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.

Join Us for a CLE Webinar on Strategies for Addressing Common, but Seldom Discussed, Mass Tort Litigation Irritants

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 routine in high-stakes litigation, but the process is disrupted by exorbitant fee demands by opposing experts, often exceeding $1,000 per hour. We will discuss how to resist and overcome such demands.
  • Third parties being targets of discovery abuse in complex litigation and receiving extravagant document subpoenas, compliance with which would disrupt their document retention policies. We will address how non-parties can quash or narrow such fishing expeditions.
  • Third Party Payor litigation, which also follows mass tort litigation as night follows day. We will discuss recent trends and developments.

CLE credit can be earned for PA, NJ and DE. The webinar is free for chapter members, is $25 for in-house counsel non-members, and is $225 for outside counsel non-members. To register, please visit this link, click the “register now” button, and select the “2020 Virtual Litigation Week” program.

Please join us for an upcoming CLE webinar, “Preparing for the inevitable: FCA investigations in a post-COVID world”

The CARES Act funding was a lifeline for many health care organizations and life sciences companies, but came with significant attached strings. Related fraud charges are already making headlines and bring with them the serious risk of False Claims Act litigation, which can have bet-the-company implications for companies.

Please join us this Wednesday, August 5 at 2 p.m. ET for a CLE webinar on “Preparing for the inevitable: FCA investigations in a post-COVID world” presented by our Life Sciences Health Industry Group partners Rick Robinson and Sarah Cummings.

This webinar will help companies understand the False Claims Act enforcement risks stemming from CARES Act funds, along with other enforcement risks stemming from COVID-related developments. Rick and Sarah will also provide an overview of recent key False Claims Act enforcement developments pre-COVID to set the stage for the discussion.

For more information, or to register, please click here.

This program is presumptively approved for 1.0 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.

Reed Smith hosts July 16 life sciences virtual roundtable on “Deal making in a post-COVID world”

While the life sciences sector has proven more resilient than most, COVID-19 has undoubtedly caused a dramatic slowdown in deal activity globally across industries. Please join Reed Smith and a panel of strategic, private equity, and venture capital leading deal makers for an engaging discussion on the impact COVID-19 has had on deal making in the life sciences sector, lessons learned, and their perspectives on deal making and deal trends in the sector in a post-COVID-19 world.

Our speakers include:

  • Iqbal Hussain, Life Sciences Transactional Partner, Reed Smith
  • A. Maria Dahl, Head of Transactions: Oncology Business Development & Licensing, AstraZeneca
  • Edward de Nor, Executive Parter, GHO Capital
  • Johan Verbeeck, Vice President Business Development, Immunology, Janssen Pharmaceutical Companies of Johnson & Johnson
  • Laurence Barker, Partner and CBO, Dementia Discovery Fund SV Heath Investors
  • James West, Director, Results Healthcare

You can register for the roundtable by clicking here.

COVID-19 pandemic: German government further extends foreign investment control rules with regard to transactions in the life sciences sector

The German Federal Ministry for Economic Affairs and Energy implemented further amendments to the Foreign Trade and Payments Ordinance (Außenwirtschaftsverordnung – AWV) due to the COVID-19 pandemic to prevent the buyout of German companies active in the life sciences and infection protection sectors by investors from outside the EU (or EFTA). The amendment entered into force on 3 June 2020.

The amendment broadens the scope of application of cross-sector reviews. In particular, the development and manufacture of the following products are covered by the cross-sectoral reviews:

  • personal protective equipment, such as face masks;
  • essential medicines such as vaccines (and including raw materials and active ingredients);
  • medical products used for diagnosing, preventing, monitoring, predicting, forecasting, treating, or alleviating life-threatening and highly contagious infectious diseases; or
  • in vitro diagnostics that are used to provide information on physiological or pathological processes or conditions, or for determining or monitoring therapeutic measures in connection with life-threatening and highly contagious infectious diseases.

Companies active in these sectors should be aware of the amendments implemented by the German government when planning and structuring such a transaction involving an investor from outside the EU (or EFTA) and a German business. For more information, please read our post on Reed Smith’s Antitrust and Competition Report blog.