Life Sciences

  • September 10, 2026

    RJ Reynolds Wants In On Suit Over FDA Vape Review Rule

    Vape and nicotine pouch subsidiaries owned by Altria and R.J. Reynolds are looking to upend the U.S. Food and Drug Administration's premarket authorization rule, claiming the agency is breaking the law by dragging out product reviews well past the statutory deadline, which delays their goods by years while illegal Chinese products flood the market.

  • September 10, 2026

    Clinical Trial Buyer Says Ex-Owner Breached $100M Deal

    Surge ECN Holdings LLC and ECN Operating LLC have accused the former owner of a clinical trial research network of violating a five-year noncompete and other restrictions tied to a deal worth more than $100 million, alleging he diverted customers, recruited key physicians and used confidential information to build a competing business.

  • September 10, 2026

    Apple Watch Ban In Masimo ITC Patent Case Hits High Court

    Apple Inc. has told the U.S. Supreme Court that the Federal Circuit improperly "lowered the bar" for meeting the U.S. International Trade Commission's domestic industry requirement in patent disputes, by affirming a decision that the Apple Watch infringed Masimo Corp. patents.

  • September 10, 2026

    Dompé To Pay $32M Over Foundation Co-Pay Kickback Claims

    The U.S. arm of Italian pharmaceutical company Dompé Farmaceutici SpA has agreed to pay $32 million to resolve allegations that it contributed funds to patient assistance foundations to induce purchases of its prescription eye drops Oxervate, the U.S. Department of Justice announced Thursday.

  • September 10, 2026

    Biosimilars Boast Big Savings But Face IP Risks, Report Says

    There are no biosimilar drugs in development for 90% of biologic products set to lose their patent exclusivity by 2034, according to a report released Thursday by the Association for Accessible Medicines, which warned that current patent policy threatens generic-drug development. 

  • September 10, 2026

    Squires Grants 10 Patent Reviews, Rejects None

    U.S. Patent and Trademark Office Director John Squires has instituted 10 more Patent Trial and Appeal Board petitions, largely in the pharmaceutical space.

  • September 10, 2026

    Colo. Judge Asked To Sanction Hospital In Gender Care Suit

    Transgender adolescent patients of Children's Hospital Colorado urged a state judge on Thursday to sanction the hospital for refusing to resume providing gender-affirming medical care for transgender youth patients, arguing that the hospital can't avoid its obligation to provide the care by blaming its providers.

  • September 10, 2026

    Patent Declaratory Judgment Actions Are Back In Vogue

    Companies facing threats of patent infringement lawsuits are increasingly embracing declaratory judgment actions, a trend attorneys attribute to two pro-patent-owner shifts: the low institution rate of Patent Trial and Appeal Board challenges and the growth of Amazon's internal patent dispute process.

  • September 10, 2026

    Judge Won't Touch Verdict In Blood Collection Patent Case

    A Delaware federal judge has denied a bid from medical equipment maker Kurin for a new trial after a jury found it owed Magnolia Medical $1.6 million for infringement of three patents covering blood culture collection products, saying the jury's verdict was not the product of confusion or a miscarriage of justice.

  • September 10, 2026

    PwC Will Pay $96M To Settle Valeant Investor Class Claims

    PricewaterhouseCoopers LLP has agreed to pay $96 million to end a long-running securities fraud suit over an alleged market manipulation scheme by Bausch predecessor Valeant Pharmaceuticals, the plaintiffs told a New Jersey federal court Thursday.

  • September 10, 2026

    Greenberg Traurig Sued Over Ex-Pharma CEO's Indictment

    Greenberg Traurig LLP devised the very business practices that got a former pharmaceutical CEO indicted for fraud and then billed the executive $1.4 million for defending the criminal case, according to a legal malpractice suit accusing the firm of an inherent conflict of interest.

  • September 10, 2026

    Indiana Justices Probe Timing Of Religious Abortion Suit

    Indiana justices sharply questioned both sides Thursday as they wrestled with whether the state's religious freedom law can be used to protect the abortion rights of Jewish women, repeatedly asking whether the case had developed enough to warrant a ruling.

  • September 10, 2026

    Frazier Life Sciences Adds $1.1B To Its Public Fund

    Healthcare-focused investment firm Frazier Life Sciences on Thursday revealed that it has closed on more than $1.1 billion of new capital commitments for its Public Fund.

  • September 09, 2026

    Nektar CEO Opens Door To Finance Questions In Eli Lilly Trial

    Nektar Therapeutics failed Wednesday to block evidence of its financial condition from entering into a California federal trial over a failed deal to codevelop its drug Rezpeg with Eli Lilly, after its CEO's testimony on cross-examination prompted the judge to allow the evidence for impeachment purposes.

  • September 09, 2026

    Humana Says Mylan 'Gamesmanship' Can't Keep Trial Paused

    Humana Inc. asked a Pennsylvania federal judge to restart the countdown to the first trial in the generic-drug price-fixing multidistrict litigation, arguing that Mylan Inc.'s "eleventh-hour delay gambit" of a potential conflict of interest is just the latest in a "carefully choreographed campaign of delaying trial to prevent accountability."

  • September 09, 2026

    3rd Circ. Stands By Upholding Lipitor Pay-For-Delay Suit Toss

    The Third Circuit has refused to rethink its decision backing a New Jersey district court's dismissal of an antitrust suit alleging Ranbaxy Laboratories Ltd. conspired to delay a generic version of the cholesterol drug Lipitor.

  • September 09, 2026

    Split PTAB Invalidates Japanese Co.'s Patent Claims

    A divided Patent Trial and Appeal Board has thrown out claims in a pair of Seikagaku Corp. patents related to endotoxin detection that were challenged by Charles River Laboratories, finding they were either obvious or anticipated.

  • September 09, 2026

    Unions, Feds Reach Deal In Gov't Shutdown Layoffs Suit

    A coalition of unions has reached a settlement in principle with the Trump administration resolving litigation in California federal court challenging layoffs at federal agencies during the 2025 government shutdown, pending approval from the U.S. Department of Justice.

  • September 09, 2026

    DC Circ. Declines To Halt DOJ's Cannabis Rescheduling

    The D.C. Circuit on Wednesday rejected a bid to freeze a final U.S. Department of Justice rule rescheduling medical marijuana while opponents challenge the policy in the appellate court.

  • September 09, 2026

    Calif. Judge Hands Eli Lilly Mixed Bag In Compound Drug Suit

    Eli Lilly failed to plausibly allege that a physician group and pharmacy conspired to falsely advertise compounded versions of its diabetes and weight loss drugs, but can continue with allegations they conspired to unfairly compete with Lilly, a California federal judge held.

  • September 09, 2026

    Sandoz Generic Would Infringe J&J Unit Patents, Judge Says

    A New Jersey federal judge has ruled that Sandoz's attempt to manufacture a generic form of a Janssen Pharmaceuticals Inc. nasal spray would infringe a group of patents the Johnson & Johnson unit has on the product.

  • September 09, 2026

    5th Circ. Appears Skeptical Of La. Abortion Pill Suit

    Louisiana's solicitor general faced tough questions Wednesday from a Fifth Circuit panel about the state's standing to challenge federal regulations that allow abortion medication to be mailed to patients in the state.

  • September 09, 2026

    Hogan Lovells Cadwalader Hires FDA Chief Counsel

    Hogan Lovells Cadwalader has hired a former U.S. Food and Drug Administration leader, who has more than 35 years of experience at the agency and worked as chief counsel, as a new member of its Washington, D.C., office, according to a Wednesday announcement.

  • September 08, 2026

    Eli Lilly 'Sabotaged' Rezpeg's Development, Nektar Tells Jury

    Eli Lilly & Co. breached its deal with Nektar Therapeutics to co-develop the autoimmune-disease drug Rezpeg and instead "sabotaged" its development in favor of a different Eli Lilly drug, a Nektar lawyer told a California federal jury during opening statements Tuesday, while Lilly's counsel countered that Nektar was unharmed by the deal's termination.

  • September 08, 2026

    Amgen Tells 4th Circ. No Point In Keeping CareFirst Suit Alive

    Amgen urged the Fourth Circuit to overrule a Virginia federal judge's refusal to dismiss CareFirst's lawsuit accusing it of unlawfully delaying biosimilar competition for Enbrel, arguing that the health insurer's alleged injury was actually caused by court orders enforcing Amgen's patents.

Expert Analysis

  • Cannabis, Psychedelics Boom Raises IP Hurdles

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    Recent data regarding patent filing activity and litigation in the cannabis and psychedelics markets indicates that as commercial interest accelerates, the scope of publicly accessible prior art is also expanding, setting a higher bar for novelty and nonobviousness in patent applications, say attorneys at Sterne Kessler.

  • State AI Safety Laws Raise New Liabilities For Healthcare Cos.

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    Healthcare and life science companies using third-party artificial intelligence tools should pay particular attention to the changing state-level legal landscape, where the rollout of multiple AI safety laws is introducing both new compliance obligations and potential consumer protection liabilities, say attorneys at McDermott.

  • Series

    Juggling And Unicycling Make Me A Better Lawyer

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    Because I juggle (sometimes with fire) and ride the unicycle, friends and family used to joke that I should join the circus, but I pursued the practice of law instead and learned that my hobbies benefit my profession in several important ways, says Morgan Eddy at Smith Currie.

  • AI Note-Taking Suits May Fill Gap In Privacy Law Structure

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    A recent class action against Granola joins other pending lawsuits against AI note-taking providers, highlighting the legal uncertainty surrounding these tools, but there are practical steps companies using "invisible" AI services can take to mitigate risk, including conducting inventories and reviewing access permissions, say attorneys at Barnes & Thornburg.

  • FDA Closeout Letter Suggests Relaxing Stance On Wearables

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    The U.S. Food and Drug Administration's recent decision not to pursue enforcement action against Whoop's wearable blood pressure tracker, read together with guidance released earlier this year, suggests a softer shift in the FDA's approach to regulating wearables, say attorneys at Arnold & Porter.

  • Fed. Circ. Dental IP Ruling Reinforces Prior Art Framework

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    The Federal Circuit's recent decision in Dental Monitoring v. Align Technology reaffirms the necessity of substantive written description support for establishing an earlier effective prior art date under the America Invents Act, and aligns Patent Trial and Appeal Board practice with district court litigation, say attorneys at Morgan Lewis.

  • Justices' Hikma Reasoning May Extend Well Beyond Pharma

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    The active steps framework announced by the U.S. Supreme Court in its Hikma v. Amarin decision, finding that Amarin failed to plausibly allege inducement of infringement, has the potential to reshape how courts evaluate inducement claims across patent, copyright and other doctrines, say attorneys at BCLP.

  • Teva MDL Loss Shows DPAs Can Return To Haunt Civil Suits

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    Teva’s recent partial summary judgment loss in antitrust multidistrict litigation reinforces the importance of carefully scrutinizing any statement of facts a company admits to in a deferred prosecution agreement, and illustrates the potential costs of resolving a criminal investigation this way, say attorneys at Sheppard.

  • An Inside Look At Squires' Discretionary Denials

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    A deep dive into the discretionary denials issued by U.S. Patent and Trademark Office Director John Squires since he took over last year identifies trends in commonly asserted arguments and how they correlate with institution outcomes, say attorneys at Kirkland & Ellis.

  • Series

    Ballet Makes Me A Better Lawyer

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    A lifetime of learning and performing ballet taught me that success — whether in dance or practicing law — comes only through hours of thorough preparation, boundless energy and relentless effort, says Sharon Katz-Pearlman at Greenberg Traurig.

  • Fed. Circ. In July: Meeting The Enablement Requirement

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    The Federal Circuit's decision in Wyeth v. AstraZeneca last month exemplifies when a generalized conception of an invention is insufficient to enable the full scope of asserted patent infringement claims, and may lead to more enablement challenges, say attorneys at Knobbe Martens.

  • Series

    Taekwondo Makes Me A Better Lawyer

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    Taekwondo has taught me to recognize when to fight for a position and when to focus on finding a solution, and that the best outcomes are often achieved by solving problems — all of which has improved my work as a bankruptcy lawyer, mediator and Subchapter V trustee, says Amy Denton Mayer at Berger Singerman.

  • Why AI Diligence Is Especially Key In IP Practice

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    In light of recent federal court sanctions against intellectual property litigators for filing work product generated by artificial intelligence without verification, it's important to consider the unique risks and consequences that can arise from overreliance on AI, which poses less visible risks in IP matters, says Stephen Ball at Husch Blackwell.

  • How 'Most Favored Nation' Regime Affects Biopharma Deals

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    As M&A activity surges in the biopharma space, companies will need to account for the Trump administration's most-favored-nation pricing proposals — durable in concept, if unsettled in detail — when drafting deals, say attorneys at Gibson Dunn.

  • What To Know As Legal Duty To Consider AI Takes Shape

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    While the U.K. Jurisdiction Taskforce’s recent statement on liability for artificial intelligence harms is nonbinding for both U.K. and U.S. lawyers, it highlights the importance of being able to distinguish between the availability of a tool and a professional obligation to use it, say Jonny Frank and Michael Costa at StoneTurn.

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