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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 sa¹ú¼Ê´«Ã½ 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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Series
Teaching Trial Advocacy Makes Us Better Lawyers
Teaching trial advocacy skills to other lawyers makes us better litigators because it makes us question our default methods, connect to young attorneys with new perspectives and focus on the needs of the real people at the heart of every trial, say Reuben Guttman, Veronica Finkelstein and Joleen Youngers.
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The Crucial Question Left Unanswered In EpicentRx Decision
The California Supreme Court recently issued its long-awaited decision in EpicentRx Inc. v. Superior Court, resolving a dispute regarding the enforceability of forum selection clauses, but the question remains whether private companies can trust that courts will continue to consistently enforce forum selection clauses in corporate charters, says John Yow at Yow PC.
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Federal AI Action Plan Marks A Shift For Health And Bio Fields
The Trump administration's recent artificial intelligence action plan significantly expands federal commitments across biomedical agencies, defining a pivotal moment for attorneys and others involved in research collaborations, managing regulatory compliance and AI-related intellectual property, says Mehrin Masud-Elias at Arnold & Porter.
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Preparing For DEA Rescheduling Of 2 Research Chemicals
A recent decision to allow the U.S. Drug Enforcement Administration to reclassify two research psychedelics in Schedule I under the Controlled Substances Act may pose significant barriers to scientific study, including stringent registration requirements, heightened security protocols and burdensome reporting obligations, say Kimberly Chew at Husch Blackwell and Jackie von Salm at Psilera.
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Why EpicentRx Ruling Is A Major Win For Business Certainty
The California Supreme Court's recent decision in EpicentRx v. Superior Court removes a significant source of uncertainty that plagued commercial litigation in California by clarifying that forum selection clauses shouldn't be invalidated solely because the selected forum lacks the right to a jury trial, say attorneys at Clark Hill.
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A Change In Big Pharma Response To FTC Delisting Warnings
While the effect of Federal Trade Commission notices to pharmaceutical companies about allegedly improper patent listings in the U.S. Food and Drug Administration's Orange Book had been de minimis through the end of last year, July data shows an increase in delistings, say Ratib Ali and Celia Lu at Competition Dynamics.
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As Product Recalls Rise, So Do The Stakes For The Bar
Recent recall announcements affecting over 800,000 Ford vehicles highlight how product recalls have become more frequent, complex and safety-critical than ever, raising key practice questions for counsel, and raising the stakes in product liability litigation, says Ken Fulginiti at Fulginiti Law.
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Series
Adapting To Private Practice: From Texas AUSA To BigLaw
As I learned when I transitioned from an assistant U.S. attorney to a BigLaw partner, the move from government to private practice is not without its hurdles, but it offers immense potential for growth and the opportunity to use highly transferable skills developed in public service, says Jeffery Vaden at Bracewell.
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Data Undermines USPTO's 'Settled Expectations' Doctrine
An analysis of inter partes review proceedings filed since 2012 appears to refute the U.S. Patent and Trademark Office's recent stance that patent owners develop a strong settled expectation that their patents will not be challenged after being in force for six years, say Jonathan DeFosse and Samuel Smith at Sheppard Mullin, and Kenzo Kasai at NGB Corp.
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Advice For 1st-Gen Lawyers Entering The Legal Profession
Nikki Hurtado at The Ferraro Law Firm tells her story of being a first-generation lawyer and how others who begin their professional journeys without the benefit of playbooks handed down by relatives can turn this disadvantage into their greatest strength.
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High Court E-Cig Ruling Opens Door For FDA Challenges
There will likely be more challenges to marketing denial orders brought before the Fifth Circuit following the Supreme Court's recent ruling in U.S. Food and Drug Administration v. R.J. Reynolds Vapor Co., where litigants have generally had greater success, say attorneys at Troutman Pepper.
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Fed. Circ. In July: Instability In IPR Requirements
The Federal Circuit's decision in Shockwave v. Cardiovascular last month provided an important, albeit short-lived, clarification to the type of evidence that can be used in an inter partes review challenge, say attorneys at Knobbe Martens.
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Structuring Noncompetes In License And Collaboration Deals
As companies grappling with coming patent cliffs look to mergers and acquisitions to compensate, contracting parties assessing biopharma license and collaboration agreements should prepare to agree on noncompetes that ensure the parties' respective objectives are met and that their incentives are aligned, both under their collaboration and beyond, says Jeff Jay at Freshfields.
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Series
Coaching Cheerleading Makes Me A Better Lawyer
At first glance, cheerleading and litigation may seem like worlds apart, but both require precision, adaptability, leadership and the ability to stay composed under pressure — all of which have sharpened how I approach my work in the emotionally complex world of mass torts and personal injury, says Rashanda Bruce at Robins Kaplan.
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7 Ways To Fetch Patents In The World Of Working Animals
Though developers rarely file patents related to working animals, and animal training techniques are generally considered unpatentable, certain aspects of training and developing animals may be ripe for patent protection, say Matthew Avery at Baker Botts, Makenzi Galvan at Perkins Coie and Lute Yang at Orrick.