Use in FDA Approval Process Not Required for Section 271 Safe Harbor Protection: Federal Circuit | Practical Law

In Edwards Lifesciences Corp. v. Meril Life Sciences PVT. Ltd., the US Court of Appeals for the Federal Circuit held that 35 U.S.C. § 271(e)(1)'s safe harbor applies to importations reasonably related to obtaining US Food and Drug Administration (FDA) approval even if the imported products are never used in the approval process.

Actual Use in FDA Approval Process Not Required for Section 271 Safe Harbor Protection: Federal Circuit

by Practical Law Intellectual Property & Technology
Published on 26 Mar 2024USA (National/Federal)
In Edwards Lifesciences Corp. v. Meril Life Sciences PVT. Ltd., the US Court of Appeals for the Federal Circuit held that 35 U.S.C. § 271(e)(1)'s safe harbor applies to importations reasonably related to obtaining US Food and Drug Administration (FDA) approval even if the imported products are never used in the approval process.
On March 25, 2024, in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., the US Court of Appeals for the Federal Circuit held that 35 U.S.C. § 271(e)(1)'s safe harbor does not require an actual use in an FDA approval process distinct from the alleged infringing act, and importation itself may qualify for the safe harbor regardless of the intent or purpose behind the importation ( (Fed. Cir. Mar. 25, 2024)).
Meril Life Sciences Pvt. Ltd. and Meril, Inc. (collectively, Meril) is an India-based medical device company that created its Myval-branded transcatheter heart valves, as part of its Myval System, to treat heart disease. Meril received regulatory approval to market its Myval System in India and Europe but needed pre-market regulatory approval to sell its system in the US. A Meril employee carried two sample systems with him into the US when traveling to attend the 2019 Transcatheter Cardiovascular Therapeutics Conference in San Francisco (TCTC), where Meril sought out potential clinical researchers for FDA clinical trials. At the conference, Meril discussed the details of the Myval System with several US doctors but did not make any offers for sale at the conference or display the imported samples, which remained at the employee's hotel.
In October 2019, following TCTC, Edwards Lifesciences Corporation and Edwards Lifesciences LLC (collectively, Edwards), a competitor medical device company, filed suit against Meril for patent infringement based on the importation of the two heart valve systems. The US District Court for the Northern District of California granted summary judgment of non-infringement in favor of Meril finding that the importation of the two systems fell within the safe harbor provision of 35 U.S.C. § 271(e)(1). Edwards appealed to the Federal Circuit, claiming:
  • There was a genuine issue of material fact regarding whether Meril imported the heart valves solely to support commercial sales, rather than to recruit clinical investigators because:
    • Meril's instructions to its employees allowed for making offers for sale to non-US entities while at TCTC;
    • Meril did not bring the valves to a dinner at TCTC for potential clinical investigators; and
    • a jury could infer that Meril had no intent to conduct a clinical trial that could be used for FDA approval because Meril ignored advice from its FDA consultant and FDA guidance regarding the voluntary pre-submission and study design.
  • The district court failed to apply the safe harbor using an objective standard, relying instead on Meril's subjective intent for the importation.
  • The district court improperly relied on declarations from Meril employees who lacked personal knowledge of the material facts.
The Federal Circuit agreed with the district court's grant of summary judgment and rejected each of Edwards' arguments finding that:
  • The Section 271(e)(1) safe harbor:
    • provides broad protection from infringement for all infringing acts concerning patented inventions where there is a reasonable basis for believing that the allegedly infringing activity will produce the types of information that are relevant to an FDA submission; and
    • applied because Meril's importation of the heart valves for the conference was a step in the process of selecting investigators to conduct the required clinical testing, an activity that qualifies for the safe harbor under Federal Circuit precedent.
  • The non-use of the devices at the conference was irrelevant because Section 271(e)(1) does not require an actual use in the FDA process separate from importation, and importation may qualify for the safe harbor regardless of the defendant's intent or the existence of any additional non-covered uses.
  • None of the evidence that Edwards pointed to created a genuine issue of material fact precluding summary judgment because no reasonabe juror could draw an inference that:
    • Meril's sole purpose for importing Myval Devices was to support its commercial sales efforts; or
    • the importation was wholly unrelated to recruiting clinical investigators and wholly unrelated to any FDA submission.
Accordingly, the Federal Circuit affirmed the district court's grant of summary judgment in Meril's favor.
Circuit Judge Lourie dissented from the majority opinion stating that: