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Life Sciences
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October 22, 2025
Trump Flouted Clean Air Act With Rule Delay, Enviro Orgs. Say
President Donald Trump violated the Clean Air Act when he delayed deadlines to comply with air pollution standards for companies in the chemical manufacturing industry, green groups alleged in Washington federal court Wednesday.
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October 22, 2025
5 Firms Guide $2.1B Alkermes-Avadel Sleep Medicine Deal
Dublin-based Alkermes PLC has agreed to buy Avadel Pharmaceuticals PLC, a fellow Irish drugmaker focused on sleep medicine, in an all-cash deal valuing Avadel at about $2.1 billion, the companies said on Wednesday.Â
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October 22, 2025
NC Biz Court Bulletin: COVID Coverage, A Suspect Signature
The North Carolina Business Court has rounded the corner into fall with insurance disputes over COVID-19 coverage at a chain of outlet malls and the theft of over $900,000 in legal THC reportedly stolen from a warehouse in the Southwest.
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October 22, 2025
Naked Whey Sued Over Reports Of Lead In Protein Powder
A proposed class of consumers is suing Naked Whey Inc. in California federal court, alleging that it knew its products contained, or risked containing, dangerous heavy metals like lead, but advertised them as clean, tested and safe protein supplements.
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October 21, 2025
Novo Nordisk Says Officials Not Qualified To Doubt Drug Bills
Attorneys for Novo Nordisk Inc. on Tuesday sought to undercut witness testimony that Medicaid claims in Washington state for the company's hemophilia drug NovoSeven were shockingly high, leading one state auditor to suspect fraud.
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October 21, 2025
Patent Landscape Shifts As Squires Takes On Key PTAB Role
The announcement that U.S. Patent and Trademark Office Director John Squires will now make all decisions on whether to institute America Invents Act patent reviews is expected to reshape litigation, by leading fewer accused companies to file challenges, attorneys say.
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October 21, 2025
Judge Trims Pharma Co. Claims Against Ex-Employees
A Florida federal judge has narrowed pharmaceutical company Lupin Inc.'s lawsuit accusing a rival of stealing trade secrets, freeing a pair of former employees of claims that they breached their fiduciary duties by allegedly swiping the company's confidential information.
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October 21, 2025
3rd Circ. Reinstates Union Rep's Pharmacy Fraud Charges
The Third Circuit said Tuesday that it had revived charges against a union representative at a telecommunications company after finding that federal prosecutors sufficiently alleged that the rep submitted false claims to a pharmacy benefits manager for medically unnecessary testing and medicine.
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October 21, 2025
10x Genomics Hits Illumina With 2 Gene Tech Patent Suits
10x Genomics accused biotech giant Illumina Inc. of infringing nine genetic sequencing patents in two Delaware federal lawsuits Tuesday, arguing that Illumina knew of at least one of the patents because it was involved in a $31 million verdict against a different company that is well-known in the biology space.
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October 21, 2025
Nexus Can't Pursue IP Dropped Before Trial, Del. Judge Says
When Nexus Pharmaceuticals Inc. dropped patent claims to narrow its suit against Exela Pharma Sciences LLC, it lost the ability to assert them later on, a Delaware federal judge said Tuesday.
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October 21, 2025
Regeneron, Rival End Patent Fight Over Eye Med Biosimilar
Regeneron and a South Korea-based rival it had accused of infringing several patents covering the U.S. biotech company's top eye medication Eylea have agreed to a settlement to put an end to the case filed in West Virginia federal court.
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October 21, 2025
Investors Tell Chancery CytoDyn Board Ignored Drug Scheme
Stockholders of CytoDyn Inc. have filed a consolidated derivative complaint in the Delaware Chancery Court, accusing the company's leadership of wrongfully refusing to investigate and sue its former CEO and others over an aligned scheme to mislead investors about the company's flagship drug.
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October 21, 2025
J&J Unit Seeks Sanctions Over Doc's Deleted Talc Emails
A Johnson & Johnson subsidiary is asking a Virginia federal court to sanction a doctor who it alleges wrote a false article linking its talc products to mesothelioma, saying the only explanation for his policy of deleting all emails as soon as he sends or reads them is to destroy evidence.
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October 21, 2025
Full Fed. Circ. Won't Rehear $125M Medtronic Patent Verdict
The full Federal Circuit has declined to revisit a panel decision that overturned a $125 million patent infringement judgment against Medtronic's CoreValve unit, letting stand a precedential opinion addressing the doctrine of prosecution history estoppel.
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October 21, 2025
J&J Appeals $25M Loss In Conn. Builder's Asbestos Case
Johnson & Johnson has appealed its losses in a Connecticut real estate developer's asbestos lawsuit, telling state trial and appellate courts that it plans to challenge denials of multiple bids to reverse a $15 million jury verdict plus an additional $10 million in punitive damages awarded by a judge.
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October 21, 2025
PE Giants Ink $18.3B Deal For Hologic Amid Megadeal Blitz
Hologic Inc. said Tuesday it will be acquired by a private equity consortium in a deal valuing the Wachtell-advised medical technology company around $18.3 billion, marking one of the largest leveraged healthcare buyouts in recent years.
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October 21, 2025
Novartis Says Alexion's 'Block The Cause' Ads Are False
Novartis Pharmaceuticals Corp. is suing rival Alexion Pharmaceuticals Inc. in Delaware federal court, alleging that Alexion's "Block the Cause" ad campaign for its Ultomiris product falsely implies that Novartis' own treatment is less effective or even dangerous.
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October 20, 2025
Novo Nordisk Trial Kicks Off Over Kickback Allegations
Lawyers in a federal whistleblower lawsuit against drugmaker Novo Nordisk Inc. on Monday offered to take jurors "behind the curtain" of what they claimed was an illegal scheme by the pharmaceutical company to bribe doctors and patients in order to boost sales of a pricey hemophilia drug, NovoSeven.
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October 20, 2025
Drugmakers Say Conn. Law Illegally Extends Beyond State
A group of generic drug manufacturers has asked a Connecticut federal court to block the enforcement of a new price-control law against sales that occur outside of Connecticut, claiming that the law violates the U.S. Constitution.
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October 20, 2025
Biotech Co. Asks SEC For Emergency Delisting Pause
Chinese biotechnology company Shineco Inc. has asked the U.S. Securities and Exchange Commission for an emergency stay of Nasdaq's suspension and delisting of its securities, arguing it will likely succeed in its pending appeal to the stock exchange.
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October 20, 2025
Sterigenics Nears Win In Georgia Ethylene Oxide Litigation
Sterigenics Inc. notched two significant wins in sprawling litigation over its alleged emissions of carcinogenic ethylene oxide at an Atlanta-area plant, as a Georgia state court judge tossed residents' specific causation claims and allegations that the plant's activities constituted a private nuisance.
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October 20, 2025
Tylenol Maker Tells FDA Not To Add Autism Warning
Tylenol maker Kenvue on Friday told the U.S. Food and Drug Administration to reject a call to add warnings about the risk of using acetaminophen during pregnancy, saying that "expansive" scientific evidence shows there is no proven link between the over-the-counter drug and autism.
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October 20, 2025
Ex-GC Says Honeywell Can't Boot Her Age Bias Suit To China
A former vice president and general counsel for a Honeywell subsidiary said the conglomerate can't skirt her age discrimination claims by punting the case to China — where she lived and worked during her employment — because she has no legal remedy under Chinese law.
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October 20, 2025
More Fed. Workers Added To TRO Blocking Shutdown Layoffs
A California federal judge who blocked the Trump administration from laying off workers from two unions representing thousands of federal workers has expanded her temporary restraining order to include three more unions and also clarified that the order covered workers with union contracts that the administration is seeking to ditch.
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October 20, 2025
Catching Up With Delaware's Chancery Court
This past week, the Delaware Chancery Court and Supreme Court handled a crowded corporate docket, weighing blockbuster merger appeals, shareholder settlement objections, fights over control involving an NBA franchise and a high-profile appeal from Elon Musk involving a massive payday from Tesla.
Expert Analysis
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A Look At Key 5th Circ. White Collar Rulings So Far This Year
In the first half of 2025, the Fifth Circuit has decided numerous cases of particular import to white collar practitioners, which collectively underscore the critical importance of meticulous recordbuilding, procedural compliance and strategic litigation choices at every stage of a case, says Joe Magliolo at Jackson Walker.
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High Court Cert Spotlights Varying Tests For Federal Removal
A recent decision by the U.S. Supreme Court to review Chevron v. Plaquemines Parish, a case involving the federal officer removal statute, highlights three other recent circuit court decisions raising federal removal questions, and serves as a reminder that defendants are the masters of removal actions, says Varun Aery at Hollingsworth.
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How To Increase 3rd-Party Preissuance Patent Submissions
Attorneys Marian Underweiser and Marc Ehrlich, who helped draft the America Invents Act, discuss changes that the U.S. Patent and Trademark Office could potentially implement to facilitate its hopes for increased participation in front-end patent challenges.
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Trump Air Emissions Carveouts Cloud The Regulatory Picture
President Donald Trump's new proclamations temporarily exempting key U.S. industries from air toxics standards, issued under a narrow, rarely-used provision of the Clean Air Act, will likely lead to legal challenges and tighter standards in some states, contributing to further regulatory uncertainty, say attorneys at GableGotwals.
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Series
Playing Baseball Makes Me A Better Lawyer
Playing baseball in college, and now Wiffle ball in a local league, has taught me that teamwork, mental endurance and emotional intelligence are not only important to success in the sport, but also to success as a trial attorney, says Kevan Dorsey at Swift Currie.
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What US Medicine Onshoring Means For Indian Life Sciences
Despite the Trump administration's latest moves to onshore essential medicine manufacturing, India will likely remain an indispensable component of the U.S. drug supply chain, but Indian manufacturers should prepare for stricter compliance checks, says Jashaswi Ghosh at Holon Law Partners.
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Series
Law School's Missed Lessons: Skillful Persuasion
In many ways, law school teaches us how to argue, but when the ultimate goal is to get your client what they want, being persuasive through preparation and humility is the more likely key to success, says Michael Friedland at Friedland Cianfrani.
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FCA Working Group Reboot Signals EHR Compliance Risk
The revival of the False Claims Act working group is an aggressive expansion of enforcement efforts by the Justice Department and the U.S. Department of Health and Human Services targeted toward technology-enabled fraud involving electronic health records and other data, say attorneys at ArentFox Schiff.
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Litigation Inspiration: How To Respond After A Loss
Every litigator loses a case now and then, and the sting of that loss can become a medicine that strengthens or a poison that corrodes, depending on how the attorney responds, says Bennett Rawicki at Hilgers Graben.
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While On Firmer Ground, Uncertainty Remains For SEC's ALJs
The U.S. District Court for the District of Columbia's recent opinion in Lemelson v. U.S. Securities and Exchange Commission affirmed the legitimacy of the SEC's administrative proceedings, but pointedly left unanswered the constitutional merits of tenure protection enjoyed by SEC administrative law judges — potentially the subject of future U.S. Supreme Court review, says Dean Conway at Carlton Fields.
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FDA's Hasty Policymaking Approach Faces APA Challenges
Though the U.S. Food and Drug Administration has abandoned its usual notice-and-comment process for implementing new regulatory initiatives, two recent district court decisions make clear that these programs are still susceptible to Administrative Procedure Act challenges, says Rachel Turow at Skadden.
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Legal Considerations Around Ibogaine As Addiction Therapy
Recent funding approval in Texas pertaining to the use of ibogaine for the potential treatment of substance use disorders signals a growing openness to innovative addiction treatments, but also underscores the need for rigorous compliance with state and federal requirements and ethical research standards, say attorneys at Husch Blackwell.
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How Patent Attys Can Carefully Integrate LLMs Into Workflows
With artificial intelligence-powered tools now being developed specifically for the intellectual property domain, patent practitioners should monitor evolving considerations to ensure that their capabilities are enhanced — rather than diminished — by these resources, say attorneys at McDonnell Boehnen.
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The Metamorphosis Of The Major Questions Doctrine
The so-called major questions doctrine arose as a counterweight to Chevron deference over the past few decades, but invocations of the doctrine have persisted in the year since Chevron was overturned, suggesting it still has a role to play in reining in agency overreach, say attorneys at Crowell & Moring.
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New PTAB Denial Processes Grow More And More Confusing
Guidance from the U.S. Patent and Trademark Office about the Patent Trial and Appeal Board's new workload management and discretionary denial processes has been murky and inconsistent, and has been further muddled by the acting director's seemingly contradictory decisions, say attorneys at Finnegan.