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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.
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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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How Value-Based Patent Fees May Shape IP Strategies
If the U.S. Patent and Trademark Office implements rumored plans to correlate patent fees with patent value, the financial and strategic consequences would largely depend on the specifics of how, when and how often patent values are assessed, say attorneys at Cleary.
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Agentic AI Puts A New Twist On Attorney Ethics Obligations
As lawyers increasingly use autonomous artificial intelligence agents, disciplinary authorities must decide whether attorney responsibility for an AI-caused legal ethics violation is personal or supervisory, and firms must enact strong policies regarding agentic AI use and supervision, says Grace Wynn at HWG.
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Using Reissue Applications To Strategically Improve Patents
Though reissue applications are an often-overlooked consideration in today's patent environment, they can offer powerful tools for correcting errors, strengthening patent protection, or adapting to evolving business and legal landscapes, says Curtis Powell at Wolf Greenfield.
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FDA Transparency Plans Raise Investor Disclosure Red Flags
The U.S. Food and Drug Administration’s recently announced intent to publish complete response letters for unapproved drugs and devices implicates certain investor disclosure requirements under securities laws, making it necessary for life sciences and biotech companies to adopt robust controls going forward, say attorneys at Arnold & Porter.
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Series
Being A Professional Wrestler Makes Me A Better Lawyer
Pursuing my childhood dream of being a professional wrestler has taught me important legal career lessons about communication, adaptability, oral advocacy and professionalism, says Christopher Freiberg at Midwest Disability.
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Patent Claim Lessons From Fed. Circ.'s Teva Decision
The Federal Circuit's recent decision in Janssen v. Teva is an important precedent for parties drafting patent claims or litigating obviousness where the prior art has potentially overlapping ranges for a claimed element, and may be particularly instructive to patent applicants in the pharmaceutical field, say attorneys at Cooley.
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Series
Law School's Missed Lessons: Adapting To The Age Of AI
Though law school may not have specifically taught us how to use generative artificial intelligence to help with our daily legal tasks, it did provide us the mental building blocks necessary for adapting to this new technology — and the judgment to discern what shouldn’t be automated, says Pamela Dorian at Cozen O'Connor.
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Ch. 11 Ruling Voiding $2M Litigation Funding Sends A Warning
A recent Texas bankruptcy court decision that a postconfirmation litigation trust has no obligations to repay a completely drawn down $2 million litigation funding agreement serves as a warning for estate administrators and funders to properly disclose the intended financing, say attorneys at Kleinberg Kaplan.
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DOJ's Novel Cybersecurity FCA Case Is A Warning To Medtech
The U.S. Department of Justice's recent False Claims Act settlement with Illumina over alleged cybersecurity deficiencies suggests that enforcement agencies and whistleblowers are focusing attention toward cybersecurity in life sciences and medical tech, but also reveals key unanswered questions about the legal viability of such allegations, say attorneys at Morgan Lewis.
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Future-Proof Patent Law By Starting Talent Pipelines Early
Law firms struggling with a narrow talent pipeline in the intellectual property space should consider beginning their recruitment strategies for potential candidates as early as high school, and raise awareness for career opportunities that do not require a law degree, says Christine Hollis at Marshall Gerstein.
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Demystifying The Civil Procedure Rules Amendment Process
Every year, an advisory committee receives dozens of proposals to amend the Federal Rules of Civil Procedure, most of which are never adopted — but a few pointers can help maximize the likelihood that an amendment will be adopted, says Josh Gardner at DLA Piper.
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How USPTO Examiner Memo Informs Software Patent Drafting
A memorandum recently released by the U.S. Patent and Trademark Office provides useful clues as to how the USPTO and examining corps will evaluate claims in software-implemented inventions for subject matter eligibility going forward, says Michael Lew at Squire Patton.
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How 2nd Circ. Cannabis Ruling Upends NY Licensing
A recent Second Circuit decision in Variscite NY Four v. New York, holding that New York's extra-priority cannabis licensing preference for applicants with in-state marijuana convictions violates the dormant commerce clause, underscores that state-legal cannabis markets remain subject to the same constitutional constraints as other economic markets, say attorneys at Harris Beach.
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Parenting Skills That Can Help Lawyers Thrive Professionally
As kids head back to school, the time is ripe for lawyers who are parents to consider how they can incorporate their parenting skills to build a deep, meaningful and sustainable legal practice, say attorneys at Alston & Bird.
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Enablement Standard Insights From Fed. Circ. Agilent Ruling
The Federal Circuit's recent enablement standard decision in Agilent v. Synthego underscores three critical takeaways for patent practitioners, including reaffirmation that the enablement inquiry under Section 102 of the Patent Act is distinct from the inquiry under Section 112, say attorneys at MoFo.