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Corporate Counsel Life Sciences

Morrison & Foerster LLP

Top 10 International Anti-Corruption Developments for July 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

Troutman Pepper Locke

2025 Mid-Year Review: State AGs in a New Era

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The United States is navigating a new era of regulatory oversight and the balance of power between federal and state regulators following the 2024 election cycle. As federal agencies retreat from and/or realign their...more

A&O Shearman

Federal Circuit Affirms Patent Trial And Appeal Board Decision, Finding Claims Of Patents Covering CRISPR Guide RNA Technology As...

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On June 11, 2025, the United States Court of Appeals for the Federal Circuit affirmed the Patent Trial and Appeal Board (PTAB) decision invalidating two patents owned by Agilent Technologies. The patents at issue, U.S. Patent...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On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more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

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of the pharma and tech industries as well as past agency leaders, the U.S. Patent and Trademark Office (USPTO) has withdrawn a proposed new rule directed at Terminal Disclaimer...more

Fenwick & West LLP

Federal Circuit Reaffirms Scope of Safe Harbor Defense to Patent Infringement

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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

MoFo Life Sciences

Federal Circuit Clarifies Scope Of Obviousness-Type Double Patenting In Allergan USA V. MSN Laboratories

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On August 13, 2024, the U.S. Court of Appeals for the Federal Circuit issued a welcomed decision to patentees in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061 (Fed. Cir. 2024) clarifying the scope of...more

Morrison & Foerster LLP

DOJ National Security Division Issues First-Ever Declination Under Voluntary Self-Disclosure Policy

On May 22, 2024, the Department of Justice’s (DOJ) National Security Division (NSD) announced its first-ever prosecution declination under its corporate voluntary self-disclosure (VSD) policy for sanctions and export controls...more

TransPerfect Legal

Trade Secret Protection in Life Sciences: Strategies for Success

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Late last month, the Association of Corporate Counsel (ACC) hosted a panel on Trade Secret Protection in Life Sciences: Strategies for Success. In today's rapidly evolving business environment, trade secrets are becoming...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

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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

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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

Foley Hoag LLP - Security, Privacy and the...

Privacy and Security of Genetic Information: The FTC Is Putting Privacy and Security Promises of DNA Companies to the Test

In the FTC’s first case focused on the privacy and security of genetic information, the FTC alleges that San Francisco-based Vitagene, Inc. – now known as 1Health.io – failed to live up to its promises and unfairly changed...more

MoFo Life Sciences

The Legal And Regulatory Landscape Evolving With AI In Life Sciences

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In the last ten years, more data and greater computing power have led to a boom in AI-related patent applications, with life and medical sciences emerging as a top application field. In 2021, more than 100 applications...more

TransPerfect Legal

The Legal and Regulatory Landscape Evolving with AI in Life Sciences

TransPerfect Legal on

In the last ten years, more data and greater computing power have led to a boom in AI-related patent applications, with life and medical sciences emerging as a top application field. In 2021, more than 100 applications...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

McDermott Will & Schulte

[Event] Life Sciences Boot Camp For In-House Counsel 2023 - April 4th, South San Francisco, CA

McDermott is pleased to bring our Life Sciences Boot Camp for In-House Counsel back to the Bay Area! Amid turbulent economic forces, life sciences companies continue to grapple with increasingly complex legal and business...more

Goodwin

2022 Year in Review: Securities Litigation Against Life Sciences Companies

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We are proud to present our seventh annual Securities Litigation Year in Review publication, in which we analyze data for securities class actions filed nationally against publicly traded pharmaceutical, biotechnology,...more

Orrick, Herrington & Sutcliffe LLP

Life Sciences Snapshot – A Quarterly Report on Financing Trends – Q1 2023

This report series examines quarterly trends in life sciences venture investment. Key findings for Q4 2022 include: • Deal value reached $7.1 billion in Q4 across 392 deals, bringing the 2022 annual total to $38.0 billion...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - December 2022

Cornerstone Research reports that during the first six months of 2022, plaintiffs filed 110 securities class actions, a pace that is generally in line — 2.8% higher — with what we saw in the second half of 2021. Looking...more

Hogan Lovells

(Patient) safety first: take steps now to promote good governance by your board

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Earlier this year, the Delaware Chancery Court approved a breathtaking $237.5 million settlement of derivative claims brought against Boeing’s board for breach of fiduciary duties regarding safety oversight. While the Boeing...more

Fenwick & West LLP

Silicon Valley Venture Capital Survey – Second Quarter 2022

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Our survey analyzed the terms of 194 venture financings closed in the second quarter of 2022 by companies headquartered in Silicon Valley. While the number of venture financings were down in the second quarter compared to...more

Wilson Sonsini Goodrich & Rosati

Negative Claim Elements and the Importance of Complete Patent Disclosures: How Novartis Lost a $2.8 Billion Drug to Generic Drug...

On June 21, 2022, Novartis Pharmaceuticals Corp.'s patent for a method of treating multiple sclerosis with fingolimod (Gilenya®) was held invalid for lack of written description under 35 U.S.C. § 112(a). Gilenya® was...more

Knobbe Martens

WTO Agrees to Partial Patent Waiver for COVID-19 Vaccines

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On June 16, 2022, the World Trade Organization (WTO) agreed to a partial waiver of intellectual property rights related to COVID-19 vaccines. The agreement came on the heels of an all-night negotiating session. The agreement...more

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