After more than 10 years providing updates on a range of topics impacting multinational and global life sciences companies, we’ve made the decision to wind down our Life Sciences Legal Update blog. While the content currently on the blog will
Life Sciences Legal Update
Analysis & commentary by Reed Smith on trends & developments in life sciences & health care law
Life Sciences Legal Update, published by Reed Smith LLP, focuses on legal developments affecting multinational and global life sciences companies. The blog covers topics such as regulatory guidance from agencies like the FDA, product recalls, patent law issues including AI inventorship, and compliance with evolving healthcare and pharmaceutical regulations. It also addresses litigation trends, industry-specific legislative changes, and risk management strategies relevant to drug and medical device manufacturers. The blog serves as a resource for legal professionals and industry stakeholders seeking updates on the intersection of law and life sciences business operations.
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Latest from Life Sciences Legal Update
U.S. Court of Appeals rules AI cannot be named an inventor
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,…
FDA finalizes guidance on voluntary recalls, issues recommendations for industry
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…
Join Us: Free CLE Webinar on the Best & Worst Drug/Medical Device Decisions of 2021
By Lisa Baird
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”…
Health care workers and private employees could be affected by new CMS interim final rule and OSHA final rule
By Lisa Baird
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…
Please Join Us: European Life Sciences Legal Insights Month: 4 – 8, 27 October
By Lisa Baird
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…
Here we go again – Unified Patent Court back on track
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…
German Patents Act (PatG) Receives New Updates
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…
A multi-agency pharmaceutical task force looks to review antitrust issues that arise during mergers and acquisitions
By Lisa Baird
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…
Join Us: Virtual Life Sciences CLE Week for In-House Counsel: November 9-13
By Lisa Baird
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:
…