by Dennis Crouch
The Federal Circuit’s divided ruling in Edwards Lifesciences Corp. v. Meril Life Sciences is now before the U.S. Supreme Court — focusing on the scope of the Hatch-Waxman Act’s safe harbor provision. At issue is whether 35 U.S.C. § 271(e)(1)’s regulatory development shield extends to activities conducted for both regulatory and commercial purposes. The statutory text excuses certain acts that would otherwise be considered patent infringement if conducted “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.” While Congress intended to ensure competitors could efficiently prepare for post-patent market entry through necessary regulatory compliance work, an expansive reading arguably erodes patent rights by immunizing activities far beyond pure regulatory preparation. The safe harbor thus sits with the uncomfortable tension of promoting timely competition and protecting innovation incentives.
The case is currently proceeding through the Supreme Court’s certiorari process, with Edwards having filed its petition in October 2024. As is common in Supreme Court practice, respondent Meril waived its right to respond to the petition, and the case has been distributed for the Justices’ conference on December 6, 2024, where they will consider whether to grant review. This is a case where I expect for the court to at least request a response from Meril.
The legal proceedings began when Edwards sued Meril for patent infringement after Meril imported transcatheter heart valve systems into the U.S. for demonstration at a 2019 Cardiovascular Therapeutics Conference. This act of importation is ordinarily an act of infringement under 35 U.S.C. 271(a), but the district court sided with Meril on summary judgment, finding the importation protected under Section 271(e)(1)’s safe harbor because it was “reasonably related” to obtaining FDA approval, even if Meril may have had additional commercial purposes. Meril claimed the conference demonstrations would help identify and recruit qualified clinical investigators needed for its planned FDA trials, though evidence showed the company also used the conference to market its CE-marked product to potential European customers.
The district court, following Federal Circuit precedent, held that “intent and alternative uses are not relevant to the application of the safe harbor once it is determined that the allegedly infringing acts were reasonably related to FDA approval.” Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., No. 19-cv-06593, 2020 WL 6118533 (N.D. Cal. Oct. 16, 2020). The Federal Circuit affirmed in a divided panel decision, holding that the safe harbor applies whenever any qualifying regulatory use is identified, “regardless of whether there are additional uses by defendant” – a reading that prompted Judge Lourie to dissent, arguing the majority had effectively “read[] the word ‘solely’ out of the statute.” Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., 96 F.4th 1347 (Fed. Cir. 2024).
The majority opinion, authored by Judge Stoll and joined by Judge Cunningham read the “solely for uses” provision as requiring that each would-be infringing use of the invention by the defendant bear a reasonable relation to the development and submission of information to the FDA. According to the majority reading, the statute does not require that the sole purpose be a qualifying purpose.
The Federal Circuit’s safe harbor jurisprudence has expanded significantly since the provision’s enactment. In Momenta Pharm., Inc. v. Teva Pharm. USA Inc., 809 F.3d 610 (Fed. Cir. 2015), the court held that the safe harbor could extend to activities where the “actual purpose” was promotional rather than regulatory, provided those activities were “consistent with” collecting data for FDA submissions. However, the Federal Circuit has also recognized some limits on the safe harbor’s scope. In Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011), the court held that the provision does not protect post-approval activities unrelated to developing information for FDA submission.
For the case at hand, the Federal Circuit’s 1997 decision in AbTox v. Exitron marked a critical expansion of Safe Harbor’s scope beyond cases where statutory symmetry exists between §§ 156 and 271(e)(1). 122 F.3d 1019 (Fed. Cir. 1997). In AbTox, the court established that § 271(e)(1) “does not look to the underlying purposes or attendant consequences” of allegedly infringing activity, so long as the use is reasonably related to FDA approval. This holding meant that defendants could use their FDA-related test data for additional purposes beyond regulatory submissions – such as business planning or investor presentations – without losing Safe Harbor protection. This aspect of AbTox significantly broadened Safe Harbor’s practical scope and serves as the foundation for the most recent Edwards decision. The Federal Circuit’s interpretation effectively shifted the focus from the subjective intent behind particular uses to the objective relationship between those uses and the regulatory process.
The Supreme Court’s prior safe harbor decisions provide important context. In Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990), the Court held that Section 271(e)(1) applies to medical devices as well as drugs, recognizing Congress’s intent to address regulatory review timing issues across regulated products. Later, in Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005), the Court endorsed a “wide berth” for activities related to FDA submissions, including early-stage experiments that might not ultimately be submitted.
The legislative history shows that the provision was designed to reverse Roche Products, Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858 (Fed. Cir. 1984), which had held that even regulatory testing constituted patent infringement. The House Report explains that the safe harbor was meant to permit “a limited amount of testing” causing minimal interference with patent rights. H.R. Rep. No. 857, 98th Cong., 2d Sess., pt. 1, at 45 (1984).
Judge Lourie’s dissent in Edwards highlights the tension between this history and modern interpretation. He argues that “solely” must do some work in the statute, and its plain meaning requires activities be exclusively for regulatory purposes. This reading would better align with Congress’s expressed intent to create a narrow exception for genuine regulatory work.
The case presents the Supreme Court with an opportunity to clarify several key doctrinal questions.
- Whether “solely” requires exclusive regulatory purpose or merely some regulatory nexus.
- How should courts evaluate activities serving both regulatory and commercial aims.
- Whether the provision’s scope should be informed by its role in Hatch-Waxman’s “careful compromise” between innovation and competition.
Based on its petition for writ of certiorari, Edwards’ core argument is that the Federal Circuit fundamentally misread the plain text of 35 U.S.C. § 271(e)(1) by effectively writing the word “solely” out of the statute, an error that traces back to the Federal Circuit’s flawed decision in AbTox. The safe harbor provision only protects acts “solely for uses reasonably related” to obtaining regulatory approval, but starting with AbTox, the Federal Circuit has held that identifying any regulatory use reasonably related to the infringement automatically immunizes all other non-regulatory purposes, including blatant commercial activities, declaring such “alternative uses” to be “irrelevant.” According to Edwards – channeling Judge Lourie – this reading renders the term “solely” completely superfluous because the provision would have the exact same meaning with or without the word.
The petition does not directly address the Supreme Court’s statement from Merck that I highlighted above about giving the safe harbor “wide berth.” While the petition does cite Merck, it does so relatively briefly in a footnote to acknowledge that Merck assigned the safe harbor “a broad scope for actual regulatory uses.” The clever rhetoric in the petition suggests that Merck’s broad reading of qualifying regulatory uses makes it even more important to properly interpret “solely” as a limitation. We can be loose there if we tighten things up here.
The outcome of the decision here has significant practical implications for how medical device and pharmaceutical companies conduct development activities. Consider the common scenario of showing devices to physicians at medical conferences. Under the Federal Circuit’s broad interpretation, companies can demonstrate products to doctors who might serve as both clinical investigators and future customers, provided there is some regulatory nexus. The majority’s view effectively immunizes such dual-purpose interactions. However, under Judge Lourie’s stricter reading, companies would need to more carefully segregate regulatory recruitment from marketing activities – perhaps limiting demonstrations to pre-identified potential investigators or maintaining separate regulatory and commercial sessions. This is particularly salient for medical devices — that typically require more physician training than would simply prescribing pills.
The Advanced Medical Technology Association (AdvaMed), representing over 400 medical technology manufacturers, filed an amicus brief supporting Edwards’ petition and arguing that the Federal Circuit’s interpretation fundamentally distorts Hatch-Waxman. AdvaMed contends that rather than asking whether activities are “solely for” regulatory uses as the statute requires, the Federal Circuit wrongly shifted the inquiry to whether the infringing acts themselves were “reasonably related” to the regulatory process. This interpretive error, according to AdvaMed, led the court to dismiss evidence of non-regulatory commercial uses that should have been disqualifying under a proper reading of Section 271(e)(1).
The amicus brief provides additional background information to the court on the medical device industry arguing:
- Medical devices have contributed to a five-year increase in U.S. life expectancy between 1980 and 2019, all while having slower price growth than general inflation;
- But, the Federal Circuit’s decision creates “easily exploited loophole for bad-faith actors” that undermine the patent protections needed to sustain the massive R&D investments driving the biggest advances.
International competitiveness concerns add another dimension to the policy debate. As noted in the AdvaMed amicus brief, the U.S. medical device industry accounts for 40% of the global market and maintains a trade surplus. Overly restrictive safe harbor interpretation could disadvantage U.S. companies competing globally, while an overly broad reading might reduce incentives for innovation by weakening patent protection.
As mentioned above, Meril has waived its right to respond to the SCOTUS petition, but it did oppose Edwards’ en banc petition at the Federal Circuit. There, the accused infringer explained that multiple Federal Circuit panels have unanimously rejected attempts to make the safe harbor turn on underlying commercial purposes rather than the objective relationship between the activities and regulatory approval. Meril argues there was only a single “use” at issue – importing two demonstration samples to recruit clinical trial investigators at a medical conference – which was indisputably related to the FDA approval process Meril had already initiated. No sales or commercial transactions occurred at the conference.
On the key statutory interpretation dispute, Meril argues that Edwards and Judge Lourie’s dissent improperly seek to rewrite the statute by suggesting safe harbor only applies to uses that are “solely” for regulatory purposes. This reading, Meril contends, would effectively add a second “solely” requirement that Congress did not include and render the phrase “reasonably related” superfluous. Meril emphasizes that the panel majority’s interpretation – that “solely” modifies “for uses” rather than creating an exclusive regulatory purpose requirement – better aligns with established canons of construction and Supreme Court precedent giving the safe harbor provision “wide berth.” The company also argues there are no “staggering economic stakes” at issue — this case involves two demo samples brought to a trade show. Rather, Meril argues that Edwards approach is to burden potential competitors with additional regulatory and litigation costs in order to avoid timely competition.
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Petitioner Edwards Lifesciences is represented by Daniel Geyser as counsel of record from Haynes and Boone, along with co-counsel Angela Oliver. Additional counsel for Petitioners includes the in-house team at Edwards: Gail Katz, Tracey Davies, Avraham Schwartz, and Jessica Hudak. At the Federal Circuit, Edwards had been represented by a mixed team of attorneys from Stradling Yocca, Knobbe Martens, and Sheppard Mullin.
The Advanced Medical Technology Association (AdvaMed) filed an amicus brief in support of Petitioners through counsel of record Daniel Lerman and Paul Brzyski of Kramer Levin.
Respondent Meril is represented by David Hadden from Fenwick & West LLP who also argued the case before the Federal Circuit.