Insights

Washington – January 10, 2024: Crowell & Moring has published Litigation Forecast 2024: What Corporate Counsel Need to Know for the Coming Year. The 12th-annual Litigation Forecast focuses on trends in intellectual property, regulatory and other U.S. litigation, with special coverage of supply chain recovery and international litigation.

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 Federal Circuit’s decision in University of South Florida Board of Trustees v. United States, 22-2248 (Fed. Cir. Feb. 9, 2024) hints at the broad scope of the federal government’s license rights under the Bayh-Dole Act. 

On February 12, 2024, Judge David Alan Ezra of the Western District of Texas dismissed a lawsuit challenging the constitutionality of the Drug Price Negotiation Program of the Inflation Reduction Act of 2022, P.L. 177-169 (IRA).[1]

A proposed overhaul of U.S. patent eligibility law could shape the patent litigation landscape in 2024, with some parties rushing to court before Congress enacts reform and others holding back on filing suit in the hope that the changes will strengthen their legal case, says Crowell & Moring partner Gang Chen.

More companies than ever before are launching smart medical devices and industry growth seems endless as new products and technologies are announced daily. However, before companies push products to market, it’s crucial to understand key aspects of device approval, and company and patient protection. In this webinar, our speakers will outline intellectual property strategies, U.S. Food and Drug Administration considerations, and data cybersecurity concerns that are inherent to all smart medical devices. They will explore the legal issues that can significantly decrease the risk profile and potential liabilities throughout a product's lifecycle and create safer, more reliable products for consumers.

Crowell & Moring New York counsel Anne Li and 2017 summer associates Brian McGrath and Greg Manring join the Hon. J. Paul Oetken of the U.S. District Court for the Southern District of New York and Stuart Pollack, Partner, DLA Piper, for a panel discussion hosted by the Honorable William C. Conner Inn of Court.