News & Analysis as of

Intellectual Property Protection United States Patent and Trademark Office Pharmaceutical Industry

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

Knobbe Martens

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

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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

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

MoFo Life Sciences

What Makes a Good Cell and Gene Therapy Application?

MoFo Life Sciences on

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

Jones Day

USPTO Acting Director Denies IPR Institution Based on "Settled Expectations"

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Under a new U.S. Patent and Trademark Office ("USPTO") policy issued in March 2025, pre-institution inter partes review ("IPR") proceedings are now bifurcated, consisting of a first phase in which the director considers...more

Wolf, Greenfield & Sacks, P.C.

Practical Guide to Claiming Small Molecules with Functional Language

Patent claims reciting compounds where at least one group of a compound genus is defined by its function are common. For example, familiar claim terms such as “chelating moiety,” “linker,” and “binding moiety” describe a...more

Venable LLP

Spotlight On: Lantus® / Lantus® SoloSTAR® (insulin glargine recombinant) / Basaglar® (insulin glargine) / Semglee® (insulin...

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Insulin Glargine 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

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

Jones Day

Innovative Insights: Legal Updates in Life Sciences | First Quarter 2025

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Artificial intelligence is revolutionizing life science R&D (particularly in the realm of drug discovery) and challenging the traditional "human inventorship" requirement for U.S. patents. Recent guidance from the USPTO...more

Jones Day

Blurring the Line Between the Dry and Wet Lab: Joint Inventorship in AI-Assisted Life Science Inventions

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In 2024, not one but two Nobel Prizes (in Chemistry and Physics) were awarded to researchers for their work in artificial intelligence ("AI"). Particularly noteworthy for the life science community is the Nobel Prize in...more

McDermott Will & Schulte

What’s the (Re)issue? Patent Term Extensions for Reissue Patents

Addressing the calculation of patent term extensions (PTEs) under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit affirmed a district court decision that under the act the issue date of the original...more

MoFo Life Sciences

Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

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On March 13, 2025, the Federal Circuit issued a decision in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., No. 23-2254 (Fed. Cir. 2025) that clarifies how patent term extension (PTE) is calculated for reissue...more

Fish & Richardson

Federal Circuit: PTE for Reissue Patents Should Be Calculated From Original Patent’s Issue Date

Fish & Richardson on

On March 13, 2025, the Federal Circuit decided in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. (No. 2023-2254) how patent term extensions (PTEs) apply to reissued patents under the Hatch-Waxman Act....more

Foley & Lardner LLP

GLP-1 Receptor Agonists and Patent Strategy: Securing Patent Protection for New Use of Old Drugs

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GLP-1 receptor agonists (GLP-1RAs) were initially approved for diabetes treatment (e.g., Ozempic®) but have revolutionized weight management (e.g., Wegovy®) and are now being explored for treating a wide range of health...more

Foley & Lardner LLP

Leveraging USPTO Delays To Maximize Patent Term

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Before the USPTO was subject to a hiring freeze, it assumed it would onboard 400 new examiners between fiscal year 2025 and fiscal year 2026, and still predicted an increase in the backlog of unexamined patent applications....more

MoFo Life Sciences

Navigating Obviousness: Federal Circuit Addresses Patentability of Pharmaceutical Dosing Methods

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On March 6, 2025, the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) issued a precedential decision in ImmunoGen, Inc. v. Stewart, in which the court clarified its standards for determining...more

Venable LLP

Spotlight On: Rituxan® (rituximab) / Truxima® (rituximab-abbs) / Ruxience® (rituximab-pvvr) / Riabni™ (rituximab-arrx) - March...

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Rituximab 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

MoFo Life Sciences

Navigating Inventorship in the Era of AI-Assisted Drug Discovery

MoFo Life Sciences on

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more

Morgan Lewis

Blockbuster Biologics Review | Issue 26

Morgan Lewis on

Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more

Venable LLP

Spotlight On: Enbrel® (etanercept) / Erelzi® (etanercept-szzs) / Eticovo® (etanercept-ykro) - February 2025

Venable LLP on

Etanercept 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

Venable LLP

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

Venable LLP on

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

Venable LLP

Spotlight On: Herceptin® (trastuzumab) / Ogivri® (trastuzumab-dkst) / Herzuma® (trastuzumab-pkrb) / Ontruzant® (trastuzumab-dttb)...

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Trastuzumab 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

Venable LLP

Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimumab-adaz) /...

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Adalimumab 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

McDonnell Boehnen Hulbert & Berghoff LLP

Aurobindo v. Merck Sharp and Dohme -- Oral Argument

The Federal Circuit heard oral argument in Auribundo's appeal of the district court's decision in favor of plaintiff Merck, in a case captioned In re Sugammadex (alternatively, Aurobindo v. Merck Sharp and Dohme). The issue...more

Alston & Bird

Intellectual Property Litigation Newsletter | January 2025

Alston & Bird on

Welcome to the Intellectual Property Litigation Newsletter, our review of decisions and trends in the intellectual property arena. In this edition, we learn that that changing a definition has consequences, an apex...more

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