News & Analysis as of

Corporate Counsel Pharmaceutical Industry

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

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

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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

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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

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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

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

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q1 2023

On February 7, the Department of Justice (DOJ) issued a press release indicating that settlements and judgments under the False Claims Act (FCA) exceeded $2.2 billion in the fiscal year ending September 30, 2022. Of this...more

McDermott Will & Emery

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

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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

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

A&O Shearman

European Commission investigation into Teva’s potential abuse of dominance – misuse of patent procedures and disparagement

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On 10 October 2022, the European Commission (EC) sent a Statement of Objections to Teva Pharmaceutical Industries Limited and Teva Pharmaceuticals Europe BV (Teva). The EC has provisionally found that Teva abused its dominant...more

Bass, Berry & Sims PLC

[Virtual Conference] Nashville Healthcare Fraud Conference - December 15th - 16th, 8:00 am - 1:00 pm CST

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Please join us for the 8th Annual Nashville Healthcare Fraud Conference hosted by Bass, Berry & Sims and the Tennessee Hospital Association. Eligible for more than seven hours of CLE credit (including ethics), this...more

K&L Gates LLP

The FTC's "New" Tool: Greater Enforcement of the Robinson-Patman Act

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While, historically, government enforcement of the Robinson-Patman Act has been virtually non-existent, the Federal Trade Commission (FTC) recently announced its intention to dust-off the oft-forgotten Act to encourage...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

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

Morrison & Foerster LLP

Quarterly Cartel Catch-Up: Recent Developments in Criminal Antitrust for Busy Corporate Counsel - Q1 2022

Since the last edition of the QCC, there has been a series of dramatic developments in the criminal antitrust enforcement space in the U.S. from the Department of Justice’s Antitrust Division (Division)....more

Wilson Sonsini Goodrich & Rosati

DOJ Civil Division's Consumer Protection Branch Features FDA Enforcement Actions in its First-Ever Annual "Recent Highlights"...

Earlier this month, the U.S. Department of Justice (DOJ) Civil Division's Consumer Protection Branch (CPB) released its first-ever annual "recent highlights" report. The report describes the CPB's accomplishments from October...more

Dechert LLP

UK Court of Appeal rules on the rights of licensees to bring patent infringement claims

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The UK Court of Appeal has issued its judgment in one of the latest hearings in Neurim Pharmaceuticals v Generics (UK) relating to Neurim’s insomnia drug, Circadin. The Court of Appeal ruled that an exclusive licensee has...more

Haug Partners LLP

FTC’s Pharmaceutical Antitrust Suit Over Opioid License Agreement Between Endo and Impax Dismissed Because Patent Act Permits...

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On Wednesday, March 30, 2022, Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia, released a redacted opinion dismissing the Federal Trade Commission’s follow-on antitrust suit regarding Endo...more

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