Federal Circuit Debates Scope of 271(e)(1) Safe Harbor and the Meaning of “Solely”

by Dennis Crouch

The Federal Circuit’s recent 2-1 decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd. highlights tensions in the court’s interpretation of the patent infringement safe harbor under 35 U.S.C. § 271(e)(1). A forceful dissent by Judge Lourie argues that the majority’s approach, while following precedent, improperly reads the word “solely” out of the statute and unduly expands the safe harbor exemption.  Lourie ends his opinion with a call for en banc rehearing.

Introduction to the § 271(e)(1) Safe Harbor

The safe harbor provision of 35 U.S.C. § 271(e)(1) provides an exemption from patent infringement liability for certain activities related to seeking regulatory approval of drugs and medical devices. The statute states:

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 ،ucts.

35 U.S.C. § 271(e)(1). As the Supreme Court explained, this provides “a wide berth for the use of patented drugs in activities related to the federal regulatory process.” Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005). The statute aims to facilitate the ability of generic drug and device manufacturers to run tests and compile data needed to obtain FDA approval before patents expire, so they can launch ،ucts immediately upon patent expiration. See H.R. Rep. No. 98-857 (1984). At the same time, the word “solely” acts as a key limitation, ensuring the safe harbor does not cover activity serving other purposes unrelated to seeking regulatory approval.

Background of the Edwards v. Meril Dispute

The case of Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd. involved a dispute over Meril’s “Myval” tran،heter heart valve system. Edwards ،lds several patents covering artificial heart valve technology.

In September 2019, Meril imported two Myval Systems into the U.S. so its employee could bring them to TCT, a major cardiovascular medicine conference in San Francisco. Meril had a booth at the conference but the imported Myval samples were never displayed or offered for sale – they remained in a bag the entire time. Meril interacted with U.S. doctors at TCT to identify ،ential investigators for future clinical trials that could support FDA approval of the Myval System.

That same year Edwards sued Meril for patent infringement based on this importation of the two heart valve systems. In the district court, Meril moved for summary judgment that its actions were exempt from infringement under the § 271(e)(1) safe harbor. The court agreed and granted partial summary judgment of non-infringement. Edwards Lifesciences Corp. v. Meril Life Scis. Pvt. Ltd., No. 19-CV-06593, 2020 WL 6118533 (N.D. Cal. Oct. 16, 2020).  The case continued for a couple more years based upon claims of trademark infringement and unfair compe،ion. T،se claims were eventually settled and Edwards appealed on the safe harbor judgment.

Arguments and Opinions on Appeal

On appeal, Edwards argued there were genuine factual disputes that s،uld have precluded summary judgment on the safe harbor defense. It pointed to evidence suggesting Meril had commercial purposes for importing the Myval devices, not just using them to recruit clinical investigators. For example, Meril instructed its TCT attendees that they could “make offer for other countries” while prohibiting offers and sales for the U.S. market. Edwards claimed this and other facts indicated the importation was intended to support Meril’s sales efforts unrelated to FDA approval.

However, the Federal Circuit affirmed the district court’s summary judgment in a 2-1 decision. Writing for the majority, Judge Stoll emphasized that the relevant inquiry is “whether the act of importation was for a use reasonably related to submitting information to the FDA,” not ،w the imported items were ultimately used. The court found no genuine factual dispute that Meril’s importation of the Myval samples was reasonably related to pursuing FDA approval. The instructions permitting offers for sales abroad did not change this.

In rea،g this conclusion, the majority relied heavily on the Federal Circuit’s prior safe harbor precedents, particularly Abtox, Inc. v. Exitron Corp., 122 F.3d 1019 (Fed. Cir. 1997). Abtox held that as long as the accused activity is reasonably related to obtaining FDA approval, the safe harbor applies regardless of any “underlying purposes or attendant consequences” of that activity. The court has since reaffirmed that “additional underlying purposes do not matter” for safe harbor ،ysis. Amgen Inc. v. Hospira, Inc., 944 F.3d 1327 (Fed. Cir. 2019). Accordingly, the Edwards majority deemed evidence of Meril’s commercial intent for the importation irrelevant.  In addition to its own prior precedent, the majority also pointed to the Supreme Court’s decision in Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005). There, the Court held the safe harbor “provides a wide berth” and focused more on the “reasonably related” portion of the statute and not on the “solely” requirement. The majority thus suggested Merck supports an expansive view of the safe harbor.

In dissent, Judge Lourie criticized the court for reading the word “solely” out of the safe harbor statute. He argued that to determine if an accused infringing act is performed “solely for uses reasonably related” to FDA approval, a fact-finder must examine all relevant purposes and intent, not just whether the act has some reasonable relation to seeking approval. Judge Lourie contended that Abtox improperly rendered intent irrelevant and that the Federal Circuit has since further strayed from the plain language of § 271(e)(1). In his view, the evidence here supported a reasonable finding that Meril’s importation was at least partially for commercial purposes beyond clinical trial recruitment. So factual disputes s،uld have precluded summary judgment.

To support his arguments, Lourie pulled up the dictionary definitions of “solely” that support his narrower interpretation of the safe harbor.  He also pointed to the same legislative history to s،w that Congress included the word “solely” to “ensure that infringing activity that was performed for purposes other than the development and submission of information under a federal [drug] law” would not be exempt.