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Biotechnology Intellectual Property Protection

Knobbe Martens

Life Science Update | August 2025

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The Trump administration is considering changing the U.S. patent maintenance fee structure from the existing three fixed flat fees to an annual, value‑based “tax” model where patent holders would pay 1%–5% of the estimated...more

Ballard Spahr LLP

Life Sciences Perspective On Emerging U.S. Patent Reform Efforts

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Though largely absent from mainstream news, proposed reforms to patent law are poised to affect everything from biotech startups to major pharmaceutical R&D programs. Specifically, there are four ongoing bipartisan efforts to...more

American Conference Institute (ACI)

[Event] Pharma & Biotech Patent Litigation USA - October 14th - 15th, New York, NY

Attend ACI's inaugural Forum on Pharma & Biotech Patent Litigation USA and garner a winning edge in the high- stakes life sciences patent ligation arena. Get the in-depth and practical information that you need to develop...more

Fenwick & West LLP

10 Critical Missteps to Avoid When Building AI Governance Policies for Life Sciences Companies

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Life sciences companies racing to harness artificial intelligence often stumble into preventable traps that can derail innovation and create lasting legal exposure. ...more

Cooley LLP

Key Trends and Considerations in Cross-Border Life Sciences Partnering-Licensing and NewCo Transactions Between Chinese and...

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Over the past decade, the landscape of cross-border partnering in the life sciences sector has undergone a dramatic transformation, particularly in transactions between Chinese biotech companies and their US and European...more

Foley & Lardner LLP

Patent Fees Reimagined: Evaluating the Trump Administration's Value-Driven Fee Structure and Its Impact on Innovators

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The WSJ reports the Trump administration wants to charge patent holders 1% to 5% of their patent’s value to maintain the patent after grant. If implemented, this would mark a dramatic departure from the traditional flat-fee...more

Goodwin

Harrow Enters Agreement to Commercialize Samsung Bioepis’s Ophthalmology Biosimilars Following Biogen’s Exit

Goodwin on

On July 17, 2025, Harrow, Inc. (“Harrow”), announced an agreement with Samsung Bioepis Co. Ltd. (“Samsung Bioepis”) to acquire the U.S. commercial rights to two of Samsung Bioepis’s biosimilars, BYOOVIZ® (ranibizumab-nuna)...more

Paul Hastings LLP

Private Company Report: Q2 2025

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This edition of the Private Company Report highlights critical updates and regulatory changes affecting private companies, including the expansion of Qualified Small Business Stock tax benefits under the One Big Beautiful...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Beyond Guinea Pigs: Patent Risks and Opportunities in AI-Enabled Drug Development

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This...more

Morgan Lewis

UK Life Sciences Sector Plan: What In-House Legal and Compliance Teams Need to Know

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The UK government recently unveiled its 10-year Life Sciences Sector Plan, putting forward a comprehensive strategy for transforming the UK into a global leader in life sciences by 2035. This LawFlash outlines key areas of...more

Sheppard Mullin Richter & Hampton LLP

Lexicography: Clear And Unequivocal

This Federal Circuit opinion analyzes lexicography in the context of claim construction. Alnylam Pharmaceuticals owns U.S. Patent Nos. 11,246,933 (parent) and 11,382,979 (child). These patents relate to biodegradable...more

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

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

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

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

Foley Hoag LLP

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

Foley Hoag LLP on

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

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

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

Mintz - Tax Viewpoints

Canada Elects 2025: Tax Policies Poised to Shape Canada’s Innovation Economy

In a historic election, given the backdrop of rising tensions between Canada and the US, Canadians elected Mark Carney and his Liberal party on April 28, 2025. Although the platform released by the Liberals (the Liberal...more

Rothwell, Figg, Ernst & Manbeck, P.C.

3 Tips for Avoiding Having to File a Budapest Treaty Declaration When Prosecuting Patent Applications on Biological Materials

The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure is an international agreement to establish a uniform system for depositing microorganisms and other...more

American Conference Institute (ACI)

[Event] 23rd Advanced Summit on Life Sciences Patents - May 19th - 20th, New York, NY

At ACI’s 23rd Advanced Summit on Life Sciences Patents, you can expect informational overviews and thorough discussion of every facet of the industry. In a time of major legislative, regulatory, and judicial change, you can't...more

Morgan Lewis

M&A Considerations Across the Evolving Life Sciences Sector: Key Takeaways

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In the latest installment of the Morgan Lewis M&A Academy, partners Laurie Burlingame and Luciana Griebel provided an overview of current market trends in mergers and acquisitions (M&A) and strategic partnerships within the...more

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