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Morrison & Foerster LLP

Top 10 International Anti-Corruption Developments for June 2025

Designed for busy in-house counsel, compliance professionals, and anti-corruption lawyers, this newsletter summarizes some of the most important international anti-corruption law and enforcement developments from the past...more

Womble Bond Dickinson

Congress Ramping Up the Pressure on Antitrust Investigations

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Many organizations evaluate antitrust risk by considering potential investigation by the U.S. Department of Justice (“DOJ”), the Federal Trade Commission (“FTC”) or private action. However, firms should also consider that...more

McCarter & English, LLP

Recent Trends in State Antitrust Enforcement

State attorneys general (state AGs) are expected to ramp up antitrust enforcement. Some would argue that enforcement is an effort to fill a perceived gap left by the Trump administration, but state AGs have been signaling...more

Morgan Lewis

China’s First Antitrust Enforcement Case Targeting Individual Liability: Strategic Guidance for Multinational Corporations

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The Administration for Market Regulation of Shanghai recently finalized penalties totaling RMB 223 million (approx. $31 million) against three pharmaceutical companies for colluding to fix prices and divide markets for...more

Dacheng

China’s First Court Ruling on Merger Control Upholds Conditional Clearance of Below-Threshold Deal

Dacheng on

In March 2025, the Beijing Intellectual Property Court issued a landmark ruling—the first case in which a filing party challenged a merger decision by the State Administration for Market Regulation (“SAMR”) through judicial...more

Womble Bond Dickinson

For Whom the Bell Tolls? The Impact of Wisconsin Bell v. United States ex rel. Todd Heath and United States v. Regeneron...

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The Supreme Court’s decision in Wisconsin Bell v. United States ex rel. Todd Heath clarifies what constitutes a “claim” under the federal False Claims Act (FCA). ...more

Proskauer - Health Care Law Brief

First Circuit Clarifies FCA Liability Standard for AKS Violations, Deepening Circuit Split

The First Circuit has issued its long-anticipated opinion in United States v. Regeneron Pharmaceuticals, Inc., clarifying the standard for establishing False Claims Act (“FCA”) liability based on Anti-Kickback Statute (“AKS”)...more

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

From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation

On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more

Wolf, Greenfield & Sacks, P.C.

A Look Ahead: Key Intellectual Property Legal Developments in 2024 - and What to Expect in 2025

From potential legal challenges to Chinese biopharma supply chains, Europe’s new Unified Patent Court (UPC), landmark decisions in life sciences, pharma’s Orange Book listings, design patent rejections, and likely shifts at...more

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

Trial Statistics Trends at the PTAB: 2024 Edition

At the end of each fiscal year running from October 1 through September 30, the Patent Trial and Appeal Board (“PTAB”) provides a summary of its trial statistics. This information provides practitioners with useful insight...more

Procopio, Cory, Hargreaves & Savitch LLP

Threat to Many Patent Portfolios Fades as USPTO Withdraws Controversial Proposed Rule

Facing strong opposition from a rare alliance of the pharma and tech industries as well as past agency leaders, the U.S. Patent and Trademark Office (USPTO) has withdrawn a proposed new rule directed at Terminal Disclaimer...more

A&O Shearman

EU Commission issues EUR462.6 million antitrust fine in landmark decision on ‘divisionals game’ and disparagement

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On October 31, 2024, the European Commission (EC) fined Teva Pharmaceutical Industries Limited and Teva Pharmaceuticals Europe BV (Teva) EUR462.6 million for abusing a dominant position in several EU Member States on the...more

Morrison & Foerster LLP

Quarterly Cartel Catch-Up: Summer Surge Foreshadows Enforcement Intrigue

Despite the summer doldrums, cartel enforcers around the world had several notable enforcement actions and, perhaps more importantly, signaled a busy fall and winter. In the United States, the Department of Justice’s...more

McDermott Will & Schulte

Key Features of the New EU Product Liability Directive: Increased Potential for Litigation in the Technology, Pharmaceutical and...

McDermott Will & Schulte on

On October 10, 2024, the Council of the European Union adopted the new EU Directive on Liability for Defective Products (New PLD), repealing Directive 85/374/EEC (PLD), adopted in 1985....more

Fenwick & West LLP

Federal Circuit Reaffirms Scope of Safe Harbor Defense to Patent Infringement

Fenwick & West LLP on

In 2019, Edwards Lifesciences Corporation sued Meril Life Sciences Pvt. Ltd. for patent infringement in the Northern District of California, with Fenwick representing Meril in the district court case and the recent appellate...more

Morrison & Foerster LLP

Takeaways for In-House Counsel from the SEC’s “Shadow Insider Trading” Trial

On April 5, 2024, a jury in California federal court found a former corporate executive liable for insider trading in SEC v. Panuwat, a novel enforcement action involving a theory known as “shadow trading.” In Panuwat, the...more

Cozen O'Connor

DOJ Signals Increased Emphasis on Data Analytics to Prosecute FCPA Global Corruption

Cozen O'Connor on

On November 29, 2023, Department of Justice (DOJ or Department) policymakers announced explicitly that they are, for the first time, leveraging data analytics to help proactively identify and prosecute crimes in foreign...more

Knobbe Martens

Federal Circuit Says Extrinsic Evidence Should Have Been Considered in Claim Construction

Knobbe Martens on

In a recent precedential opinion, the Court of Appeals for the Federal Circuit vacated an infringement judgement against Mylan (Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., No. 2022-1889, Fed. Cir. Nov. 6,...more

A&O Shearman

European Commission sanctions first ever pharmaceuticals cartel and scores victory in pay-for-delay appeal

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The European Commission (EC) has fined five pharmaceutical companies a total of EUR13.4 million for participating in a cartel concerning N-Butylbromide Scopolamine/Hyoscine (SNBB) – an active pharmaceutical ingredient (API)...more

Jones Day

DOJ Obtains First Divestitures in a Criminal Antitrust Case

Jones Day on

The U.S. Department of Justice Antitrust Division ("DOJ") recently resolved a criminal case with Teva Pharmaceuticals and Glenmark Pharmaceuticals via deferred prosecution agreements ("DPAs"), which include a novel remedy for...more

A&O Shearman

European Commission’s record gun-jumping fine on Illumina serves as warning to merging parties

A&O Shearman on

The European Commission (EC) has imposed a fine of around EUR432 million on genomics company Illumina for closing its acquisition of blood-based cancer test developer GRAIL before the conclusion of the EC’s merger control...more

Dinsmore & Shohl LLP

The Supreme Court Clarifies the Meaning of “Knowingly” Under the False Claims Act

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On June 1, 2023, the United States Supreme Court issued an important decision addressing the intent element of the False Claims Act (“FCA”) in United States ex rel. Tracy Schutte v. SuperValu Inc. and United States ex rel....more

Womble Bond Dickinson

Supreme Court Focuses Scope of Patent Enablement - What Patent Owners Need to Know

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A closely watched and hotly debated life sciences patent dispute saw the U.S. Supreme Court affirm a narrow interpretation of patent enablement when filing for patent protection....more

Gardner Law

[Hybrid Event] Navigating the M&A Waters of FDA-Regulated Companies - May 18th, Spring Park, MN

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Join Gardner Law and colleagues live from Lord Fletcher's on Lake Minnetonka, Minnesota for a complimentary CLE event. Hear from a panel of experts on compliance, data breaches, FDA regulations, privacy, and more....more

Morrison & Foerster LLP - Government...

Supreme Court Weighs In On The Role Of Subjective Intent Under The False Claims Act

On Tuesday, April 18, 2023, the Supreme Court heard argument in the consolidated cases of United States ex rel. Schutte v. SuperValu, Inc., and United States ex rel. Proctor v. Safeway, Inc., to consider whether subjective...more

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