Life Sciences

  • September 18, 2025

    Valitic Soap Is Unapproved Drug, Class Of Buyers Claims

    A proposed class of soap buyers is suing the maker of Valitic soap in New York federal court, alleging that it is an illegal drug as it claims to be able to treat dark spots, acne and other skin conditions without U.S. Food and Drug Administration approval.

  • September 17, 2025

    J&J Whistleblowers Defend $1.6B False Claims Act Win

    Whistleblowers filed a brief Wednesday in the Third Circuit in a closely watched False Claims Act appeal involving a $1.6 billion judgment against Johnson & Johnson unit Janssen as well as the constitutionality of the FCA's "qui tam" whistleblower provisions, arguing that the act's lawfulness has been settled by its "unbroken 162-year history."

  • September 17, 2025

    Chancery Mulls Limited Discovery In $8.7B Cerevel Sale Suit

    A Delaware vice chancellor said Wednesday he is considering denial of a motion to dismiss as well as limited plaintiff discovery in a suit accusing Cerevel Therapeutics Holdings Inc. insiders of lining up a secondary stock sale ahead of the biopharma's disclosure of a proposed $8.7 billion sale to AbbVie.

  • September 17, 2025

    FDA Says Vape Manufacturer Lying About Marketing Approval

    The U.S. Food and Drug Administration on Tuesday sued manufacturers of flavored vapes in New Jersey federal court to seek an end to their sales, saying that they are falsely representing that their products had received marketing approval.

  • September 17, 2025

    Don Jr.-Backed Patent Co. Hires Nokia Licensing Exec

    SIM IP, the newest venture by high-profile patent monetizer Erich Spangenberg, has brought on Nokia's chief licensing officer to serve as managing director.

  • September 17, 2025

    Missouri AG Can Seek Unredacted Trans Care Records

    The Missouri attorney general can demand that a hospital turn over unredacted records on patients getting transgender care as part of a probe of a whistleblower complaint, a state appeals court held Tuesday.

  • September 17, 2025

    Ex-CDC Head Says RFK Jr. Urged Vax Schedule Rubber Stamp

    Susan Monarez, the former head of the Centers for Disease Control and Prevention, told federal lawmakers on Wednesday she was abruptly fired just weeks into her tenure for "holding the line on scientific integrity."

  • September 17, 2025

    Purdue Can Pay CEO Ch. 11 Bonus After Trimming Comp

    A New York bankruptcy judge Wednesday approved a nearly $3 million incentive program for Purdue Pharma's chief executive after he agreed to reduce his total compensation by $500,000.

  • September 16, 2025

    Exactech Enters $8M Deal To Resolve Implant Failure Claims

    Orthopedic implant-maker Exactech Inc. agreed to pay $8 million to resolve allegations it marketed and sold faulty components of its knee-replacement systems that were to be used on patients on Medicare, Medicaid and U.S. Department of Veterans Affairs assistance, federal prosecutors in Maryland and Alabama announced Tuesday.

  • September 16, 2025

    Merck Says Vaccine Case 'Poor Vehicle' For Antitrust Review

    Merck & Co. told the U.S. Supreme Court to reject a bid from physicians looking to revive antitrust claims over submissions the pharmaceutical giant made to federal regulators concerning its mumps vaccine, arguing that the case is "an exceptionally poor vehicle" for review.

  • September 16, 2025

    BrainStorm Can't Shed Investors' ALS Treatment Trial Claims

    Biopharmaceutical company BrainStorm Cell Therapeutics Inc. must face a proposed investor class alleging it misrepresented feedback from the U.S. Food and Drug Administration regarding clinical trials for an ALS product candidate that failed to get approval, though a Manhattan federal judge has tossed the suit's insider trading allegations and certain fraud claims.

  • September 16, 2025

    The Patent Workforce Is Attracting Fewer Attys, More Agents

    The pool of patent practitioners registered with the U.S. Patent and Trademark Office has undergone a dramatic shift over the past few decades, with the number of attorneys taking the bar exam decreasing at the same time more patent agents are entering the field.

  • September 16, 2025

    Jazz Can't Escape Antitrust Claims Over Sleep Disorder IP

    A Delaware federal judge has refused to let Jazz Pharmaceuticals dodge antitrust claims that it wrongly listed a patent covering a way to distribute a narcolepsy drug in the U.S. Food and Drug Administration's Orange Book.

  • September 16, 2025

    CVS Caremark Takes $290M Overbilling Judgment To 3rd Circ.

    CVS's pharmacy benefits manager will appeal a judgment against the company that was recently increased from $95 million to $290 million in a suit alleging it overbilled Medicare Part D-sponsored drugs, according to a notice of appeal filed in Pennsylvania federal court.

  • September 16, 2025

    FTC Chair Pledges 'Action' Against Late Merger Fixes

    Federal Trade Commission Chairman Andrew Ferguson vowed Tuesday to take unspecified "action" against tactics by merging companies to propose fixes only after antitrust enforcers bring a transaction challenge, a strategy he called "bad for the system."

  • September 16, 2025

    Jones Day Adds FDA Regulatory Expert As Of Counsel In DC

    Jones Day on Tuesday announced the arrival of an attorney who brings over a decade of experience at the U.S. Food and Drug Administration advising on drug regulation.

  • September 16, 2025

    For Cahill Atty, Rare Disease Pro Bono Work Is Personal

    John MacGregor of Cahill Gordon & Reindel LLP didn't have any experience in healthcare law before taking on a pro bono client that supports people with a rare form of epilepsy. MacGregor's son is one of them.

  • September 16, 2025

    VarmX Partners With Biotech CSL In Deal Worth Up To $2.2B

    European life sciences venture capital firm EQT Life Sciences on Tuesday announced that its portfolio company VarmX, a Netherlands-based biotech, has entered into an exclusive option agreement to be bought by global biotech CSL in a deal worth up to $2.2 billion.

  • September 15, 2025

    Jazz Loses Bid To Block Avadel From Seeking Sleep Drug OK

    Jazz Pharmaceuticals Inc. cannot block Avadel CNS Pharmaceuticals LLC from seeking U.S. Food and Drug Administration approval for its sleep disorder treatment, a Delaware federal judge ruled, saying the act of seeking FDA approval is not an infringing activity that can be enjoined.

  • September 15, 2025

    AbbVie Settles Rinvoq Litigation, Blocks Generics Until 2037

    AbbVie Inc. has settled litigation with drug manufacturers, blocking generic versions of its immunosuppressant Rinvoq drug from the market for just over a decade and closing out litigation that accused generic-drug makers of infringing a slew of its patents.

  • September 15, 2025

    Ch. 11 Plan Faces Blowback From 23andMe Breach Claimants

    More than 30,000 individuals who elected to pursue arbitration rather than sign on to a proposed class settlement over a data breach at 23andMe are urging a Missouri bankruptcy judge to reject the DNA testing company's notice of its reorganization plan, arguing that the disclosure provides misleading and inflated information about the company's agreement with these claimants.

  • September 15, 2025

    Bayer Urges 9th Circ. Not To Revive Tevra Flea, Tick Meds Suit

    Bayer is urging the Ninth Circuit not to grant a new trial over claims that it locked up the market for pet flea and tick treatment, saying the only evidence that rival Tevra showed a jury at trial was "highly dubious."

  • September 15, 2025

    Ex-PTAB Leader Reflects On USPTO After Leaving Agency

    One of the Patent Trial and Appeal Board's most senior judges has left the U.S. Patent and Trademark Office after more than 13 years, and soon after joining private practice she spoke with Law360 about her history at the agency and the current dynamics playing out at the office.

  • September 15, 2025

    Investor Says $16M Ouraring Fight Shouldn't Go To Finland

    An early investor in the Oura health and fitness tracker is fighting Ouraring Inc.'s attempt to send his $16 million dispute to arbitration in Finland, saying there is no underlying agreement to arbitrate and his lawsuit should stay in California federal court.

  • September 15, 2025

    Stewart Says New Policies Seek Fairness For Patent Owners

    Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart said Monday the numerous changes to patent reviews she has implemented are intended to provide "more balance and fairness" for patent owners, and bring the reviews "back to how they were originally intended."

Expert Analysis

  • Opinion

    New USPTO Leadership Must Address Low-Quality Patents

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    With John Squires in line to become the new director of the U.S. Patent and Trademark Office, the agency has an opportunity to refocus its mission on prioritizing quality in patent examination and taking a harsher stance against low-quality patents and patent trolls, says Jill Crosby at Engine Advocacy & Foundation.

  • Opinion

    High Court Must Overrule Outdated Patent Eligibility Doctrine

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    A certiorari petition should directly ask the U.S. Supreme Court to correct its 1972 patent decision in Gottschalk v. Benson, the critical point where patent eligibility law veered from the statutory text toward judicial policymaking, says Robert Greenspoon at Dunlap Bennett.

  • Series

    Playing The Violin Makes Me A Better Lawyer

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    Playing violin in a string quartet reminds me that flexibility, ambition, strong listening skills, thoughtful leadership and intentional collaboration are all keys to a successful legal practice, says Julie Park at MoFo.

  • The State Of AI Adoption In The Patent Field

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    The use of generative artificial intelligence in patent-related practices has lagged behind early predictions, which may be explained by a number of core concerns that organizations must address before seriously considering adoption, say attorney Michael Drapkin and leadership coach Michael Colacchio.

  • Purdue Case Could Transform Patent Obviousness Analyses

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    If accepted for review by the U.S. Supreme Court, Purdue Pharma v. Accord Healthcare — concerning whether Purdue's abuse-deterrent opioid formulation patents were invalid as obvious — could significantly shift how courts weigh secondary considerations in patent obviousness analyses, say attorneys at Lathrop.

  • Federal Regs Order May Spell Harsher FDCA Enforcement

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    A recent executive order aimed at reducing criminal prosecutions of those who unknowingly violate complex federal regulations may actually lead to more aggressive felony indictments under the Federal Food, Drug and Cosmetic Act, but companies and executives can mitigate risks by following several key principals, say attorneys at McGuireWoods.

  • Series

    Law School's Missed Lessons: Practicing Self-Care

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    Law schools don’t teach the mental, physical and emotional health maintenance tools necessary to deal with the profession's many demands, but practicing self-care is an important key to success that can help to improve focus, manage stress and reduce burnout, says Rachel Leonard​​​​​​​ at MG+M.

  • ABA Opinion Makes It A Bit Easier To Drop A 'Hot Potato'

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    The American Bar Association's recent ethics opinion clarifies when attorneys may terminate clients without good cause, though courts may still disqualify a lawyer who drops a client like a hot potato, so sending a closeout letter is always a best practice, say attorneys at Thompson Hine.

  • IRhythm IPR Denial Raises Key PTAB Discretion Questions

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    By giving the passage of time a dispositive role in denying institution of five inter partes review petitions filed by iRhythm Technologies, the U.S. Patent and Trademark Office has upended the strategic considerations for filing and defending against IPRs, disclosing prior art during prosecution, and engaging in licensing negotiations, say attorneys at Dentons.

  • Canadian Suit Offers Disclosure Lesson For US Cannabis Cos.

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    A Canadian class action asserting that Aurora Cannabis failed to warn consumers about the risk of developing cannabinoid hyperemesis syndrome may spawn copycat filings in the U.S., and is a cautionary tale for cannabis and hemp industries to prioritize risk disclosure, says Ian Stewart at Wilson Elser.

  • Opinion

    IPR Denial In IRhythm Should Not Set A Blanket Rule

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    Though the Patent Trial and Appeal Board's discretionary denial in iRhythm v. Welch Allyn last month raised concerns that mere knowledge of a patent could bar inter partes review institution, a closer look at the facts and reasoning reveals why this case's holdings should not be reflexively applied to all petitioners, says David McCombs at Haynes Boone.

  • What High Court's Tenn. Trans Care Ruling Means Nationally

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    The U.S. Supreme Court's decision in U.S. v. Skrmetti, upholding a Tennessee ban on gender-affirming medical care for minors, is fairly limited in scope and closely tailored to the specific language of Tennessee's law, but it may have implications for challenges to similar laws in other states, say attorneys at Hall Render.

  • How Trump's Trade Policies Are Shaping Foreign Investment

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    Five months into the Trump administration, investors are beginning to see the concrete effects of the president’s America First Investment Policy as it presents new opportunities for clearing transactions more quickly, while sustaining risk aversion related to Chinese trade and potentially creating different political risks, say attorneys at Covington.

  • Series

    My Opera And Baseball Careers Make Me A Better Lawyer

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    Though participating in opera and the world of professional baseball often pulls me away from the office, my avocations improve my legal career by helping me perform under scrutiny, prioritize team success, and maintain joy and perspective at work, says Adam Unger at Herrick Feinstein.

  • Opinion

    Subject Matter Eligibility Test Should Return To Preemption

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    Subject matter eligibility has posed challenges for patentees due to courts' arbitrary and confusing reasoning, but adopting a two-part preemption test could align the applicant, the U.S. Patent and Trademark Office and the courts, says Manav Das at McDonnell Boehnen.

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