Edwards Lifesciences Corporation v. Meril Life Sciences Pvt. Ltd.

Background

Edwards Lifesciences Corporation supplies medical devices for treating heart disease, including SAPIEN transcatheter prosthetic heart valves. Meril Life Sciences Pvt. Ltd. created the Myval transcatheter heart valve and Navigator delivery system. Meril, Inc. is its wholly owned subsidiary.

Edwards alleged that Meril infringed Edwards’s patents through two acts: importing the Myval System into the United States in 2017 for a preclinical cadaver study at the University of Washington, and importing and exhibiting at least one Myval System at the 2019 Transcatheter Cardiovascular Therapeutics Conference. The opinion states that Meril brought physical samples to the conference but did not remove them from their bag or display them, sell them, or offer them for sale. Meril had discussed the device with doctors and sought potential clinical investigators while preparing for the FDA approval process.

Summary-judgment ruling

The defendants moved for summary judgment, which asks whether the record shows no genuine dispute about an important fact and entitles the moving party to judgment under the law. They relied on the safe-harbor provision in 35 U.S.C. § 271(e)(1). That provision protects making, using, offering to sell, selling, or importing a patented invention when the activity is solely for uses reasonably related to developing or submitting information under federal laws regulating drugs or medical devices.

The court held that the safe harbor covered Meril’s transportation of the Myval samples to the 2019 conference. Meril had taken steps toward FDA approval, including preparing a clinical-trial synopsis, preparing a draft submission seeking FDA input, communicating with the FDA, and hiring an FDA consultant. Because Meril did not sell or offer the device for sale at the conference, the court found that transporting the samples to a conference attended by potential clinical investigators was reasonably related to providing information needed for clinical testing and FDA approval. The court rejected Edwards’s argument that the defense required actual use of the samples.

The court also held that the safe harbor covered the shipment to the University of Washington. The cadaver study examined whether the device could be safely implanted in human subjects, produced information about positioning the valve in the body, and related to the preclinical information required for the FDA approval process. The court stated that the safe harbor can apply even when study information is not ultimately submitted to the FDA.

The court further held that the safe-harbor analysis focused on whether the challenged acts were reasonably related to FDA approval, rather than on Meril’s purpose or motive. It concluded that both challenged activities fell within the safe harbor and that there was no infringement on the record before it. The court therefore GRANTED Defendants’ Motion for Summary Judgment.

Discovery ruling

Edwards sought relief under Federal Rule of Civil Procedure 56(d), arguing that it needed additional discovery about Meril’s alleged infringement and plans for the Landmark Trial. The court denied that request because Edwards had not diligently pursued the discovery, including by waiting to provide a draft motion to compel until shortly before a scheduled deposition. The court expressly DENIES Plaintiff’s Rule 56(d) motion.

The opinion also states that additional alleged acts, including the Skirball Study, were not presently before the court because Edwards’s amended complaint addressed only the University of Washington study and the 2019 conference. The court declined to grant summary judgment on those additional acts based on an argument first raised in Meril’s reply.

Motions to seal

The court applied the requirement that a party seeking to seal material connected to a dispositive motion must show compelling reasons overcoming the presumption of public access.

The court GRANTED Meril’s motion to seal at Docket No. 66 because the identified material contained proprietary information about Meril’s clinical and regulatory strategies. The court DENIED the sealing request at Docket No. 81 because the parties’ confidentiality designations alone did not establish compelling reasons. The court GRANTED Meril’s revised motion at Docket No. 87 after finding that the specified material contained proprietary clinical, regulatory, and trade-show business information. The court also GRANTED Meril’s motion at Docket No. 89 concerning material about the Landmark Trial, FDA submissions, preclinical studies, and confidential business strategies.

Thus, the order’s overall disposition was to GRANT IN PART and DENY IN PART the Motions to Seal. The court vacated the claim-construction hearing scheduled for November 6, 2020, set a further case-management conference for November 3, 2020, and directed the parties to submit a case-management statement and proposed schedule. The order refers to remaining causes of action.