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McDonnell Boehnen Hulbert & Berghoff LLP

Lynk Labs, Inc. v. Samsung Electronics Co. (Fed. Cir. 2025)

Published Patent Applications Are Prior Art as of the Filing Date, Not the Publication Date - Lynk Labs raises a simple question of statutory interpretation with surprisingly important ramifications:  in inter partes review,...more

Akin Gump Strauss Hauer & Feld LLP

Revocation Actions at the UPC: State Your Defense or Risk Losing Your Patent

The Unified Patent Court (UPC) aims to provide expeditious decisions for its litigants. That means that there is a higher bar for obtaining extensions of time. As exemplified in BMW v. ITCiCo, the UPC’s reluctance to grant...more

Alston & Bird

Top Ten Takeaways from California AG’s Healthcare AI Advisory

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On January 13, 2025, California Attorney General (“AG”) Rob Bonda issued an advisory describing providers’ and businesses’ obligations related to the development, sale, and use of artificial intelligence (“AI”) and automated...more

Goodwin

Entry into force of DORA on January 17, 2025: The CSSF will be at the heart of the compliance framework in Luxembourg

Goodwin on

Digital Operational Resilience Act (DORA) aims to harmonize provisions related to cybersecurity and information and communication technology (ICT) risk management in the financial sector. Its scope covers nearly all entities...more

DLA Piper

FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for...

DLA Piper on

The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting requirements for a nonprescription drug product with an “additional condition for...more

Lathrop GPM

Federal Circuit Upholds Validity of Entresto Patent In Precedential Decision Concerning Written Description and Enablement

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In a Jan. 10 precedential ruling by the United States Court of Appeals for the Federal Circuit, the validity of the U.S. patent covering Novartis’s blockbuster drug Entresto was upheld, reversing an earlier decision by the...more

Wiley Rein LLP

BIS Restricts Import and Sales of Automotive Tech Produced by Entities in China and Russia

Wiley Rein LLP on

On January 14, 2025, the Department of Commerce Bureau of Industry and Security (BIS) published its Final Rule (Final Rule or the Rule) on “Securing the Information and Communications Technology and Services Supply Chain:...more

MoFo Life Sciences

FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety,...

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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

Vicente LLP

New Cannabis Testing Requirements in Massachusetts: What We Know Right Now

Vicente LLP on

In an effort to address a variety of concerns that have arisen over the past several years related to “lab shopping” for the most favorable cannabis test results, the Massachusetts Cannabis Control Commission (the...more

Fox Rothschild LLP

Do App Permissions Satisfy Requirements for Valid Consent for the Purpose of GDPR?

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App permissions do not satisfy the requirements for valid consent for the purpose of GDPR because they lack sufficient detail and granularity, according to the Commission Nationale de l’Informatique et des Libertés (CNIL)....more

Jones Day

Understanding DORA: Digital Operational Resilience Act Now in Effect for Financial Entities and ICT Service Providers

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DORA, the first EU regulation designed to establish a unified and robust digital resilience standard for the financial sector, becomes directly applicable on January 17, 2025, introducing significant penalties and...more

DLA Piper

DORA: Navigating the New Era of Digital Operational Resilience in EU Financial Services

DLA Piper on

It’s DORA day! The EU financial services sector has been anticipating today since the Digital Operational Resilience Act was published in December 2022. DORA brings a significant shift to the sector in terms of how financial...more

Vorys, Sater, Seymour and Pease LLP

The Precedent: Honeywell Int’l Inc. v. 3G Licensing, S.A.

In this edition of The Precedent, we outline the recent federal circuit decision in Honeywell Int’l Inc. v. 3G Licensing, S.A. (Fed. Cir. Jan. 2, 2025). The Federal Circuit reversed the Patent Trial and Appeal Board’s (the...more

Shook, Hardy & Bacon L.L.P.

The Year Ahead in Artificial Intelligence

2025 is set to see an even greater level of activity in the AI governance space. Colorado will not be the only state with a comprehensive AI law by the time 2025 comes to a close. ...more

Hogan Lovells

Slew of OCR activity underscores agency’s focus on security and AI

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Recent enforcement actions, audit activity, proposed rulemakings, and guidance issued by the U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) highlight the agency’s focus on health data...more

Goodwin

How to (Finally) Get Your SIUU Out: FDA Issues Final Guidance on Communicating Off-Label Scientific Information

Goodwin on

On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more

Hogan Lovells

CNIL 2025-2028 strategic plan: AI, Minors, Mobile Apps & Cybersecurity

Hogan Lovells on

Anticipating enforcement priorities of regulators may partly rely on their long-term trajectory and domestic dynamics, which differ from a country to another. This action plan reflects CNIL’s ambition (i) to be appointed by...more

Jackson Lewis P.C.

California Attorney General Issues Two Advisories Summarizing Law Applicable to AI

Jackson Lewis P.C. on

If you are looking for a high-level summary of California laws regulating artificial intelligence (AI), check out the two legal advisories issued by California Attorney General Rob Bonta. The first advisory is directed at...more

Miller Canfield

Tickled Pink No More: Federal Circuit Affirms Cancellation of CeramTec’s Trademarks for Pink Ceramic Hip Implants

Miller Canfield on

Color trademarks have traditionally been difficult to obtain. Of the over 4 million trademark registrations, there were less than 1000 color trademarks as of 2019. To be eligible for trademark registration, a color must have...more

Fox Rothschild LLP

New Year, New Public Domain Works: Copyright Public Domain Day 2025

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Every year, the world celebrates the first of January as Public Domain Day, marking the release of copyrighted works into the public domain. In 2024, we saw popular intellectual properties enter the public domain, including...more

Venable LLP

Amgen Launches Wezlana™ as the First Stelara® Interchangeable Biosimilar through Optum’s Nuvaila

Venable LLP on

On January 1, 2025, Amgen launched the first interchangeable biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab), Wezlana™ (ustekinumab-auub), as a private label product through Optum Health’s Nuvaila....more

Cozen O'Connor

California and New Jersey Release AI-Related Advisories and Guidance

Cozen O'Connor on

In a continuation of the trend of artificial intelligence becoming a regulatory focal point, California AG Rob Bonta issued legal advisories on the application of California law to AI, while New Jersey AG Matthew Platkin...more

Husch Blackwell LLP

FTC Finalizes Changes to the Children’s Online Privacy Protection Rule

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The Federal Trade Commission (“FTC”) finalized changes to the Children’s Online Privacy Protection Act (“COPPA”) Rule today, making the first updates to the Rule since 2013. In January 2024, the FTC proposed changes to the...more

Lathrop GPM

USPTO Issues Strategy Outlining the Goals for AI Usage Within Agency Operations

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Released on January 14, the United States Patent and Trademark Office’s Artificial Intelligence Strategy aims to serve as a guide for the challenges and goals the agency navigates while working toward the full capabilities of...more

Hogan Lovells

UK electric vehicle charge points – a growing network to challenge your range anxiety

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Let’s face it petrolheads, one of your reasons for not joining the move to electric vehicles is your range anxiety; the risk of your vehicle running out of charge and the need to find somewhere convenient to re-charge it....more

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