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A&O Shearman

Second Circuit Upholds Dismissal Of Federal Securities Law Claims Against Cryptocurrency Trading Platform Operator

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On February 26, 2025, the United States Court of Appeals for the Second Circuit affirmed the dismissal of federal securities claims against the developers of a decentralized cryptocurrency exchange and the exchange’s venture...more

Sheppard Mullin Richter & Hampton LLP

Reminder: FDA Does, In Fact, Review DOF

When was the last time you thought about “data on file” (“DOF”)? Probably not recently, but last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted an untitled letter (the...more

A&O Shearman

ESMA guidelines on maintenance of systems and security access protocols under MiCAR

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The European Securities and Markets Authority (ESMA) has published official translations of the guidelines on the maintenance of systems and security access protocols for offerors and persons seeking admission to trading of...more

CloudNine

Key Takeaways from The Masters Conference in Dallas…Here’s a Hint…It’s about AI!

CloudNine on

I had the pleasure of attending The Masters Conference in Dallas, and the discussions were nothing short of insightful. If you’re in the legal field and haven’t attended one of these conferences yet, I highly recommend...more

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

PTAB Year in Review – PTAB Trends in 2024: Challenges to Genus Claims

In the biotechnology and chemical spaces, genus claims are often sought by patent applicants to protect not only a specific product of interest, but also as a means to protect against others making related products that...more

A&O Shearman

SEC Declares Meme Coins Are Not “Securities” In New Statement

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On February 27, 2025, the Securities and Exchange Commission (the “SEC”) issued a statement to provide clarity on the application of federal securities laws to crypto assets by declaring that “meme coins” do not fall under...more

Blake, Cassels & Graydon LLP

Canada Publishes Final State of Per- and Polyfluoroalkyl Substances (PFAS) Report

Introduction - The Government of Canada has announced its intention to designate PFAS, a family of thousands of human-made chemicals known for their oil- and water-resistant properties, as “toxic” under the Canadian...more

Morgan Lewis

The Evolving Framework of Data Governance: A Global Perspective

Morgan Lewis on

Data privacy laws are evolving rapidly worldwide, with jurisdictions such as California, Japan, Canada, and Brazil adopting frameworks inspired by the EU’s General Data Protection Regulation (GDPR). Businesses operating...more

Miller Nash LLP

Considerations for K-12 Schools When Using Generative Artificial Intelligence Tools

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Artificial intelligence or “AI” traces its roots to Alan Turing’s work in the 1950s. While it’s a current hot topic, AI is far from new. Students and teachers have been using AI in some form for years in everyday life, such...more

Latham & Watkins LLP

First Circuit Reins In Broad Theory of Liability Under AntiKickback Statute by Adopting “But-For Causation” Standard

Latham & Watkins LLP on

The First Circuit joins the Sixth and Eighth Circuits in adopting a more exacting causation standard for False Claims Act liability premised on Anti-Kickback Statute violations. In a victory for False Claims Act (FCA)...more

McDonnell Boehnen Hulbert & Berghoff LLP

President Nominates John Squires to be Next USPTO Director

On Monday, President Trump's nomination for Under Secretary of Commerce for Intellectual Property and Director of the U.S. Patent and Trademark Office, John A. Squires, was submitted to the U.S. Senate for confirmation.  Mr....more

McDonnell Boehnen Hulbert & Berghoff LLP

Immunogen, Inc. v. Stewart (Fed. Cir. 2025)

After creating something of a frisson due to the apprehension that the Federal Circuit might be convinced to re-evaluate whether it was a necessary element for establishing obviousness for the skilled artisan to have had a...more

Kramer Levin Naftalis & Frankel LLP

USPTO Withdraws Its Former Artificial Intelligence Strategy Document

We recently reported the USPTO’s publication on Jan. 14, 2025, of an artificial intelligence strategy document, just days before the appointment of new Acting Director Coke Morgan Stewart. Wasting no time, the USPTO has now...more

Hogan Lovells

Important update for the banking, payments and lending sectors: the Central Bank of Ireland (CBI) highlights its key risks and...

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The Central Bank of Ireland’s (CBI) Regulatory and Supervisory Outlook 2025 outlines key risk topics which it deems to be most material from a supervisory perspective across the Banking and Payments Sector. Under section four...more

Faegre Drinker Biddle & Reath LLP

Trump’s EO Seeks to Eliminate ‘Unconstitutional’ Regulations; EU Commission Scraps AI Liability Directive; Lawsuit Alleges Racial...

This month’s briefing covers President Trump’s executive orders, as well as the EU Commission’s decision not to proceed with the AI Liability Directive. Meanwhile, an advocacy organization’s lawsuit alleges Meta’s ad...more

Knobbe Martens

Federal Circuit Review | February 2025

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In HD Silicon Solutions LLC V. Microchip Technology Inc., Appeal No. 23-1397, the Federal Circuit held that  all but one patent claim were invalid as obvious because the claimed material, as properly construed, was disclosed...more

Lighthouse

Strategic Insights for Safeguarding Information with Microsoft Purview

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Successful Microsoft Purview deployments require more than just technical implementation—they demand strategic planning, cross-functional collaboration, and ongoing optimization. Read about the key steps required to...more

Latham & Watkins LLP

SEC Staff Clarifies That Meme Coins Are Not Securities

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The Staff stated that most meme coins are not subject to federal securities laws or SEC fraud enforcement; who will oversee meme coins remains an open question. On February 27, 2025, the Securities and Exchange...more

Venable LLP

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) / Avtozma® (tocilizumab-anoh) -...

Venable LLP on

Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more

Frost Brown Todd

Proposed HIPAA Security Rule Requires AI Governance

Frost Brown Todd on

In terms of healthcare data breaches, 2024 was the worst year ever, with the records of at least 53% of the U.S. population involved and two of the biggest healthcare data breaches of 2024 ranking in the top 10 of all time. ...more

Secretariat

Mitigating AI Risks: Insights from Regulatory Guidance and Enforcement

Secretariat on

Introduction - The rapid rise of Artificial Intelligence (AI), particularly Generative AI, has transformed various industries. From finance, where AI algorithms help manage investment portfolios and detect fraud, to...more

Axinn, Veltrop & Harkrider LLP

Key Questions for Navigating the Changing Competition Landscape in the Nordics and EU

As U.S. antitrust counsel to global companies, it is increasingly important to track major developments in the international competition law landscape, including at the European Commission and the National Competition...more

Fenwick & West LLP

5 Considerations for Video Game Companies in 2025

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Video game companies are often eager to adopt new technologies, like artificial intelligence (AI), to enhance player experiences. However, stricter privacy and AI regulations require companies to take extra precautions to...more

Cornerstone Research

SEC Accounting and Auditing Enforcement Activity Plummeted in Final Year of Gensler Administration

Cornerstone Research on

The U.S. Securities and Exchange Commission (SEC) drastically reduced its accounting and auditing enforcement activity in fiscal year 2024, the final year of Gary Gensler’s administration, ending two consecutive years of...more

Venable LLP

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

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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

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