Life Sciences

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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."

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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."

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • October 30, 2025

    Novo Nordisk Bids $9B For Metsera, Jeopardizing Pfizer Deal

    Metsera Inc. said Thursday that Novo Nordisk has put forth a $9 billion buyout proposal that is "superior" to its existing agreement to sell itself to Pfizer, prompting a response from Pfizer stating that it is prepared to "pursue all legal avenues" to keep its agreement intact.

Expert Analysis

  • Puzzling Out When Similar Insurance Claims Are Related

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    A recent decision in Virginia federal court shows that more than identical allegations of negligent business practices across two lawsuits may be necessary to satisfy the strict definition of relatedness under claims-made liability insurance policies, say attorneys at Hunton.

  • A Shifting Trend In FDA Form 483 Disclosure Obligations

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    A New York federal court's Checkpoint Therapeutics decision extends a recent streak of dismissals of securities class actions alleging that pharmaceutical companies failed to disclose U.S. Food and Drug Administration Form 483 inspection reports, providing critical guidance for companies during the FDA approval process, say attorneys at Alston & Bird.

  • Trending At The PTAB: IPR Memo And Its Fed. Circ. Backdrop

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    There are new rules for when and how evidence other than patents or printed publications can be considered in inter partes reviews, and while this change is intended to reflect current Federal Circuit precedent, the U.S. Patent and Trademark Office's memo seems to acknowledge tension with last month's Shockwave decision, say attorneys at Finnegan.

  • Lessons From 7th Circ.'s Deleted Chat Sanctions Ruling

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    The Seventh Circuit’s recent decision in Pable v. Chicago Transit Authority, affirming the dismissal of an ex-employee’s retaliation claims, highlights the importance of properly handling the preservation of ephemeral messages and clarifies key sanctions issues, says Philip Favro at Favro Law.

  • Breaking Down The Proposed Hemp Bill

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    A proposed bill in the U.S. House of Representatives, recently approved by the House Appropriations Committee, contains a rider that would significantly change the definition of hemp and dramatically reshape the current hemp-derived product market, say attorneys at King & Spalding.

  • Assessing Federal Securities Class Action Stats In '25 So Far

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    The settlement amount as a percentage of damages in securities class actions has continued to decline in the first half of 2025, a trend that may be important for assessing exposure and risk in future securities litigation, say analysts at Analysis Group.

  • Series

    Quilting Makes Me A Better Lawyer

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    Turning intricate patterns of fabric and thread into quilts has taught me that craftsmanship, creative problem-solving and dedication to incremental progress are essential to creating something lasting that will help another person — just like in law, says Veronica McMillan at Kramon & Graham.

  • How Agentic AI Is Testing The Limits Of Patent Law

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    While a recent Swiss court ruling suggests that human-centric rules regarding inventorship will likely remain in place for the near future, it captures a core tension confronting patent systems worldwide as the technology producing patent-worthy ideas is becoming increasingly autonomous, says Matthew Carey at Marshall Gerstein.

  • How To Prep For Potential Passage Of SAFER Banking Act

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    The Secure and Fair Enforcement Regulation, or SAFER, Banking Act, could fundamentally reshape how financial institutions interact with cannabis businesses, so operators that move now to get their house in order will be best positioned to capitalize if and when change comes, says Alex Leonowicz at Howard & Howard.

  • A Former PTAB Judge Weighs The End Of Remote Hearings

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    Former Patent Trial and Appeal Board Judge Amanda Wieker, now at McGuireWoods, examines the costs and benefits of the PTAB's impending in-person hearing requirement, and offers suggestions for making the most out of this new regime.

  • The Future Of Lab-Test Regs After FDA Rescinds Rule

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    The U.S. Food and Drug Administration recently rescinded its laboratory-developed tests rule in response to a Texas federal court decision this spring, reinforcing a separation of authority between the FDA and the Centers for Medicare & Medicaid Services, and calling into question the FDA's role in overseeing such tests without congressional action, say attorneys at Venable.

  • SDNY Ruling Reinforces Joint Steering Committee Obligations

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    The recent Southern District of New York decision in ChemImage v. Johnson & Johnson makes joint steering committees a valuable tool in strategic relationships, as provisions for such committees can now be wielded to demand attention to core issues, say Lisa Bernstein at the University of Chicago Law School, and Reginald Goeke and Brad Peterson at Mayer Brown.

  • What 2 Profs Noticed As Transactional Law Students Used AI

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    After a semester using generative artificial intelligence tools with students in an entrepreneurship law clinic, we came away with numerous observations about the opportunities and challenges such tools present to new transactional lawyers, say professors at Cornell Law School.

  • What Patent Claim 'Invalidity' Means In Different Forums

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    A recent Federal Circuit order allowing a patent suit to proceed despite similar claims being invalidated in an inter partes review underscores how fractured the patent litigation landscape has become, leading to critical nuances in how district courts, the U.S. International Trade Commission and Patent Trial and Appeal Board treat invalidity, says Jason Hoffman at BakerHostetler.

  • Rebuttal

    BigLaw Settlements Should Not Spur Ethics Deregulation

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    A recent Law360 op-ed argued that loosening law firm funding restrictions would make BigLaw firms less inclined to settle with the Trump administration, but deregulating legal financing ethics may well prove to be not merely ineffective, but counterproductive, says Laurel Kilgour at the American Economic Liberties Project.

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