Life Sciences Legal Update News; A must-read for all subscribers

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 still be available to access online in the immediate future, no new content will be posted. Our team has greatly enjoyed using the blog as a vehicle to update subscribers on numerous developing topics, industry trends, and new laws and regulations in this ever-changing industry.

We hope you will join us on by subscribing to our other blogs and platforms, listed below, for future updates.


Please subscribe to Reed Smith’s Health Industry Washington Watch blog for updates regarding legislative and regulatory developments that affect the health care industry.

Please subscribe to the award-winning Drug & Device Law blog for updates and commentary on drug and device product liability developments.


Please subscribe to the Health Care & Life Sciences topic on Passle/Viewpoints for current industry updates.

Thank you for your support over these past 10 years! Happy New Year, and we hope to see you on our other platforms in 2023!

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, 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, inventors must be humans.

In 2019, Steven Thaler filed two separate patent applications with the U.S. Patent and Trademark Office (“PTO”) for inventions allegedly developed only by his AI system “DABUS.” When the PTO found the applications to be missing a valid inventor and thus incomplete, it asked Thaler to identify valid inventors. The case made its way up to the Federal Circuit after Thaler unsuccessfully tried to have his AI recognized as an inventor on the applications.

Whether AI can be an inventor is a question being faced around the world. Currently, under U.S., European, and Australian patent laws, AI cannot be an inventor.

Reed Smith’s client alert discussing the Thaler case is available here.

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 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.

The guidance breaks the voluntary recall process into four aspects: 1) how a firm in a product distribution chain should prepare to facilitate timely initiation of a voluntary recall; 2) what a firm should do if it discovers a problem with a distributed product; (3) how a firm should initiate a voluntary recall; and (4) how the FDA will work with a recalling firm to initiate a voluntary recall in a timely fashion.

Firms in the product distribution chain

The FDA guidance tells firms in the product distribution chain that it is critical that they be “recall ready.” That is, firms should prepare for the possibility of a recall before a recall is actually initiated.

To accomplish this, the FDA urges firms to start establishing the framework for their recall team. That involves identifying and training appropriate personnel to be involved in a recall and to establish an internal and external communications plan about the recall, informing the FDA, direct accounts, and the public.

Additionally, firms are encouraged to prepare for the logistics of a recall. That includes identifying any reporting requirements for distributed products, using adequate product coding, and maintaining distribution records to facilitate the location of products being recalled.

Finally, firms in the product distribution chain should create a set of written procedures for a possible recall. This will allow the firm to make a timely recall of all products on the market and limit the amount of time that any violative products remain on the market.

Problems revealed in a distributed product

The FDA guidance has recommendations for what firms should do if there is an indication that a product may be in violation of the Food Drug and Cosmetic Act or any of the other statutes that the FDA administers.

The guidance recommends that the firm take the following steps when problems are revealed with a product:

  • Identify the problem
  • Investigate the problem
  • Make decisions and take action
  • Consult with the FDA

Companies face decisions such as whether to initiate a voluntary recall, the scope and depth of that recall, and the need to discontinue the production/distribution of the product.

FDA in its guidance says it is available for consultation while the product is being investigated, and offers a comprehensive list of FDA recall coordinators on its website.

Initiation of a voluntary recall

In its guidance, the FDA recommends that firms initiate a voluntary recall by promptly notifying each of its affected direct accounts and by making some form of public notice, such as issuing a press release. It is this first communication, either to the public or to the direct accounts that the FDA considers to be the initiation date of the recall, regardless of what time may have elapsed during the investigation of the problem.

The FDA also urges firms not to wait for FDA review of its recall procedures or communications to initiate a recall. This is why the guidance in an earlier part recommends that firms establish recall procedures and strategies in advance to be ready to start the process and remove the violative products from the market.

The guidance also requests that firms immediately notify the FDA of any voluntary recall effort.

FDA interaction on initiation of voluntary recall

The FDA pledged to work cooperatively with firms initiating voluntary recalls. To that end, the agency provides recall coordinators who can help review firm communications and advise on the process of destruction, reconditioning or disposition of the recalled product.

Additionally, the FDA included warnings about how and when the agency might request a firm to initiate a recall and whether the failure of a voluntary recall to sufficiently address the problem with the product could lead to additional actions.

Reed Smith will continue to follow this and other developments. If you have any questions about regulatory issues in general or FDA product recalls specifically, please reach out to the health care lawyers at Reed Smith.

Join Us: Free CLE Webinar on the Best & Worst Drug/Medical Device Decisions of 2021

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, Stephen McConnell, Eric Alexander, and Rachel Weil will be presenting this year’s webinar and providing an in-depth analysis into these industry changing decisions. 

This program is presumptively approved for 1.5 CLE credits in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas and West Virginia. Applications for CLE credit will be filed in Delaware, Florida, Ohio, and Virginia. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance but Reed Smith only provides credit for the states listed. Please allow 4-6 weeks after the program to receive a certificate of attendance.

 You can register for the webinar here

Health care workers and private employees could be affected by new CMS interim final rule and OSHA final rule

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 Administration (OSHA) final rule. OSHA has issued its COVID-19 Emergency Temporary Standard (ETS) for private employers, which goes into effect on December 5, 2021, though as of this posting, the U.S. Court of Appeals for the 5th Circuit temporarily blocked the mandate while the court reviews it.

Please Join Us: European Life Sciences Legal Insights Month: 4 – 8, 27 October

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 practices, generics exclusion and price gouging
  • New legislative hurdles and unintended pitfalls: Regulatory considerations and strategies for global pharma and medtech companies
  • Access to data: Is harmonisation across the EEA achievable?
  • Listing on the LSE: experiences of U.S. life sciences companies
  • Doing business with research institutions: whose right is it anyway?
  • Deal making in the Life Sciences sector: how to successfully navigate the convergence of Intellectual Property and Competition Law

For more information or to attend any of these sessions, please click here to visit the registration page!

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 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 enforce their blockbuster patents in parallel proceedings in the most relevant jurisdictions. The new system and the availability of pan-European injunctions means that claimants will be able to move from five parallel cases to one. However, the new system also comes with disadvantages such as pan-European invalidation proceedings. Nobody can predict the quality of judgments issued by the future court. For owners of European patents who are concerned about losing their IP rights, now is the time to identify the crown jewels and to make an informed decision about opting out.

To read more about the new provisions to PatG please read the client alert written by Dr. Anette Gärtner and Dr. Alexander R. Klett.

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 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, which currently leaves significant room for interpretation.
  • Implications. The reference to “third party interests” in the context of proportionality is not a welcome development, because it may limit the availability of preliminary and permanent injunctions. That said, we are yet to see how the courts will interpret the codified principle, and the open wording of the new provisions may enable judges to decide cases in a more flexible manner than is currently possible. The extension of the confidentiality club definitely is a step in the right direction, because it addresses potential concerns of litigants, which otherwise would not be prepared to disclose commercially sensitive information or technical know-how in court.

To read more about the new provisions to PatG please read the client alert written by Dr. Anette Gärtner and Dr. Alexander R. Klett.

A multi-agency pharmaceutical task force looks to review antitrust issues that arise during mergers and acquisitions

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 anticompetitive effects from pharmaceutical mergers and acquisitions. The task force will use these new ideas to understand when concerns are likely to arise and when to challenge and oppose problematic mergers. 

For further information, please see this recent client alert by Reed Smith partners Ross Mackenzie, Michelle A. Mantine, and Isabelle Rahman

Join Us: Virtual Life Sciences CLE Week for In-House Counsel: November 9-13

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 Act and antitrust enforcement

Each webinar in this series is presumptively approved for CLE credit in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas and West Virginia. Applications for CLE credit will be filed in Delaware, Florida, Ohio, and Virginia. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance but Reed Smith only provides credit for the states listed. For more detailed information on the credit offered for each session, please visit the registration page and click on the session of interest.

To register, please click here.