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Life Sciences
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October 31, 2025
Amgen Again Challenges Colo. Price Cap For Arthritis Drug
Amgen has once again sued Colorado over its price cap for the arthritis drug Enbrel, claiming that the Centennial State's drug price-control statute violates the U.S. Constitution, conflicts with federal patent law and threatens patients' access to lifesaving medications.
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October 31, 2025
Ga. Panel Says McClain Standard Applies In Sterigenics Case
The Georgia Court of Appeals on Friday vacated a trial court's decision in eight toxic tort bellwether suits claiming harmful emissions from a Sterigenics sterilization plant caused cancer and birth defects, saying the trial court used the wrong legal standard regarding expert testimony in toxic tort cases.
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October 31, 2025
Wheeling & Appealing: The Latest Must-Know Appellate Action
In this installment of Wheeling & Appealing, November's appellate calendar features a Trump lawsuit against Hillary Clinton, New York City housing disputes, drug pricing battles, immigrant rights cases, and challenges to so-called patent troll laws.
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October 31, 2025
Monthly Merger Review Snapshot
The Justice Department battled with state attorneys general trying to peek behind its controversial settlement clearing Hewlett Packard Enterprise's Juniper purchase, United Kingdom officials deepened their probe into Getty's proposed acquisition of Shutterstock and Pfizer cried foul when Novo Nordisk tried to swoop in over its Metsera purchase.
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October 31, 2025
Hawaii Judge Declares FDA's Mifepristone Regs Unlawful
The U.S. Food and Drug Administration failed to sufficiently justify restrictions on the abortion drug mifepristone, a Hawaii federal judge ruled in an order declaring the restrictions unlawful under the Administrative Procedure Act.
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October 31, 2025
Gov't Owes $330K In Fees For NSF Funding Fight, Court Told
A higher education association seeks more than $330,000 in attorney fees and costs from the government after winning a ruling blocking the Trump administration from cutting certain National Science Foundation funding, according to a memorandum filed in Massachusetts federal court.
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October 31, 2025
FDA Warns Against Fluoride Use In Young Children
The U.S. Food and Drug Administration on Friday said it is stopping sales of unapproved fluoride products labeled for use by children under the age of three as part of the Trump administration's Make America Healthy Again movement.
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October 31, 2025
Bayer Investors Get Final OK For $38M Settlement, Atty Fees
A California federal judge has finalized a $38 million settlement between Germany-based Bayer AG and a class of investors who claim the company deceived them about the litigation risks of acquiring Roundup producer Monsanto, with the lead plaintiffs' attorney saying the deal reaffirmed investors' ability to hold foreign companies responsible for violating U.S. securities laws.
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October 31, 2025
Squires Vows To Open USPTO Doors To AI Technologies
New U.S. Patent and Trademark Office Director John Squires said Friday his agency will embrace artificial intelligence technologies during his tenure, telling attorneys at the American Intellectual Property Law Association's annual gathering in Washington, D.C., that AI is "the most transcendent and transformative technology of our time — perhaps of any time."
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October 31, 2025
Obesity Drugmaker Escapes Clinical Trial Securities Suit
Biopharmaceutical company BioAge Labs Inc. has, for now, escaped a suit alleging investors were hurt by plummeting share prices after the company unexpectedly halted a clinical trial for a weight loss drug, saying that the investors failed to plausibly show the company did not properly disclose risks to the trial.
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October 31, 2025
3 Argument Sessions Benefits Attys Should Watch In Nov.
The Third Circuit will hear a union's appeal in a withdrawal liability battle, a union health plan defends its partial win in a coverage fight at the Ninth Circuit, and pharmacy benefit managers will take a challenge to the Federal Trade Commission's authority to the full Eighth Circuit. Here are three arguments to keep an eye on in November.
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October 31, 2025
Industry Groups Seek More Time To Comment On PTAB Rules
A coalition of organizations representing the technology, automotive and pharmaceutical sectors has urged U.S. Patent and Trademark Office Director John Squires to allow 30 additional days of public comments regarding new proposed rules that would curtail the number of Patent Trial and Appeal Board reviews.
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October 31, 2025
3rd Circ. Preview: BMW, MiLB And Sandoz Top Nov. Lineup
The Third Circuit in November will hear a pair of disputes over awards handed out in New Jersey federal court, including a nearly $4 million attorney fee for class counsel representing BMW drivers and a $70 million win for Sandoz Inc. in a contract battle over blood pressure medicine.
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October 30, 2025
Philly Accuses PBMs Of Knowingly Enabling Opioid Crisis
Philadelphia on Thursday sued CVS Caremark, Express Scripts and Optum, accusing the pharmacy benefit managers of contributing to the city's opioid epidemic via deceptive marketing and conspiring with drugmakers to increase the sale of OxyContin and other prescription opioids.
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October 30, 2025
Med Robot Co. Tells 9th Circ. Not To Revive 'Disfavored' Suit
Intuitive Surgical urged the Ninth Circuit not to revive a surgical repair company's claims alleging it blocked third parties from refurbishing components for its popular da Vinci surgery robot, defending the district court's findings that cases alleging anticompetitive harm to a single brand aftermarket are "rare and disfavored."
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October 30, 2025
Fiber Optics Co. Agrees To Reforms To End Derivative Suit
Fiber optic equipment company Luna Innovations Inc. has reached a deal with its investors to settle their derivative claims alleging the company was damaged by its failure to properly recognize revenue in its filings with the U.S. Securities and Exchange Commission.
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October 30, 2025
Avantor Minimized Competition On Lab Biz, Investor Says
Biotech company Avantor Inc. was hit with a proposed securities class action in Pennsylvania federal court Thursday alleging it misled investors when it minimized the effects of increased competition on its business and operations while touting strong competitive positioning, causing stock prices to plunge when the truth came out.
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October 30, 2025
Fed. Circ. Explains Rule While Upholding Merck PTAB Loss
The Federal Circuit sided with generics makers Thursday and upheld the Patent Trial and Appeal Board's invalidation of claims in two Merck KGaA patents on the blockbuster multiple sclerosis drug Mavenclad, while clarifying how to treat invalidity arguments that involve overlapping inventors.
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October 30, 2025
2nd Ex-Magellan Exec Avoids Jail Over Faulty Lead Tests
A second former Magellan Diagnostics executive ducked prison time Thursday for his role in an alleged scheme to hide a defect in the company's lead-testing devices ahead of its sale in 2016.
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October 30, 2025
Lawmakers Slam Value-Based Patent Fee Proposal
Six members of the U.S. House of Representatives wrote to U.S. Secretary of Commerce Howard Lutnick on Thursday expressing concern over the proposal to charge patent holders fees based on their patent's value, saying that will harm innovation and economic growth.
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October 30, 2025
J&J's Janssen Says 3rd Circ. Should Reverse $1.6B FCA Win
Johnson & Johnson's Janssen Products LP urged the Third Circuit to overturn a $1.6 billion False Claims Act judgment over two of its HIV drugs, arguing the district court allowed whistleblowers to prove fraud based solely on "off-label" marketing rather than any false claim actually submitted to the government.
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October 30, 2025
Generic-Drug Firms Want To Fast-Track Conn. Price Cap Fight
An industry group for generic and biosimilar pharmaceutical companies has asked a Connecticut federal judge to fast-track its lawsuit seeking to block the state's new drug price cap, claiming it will suffer "imminent harm" if the case is delayed.
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October 30, 2025
McCarter & English Used Doctrine As 'Whipsaw,' Panel Hears
A biotech company on Thursday urged a New Jersey appellate panel to revive its legal malpractice suit against McCarter & English LLP, arguing that the claims were distinct from the firm's own suit seeking unpaid fees.
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October 30, 2025
Mich. Top Court Upholds Gilead Immunity In COVID Drug Case
The Michigan Supreme Court on Wednesday said it won't consider an appeal from a man who was injected with a COVID-19 treatment made by Gilead Sciences Inc. that was later recalled for containing glass shards, a few months after a lower appellate court found the company immune because of a federal health emergency law.
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October 30, 2025
Judge Unpauses 'Important' Suit Over Vax Guidelines
A Massachusetts federal judge agreed Thursday to lift a government shutdown-related stay of litigation challenging new COVID-19 vaccine recommendations for children and pregnant women, calling the case a "matter of national importance" that warrants keeping the case moving over the U.S. Department of Justice's objection.
Expert Analysis
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What Ethics Rules Say On Atty Discipline For Online Speech
Though law firms are free to discipline employees for their online commentary about Charlie Kirk or other social media activity, saying crude or insensitive things on the internet generally doesn’t subject attorneys to professional discipline under the Model Rules of Professional Conduct, says Stacie H. Rosenzweig at Halling & Cayo.
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Junior Attys Must Beware Of 5 Common Legal Brief Mistakes
Excerpt from Practical Guidance
Junior law firm associates must be careful to avoid five common pitfalls when drafting legal briefs — from including every possible argument to not developing a theme — to build the reputation of a sought-after litigator, says James Argionis at Cozen O'Connor.
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Opinion
State AGs, Not Local Officials, Should Lead Public Litigation
Local governments’ public nuisance lawsuits can raise constitutional and jurisdictional challenges, reinforcing the principle that state attorneys general — not municipalities — are best positioned to litigate on behalf of citizens when it is warranted, says former Utah Attorney General John Swallow.
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3rd Circ. Clarifies Ch. 11 3rd-Party Liability Scope Post-Purdue
A recent Third Circuit decision that tort claims against the purchaser of a debtor's business belong to the debtor's bankruptcy estate reinvigorates the use of Chapter 11 for the resolution of nondebtor liability in mass tort bankruptcies following last year's U.S. Supreme Court ruling in Purdue Pharma, say attorneys at Sullivan & Cromwell.
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Texas Suit Marks Renewed Focus On Service Kickback Theory
After a dormant period at the federal level, a theory of kickback enforcement surrounding nurse educator programs and patient support services resurfaced with a recent state court complaint filed by Texas against Eli Lilly, highlighting for drugmakers the ever-changing nature of enforcement priorities and industry landscapes, say attorneys at Sheppard Mullin.
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Series
Power To The Paralegals: How And Why Training Must Evolve
Empowering paralegals through new models of education that emphasize digital fluency, interdisciplinary collaboration and human-centered lawyering could help solve workforce challenges and the justice gap — if firms, educators and policymakers get on board, say Kristine Custodio Suero and Kelli Radnothy.
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Series
Playing Softball Makes Me A Better Lawyer
My time on the softball field has taught me lessons that also apply to success in legal work — on effective preparation, flexibility, communication and teamwork, says Sarah Abrams at Baleen Specialty.
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5 Years In, COVID-19 Fraud Enforcement Landscape Is Shifting
As the government moves pandemic fraud enforcement from small-dollar individual prosecutions to high-value corporate cases, and billions of dollars remain unaccounted for, companies and defense attorneys must take steps now to prepare for the next five years of scrutiny, says attorney David Tarras.
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Fed. Circ. In August: A Framework For AIA Derivation Disputes
In Global Health Solutions v. Selner, the Federal Circuit established how to assess derivation challenges under the America Invents Act's first-to-file system, making it easier for petitioners to determine a challenge's odds of success, say attorneys at Knobbe Martens.
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USPTO's Track One A Reliable Patent Pathway Amid Backlog
As the U.S. Patent and Trademark Office faces a backlog of unexamined utility, plant and reissue patent applications, patent applicants should consider utilizing the USPTO's Track One Program, which not only expedites the process but also increases the likelihood of working with more senior examiners, says Ryan Schermerhorn at Marshall Gerstein.
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Vanda Ruling Opens Door For Contesting FDA Drug Denials
The D.C. Circuit's recent decision in Vanda Pharmaceuticals v. U.S. Food and Drug Administration creates new opportunities and considerations for drug companies navigating the FDA approval process, establishing that litigation is an option when the FDA refuses to hold a hearing, say attorneys at Polsinelli.
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Series
Law School's Missed Lessons: Mastering Time Management
Law students typically have weeks or months to prepare for any given deadline, but the unpredictability of practicing in the real world means that lawyers must become time-management pros, ready to adapt to scheduling conflicts and unexpected assignments at any given moment, says David Thomas at Honigman.
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Rare Del. Oversight Ruling Sends Governance Wake-Up Call
An unusual ruling from the Delaware Court of Chancery recently allowed Caremark oversight claims to proceed against former executives of a company previously known as Teligent, sending a clear reminder that boards and officers must actively monitor and document oversight efforts when addressing mission-critical risks, say attorneys at WilmerHale.
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How Hyperlinks Are Changing E-Discovery Responsibilities
A recent e-discovery dispute over hyperlinked data in Hubbard v. Crow shows how courts have increasingly broadened the definition of control to account for cloud-based evidence, and why organizations must rethink preservation practices to avoid spoliation risks, says Bree Murphy at Exterro.
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Pharma Copay Programs Raise Complex Economic Questions
The growing prevalence of copay accumulator and maximizer programs in the pharmaceutical industry is drawing increased scrutiny from patients, advocacy groups, lawmakers and courts, bringing complex questions about how financial responsibility for prescription drug purchases is determined and complicating damages assessments in litigation, say analysts at Analysis Group.