Life Sciences

  • 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.

  • October 29, 2025

    DOJ Subpoena Called 'Pressure' To Ax Gender-Affirming Care

    The U.S. Department of Justice issued a subpoena to intimidate a telehealth organization into ending gender-affirming medical care, a Seattle federal judge said in a ruling that found the agency is using the guise of an investigation to further the Trump administration's stated goal of eliminating transgender and gender-diverse patients' access to healthcare.

  • October 29, 2025

    DexCom Misled Investors About Its Diabetes Tech, Suit Says

    Medical device maker DexCom is facing a proposed investor class action in Manhattan federal court alleging the company hurt shareholders by failing to disclose changes to a glucose monitoring device affecting the reliability of the device's readings.

Expert Analysis

  • 2 Fed. Circ. Rulings Underscore Patent Prosecution Pitfalls

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    Two recent patent decisions from the Federal Circuit, overturning significant judgments, serve as reminders that claim modifications and cancellations may have substantive effects on the scope of other claims, and that arguments distinguishing prior art and characterizing claims may also limit claim scope, say attorneys at Morgan Lewis.

  • Rebutting Price Impact In Securities Class Actions

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    Defendants litigating securities cases historically faced long odds in defeating class certification, but that paradigm has recently begun to shift, with recent cases ushering in a more searching analysis of price impact and changing the evidence courts can consider at the class certification stage, say attorneys at Katten.

  • 7 Document Review Concepts New Attorneys Need To Know

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    For new associates joining firms this fall, stepping into the world of e-discovery can feel like learning a new language, but understanding a handful of fundamentals — from coding layouts to metadata — can help attorneys become fluent in document review, says Ann Motl at Bowman and Brooke.

  • Ruling On Labor Peace Law Marks Shift For Cannabis Cos.

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    Currently on appeal to the Ninth Circuit, an Oregon federal court’s novel decision in Casala v. Kotek, invalidating a state law that requires labor peace agreements as a condition of cannabis business licensure, marks the potential for compliance uncertainty for all cannabis employers in states with labor peace mandates, say attorneys at Sheppard Mullin.

  • Fed. Circ. Rulings Refine Patent Claim Construction Standards

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    Four Federal Circuit patent decisions this year clarify several crucial principles governing patent claim construction, including the importance of prosecution history, and the need for error-free, precise language from claims drafters, say attorneys at Taft.

  • How Value-Based Patent Fees May Shape IP Strategies

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    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.

  • Agentic AI Puts A New Twist On Attorney Ethics Obligations

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    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.

  • Using Reissue Applications To Strategically Improve Patents

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    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.

  • FDA Transparency Plans Raise Investor Disclosure Red Flags

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    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.

  • Series

    Being A Professional Wrestler Makes Me A Better Lawyer

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    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.

  • Patent Claim Lessons From Fed. Circ.'s Teva Decision

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    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.

  • Series

    Law School's Missed Lessons: Adapting To The Age Of AI

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    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.

  • Ch. 11 Ruling Voiding $2M Litigation Funding Sends A Warning

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    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.

  • DOJ's Novel Cybersecurity FCA Case Is A Warning To Medtech

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    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.

  • Future-Proof Patent Law By Starting Talent Pipelines Early

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    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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