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Intellectual Property Protection Patents Regulatory Requirements

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

Foley & Lardner LLP on

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

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

Smart & Biggar on

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

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

Foley Hoag LLP on

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

Quarles & Brady LLP on

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

Jones Day on

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

BakerHostetler on

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.

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

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

Lowenstein Sandler LLP

USPTO Announces Accelerated Patent Issuance Timeline

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Summary: The United States Patent and Trademark Office (USPTO) has accelerated the patent issuance timeline due to modernization efforts, which include publishing electronic patent grants (eGrants) via the USPTO’s Patent...more

Ballard Spahr LLP

USPTO Procedure Adds New Hurdle to PTAB Trial Institution

Ballard Spahr LLP on

On March 26, 2025, the United States Patent and Trademark Office (USPTO) announced changes to the Patent Trial and Appeal Board (PTAB) trial institution process, creating a new bifurcated approach to institution decisions....more

Axinn, Veltrop & Harkrider LLP

Compounding Problems: Recent Decisions on Tirzepatide Highlight Interplay Between FDA Anti-Compounding Enforcement and Private...

Earlier this month, a federal district court denied the Outsourcing Facilities Association’s preliminary injunction motion, which sought to preclude FDA from taking enforcement action against compounded tirzepatide...more

MoFo Life Sciences

Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

MoFo Life Sciences on

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

Fox Rothschild LLP

New USPTO Continuation Fee: A Hidden Trap for Patent Filers

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The United States Patent and Trademark Office (USPTO) recently introduced a Continuing Application Fee (CAF) to address the growing backlog of continuing applications and encourage timely prosecution. Effective January 19,...more

Knobbe Martens

Federal Circuit’s Lashify Decision Expands “Domestic Industry” at the International Trade Commission

Knobbe Martens on

Lashify, Inc. v. International Trade Commission Before: Prost, Taranto, and Chen. Appeal from ITC Investigation. The Federal Circuit expands the economic prong of the domestic-industry analysis to include domestic spending on...more

BCLP

Patent Office Withdraws Previous Discretionary Denial Guidance for Post-Grant Proceedings

BCLP on

On Friday afternoon, February 28, 2025, the United States Patent and Trademark Office (USPTO) issued a brief “bulletin” rescinding a memorandum issued by the former Director Kathy Vidal (“Vidal Memo”) providing guidance on...more

Troutman Pepper Locke

New Federal Circuit Ruling Opens the ITC to Many More IP Owners

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In a recent ruling, the U.S. Court of Appeals for the Federal Circuit upended years of settled law and ruled that sales and marketing expenses, by themselves, can be the basis for a finding of domestic industry in an...more

Ropes & Gray LLP

[Podcast] Talkin’ Trade: Section 337 Domestic Industry Shake-Up—Exploring the Lashify Decision

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On this episode of Ropes & Gray's ITC-focused podcast series, Talkin' Trade, IP litigators Matt Rizzolo, Matt Shapiro, and Patrick Lavery discuss a groundbreaking Federal Circuit decision in Lashify v. ITC. This pivotal...more

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