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Dinsmore & Shohl LLP

Patent Trial and Appeal Board Hearings to be Held in Person

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A recent notice from the United States Patent and Trademark Office (USPTO) informed patent owners that “Starting September 1, 2025 all Patent Trial and Appeal Board (PTAB) hearings will be held in person.” (Emphasis added)....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

Offit Kurman

Patents and the FDA: Four Critical Considerations Medical Device Companies Must Know to Successfully Introduce New Products into...

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The intersection of patent strategy and FDA regulatory strategy is a critical consideration for medical device companies. A well-integrated approach can create powerful barriers to entry, strengthen intellectual property (IP)...more

Foley & Lardner LLP

Navigating FDA’s Proposed Guidance on AI and Non-Animal Models: Safeguarding Innovation in Drug Development

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In April 2025, the U.S. Food and Drug Administration (FDA) released a landmark guidance titled “Roadmap to Reducing Animal Testing in Preclinical Safety Studies,” outlining its commitment to advancing New Approach...more

Hogan Lovells

Officially liked: EU Commission endorses SEP licensing group and green procurement deal

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On 9 July 2025, the European Commission (EC) issued its first-ever comfort letters under the 2022 Notice on Informal Guidance. One letter endorses a joint licensing initiative for standard essential patents (SEPs) in the...more

Jones Day

EU Commission Signs-off on ESG Related Competitor Collaboration

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The European Commission has issued its first-ever informal approvals of two separate sustainability initiatives among rivals under its revised Informal Guidance Notice and provided guidance on how the companies in question...more

ArentFox Schiff

USPTO Raises Annual Cap on Prioritized Patent Examination Requests

ArentFox Schiff on

The US Patent and Trademark Office (USPTO) has finalized a rule increasing the annual limit on accepted requests for prioritized patent examination from 15,000 to 20,000, effective with fiscal year 2025 (FY 2025). This...more

Smart & Biggar

2025 mid-year highlights in Canadian life sciences IP and regulatory law

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In the first half of 2025, the Rx IP Update team reported on a number of developments in Canadian life sciences IP and regulatory law. Below are our top stories....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

Goodwin

EMA Adopts Positive Opinions for Multiple Biosimilars

Goodwin on

In its June 2025 meeting, the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted positive opinions for six biosimilar medicines. ...more

K&L Gates LLP

USPTO Discontinuing the Accelerated Examination Program for Utility Applications

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On 10 June 2025, the US Patent and Trademark Office (USPTO) published a Final Rule announcing the discontinuation of the Accelerated Examination program for utility applications beginning 10 July 2025. The change affects the...more

Blake, Cassels & Graydon LLP

Incidence de l’IA sur le droit canadien

L’évolution de la technologie de l’intelligence artificielle (« IA ») entraîne des changements considérables dans bien des secteurs au Canada, au point de nécessiter une évaluation des cadres juridiques en place. Que ce soit...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report – June 2025

This latest edition features articles on succeeding in the current life sciences funding market, strategic and legal considerations in digital health combinations, the corporate practice of medicine and guidance for...more

Foley Hoag LLP

Patents Under Lock and Key: Managing Dual Use Technology in a Globalized World

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Dual use technologies are innovations that have both civilian and military applications. Notable examples include advanced semiconductors, artificial intelligence (AI), encryption software, 3D printing, chemical and...more

Quarles & Brady LLP

USPTO Expediting Design Patent Issuances and De-Expediting Design Examination

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Starting May 13, 2025, the USPTO has begun accelerating the issuance of patents after the issue fee has been paid. Specifically, the duration between the Issue Notification and the Issue Date will be reduced to approximately...more

Blake, Cassels & Graydon LLP

Mapping the Intersection of AI and Canadian Law

The evolving field of artificial intelligence (AI) is significantly reshaping various sectors across Canada, prompting a critical evaluation of our legal frameworks. From intellectual property to financial markets, AI...more

Jones Day

Revolutionizing EU Design Protection: Key Changes Under the New Designs and Models Regulation

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May 1, 2025, marked the entry into force of most provisions of Phase I of the new Regulation (EU) 2024/2822, which forms part of the "Designs and Models Package" adopted within the European Union. This text, in addition to...more

Knobbe Martens

International Patent Activity and Government Policies in the Aerospace, Defense & Security Industries

Knobbe Martens on

Patent activity in the aerospace, defense, and security industries decreased during 2024, Army Technology reports. The story references statistics from GlobalData that the “global aerospace, defense & security industries...more

BakerHostetler

US Patents Set to Issue 33 Percent Faster from the Notification Date

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Starting May 13, the U.S. Patent and Trademark Office (USPTO) will accelerate the time between issue notification and the issue date of a patent. That is, the time frame will be cut from about three weeks to two weeks –...more

MoFo Life Sciences

Patent-Eligibility Considerations & Prosecution Strategies for AI-Based Life Sciences Patent Applications

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

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

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline – Updated May 2, 2025

FDA approves Omylco® (omalizumab), first biosimilar of Xolair®. After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025....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

Robins Kaplan LLP

Vanda Pharms., Inc. v. FDA

Robins Kaplan LLP on

Hetlioz® (tasimelteon) - Case Name: Vanda Pharms., Inc. v. FDA, Civ. No. 23-280 (TSC), 2025 WL 485401 (D.D.C. Feb. 13, 2025) (Chutkan, J.) Drug Product and Patent(s)-in-Suit: Hetlioz® (tasimelteon); U.S. Patent No. , a...more

Fish & Richardson

Munich Appeals Court Reinforces Security-Centric FRAND Framework in SEP Dispute

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Standard-essential patent (SEP) licensing remains a critical issue in Europe, where political bodies and national courts at times diverge in the interpretation of fair, reasonable, and non-discriminatory (FRAND) licensing...more

A&O Shearman

Navigating the UPC’s evidence minefield: when confidentiality issues clash with procedural deadlines

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In July 2024, the UPC Court of Appeal (CoA) clarified its procedural rules surrounding evidence preservation and confidentiality. It confirmed that the deadline for bringing an action on the merits only starts to run after...more

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