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Intellectual Property Litigation Regulatory Requirements

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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

IP Hot Topic: The Federal Circuit Confirms That Commission Cannot Be Compelled to Issue Sua Sponte Order

The Federal Circuit upheld the ITC Commission’s discretionary power not to issue sua sponte orders to show cause why a party has not committed sanctionable conduct under Commission Rules or to explain its reason for not...more

BakerHostetler

[Podcast] A New World: Indemnification, Artificial Intelligence and Intellectual Property

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To describe the rise of artificial intelligence (AI) as rapid is a vast understatement. From its ubiquitous presence assisting us in our most mundane daily tasks to its warm embrace by business leaders eager to revolutionize...more

Troutman Pepper Locke

Trade Dress Disputes Continue To Be a Bitter Pill in Pharma

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A recent federal court decision highlights the delicate balance between U.S. Food and Drug Administration (FDA) guidance and trade dress protections for drugs administered in a tablet or capsule form. Last month, a district...more

Proskauer - The Patent Playbook

Focus on Fintiv: Shift in Patent Office Guidance for Discretionary Denials of Patent Challenges

On February 28, 2025, the U.S. Patent and Trademark Office announced that it was rescinding a 2022 memorandum that provided guidance regarding the application of the Apple v. Fintiv decision to the Patent Trial and Appeal...more

Knobbe Martens

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

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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

Arnall Golden Gregory LLP

Federal Circuit Expands Types of Investments That Satisfy the ITC’s “Domestic Industry” Requirement

Two recent Federal Circuit decisions open the doors of the United States International Trade Commission (“ITC”) to smaller companies that are threatened by unfair imports....more

McDermott Will & Emery

PTO Reverts to Prior Post-Grant Guidelines for Cases Involving Parallel District Court Litigation

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On February 28, 2025, the acting director of the US Patent & Trademark Office (PTO) announced that the agency will revert to previous guidelines for discretionary denials of petitions for post-grant proceedings where there is...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

ArentFox Schiff

USPTO Rescinds Vidal’s 2022 Guidance on PTAB Discretionary Denials

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On February 28, the US Patent and Trademark Office (USPTO) rescinded former Director Kathi Vidal’s 2022 memorandum on discretionary denials in Patent Trial and Appeal Board (PTAB) post-grant proceedings running parallel to...more

Venable LLP

Spotlight On: Biosimilar Litigations - March 2025

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Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

Akin Gump Strauss Hauer & Feld LLP

USPTO Withdraws Fintiv Memo on Discretionary Denials in Post-Grant Proceedings

On February 28, 2025, the USPTO announced that it was rescinding former Director Vidal’s 2022 memorandum on discretionary denials by the Patent Trial and Appeal Board. The 2022 memorandum effectively narrowed the application...more

Wolf, Greenfield & Sacks, P.C.

Federal Circuit Removes Limits on “Qualifying” Domestic Industry Activities at the ITC

On March 5, 2025, the Federal Circuit rejected the ITC’s longstanding practice of excluding certain types of activities from qualifying as “domestic industry” activities under Section 337(a)(3)(B), finding the ITC’s approach...more

Polsinelli

Personal Jurisdiction Considerations for International Biosimilars Companies

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The Federal Circuit recently issued decisions in a pair of appeals that provide guidance about when international filers of abbreviated Biologics License Applications (aBLAs) are subject to jurisdiction in the United States....more

K&L Gates LLP

Fashion Law Update – February 2025

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In this edition of Fashion Law, we have compiled thought leadership published on our blogs and website throughout 2024—providing an overview of significant legal and regulatory updates in the fashion industry over the past...more

Jones Day

Global Trade Secret Update - Key Developments in 2024

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This publication summarizes noteworthy 2024 legal developments in trade secret law in key centers of commerce throughout the world. Understanding these legislative and judicial developments can help trade secret owners...more

MoFo Life Sciences

Patents and Trade Secrets in AI and Life Sciences

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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

Robins Kaplan LLP

Novartis Pharms. Corp. v. Becerra

Robins Kaplan LLP on

Entresto® (sacubitril/valsartan) - Case Name: Novartis Pharms. Corp. v. Becerra, Civ. No. 24-cv-2234 (DLF), 2024 WL 4492072 (D.D.C. Oct. 15, 2024) (Friedrich, J.)  Drug Product and Patent(s)-in-Suit: Entresto®...more

Smart & Biggar

Federal Court rules on patent listing again, confirms generic not required to address patent submitted before ANDS filing but...

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On January 20, 2025, Justice O’Reilly of the Federal Court dismissed Bayer’s judicial review of the Minister of Health’s decision to list Canadian Patent No. 2,970,315 (315 Patent) on the Patent Register eight days after it...more

Robins Kaplan LLP

Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC

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ProAir® HFA (albuterol sulfate) - Case Name: Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC, No. 2024-1936, 2024 WL 5176737 (Fed. Cir. Dec. 20, 2024) (Circuit Judges Prost, Taranto, and Hughes...more

Smith Anderson

Biotech Licensing Caselaw Update - 2024 Year in (Brief) Review

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Last year was a surprisingly big one for legal decisions impacting the biotechnology transactions and licensing space. Given that most biotech deals are subject to confidential alternative dispute resolution, it is unusual...more

Akin Gump Strauss Hauer & Feld LLP

District Court: Factual Disputes Preclude Application of Safe Harbor to Gene Editing Technology at the Pleading Stage

The District of Delaware recently denied a motion to dismiss a patent infringement complaint involving gene editing technology that sought relief under the Safe Harbor Provision of the Hatch-Waxman Act. Specifically, the...more

A&O Shearman

Brussels enterprise court clarifies requirements for SPC manufacturing waiver

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In a judgment of 23 December 2024, the Dutch-speaking Enterprise Court of Brussels followed the reasoning of a Dutch court earlier in 2024, ruling that (i) manufacturers are not obliged to provide the reference number of...more

Baker Botts L.L.P.

When Algorithms Meet Regulators - The Unexpected Vulnerability of AI Trade Secrets

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Companies deploying and developing Artificial Intelligence (“AI”) face a critical intellectual property dilemma: How should I protect AI trade secrets in a regulatory landscape that demands transparency?...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

The U.S. Copyright Office’s Position on the Copyrightability of Works Made with the Assistance of Generative AI (Part One)

Since the release and popularization of platforms such as Midjourney and DALL-E, the past few years have seen a staggering proliferation of art made using text-to-image models—familiarly known as “AI art.” Tens of millions of...more

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