Fenwick & West LLP
What You Need To Know
On August 21st, the Federal Circuit denied an en banc review to a precedential decision it issued earlier in this year in Edwards Lifesciences Corp. The Federal Circuit clarifies when acts of alleged infringement of patents are protected by the safe harbour of 35 U.S.C. SS 271(e)(1).
- The Court’s opinion reaffirms that the safe harbor is an objective standard that depends on whether an act of alleged patent infringement was solely for uses reasonably related to the development and submission of information to the U.S. Food and Drug Administration. An accused infringer’s subjective intent is not relevant.
- The opinion reaffirms a long line of Federal Circuit cases holding that demonstrating a product at a conference to recruit clinical trial investigators falls within the safe harbor.
- District Court Proceedings
In 2019, Edwards Lifesciences Corporation sued Meril Life Sciences Pvt. Ltd. for patent violation in the Northern District of California. Fenwick represented Meril both in the district court case as well as the recent appeals victory. Meril imported two demonstration samples for its Myval transcatheter valve (THV), which was used to recruit clinical investigators in a clinical study that would support FDA approval, into the United States. Edwards alleged that Meril’s importation of these two samples infringed Edwards’ patents.
Meril sought summary judgment from the district court, arguing that its importation of the two Myval THV devices was protected under the safe harbor of Section 271(e)(1), which provides a safe harbor to acts that would otherwise infringe a U.S. patent if those acts are “solely for uses reasonably related to the development and submission of information” to the FDA. The district court granted the motion because, at the time of the importation, Meril had taken significant steps towards obtaining FDA approval for the Myval system, Meril met with potential clinical investigators at the TCT conference, and there was no evidence of any sales or offers for sale of the Myval system at the conference.
Affirming and Clarifying Prior Safe Harbor Decisions
On appeal, the Federal Circuit affirmed summary judgment of non-infringement under the safe harbor. The panel majority–including Judges Kara F. Stoll and Tiffany P. Cunningham–concluded that “for each act of infringement
the safe harbor is available only [,] for acts or uses that bear a reasonable relation to the development and submission of information to the FDA.” In other words, “[i.e., solely]t is not that the use must only be reasonably related to the development and submission of information to the FDA” as Edwards had argued.[i]The panel majority also addressed and rejected the arguments raised by Edwards in the appeal. The majority rejected Edwards’ argument that a jury might have found that Meril imported devices to support commercial sales rather than recruit clinical investigators. It was undisputed that there were no sales or offers to sell at the TCT Conference. The majority also held there is no requirement to “use” a device before an activity qualifies for the safe harbor. Instead, the statute protects activities including making, using, selling, offering for sale, and importing so long as those activities are reasonably related to obtaining FDA approval.
Judge Alan D. Lourie dissented. The dissent acknowledged that the district court followed Federal Circuit’s precedent on safe harbor. But the dissent wrote that the statute should apply “only for uses, sales, and importations that solely are for…development of information for the FDA,” and advocated for en banc review to revisit the statutory interpretation.
Edwards petitioned for rehearing en banc. Edwards, like the dissenting panel, argued that the panel’s decision excuses commercial “alternative use” and that the statute only protects uses that are “solely regulatory uses”. The Federal Circuit denied Edwards’ petition on August 21, 2020, without any further opinions. The subjective intent of a company or its alleged alternative uses are irrelevant in determining whether or not the safe harbour applies. What matters is if the act was “reasonably” related to the development or submission to FDA of information.
