Navigating Trade Shows: Avoiding Patent Infringement in View of Edwards v. Meril

Members of industry routinely attend trade shows for their respective businesses. For medical device professionals, these events are important venues for displaying new products, networking with industry colleagues, and promoting the research and development of new technologies. During these events, activity associated with making, using, selling, offering to sell, or importing commercial products or experimental products into the United States may result in patent infringement under U.S. patent law.¹ A patent infringement lawsuit can take years to resolve, consume financial resources, and be an emotional drain on the participants. Losing a patent infringement lawsuit can subject the infringer to significant monetary damages and injunctions. Therefore, activity at a trade show must be carefully managed to mitigate liability for patent infringement, especially when dealing with experimental products that will compete with another company’s offerings. The recent decision by the United States Court of Appeals for the Federal Circuit (CAFC) in Edwards Lifesciences Corporation v. Meril Life Sciences PVT. LTD.² provides insight into some best practices that exhibitors should consider when participating in trade shows, especially when modern technology is being presented.

Patent Basics: The Safe Harbor Provision

Patents are essential for protecting intellectual property. A patent does not guarantee the holder the right to market a product, since oftentimes government regulatory approvals are typically required prior to commercialization, such as U.S. Food and Drug Administration (FDA) approval. Instead, the value of a patent lies in its ability to exclude others from making, using, selling, offering to sell, or importing a patented product into the U.S. when permission from the patent holder has not been obtained.¹ In spite of the protection provided by a patent, some activities are exempt from patent infringement in the U.S. One exception is the Safe Harbor provided under U.S. patent law, which protects activities deemed reasonably related to obtaining FDA approval from being considered an infringing activity.³

This exemption is pertinent for medical device companies undergoing the FDA approval process. Commercial activity—which, under normal circumstances, could be considered infringing activity—is permitted if performed strictly for purposes of obtaining regulatory approval. A recent opinion from the CAFC (the Federal Court for all patent appeals) provided clarity on how non-FDA approved devices and related activity at a trade show are protected from what otherwise could be patent infringement.

Overview of Edwards v. Meril

The dispute between Edwards Lifesciences Corporation (Edwards) and Meril Life Sciences PVT. LTD. (Meril) centered on Meril’s importation of two samples of a transcatheter heart valve system to a cardiology conference in San Francisco. Edwards sued Meril for patent infringement, asserting the importation of these devices into the U.S. constituted an infringing activity.
Meril countered that their actions were protected under the Safe Harbor provision, arguing the devices were imported solely as a part of their efforts to obtain FDA regulatory approval.
Meril is based in India and was developing a transcatheter heart valve system, while Edwards is a global player in the heart valve space, and thus, the two companies are competitors.
Meril received approval to commercialize its heart valve system in India in 2018, followed by receipt of a European CE mark in 2019, permitting European commercialization. Meril did not have FDA approval in the U.S., where the heart valve system required extensive data to be submitted for FDA regulatory review and approval prior to commercialization. As a result, Meril needed to recruit clinical investigators to implant the heart valves in humans, collect data from the testing, and then submit the data to the FDA as a part of the regulatory approval process.

Meril had a booth at the San Francisco cardiology conference in 2019. Prior to attending, Meril consulted with their attorneys and based on legal advice, instructed their staff not to sell the heart valve system or offer it for sale while in the U.S. for the U.S. market.

A Meril employee traveled to the conference and carried two sample heart valve systems. The samples were stored with written instructions clearly indicating they were not for sale and were for demonstration only. The samples were initially stored in a bag in an employee’s hotel room and then later placed in a storage room at the conference center. The samples were never removed from the bag. During the conference, Meril did have displays and presentations related to their new heart valve system but did not include pricing or any commercial promotion. Conference attendees were informed the heart valve system was not FDA approved and not available for sale in the U.S. Meril also did discuss the new heart valve system with several physicians as a part of their clinical investigator recruitment. At the conclusion of the conference, the two sample products were transported to Europe.

Later in 2019, Meril submitted a proposal to the FDA for conducting clinical trials of the heart valve system, and in October 2019, Edwards filed a lawsuit against Meril alleging patent infringement based on the importation of the two sample heart valve systems into the U.S. A year later, the federal district court dismissed Edwards’ complaint against Meril, finding the allegedly infringing activity was exempt from infringement under the Safe Harbor provision of U.S. patent law. On appeal, the CAFC upheld the lower court’s finding of non-infringement.

The Court’s Rationale

The Court analyzed whether Meril’s actions fell within the Safe Harbor provision. It emphasized the devices were never displayed or offered for sale, clarifying that their presence was solely for the purpose of engaging potential clinical investigators. This distinction was crucial in finding that Meril’s actions were for the purpose of seeking FDA regulatory approval, thus falling within the Safe Harbor.

Specific evidence that supported this conclusion included working with regulatory consultants to prepare clinical trial plans and documents that were communicated to the FDA before and after the conference. This was also enforced by the fact Meril never offered the heart valve system for sale during the conference. These facts were undisputed by Edwards, and thus, the Court affirmed the lower court holding of no patent infringement and the case was dismissed on summary judgment.

Best Practices

Based on the Court’s holding, some best practices are suggested that may help minimize patent infringement, especially when dealing with an experimental medical device undergoing FDA approval.

The Court’s opinion underscores the importance of planning and strict compliance when participating in and bringing non-FDA approved devices to trade shows. Medical device professionals should consider the following best practices to minimize patent infringement risks:

• Documentation: Document intent to use devices solely for FDA approval processes. This includes documenting transportation, storage, and handling of the samples.
• Non-Disclosure Agreements (NDAs): Execute NDAs with clinical investigators and other personnel that indicate the experimental and investigational nature of any product demonstrations, that sample devices are not yet FDA approved, and that the technologies are for investigational use only.
• Training: Conduct training for all staff involved in tradeshows. Staff should clearly articulate to others that the devices are for investigational use and not for sale.
• Labeling: Clearly label all samples as “Not for Sale” and “For Demonstration Only,” as well as indicating the lack of FDA approval status.
• Controlled Access: Limit display and discussion of experimental devices to private meetings, such as with clinical investigators. Avoid public disclosure or displays that could be misconstrued as commercial promotion.
• Legal Counseling: Consult with legal experts who specialize in FDA regulatory and intellectual property law. Their insights can help navigate the complexities of the Safe Harbor provision and other relevant legal standards, especially in view of evolving judicial decisions that may alter interpretation of the law.

Conclusion

The Edwards v. Meril decision is a reminder of the nuanced legal landscape associated with bringing new medical technologies to market. By adhering to the outlined best practices and understanding the scope of the Safe Harbor provision, companies can leverage trade shows as effective platforms for advancing innovative technology while mitigating legal risk. As the medical device industry continues to evolve, staying informed and vigilant about patent law and FDA regulations will remain crucial for commercial success. 

References

1. 35 U.S.C. § 271(a)
2. Edwards Lifesciences Corporation v. Meril Life Sciences PVT. LTD., Appeal No. 22-1877 (Fed. Cir. March 25, 2024).
3. 35 U.S.C. § 271(e)(1)

 

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Doug Portnow is a registered patent attorney and Of Counsel at Schwegman Lundberg & Woessner P.A. His practice focuses primarily on medical device patent preparation, prosecution, and intellectual property due diligence. Prior to entering the legal profession, Portnow was an engineer designing medical and surgical devices.