According to the U.S. Court of Appeals for the Federal Circuit’s August 5th ruling in Thaler v. Vidal, No. 2021-2347 (Fed. Cir. 2022), artificial intelligence (“AI”) cannot be named as an inventor on a U.S. patent application. In its opinion, the Federal Circuit considered whether an inventor of a U.S. patent can be anything other than a human being. The Federal Circuit considered the statutory language of the U.S. Patent Act, which includes the definition of an “inventor” but not for an “individual.” Looking to various sources, the Federal Circuit determined that under the U.S. Patent Act, in ..read more

The Food and Drug Administration on March 4 issued new guidance for voluntary recalls of biologics, drugs, devices, and other products. The guidance finalizes an April 2019 draft that advised how firms in a distribution chain can prepare when conducting a voluntary recall. The guidance includes nonbinding recommendations and explicitly does not establish legally enforceable responsibilities on industry members or FDA staff. Instead, the guidance provides insight into the approach that FDA will take in working with industry to initiate voluntary recalls of products subject to FDA jurisdiction ..read more

It’s that time of year again! The Reed Smith bloggers from the Drug and Device Law Blog will be hosting their annual CLE webinar, “The good, the bad, the ugly: the best and worst prescription drug/medical device decisions of 2021” on Friday, January 21, 2022 at 12:30 PM ET.  Since 2013, Reed Smith’s contributors have hosted this exciting webinar discussing the top 10 best and worst decisions from the prior year. These cases are selected based on their likely precedential value, their importance to drug and device manufacturers, and their inherent (and subjective) merit. Bloggers Jim Beck ..read more

On November 5, 2021, the Centers for Medicare and Medicaid Services (CMS) published an interim final rule that requires vaccinations for certain health care workers. The rule is limited to only those entities who are surveyed by CMS and have Conditions of Participation, Conditions for Coverage, or Requirements for Participation in the Medicare and Medicaid programs. Our health care team recently summarized the rule, and is continuing to follow developments in this area. In addition, our labor and employment team also provided a similar overview of the new Occupational Safety and Health Adminis ..read more

Reed Smith will be presenting a virtual webinar series highlighting the numerous regulatory, litigation and transactional changes occurring in the European life sciences industry during the month of October. Our skilled life sciences team – joined by in-house counsel and industry professionals – will share their views on current industry developments. Sessions include: Multi-jurisdictional investigations in the life sciences sector – key updates from across the globe Helping life sciences companies manage competition trends for post-pandemic success. A topical update on pay-for-delay practice ..read more

The German Constitutional Court issued a landmark decision with implications for many companies doing business in Europe on July 9, 2021. For decades, the European Commission and EU member states strived to create a pan-European Unified Patent Court (UPC). After overcoming many hurdles, any sensible commentator will be cautious in making statements about the future of the UPC. That said, for the first time in years it now appears that the pan-European patent litigation system may finally come into being. This is particularly relevant for companies from the life sciences sector that tend to enf ..read more

Germany recently passed a reform bill for the Patent Act (PatG) and its new provisions will likely be coming into force sooner rather than later. The reform is particularly relevant for companies from the life sciences sector, which often litigate in this pro-patentee jurisdiction. The modifications to PatG address: Confidentiality concerns. New section 145a PatG states the relevant provisions of the Trade Secrets Act will also now apply in patent infringement cases. In short, Germany extends the confidentiality club to patent proceedings. Codification of the principle of proportionality, whi ..read more

A task force, composed of key antitrust enforcement agencies including the Federal Trade Commission (FTC), and the Canadian Competition Bureau, is seeking information from the public regarding the effects of pharmaceutical mergers. This information will be used to update the practices for future pharmaceutical mergers by the task force’s constituent agencies.  Following concerns within the agencies that their current practice of reviewing pharmaceutical mergers ignores the competitive landscape in the sector, the new information collected from the public will better address all anticompet ..read more

Reed Smith is pleased to present a virtual life sciences CLE week from November 9 – 13, covering hot litigation and regulatory topics of interest to our pharmaceutical, biotech, and medical device clients. Sessions include: The ABCs of an MDL: Lessons learned through the lens of a case The benefits of arbitration for life sciences and health care industry disputes Albrecht and implied preemption – Is there any clear evidence where we go from here? Best practices and war stories from remote litigation and arbitration Pharma’s evolving relationship with telehealth Current trends in False Claims ..read more

As part of the Greater Philadelphia chapter of the Association of Corporate Counsel’s Litigation Law CLE Week, I am pleased to be joining my Reed Smith colleague Jim Beck and Endo Pharmaceuticals’ Vice President and Assistant General Counsel – Litigation and Risk Jobina Jones-McDonnell to present a 12 p.m. ET webinar tomorrow on “Out of the Shadows: Strategies for Addressing Common, But Seldom Discussed, Mass Tort Litigation Irritants.” Discovery abuse abounds in mass tort litigation. We will be discussing aspects that often fly under the radar, including: Expert depositions. These are routin ..read more