Sidley Global Life Sciences

Join the Women’s Life Sciences Network on Tuesday, October 22 in Basel, Switzerland for “Combination Therapies – EU Regulatory and Competition Law Headwinds and Strategies.” The event will feature insights from Swissmedic’s Dr. Sandra Zaugg Kunz, Takeda’s Elisabeth Leimbacher, and Novartis’ Celine Fang on key considerations related to authority expectations as well as challenges – and potential strategies for EU regulatory and competition law compliance for combination therapies. Learn more and register here, https://bit.ly/3YUTj7l.

Both U.S. and P.R.C.-based biotechs are anxiously watching attempts to pass the U.S. BIOSECURE Act into law. Michael Borden and Andy Shoyer explain what this month’s developments mean, and why the legislation, even with so much attention and publicity, may never actually become law. Read more on "How, When, and If the U.S. BIOSECURE Act Is Likely to Become Law."

Join Sidley partners Brenna Jenny and Sean Griffin on August 28 for the Washington Legal Foundation’s webinar “High Court’s Healthcare Impact: Fines, FDA Authority, and More Post-Loper Bright and Jarkesy.” Learn more and register here, https://bit.ly/4fMpP1t.

A recent bipartisan bill unanimously passed by the U.S. Senate—the Affordable Prescriptions for Patients Act of 2023—proposes changes to the Patent Act which could affect future patent infringement suits under the Biologics Price Competition and Innovation Act (BPCIA). If enacted, the bill would amend the Patent Act to limit the number of certain types of patents that biologic innovators can assert against biosimilar applicants in BPCIA litigation. Read here for our insights, https://bit.ly/4fJOTGm.

Recently, DOJ, the State of Florida, and the State of Minnesota reached a nearly US$15 million FCA settlement to resolve allegations that a provider knowingly submitted claims for services related to the management of patients in assisted living facilities, group homes, and memory care units that did not comply with applicable federal healthcare program requirements. In this Westlaw Today article, Sidley’s Jaime Jones, Brenna Jenny, and Francesca R. Ozinal share their insights on the agreement—one of the first FCA settlements involving chronic care management. Read more here, https://bit.ly/4dzUjlM.

Investors are eyeing up the opportunities to invest in healthcare AI as it pushes the healthcare industry into new and exciting territory. R&D is currently focused on genomic sequencing, mapping, understanding populations and the treatment of rare diseases and hereditary cancer. AI applications are fundamentally altering how such R&D is conducted, as well as changing healthcare services to improve patient experience and outcomes. Read more on "Investor Attitudes to Healthcare AI Technologies" on Chad D. Ehrenkranz's blog post.

Join us on Tuesday, September 24 in London for the Sidley Healthcare Investment Conference 2024. Hosted at The Francis Crick Institute, this year’s conference will gather global #pharma, #biotech, healthcare, private equity, and venture capital leaders to share their perspectives on the issues, trends, and opportunities critical to the success of #lifesciences and #healthcare innovation. The event will also feature a fireside chat with Richard Francis, President and CEO of Teva, titled “A Life in Pharma and Pivoting to Innovation.”   Learn more and register here, https://bit.ly/3L41tSO. hashtag#SidleyHIC2024

Sidley represented Novo Holdings, a leading international life science investor, on their £50 million investment in Oxford Nanopore Technologies, the leading UK-listed company behind a new generation of molecular sensing technology based on nanopores. The Sidley team was led by Private Equity partner Robert Darwin, supported by partner James Wood, counsel Ed Perry, and associate Jessica Edwards. Read more here, https://bit.ly/4dcy9WL.

Thank you to all who joined us this week for Sidley’s Bay Area Lifesciences Roundtable at SFMOMA San Francisco Museum of Modern Art. Attendees discussed industry trends and hot topics including opportunities across Asia, innovations in AI-enabled life sciences technologies, and the latest paradigm-shifting FDA developments. A special thank you to our panelists: Tom Duley, Joshua Hofheimer, Stephen Abreu, Meenakshi Datta, Torrey Cope, Emily Marden, Judith Li, Mark Noguchi, Andrew Wong, Colin Hill, Joshua Reicher, M.D., Ryan Spiers, Robin Harper Cowie, Jun Li, and Amar Murugan.

On July 2, 2024, the Centers for Medicare & Medicaid Services issued a two-part information collection request seeking comment on the cost burden of two components of the Medicare Drug Price Negotiation Program for Initial Price Applicability Year 2027: the Negotiation Data Elements and the Drug Price Negotiation Process. Comments are due by September 3, 2024. Read our insights here.