Insights

Brussels and Doha – April 1, 2024: The Legal 500 Europe, Middle East & Africa (EMEA) 2024 edition has recognized 16 practice areas and 11 lawyers in Crowell & Moring’s Brussels and Doha offices. The 11 individual lawyers received 18 total rankings across the 16 different practice areas.

Brussels – March 20, 2023: Chambers and Partners has ranked four Crowell & Moring practice groups and six individual lawyers in the Chambers Europe 2023 guide. The rankings are driven by independent interviews of clients and members of the legal community.

Following federal lawmakers’ initiative to lower prescription drug prices under the Inflation Reduction Act of 2022, several states have taken similar steps to limit certain drugs’ prices. Drug affordability for consumers is a top priority for federal and state lawmakers and regulators because it is a bipartisan issue that directly impacts consumers’ wallets. With negotiations between the federal government and drug manufacturers over 10 drugs’ prices for Medicare beneficiaries well underway under the Inflation Reduction Act, 11 states, including Maryland and Colorado, have created drug affordability review boards to more directly tackle rising prices for both brand and generic drugs.[1] And another 12 states have pending legislation to create these boards.[2] 

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.

On March 1, 2024, Judge Colm F. Connolly of the District of Delaware granted the government’s motion for summary judgment in the first substantive ruling on the constitutionality of the Inflation Reduction Act (“IRA”).  The court first held that AstraZeneca Pharmaceuticals LP and AstraZeneca AB’s (collectively, “AstraZeneca”) lacked Article III standing to challenge the Center for Medicare and Medicaid Services’ (“CMS”) guidance under the Administrative Procedure Act (“APA”).  The court then rejected AstraZeneca’s challenge to the IRA as an unconstitutional taking on the merits because, in its view, AstraZeneca “ha[d] not identified a property interest protected by the Constitution that is put in jeopardy by the Program.”[1] The court’s opinion comes on the eve of oral argument in a closely-followed related case in the District of New Jersey and marks a significant development in IRA jurisprudence.

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.