What You Need to Know
- Key takeaway #1Broad Interpretation of Safe Harbor: The Federal Circuit’s decision underscores a broad interpretation of the safe harbor provision. Companies can be reassured that activities potentially perceived as an infringing importation or use may still fall under safe harbor if they are in any way related to the development and submission of information to regulatory bodies like the FDA, including the recruitment of clinical investigators for clinical trials and research.
- Key takeaway #2Importance of Demonstrating Regulatory Intent: To leverage the safe harbor provision, it is crucial for companies to clearly demonstrate that their actions, especially when involving potentially patented technologies, are primarily intended to facilitate regulatory approval. Documenting the regulatory purpose behind each activity can provide essential evidence if the safe harbor defense is needed. Consider including with any demonstration samples a declaration disavowing any commercial intent as a “get out of jail free card” and contemporaneous evidence of subjective intent.
- Key takeaway #3Navigating Commercial Intent: While the majority opinion suggests that activities with mixed purposes may still qualify for safe harbor protection, Judge Lourie’s dissent warns against overlooking commercial intents. Companies should be cautious of engaging in activities that could be construed as having a commercial motive, which could potentially exclude them from safe harbor protection.
On March 25, 2024, the Federal Circuit issued a precedential opinion in Edwards Lifesciences Corporation v. Meril Life Sciences Pvt. Ltd., a case with significant implications for the application of the safe harbor provision of 35 U.S.C. § 271(e)(1). This case involved the importation of two transcatheter heart valve systems by Meril Life Sciences Pvt. Ltd., an India-based medical device company, to San Francisco for a medical conference. According to Meril, these heart valve systems, part of Meril’s Myval System designed to treat heart disease, were never displayed or offered for sale at the conference but were instead stored in a bag in a hotel closet and later in a storage room. The Court’s decision to affirm the district court’s grant of summary judgment of noninfringement in favor of Meril brings to light the nuances of applying the safe harbor provision in patent infringement cases.
The dispute arose when Edwards Lifesciences, a competing medical device company, filed suit against Meril for infringement, arguing that the importation of the heart valve systems constituted an act of patent infringement. However, the district court granted summary judgment in favor of Meril, determining that the importation fell within the safe harbor provision of 35 U.S.C. § 271(e)(1), meant to exempt certain infringing activities that are “reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.”
The Federal Circuit affirmed the district court’s decision, emphasizing that the actions taken by Meril, including the importation of the heart valve systems, were reasonably related to obtaining FDA approval. The court highlighted that an exemption under § 271(e)(1) does not require the actual use of the imported devices, nor does it turn on the party’s subjective intent behind the act of importation.
The Federal Circuit held that Meril’s importation of the heart valve systems was part of its broader efforts to gain FDA approval for the Myval System in the U.S. Prior to the conference, Meril had been engaging with the FDA and planning a clinical trial comparing the Myval System with leading devices in Europe, including Edwards’s SAPIEN valves. The trial, dubbed the “Landmark Trial,” aimed to include data as part of future submissions to the FDA. Meril also sought assistance from CardioMed LLC, a consulting firm, for preparing a premarket approval submission. According to Meril, its activities at the Transcatheter Cardiovascular Therapeutics Conference in San Francisco—where the devices were stored but not displayed—were aimed at recruiting clinical investigators for the FDA clinical trials. Also highly relevant to the Court’s analysis was the fact that the samples were accompanied by a handwritten note stating that the samples were “for demonstration purpose only” and that they “have no commercial value & hence it is not used for any sales purpose.”
The Court’s ruling builds on past interpretations of § 271(e)(1) that emphasize a broad application of the safe harbor, extending protection to all uses of patented inventions that are reasonably related to the development and submission of information under federal law regulating drugs or medical devices. This broad interpretation has been justified by the Court’s view that § 271(e)(1)’s exemption from infringement applies irrespective of the research stage or whether the information developed is ultimately submitted to the FDA.
However, Judge Lourie’s dissent voices a fundamental disagreement with this broad interpretation, particularly highlighting a tension between the Federal Circuit’s precedent and the literal wording of the statute. Judge Lourie advances the viewpoint that the safe harbor’s scope should be reevaluated in light of the statutory language. His critique suggests that the Court’s current trajectory potentially expands the safe harbor beyond its intended bounds, offering protection to activities that may not be solely for FDA approval-related activities. Judge Lourie’s dissent calls for a more nuanced consideration of the safe harbor provision, taking into account both the activities’ relation to FDA approval processes and the underlying intent behind these activities. As applied to the facts of this case, Judge Lourie would have reversed the district court, finding that there was a genuine dispute of material fact as to whether Meril’s importation of the devices were “solely” to recruit clinical investigators as opposed to including some other commercial purpose.
This case illustrates the complexities surrounding the safe harbor provided by 35 U.S.C. § 271(e)(1) and underscores that its application under the current rubric may be broadly applied. Companies involved in the development and regulatory approval of medical devices or drugs should carefully consider how their actions may be perceived under the law, regardless of subjective intent, and ensure they are in the best position to defend their use of the safe harbor provision if challenged.
For further information, please contact:
Jon Gurka, Partner, Crowell
jgurka@crowell.com
