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 products.
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 products 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” transcatheter heart valve system. Edwards holds 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 potential 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 competition. Those 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 should 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 how 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 reaching 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 analysis. 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 should 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 show 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.
Judge Lourie also spent some time focusing on intent — arguing that the majority unduly limited analysis of intent when the reality is that determining whether something is “solely” related to FDA submission requires a substantial focus on intent.
Conclusions and Call for En Banc
In this case, I believe that the majority was bound by precedent to affirm. However, Judge Lourie may be right that “the law could usefully be clarified by an en banc holding of this court, expressly returning the word “solely” to its Congressionally-enacted place in the statute.”
“that the Federal Circuit has since further strayed from the plain language of § 271(e)(1)”
What a joke. So why then is it O.K. for the Federal Circuit to stray — and further stray (by the month) — from what SCOTUS unconstitutionally plain language commanded in Alice?
Hypocrisy reigns. And when it eligibility-reigns, it pours.
Drowning innovation here, there, and everywhere.
The world “solely” here is in a U.S. statute, re U.S. activities, re U.S. FDA approval.
Why would “solely” be interpreted as having international scope violated by foreign country only marketing?
If the units were imported, but not sold or intended to be sold & did not affect the stream of commerce in any other way, what is the theory of damages?
It can’t be some gain of knowledge of the function of the units- that’s supposed to be disclosed anyway in the patent document.
There was no ongoing importation, so no point of an injunction.
What right(s) of exclusion were affected by this behavior?
What remedy was the patentee seeking?
Even if this minimal importation was not held non-infringing under the 271(e)(1) Safe Harbor “solely” for FDA approval activity, what or how much provable infringement damages are there here? What are the real motives for this kind of lawsuit?
This is easy. Judge Lourie is correct and if the CAFC doesn’t fix it en banc then the Supremes will do it for them. Not the first time this has happened in the context of 271, either, as Judge Chen’s sore behind surely remembers (Promega v Life Tech).
I disagree. In general, I’m skeptical of liability for pre-commercialization activities. The patentee has suffered no economic damage; if any damage eventually happens as a result of a marketed product, you can sue then. Why is that so inadequate?
I’m even more skeptical in the FDA approval context, where FDA requires you to make batches that will be used for commercial product in order to analyze the product and validate processes. I’m not sure the federal circuit understands that, so cases have focused on whether each pre-approval batch was “required to be made” for the approval process or not. It’s not a clean distinction.
I also think that a complaint accusing a pre-approval product must plausibly allege that the accused activities are not safe harbor-protected in order to state a claim for infringement.
Kyle – Please take even a rudimentary patent course.
“The patentee has suffered no economic damage; if any damage eventually happens as a result of a marketed product, you can sue then. Why is that so inadequate?”
What exactly is the right having been transgressed?
A patent is not an affirmative right to make anything.
A patent is a negative right to keep others out – to exclude.
Damage is to the right of exclusion.
Come litigators – P L E A S E inform yourselves.
I’m well aware that a patent is a negative right to exclude, thank you.
There’s a reason that I said I’m generally skeptical of pre-commercialization infringement liability, NOT that there should be an absolute bar to it. There are reasons that suing someone early in their product development doesn’t make a lot of sense and can be wasteful or duplicative or oppressive, but maybe it could make sense for a cash-strapped patentee or to achieve FTO before significant investments have occurred.
You seem to have a problem with people thinking for themselves about patent law issues. Why?
It is far less a problem with people thinking for themselves and far more a person NOT thinking with patent fundamentals clearly grasped.
That’s why.
+1
“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.”
I looked at this issue years ago, and felt that the court was reading the word “solely” out. Is a panel obligated to misinterpret the statute because a prior panel or panels did?
If there is precedent, it seems improper for Lourie to “dissent.” He shouldn’t be able to choose which precedent he wants to follow. The proper way to express his opinion would be to concur in the judgment and then file additional remarks to state why the precedent is incorrect.
How quaint.
Judge Nies did it the correct way:
link to caselaw.findlaw.com