Background
Edwards Lifesciences Corporation is a leading manufacturer of transcatheter heart valves — minimally invasive devices used to replace damaged heart valves without open-heart surgery. Edwards held multiple patents covering these devices. Meril Life Sciences Pvt. Ltd. is an Indian medical device company seeking FDA approval for its own transcatheter heart valve system. As part of its U.S. regulatory strategy, Meril imported two of its heart valve systems into the United States to display at a cardiology conference in San Francisco.
Edwards sued Meril for patent infringement based on the importation of these two valve systems. Meril defended under the safe harbor provision of 35 U.S.C. § 271(e)(1), which exempts from infringement uses of patented inventions “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 biological products” — in practical terms, activities conducted in connection with FDA approval. The district court ruled in Meril’s favor. Edwards appealed, arguing that because the imported devices were also shown at a commercial conference — not just used in regulatory testing — the safe harbor did not apply.
The Court’s Holding
The Federal Circuit majority affirmed. The court held that § 271(e)(1)’s safe harbor is available whenever a challenged act bears a reasonable relationship to developing and submitting information for FDA approval — even if the same act also serves other purposes. The word “solely” in the statute, the majority reasoned, modifies the uses that are protected (i.e., uses reasonably related to FDA approval), not the actor’s exclusive motivation. As long as the importation was reasonably related to FDA-approval activities, the safe harbor applies, regardless of whether the importer also had commercial promotional motivations for attending the conference.
Judge Lourie wrote a pointed dissent, arguing that the majority’s reading drains the word “solely” of its meaning. In his view, the statute requires that the infringing act be used solely — that is, exclusively — for regulatory purposes; acts that blend regulatory and commercial purposes should not qualify. The dissent’s approach would narrow the safe harbor significantly, creating additional exposure for companies importing products for dual regulatory-and-commercial purposes. The Supreme Court petition filed by Edwards raises precisely this debate, and the case may yet draw high court review.
Key Takeaways
- The § 271(e)(1) safe harbor protects importation of patented medical devices when the importation is reasonably related to FDA approval activities, even if the imported products are also displayed at commercial conferences.
- The “solely” qualifier in § 271(e)(1) modifies the types of uses that are protected (regulatory-related uses), not the exclusivity of the actor’s purpose — mixed-purpose activities can still qualify for the safe harbor.
- Medical device and pharmaceutical companies developing products for the U.S. market can import those products for regulatory-related purposes (conferences, investigational use, clinical trials) without triggering infringement liability, provided a reasonable relationship to FDA approval exists.
- The dissent’s competing interpretation — that “solely” requires exclusivity of purpose — remains live in the field and may invite further judicial or legislative attention.
Why It Matters
The § 271(e)(1) safe harbor is a critical provision for the global medical device and pharmaceutical industries. Foreign companies seeking FDA approval for products that incorporate patented technologies routinely need to import those products into the United States for testing, clinical trials, and regulatory submissions. Without the safe harbor, every importation step in the approval process would risk infringement liability, significantly chilling innovation and competitive entry.
This ruling provides important clarity to medical device companies that importing products for a conference — where regulatory and commercial activities naturally overlap — can still fall within the safe harbor if there is a genuine regulatory connection. However, the dissent’s concern about abuse of the safe harbor for primarily commercial activities is not frivolous, and companies should document the regulatory purpose of any importation carefully to withstand scrutiny if challenged. The pending Supreme Court petition means this area of law remains unsettled.