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Intellectual Property Protection Life Sciences

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

Hogan Lovells

FDA releasing Complete Response Letters for drugs and biologics that have not yet been approved

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The U.S. Food and Drug Administration (FDA) is now releasing complete response letters (CRLs) for BLA and NDA products not yet approved – including CRLs associated with pending or withdrawn applications. ...more

Jones Day

Japanese Court Shatters Previous Record for Damages Award in a Patent Infringement Case

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On May 27, 2025, the Intellectual Property High Court of Japan awarded plaintiff Toray Industries, Inc. ("Toray") ¥21.76 billion (US$151 million; €133 million) in damages for patent infringement by defendants Sawai...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

Ballard Spahr LLP

Key Trends Shaping Life Sciences IP Licensing

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The life sciences industry continues to evolve rapidly, driven by technological advancements, shifting economic conditions, and global market dynamics. As companies navigate this complex landscape, several key trends are...more

Williams Mullen

PODCAST: Williams Mullen's Trending Now: An IP Podcast - Who Owns AI Innovation? IP in the Age of Artificial Intelligence

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On this episode of Trending Now – An IP Podcast, Janet Cho and former summer associate Evan Klick* explore the evolving intersection of artificial intelligence (AI) and intellectual property (IP) law in the life sciences...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

American Conference Institute (ACI)

[Virtual Conference] Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 14th - 30th, 1:00 pm EST

ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...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

Venable LLP

Spotlight On: Neulasta® (pegfilgrastim) / Fulphila® (pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) / Ziextenzo®...

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Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Knobbe Martens

Eyeing the Prize of the U.S. Patent System, the Trump Administration Proposes Patent Maintenance Fee Overhaul

Knobbe Martens on

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

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

Gardner Law

Why Every Manufacturer Needs a Robust Information Security Program

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Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...more

Troutman Pepper Locke

Federal Circuit Ruling Broadens Reach of Prosecution History Estoppel to Include Canceled Claims

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Prosecution history estoppel typically arises when a claim is rejected during prosecution and is then amended (narrowed) to overcome the rejection. However, in Colibri Heart Valve LLC v. Medtronic CoreValve, LLC, No....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

Troutman Pepper Locke

Strategic Alignment With Collaboration Partners Is Essential to a Successful Life Sciences M&A Exit

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In the midst of shifting political headwinds and a tight funding market, many life sciences companies are considering their M&A exit. Potential acquirers (both strategic and private equity) have plenty of dry powder and are...more

Carlton Fields

Court Finds MSN Does Not Infringe Novartis’s Patent and Clears the Way for Generic Entresto

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In In re Entresto (Sacubitril/Valsartan) Patent Litigation, Judge Richard G. Andrews of the U.S. District Court for the District of Delaware granted MSN Pharmaceuticals Inc. a victory on noninfringement of U.S. Patent No....more

Jones Day

Discretionary Denial of IPR Institution Due to Advanced Hatch-Waxman Litigation

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In a recent decision, the Patent Trial and Appeals Board (“PTAB”) exercised its discretion under 35 U.S.C. § 314(a) to deny institution of an inter partes review (“IPR”) after applying the Fintiv factors, despite Petitioner’s...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

Jones Day

Physical Products Cannot Form Basis of an IPR

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On May 1, 2025, the Patent Trial and Appeal Board (PTAB) denied institution of inter partes review (IPR) of U.S. Patent No. 11,140,841 in the case of Aardevo North America, LLC v. Agventure B.V. The patent in question, owned...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

Troutman Pepper Locke

FTC Holds Its First Listening Session on Practices and Regulations Impacting Pharmaceutical Generic or Biosimilar Competition

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On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as...more

American Conference Institute (ACI)

[Virtual Conference] Inaugural Summit on GLP-1 Law & Policy - July 24th, 8:15 am - 5:15 pm ET

The $100B+ Weight-Loss Drug Market Is Red Hot—But So Are the Legal, Regulatory, and Compliance Risks. As the GLP-1 revolution reshapes the future of metabolic health, life sciences companies face mounting scrutiny from...more

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