News & Analysis as of

Biotechnology

Fenwick & West LLP

House Reconciliation Bill Would Restore Expensing for Domestic R&D Prospectively

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On May 22, 2025, the U.S. House of Representatives passed a reconciliation bill (commonly referred to as the “One Big Beautiful Bill”), which would restore expensing for domestic research and development expenses incurred in...more

Arnall Golden Gregory LLP

FDA in the “Computer Age” — AI Adoption Accelerates as Staffing Shrinks

Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more

Woodruff Sawyer

[Ongoing Program] Risk Management for Your Life Sciences Company: Webinar 3 - International Clinical Trials Country Requirements-...

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From lab to commercialization: Navigate the evolving risks of life science companies - Life science companies face rapidly evolving risks—from navigating insurance needs during early funding stages to understanding...more

Woodruff Sawyer

[Ongoing Program] Risk Management for Your Life Sciences Company: Webinar 2 - AI In Real Life (Science): Exploring Real World...

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From lab to commercialization: Navigate the evolving risks of life science companies - Life science companies face rapidly evolving risks—from navigating insurance needs during early funding stages to understanding...more

Woodruff Sawyer

[Ongoing Program] Risk Management for Your Life Sciences Company: Webinar 1 - Navigating Risk from Lab to IPO: A Guide to...

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From lab to commercialization: Navigate the evolving risks of life science companies - Life science companies face rapidly evolving risks—from navigating insurance needs during early funding stages to understanding...more

Cooley LLP

Driving Business Growth Through Investment Funds: Analyses and Practical Insights for Chinese Biotechs

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Over the past few years, we have been deeply engaged in – and have closely observed – the rapid growth of Chinese biotech companies. Despite a challenging market environment, these companies have continued to make remarkable...more

Bergeson & Campbell, P.C.

House Subcommittees Will Hold Hearing on “Pursuing the Golden Age of Innovation: Strategic Priorities in Biotechnology” on June 5

On June 5, 2025, the House Science and Technology Subcommittees on Energy and on Research and Technology will hold a joint hearing on “Pursuing the Golden Age of Innovation: Strategic Priorities in Biotechnology.” The...more

Foley & Lardner LLP

GLP-1 Receptor Agonists: The Surge of M&A Activity and the Future of Metabolic Health

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Over the past decade, the global pharmaceutical industry has witnessed a transformation in the treatment landscape for metabolic disorders, particularly type 2 diabetes and obesity. At the heart of this shift is the explosive...more

Goodwin

EMA Issues Positive CHMP Opinions for Fresenius Denosumab Biosimilars

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On May 27, 2025, Fresenius Kabi (“Fresenius”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Fresenius’s two denosumab biosimilar candidates....more

Knobbe Martens

Bipartisan Law Introduced to Clarify Patent Eligibility

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For the past decade, controversy regarding the laws of patent eligibility has created uncertainty in the minds of inventors and investors, especially in the biotechnology, medical diagnostics, and software industries adjacent...more

Foley & Lardner LLP

Rethinking University Research: Innovating the Innovation Ecosystem to Support Life Sciences and Personalized Medicine

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Personalized medicine—tailoring treatments to individual patients based on their genetic makeup, lifestyle, and environment—is transforming healthcare. But this revolution didn’t begin in the private sector. It was sparked...more

White & Case LLP

Federal Circuit Clarifies Standard for Patent Conception in Ongoing CRISPR Dispute

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On May 12, 2025, the U.S. Court of Appeals for the Federal Circuit issued a long-awaited decision in Regents of the University of California v. Broad Institute (Nos. 22-1594, 22-1653) addressing priority for disputed...more

McDermott Will & Emery

Take That Conception Out of the Oven – It’s CRISPR Even If the Cook Doesn’t Know

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Addressing the distinction between conception and reduction to practice and the requirement for written description in the unpredictable arts, the US Court of Appeals for the Federal Circuit explained that proof of conception...more

Alston & Bird

Patent Case Summaries | Week Ending May 16, 2025

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The Regents of the University of California, et al. v. The Broad Institute, Inc., et al., Nos. 2022-1594, -1653 (Fed. Cir. (PTAB) May 12, 2025). Opinion by Reyna, joined by Hughes and Cunningham....more

Sheppard Mullin Richter & Hampton LLP

Guarding Against the Unknown: M&A Due Diligence of AI Companies in Data-Sensitive Sectors

M&A in the AI sector is redefining deal risk, especially when sensitive data is involved. As AI companies power breakthroughs in biotech, healthcare, defense, and critical infrastructure, the stakes for companies acquiring...more

Foley Hoag LLP

A Super CRISPR Week – the Week of May 12, 2025: Patent Battles, Clinical Milestones, and Next-Gen Tools

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Key Takeaways: Federal Circuit Reopens CRISPR-Cas9 Priority Fight. The CAFC vacated the PTAB’s earlier ruling that UC lacked prior conception of CRISPR-Cas9 in eukaryotic cells, remanding the interference for reconsideration...more

Troutman Pepper Locke

Embattled Biotechs Facing Uncertainty at the FDA Look to Collaborative Deal Structures

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Biotechs have faced several challenging years with slumping valuations and a competitive funding environment. However, the latest slew of retirements and layoffs at the FDA could present their greatest challenge yet....more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: The Regents of the University of California v. The Broad Institute

The Regents of the University of California v. The Broad Institute, Inc., Appeal Nos. 2022-1594, -1653 (Fed. Cir. May 12, 2025) Must an inventor know their invention will work to demonstrate that they “conceived” of it? ...more

Parker Poe Adams & Bernstein LLP

Life Sciences Companies Have New Avenue to Challenge Patent Applications After Federal Court Ruling

Drugmakers and other companies in the life sciences industry seeking to invalidate patents have another arrow in their quiver thanks to a recent federal court decision....more

McDermott Will & Emery

Investment Opportunities in TechBio and Pharma Services - European Health & Life Sciences Symposium 2025

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In April 2025, McDermott once again hosted its annual European Health & Life Sciences Symposium at the Shangri-La hotel in Paris. Attended by some 300 delegates from across the industry, participants including investors,...more

Morrison & Foerster LLP

Federal Circuit Vacates and Remands in Long-Pending Dispute over CRISPR IP

Those hoping the Court of Appeals for the Federal Circuit would finally resolve priority in the long-pending dispute between the University of California and the Broad Institute will have to wait a little longer. Oral...more

McDermott Will & Emery

Transaction and Financing Trends in Life Sciences - European Health & Life Sciences Symposium 2025

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In April, McDermott was pleased to once again host our annual European Health & Life Sciences Symposium in Paris. Welcoming a crowd of more than 300 innovators, investors, business leaders and advisers from across the...more

Bennett Jones LLP

BBHIC 2025: Key Insights From Canada’s Leading Healthcare Investment Conference

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The Bloom Burton & Co. Healthcare Investor Conference (BBHIC), held in Toronto this week, drew over 1,500 global participants to one of Canada's leading events for healthcare investment and innovation. The conference brought...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences...

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Recorded at SCBio’s 2025 annual conference, hosts Heather and Matthew welcome keynote speaker John Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), the world’s leading advocacy group for the life...more

Maynard Nexsen

Patenting Microbial Products: Pitfalls, Value, and Special Concerns

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The use of microorganisms in human industry is ancient, but has increased markedly in recent years. The modern recognition of the role of microbial communities in the human body has intensified innovation in fields like...more

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