News & Analysis as of

Biotechnology

DLA Piper

The Battle for CRISPR: Federal Circuit Draws a Crisp Line Between Conception and Reduction to Practice

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The dispute over who invented CRISPR-Cas9 (CRISPR), a gene-editing technology awarded the 2020 Nobel Prize in Chemistry, has been one of the most closely watched legal battles in the world of biotechnology. For more than a...more

Foley & Lardner LLP

The Patent Eligibility Restoration Act and Life Sciences Innovation

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The biotechnology and life science sectors underpin breakthroughs in health care, agriculture, and environmental sustainability by leveraging living systems to create next-generation medicines, diagnostics, and bio-based...more

Troutman Pepper Locke

Exclusive Licensing May Offer Biotechs a Financial Lifeline

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With volatile market conditions and recent FDA shakeups, biotech companies are increasingly focused on bolstering cash runways and accelerating R&D efforts. But fierce competition for financing has some biotechs turning to...more

Hogan Lovells

FDA’s creation of public database of 200 Complete Response letters raises questions

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The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies whose drug and biological...more

A&O Shearman

Creative deal structures help life sciences innovators ride out the macro storm

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Globally, market volatility has eroded confidence and subdued M&A activity. A “wait and see” approach is the prevailing sentiment for many market participants; it is difficult to convince boards to advance deals while...more

Haug Partners LLP

In CRISPR Patent Dispute, the Federal Circuit Clarifies the Conception and Written Description Standards

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On May 12, 2025, the Federal Circuit issued a decision in Regents of the Univ. of California v. Broad Inst., Inc.1 concerning the ongoing priority dispute relating to competing inventor groups for the CRISPR-Cas9 eukaryotic...more

MoFo Life Sciences

What Makes a Good Cell and Gene Therapy Application?

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Cell and gene therapies represent a transformative frontier in modern medicine, offering potential cures for previously untreatable conditions. However, securing intellectual property (IP) protection for these innovations...more

Knobbe Martens

FDA Clears Fasikl’s AI-Powered Felix NeuroAI Wristband for Essential Tremor

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Fasikl, a neurotechnology company spun out of the University of Minnesota, has received FDA 510(k) clearance for its Felix™ NeuroAI™ Wristband, a noninvasive, AI-driven wearable designed to reduce upper limb tremors in adults...more

Jackson Walker

Texas Legislature Expands Business Court Role in Intellectual Property Matters with Passage of HB 40

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The 2025 biennial session of the Texas Legislature brought changes to the Texas Business Court that was created in 2023. With the passage of House Bill 40 (HB 40), the legislature expanded the Business Court’s jurisdiction to...more

Knobbe Martens

CRISPR Dispute Heats Up With Recent Federal Court Decision

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On May 12, 2025, the U.S. Court of Appeals for the Federal Circuit (CAFC) revived the Regents of the University of California’s (Regents) challenge to the Broad Institute’s CRISPR-Cas9 patents, overturning a 2022 decision by...more

Bergeson & Campbell, P.C.

NSCEB Seeks Input to Modernize Biotechnology Product Regulation

The National Security Commission on Emerging Biotechnology (NSCEB) announced on July 1, 2025, that it is gathering input to modernize U.S. biotechnology product regulation and create simpler, faster, science-based pathways to...more

Patrick Malone & Associates P.C. | DC Injury...

Better Health Care Newsletter - July 2025

With 10,000 baby boomers turning 65 each day, it’s not hard to see why aging well — even spectacularly well — has become a leading obsession of our era. The good news is that yes, there are practical ways to extend life,...more

Bergeson & Campbell, P.C.

BIOTech Caucus Will Advance Domestic Bioeconomy and Competitive Posture

On June 26, 2025, Representatives Chrissy Houlahan (D-PA) and Stephanie Bice (R-OK) announced the formation of the BIOTech Caucus. According to Houlahan’s June 26, 2025, press release, the Caucus’ mission “is to advance...more

Goodwin

BioNTech Announces Transaction to Acquire CureVac

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On June 12, 2025, BioNTech SE (“BioNTech”) announced its entry into a definitive purchase agreement to acquire all shares of CureVac N.V. (“CureVac”), with an implied aggregate equity value for CureVac of approximately $1.25...more

Bergeson & Campbell, P.C.

NASEM Will Hold Workshop on Synthetic Biology for Biomanufacturing and Predictable Engineering on July 1, 2025

On July 1, 2025, the National Academies of Sciences, Engineering, and Medicine (NASEM) will hold a workshop session on transformative science and technology for the U.S. Department of Defense (DOD), “Synthetic Biology for...more

Woodruff Sawyer

Life Sciences Insurance: Navigating Risk from Lab to IPO

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In our new webinar series, Risk Management for Your Life Sciences Company, we discuss the insurance and risk management milestones life science companies should prepare for as they move from early funding through clinical...more

Bergeson & Campbell, P.C.

APHIS Announces Updated Pre-Application Questionnaire in APHIS eFile

On June 13, 2025, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that its Biotechnology Regulatory Services (BRS) has launched an updated Pre-Application Questionnaire...more

Goodwin

Delaware Court Awards More Than $180 Million for Breach of Commercially Reasonable Efforts Obligation in Drug Development...

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On June 11, 2025, the Delaware Court of Chancery found Alexion Pharmaceuticals liable for more than $180 million in damages to former stockholders of Syntimmune, Inc., following the Court’s September 2024 ruling that Alexion...more

Wolf, Greenfield & Sacks, P.C.

Unexpected Paths to IP Law with Dan Young and Colin White

For many, the journey to IP law is circuitous. And that’s undoubtedly true for Wolf Greenfield Shareholder Dan Young and Technology Specialist Colin White. Both had interesting careers outside of the legal industry before...more

Fenwick & West LLP

What We’re Watching Ahead of BIO 2025: Trends Shaping the Future of Biotech

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As we head into BIO 2025 in Boston, our teams are closely watching trends in biotech and how those affect financings, business development, IP protection, risk, and litigation strategy. Here are eight key trends we’re...more

Paul Hastings LLP

Biotech Spin-Off Transactions

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As we previously discussed (here and here), the biotech mergers and acquisitions market currently faces significant headwinds. These challenges include frozen capital markets, regulatory uncertainty at the Food and Drug...more

Morgan Lewis

SEC Focus on the Life Sciences Industry: What to Expect and How to Prepare

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The life sciences sector remains a critical area of focus for the US Securities and Exchange Commission (SEC) under the current administration. Companies operating in the healthcare, pharmaceutical, biotechnology, and medical...more

Bergeson & Campbell, P.C.

Call for Evidence for Impact Assessment of the European Biotech Act Will Close June 11, 2025

The European Commission (EC) began a call for evidence on May 14, 2025, for an impact assessment of the European Biotech Act. The EC states that the overall objective is to improve the size and competitiveness of the...more

Venable LLP

Court Finds bluebird bio’s Gene Therapy Zynteglo® (betibeglogene autotemcel) Does Not Infringe San Rocco Therapeutics’ Patents

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On May 16, 2025, the Court in Case No. 1:21-cv-01478 (D. Del.) granted bluebird bio’s motion for summary judgment, finding that its gene therapy Zynteglo® (betibeglogene autotemcel) does not infringe San Rocco Therapeutics‘...more

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

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