Northern District Of California Finds Importation Of Medical Device Samples Protected Under The Section 271(e)(1) Safe Harbor
On October 16, 2020, the United States District Court for the Northern District of California issued an order granting summary judgment of noninfringement under 35 U.S.C. § 271(e)(1). Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd. , Case No. 4:19-cv-06593-HSG, Dkt. No. 98 (N.D. Cal., Oct. 16, 2020). The Court found that defendant’s importation of samples into the United States for conducting preclinical investigations and for intended demonstrations at a clinical conference were exempt from patent infringement liability, regardless of whether there was a commercial purpose underlying such conduct.
The Section 271(e)(1) safe harbor allows competitors, before expiration of a patent, to engage in otherwise infringing activities if such activities are reasonably related to obtaining approval from regulatory agencies like the FDA. Congress enacted the safe harbor to prevent creation of a de facto patent term extension for patents covering products, such as drugs and medical devices, that require regulatory approval before market entry. Without the safe harbor, competitors would not be able to begin the regulatory approval process until after expiration of the patent.
On October 14, 2019, Edwards Lifesciences Corp. filed a complaint against Meril Life Sciences Pvt. Ltd. alleging infringement of five patents related to transcatheter heart valves. On April 6, 2020, plaintiff filed an amended complaint alleging infringement based on two acts of importation:1. In 2017, defendant shipped samples of the accused devices to the University of Washington (UW) to conduct preclinical cadaver investigations.2. In 2019, after defendant had begun the FDA approval process for the accused devices, an employee of defendant brought samples of the devices to a clinical conference in San Francisco, California for nonsale demonstrations. Defendant solicited potential clinical researchers for its clinical studies on human subjects while at the conference but did not show the samples due to technical difficulties with its accompanying presentation.
Defendant moved for summary judgment of noninfringement, arguing that the alleged conduct was exempt from liability under the Section 271(e)(1) safe harbor because it was reasonably related to furthering clinical investigations of the accused products for future FDA approval. The Court granted defendant’s motion.
First, relying on Supreme Court precedent, the Court found that the importation for the 2017 preclinical investigation was protected under the Section 271(e)(1) safe harbor because defendant used the results to determine the feasibility and safety of implanting the accused devices into live human subjects during clinical studies required for FDA pre-market approval.
Second, relying on Federal Circuit precedent, the Court found that the importation for the 2019 clinical conference was also protected under the safe harbor because, although defendant did not demonstrate and use the accused devices at the conference (which would have been protected conduct), its transportation of the samples was reasonably related to the submission of information to the FDA, including educating potential clinicians at the conference about the accused devices. The Court also rejected plaintiff’s argument that there must have been actual use—not just importation—for the safe harbor to apply, noting that the statute explicitly exempts any allegedly infringing activity.
Finally, the court rejected plaintiff’s argument that the safe harbor does not apply because defendant’s conduct had a commercial purpose, to promote and market the accused devices. Noting that the safe harbor inquiry focuses only on the allegedly infringing conduct, the Court held that because defendant proved that its allegedly infringing acts are reasonably related to obtaining FDA approval, defendant’s intent and underlying purposes are irrelevant.