IP Law Daily, PATENT NEWS: Edwards Lifesciences asks High Court to address Federal Circuit's broad interpretation of Hatch-Waxman Act safe harbor, (Oct 17, 2024)

By Saurabh Kashyap, B.A., LL.B., LL.M.

The petition alleges that the broad interpretation of safe harbor provisions undermines patent rights and market fairness.

Edwards Lifesciences Corporation has filed a petition for a writ of certiorari with the U.S. Supreme Court against Meril Life Sciences Pvt. Ltd. alleging that the Federal Circuit misinterpreted the safe harbor provision under the Hatch-Waxman Act 35 U.S.C. § 271(e)(1), by protecting activities conducted for both regulatory and non-regulatory purposes. It seeks the Supreme Court's review to overturn the ruling and clarify the correct application of the statute (Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., Dkt. No. 24-428 (U.S. Oct. 15, 2024)).

Background. Edwards Lifesciences is a global leader in medical innovations, specializing in designing and manufacturing heart-related technologies, including transcatheter prosthetic heart valves. These valves are integral to minimally invasive surgeries for patients suffering from structural heart diseases. Meril Life Sciences Pvt. Ltd. and Meril, Inc., based in India, similarly develop and produce medical devices, including their Myval heart valves, which operate in the same therapeutic space as Edwards’ products.

Edwards’ petition is based on its U.S. Patent No. 8,002,825 (the ’825 patent), titled “Prosthetic Heart Valve Apparatus.” The ’825 patent relates to the design, structure, and deployment method of prosthetic heart valves used to treat various heart conditions. It covers specific innovations in the assembly of transcatheter valves and the mechanics of their expansion during implantation. Edwards asserts that Meril's Myval heart valves infringe on this patent by replicating core elements of its patented technology.

The central issue in the case concerns Meril’s importation of two Myval valve devices into the United States for the 2019 Transcatheter Cardiovascular Therapeutics Conference in San Francisco. Edwards contends that this importation constituted patent infringement and argues that the safe harbor provision under 35 U.S.C. § 271(e)(1) does not apply. Edwards alleges that Meril’s activities at the conference were not conducted “solely” for regulatory purposes, but also had a commercial aspect, as the company promoted its devices to attendees, including potential customers and collaborators.

District court decision. The federal district court in California granted summary judgment in favor of Meril. The court held that the importation of the Myval devices was protected under the safe harbor provision, which exempts activities reasonably related to obtaining federal regulatory approval from patent infringement liability. The district court concluded that as long as some of Meril's activities were related to the United States Food and Drug Administration (FDA) approval process, the entire activity fell within the safe harbor, regardless of additional non-regulatory purposes.

Federal Circuit ruling. On appeal, the Federal Circuit affirmed the district court’s decision in a split-panel ruling, holding that Meril’s importation of the Myval devices was protected under the safe harbor provision of 35 U.S.C. § 271(e)(1). The majority found that the safe harbor applies if any part of the infringing activity is reasonably related to the development or submission of information for regulatory approval, even if the activity serves additional non-regulatory purposes.

The court determined that Meril’s importation and intended use of the Myval devices at the 2019 Transcatheter Cardiovascular Therapeutics Conference were consistent with efforts to recruit clinical investigators and further its premarket approval submission to the FDA. Although the devices were not displayed due to technical difficulties, the court concluded that their intended use was sufficiently tied to Meril’s regulatory preparation to qualify for the safe harbor.

Edwards had argued that Meril’s promotional activities at the conference, including references to CE-mark approval, indicated commercial intent. However, the Federal Circuit rejected this argument, noting that promotional activities do not disqualify a party from safe harbor protection if the actions are reasonably connected to regulatory approval. The court affirmed that Meril’s importation of the devices fell within the scope of the exemption, supporting the district court’s grant of summary judgment.

Dissenting opinion. Circuit Judge Alan D. Lourie dissented, arguing that the majority misapplied the statute by disregarding the statutory term “solely.” Judge Lourie contended that the safe harbor provision only applies to activities conducted exclusively for regulatory purposes. He expressed concern that the majority’s interpretation effectively removes the word “solely” from the statute, allowing competitors to use the safe harbor to shield commercial activities that overlap with regulatory efforts. According to Judge Lourie, Meril’s promotional activities at the conference, including showcasing its CE-mark approval for European markets, demonstrated a clear commercial intent that should disqualify it from the safe harbor exemption.

Petition for certiorari. In its certiorari petition, Edwards Lifesciences argues that the Federal Circuit's interpretation of the Hatch-Waxman Act's safe harbor provision under 35 U.S.C. § 271(e)(1) conflicts with the statute's plain language. Edwards asserts that the safe harbor provision should apply only to activities conducted solely for regulatory purposes, without any commercial elements. The company contends that the Federal Circuit’s decision undermines the balance Congress intended between fostering innovation through patent protections and allowing limited exemptions to facilitate regulatory approvals.

According to Edwards, the key statutory language—specifically the word "solely"—was disregarded in the Federal Circuit's ruling. The complaint emphasizes that Congress included the term "solely" as a critical limitation to ensure that only activities strictly related to developing and submitting information to federal regulators, such as the FDA, would qualify for the exemption. By expanding the safe harbor to cover mixed-purpose activities—those involving both regulatory and commercial objectives—Edwards argues that the Federal Circuit’s interpretation weakens the intended protections for patent holders.

Edwards highlights that the Supreme Court has previously reviewed the scope of the safe harbor in similar cases, such as Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005), and Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990). These rulings established that the safe harbor applies only to activities reasonably related to obtaining federal regulatory approval. The company argues that these decisions affirm that the exemption is intended to be narrow, covering only acts necessary for preparing regulatory submissions and not allowing infringers to engage in broader activities under the guise of regulatory preparation.

The petition states that the Federal Circuit’s interpretation creates significant risks for patent holders, particularly in high-stakes industries like medical devices and pharmaceuticals, where regulatory compliance and market competition are closely intertwined. Edwards contends that the ruling permits competitors to exploit the safe harbor by engaging in infringing activities with dual purposes, such as promoting products to customers while simultaneously preparing for regulatory approval. It warns that such an expansive reading of the exemption will erode the value of patents by giving competitors a head start in the marketplace and reducing the exclusivity that patents are intended to provide.

The petition emphasizes the economic stakes involved, noting that the decision affects the medical device industry and the broader innovation landscape. Edwards argues that companies that invest heavily in research and development need the certainty of patent protections to justify their investments. Allowing competitors to engage in promotional activities while seeking regulatory approval undermines these incentives, potentially discouraging innovation and shifting the competitive dynamics Congress sought to protect with the Hatch-Waxman Act.

Edwards has requested the Supreme Court to clarify the proper scope of the safe harbor provision, reaffirming that it applies only to activities conducted exclusively for regulatory purposes. The company asks the Court to restore the original statutory limitation by ruling that mixed-purpose activities, such as those with regulatory and commercial elements, are not exempt from infringement under the safe harbor. Edwards further requests that the Court reverse the Federal Circuit's decision and provide clear guidance to ensure that the safe harbor cannot be used to shield commercial activities under the pretext of regulatory compliance.

The question presented by Edwards’ petition is: “Whether, under Hatch-Waxman’s safe harbor, an infringing act is “solely for uses reasonably related” to the federal regulatory process, when the infringing act is performed for both regulatory and non-regulatory uses.”

The Case is Dkt. No. 24-428.

Attorneys: Daniel L. Geyser (Haynes and Boone, LLP) for Edwards Lifesciences Corp.

Companies: Edwards Lifesciences Corp.; Meril Life Sciences Pvt. Ltd.

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