Life Sciences

  • September 21, 2025

    Chinese Exec Who Shipped Fentanyl Ingredients Gets 25 Yrs

    A Manhattan federal judge on Friday sentenced a Chinese national and chemical company executive to 25 years in prison for shipping large quantities of fentanyl ingredients to the U.S., citing the defendant's "egregious, callous" disregard for the deaths caused by the drugs he helped create.

  • September 19, 2025

    Stewart Issues Mixed Bag Of Referrals, Denied Petitions

    Coke Morgan Stewart issued some of her final decisions as acting director of the U.S. Patent and Trademark Office, discretionarily denying a host of petitions for Patent Trial and Appeal Board review, while also referring a group of Apple Inc.'s petitions to the board for scrutiny.

  • September 19, 2025

    Call For Gov't Cut Of University Patent Cash Spurs Concern

    Commerce Secretary Howard Lutnick's comments that the government should get as much as half of the revenue that universities generate from patents developed with federal funding have caused worry among industry groups and attorneys, who say it would inhibit efforts to commercialize publicly funded inventions.

  • September 19, 2025

    Goodwin, Latham Steer E-Commerce Co. Pattern's $300M IPO

    Top Amazon.com reseller Pattern Group Inc. kicked off its public-market trading debut on the Nasdaq on Friday with a $300 million initial public offering guided by Goodwin Procter LLP, and Latham & Watkins LLP represented the underwriters, which include Goldman Sachs & Co. LLC and J.P. Morgan.

  • September 19, 2025

    PTAB Invalidates Johns Hopkins Patent In Keytruda Fight

    The Patent Trial and Appeal Board has invalidated an anti-cancer therapy patent owned by Johns Hopkins University, handing a win to challenger Merck Sharp & Dohme LLC in a larger fight relating to Merck's Keytruda treatment.

  • September 19, 2025

    DA In Gilgo Beach Killings Case Talks Advances In DNA Use

    Law360 sat down with Suffolk County, New York, District Attorney Ray Tierney, who is prosecuting architect Rex Heuermann on charges that he murdered seven women on Long Island, to discuss the use of a newer form of DNA testing that has passed rigorous admissibility standards for the first time, among other aspects of the case.

  • September 19, 2025

    Moderna Wants Fed. Circ. Reversal Of Vax Patent Invalidation

    Moderna has told the Federal Circuit that the Patent Trial and Appeal Board got it wrong when it found that the success of the inventions behind two of its COVID-19 vaccine patents challenged by Pfizer and BioNTech didn't outweigh the evidence they were invalid as obvious.

  • September 19, 2025

    Rite Aid Gets OK To Seek Votes On Dual-Track Ch. 11 Plan

    A New Jersey bankruptcy judge on Friday approved drugstore chain Rite Aid's bid to take votes on a Chapter 11 plan as the debtor weighs whether to complete a deal with McKesson Corp. or formally seek to dismiss its bankruptcy case.

  • September 19, 2025

    CDC Panel Urges Caution On COVID Vax, Punts On Hep B

    A panel of advisers at the Centers for Disease Control and Prevention on Friday voted unanimously to recommend that people receiving the COVID-19 vaccine this season do so only after discussing it with their health providers.

  • September 18, 2025

    Federal Vaccine Panel Votes To Tweak MMRV Recommendation

    A panel of federal vaccine advisers on Thursday changed its recommendation for a long-used vaccine for children but allowed a key government program to continue paying for the shots.

  • September 18, 2025

    Cytokinetics Investor Sues Over Heart Drug Approval Claims

    Biopharmaceutical company Cytokinetics and its CEO have been hit with a proposed investor class action in California federal court alleging they made false and misleading statements about the regulatory timeline for one of the company's new drugs, which caused a share price drop when the truth came to light.

  • September 18, 2025

    Brothers Blame Associate For $90M HIV Drug Fraud Scheme

    Two Maryland brothers accused of selling $90 million worth of mislabeled HIV drugs told a Florida federal jury on Thursday that their charges stem from an associate hired for his pharmaceutical industry connections, but who instead lied about the medication's black market origins and told them it was purchased legitimately.

  • September 18, 2025

    HHS Shutters Miami Organ Donor Org. For 'Unsafe' Practices

    Federal health officials have decertified a Miami-based organ procurement organization that arranges organ donations after an investigation found a pattern of "unsafe" practices, marking the first time the federal government has revoked the certification of such a group, according to an announcement Thursday from Health Secretary Robert F. Kennedy Jr. 

  • September 18, 2025

    Senate Confirms Squires To Lead USPTO

    The U.S. Senate on Thursday confirmed Dilworth Paxson LLP partner John Squires to serve as the next U.S. Patent and Trademark Office director.

  • September 18, 2025

    Senate Confirms Trump's Pick To Lead DOL Benefits Arm

    The Senate confirmed fiduciary liability insurance expert Daniel Aronowitz on Thursday to lead the U.S. Department of Labor's employee benefits division, which oversees regulation and enforcement of employer-provided health and retirement plans.

  • September 18, 2025

    Steptoe Adds Jones Day Biotech Patent Pro To NY Office

    Steptoe LLP has bolstered its intellectual property practice with an attorney arriving from Jones Day with multinational experience advising biotech and biopharmaceutical companies on patent issues.

  • September 18, 2025

    Colibri Wants Full Fed. Circ. To Rethink Medtronic Patent Case

    Colibri Heart Valve LLC wants the full Federal Circuit to review a panel's ruling overturning a patent infringement judgment of more than $125 million against Medtronic's CoreValve unit, saying the panel wrongly applied a reading of the law that is too broad.

  • September 18, 2025

    NJ City Makes 3rd Escape From Pot Co.'s Zoning Suit

    For the third time, a New Jersey federal judge has dismissed claims from a would-be cannabis dispensary alleging the city of Asbury Park and its zoning board conspired to deny its application for a medical marijuana store.

  • September 18, 2025

    Dorsey & Whitney IP Atty Joins Foley Hoag In Denver

    Foley Hoag LLP announced the addition of its first intellectual property partner in the West with the hire of a longtime Dorsey & Whitney LLP attorney in its fast-growing Denver office.

  • September 18, 2025

    Montreal-Based Corp. Atty Moves To Akerman's NY Office

    Akerman LLP has announced that a former Quebec-based partner at the Canadian business law firm Davies Ward Phillips & Vineberg LLP is returning to New York to join its corporate practice group.

  • September 18, 2025

    Japanese Glycine Exporter Hit With 86% Antidumping Duty

    The U.S. Department of Commerce issued a notice Thursday indicating a Japanese supplier of glycine faces a more than 86% antidumping duty rate, saying the company failed to cooperate with the federal government's investigation.

  • September 18, 2025

    Group Of US Investors To Buy TikTok, Plus More Rumors

    A consortium of big-name buyers including Oracle, Silver Lake and Andreessen Horowitz are rumored to be taking a majority stake in TikTok after a long search to find the app a U.S. owner; Paramount Skydance is reportedly ready to make an offer for Warner Bros. Discovery; and private equity shop CVC is close to inking a $1.5 billion deal to acquire web-hosting provider Namecheap. Here, Law360 breaks down these and other deal rumors from the past week.

  • 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.

Expert Analysis

  • High Court Cert Spotlights Varying Tests For Federal Removal

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    A recent decision by the U.S. Supreme Court to review Chevron v. Plaquemines Parish, a case involving the federal officer removal statute, highlights three other recent circuit court decisions raising federal removal questions, and serves as a reminder that defendants are the masters of removal actions, says Varun Aery at Hollingsworth.

  • How To Increase 3rd-Party Preissuance Patent Submissions

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    Attorneys Marian Underweiser and Marc Ehrlich, who helped draft the America Invents Act, discuss changes that the U.S. Patent and Trademark Office could potentially implement to facilitate its hopes for increased participation in front-end patent challenges.

  • Trump Air Emissions Carveouts Cloud The Regulatory Picture

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    President Donald Trump's new proclamations temporarily exempting key U.S. industries from air toxics standards, issued under a narrow, rarely-used provision of the Clean Air Act, will likely lead to legal challenges and tighter standards in some states, contributing to further regulatory uncertainty, say attorneys at GableGotwals.

  • Series

    Playing Baseball Makes Me A Better Lawyer

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    Playing baseball in college, and now Wiffle ball in a local league, has taught me that teamwork, mental endurance and emotional intelligence are not only important to success in the sport, but also to success as a trial attorney, says Kevan Dorsey at Swift Currie.

  • What US Medicine Onshoring Means For Indian Life Sciences

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    Despite the Trump administration's latest moves to onshore essential medicine manufacturing, India will likely remain an indispensable component of the U.S. drug supply chain, but Indian manufacturers should prepare for stricter compliance checks, says Jashaswi Ghosh at Holon Law Partners.

  • Series

    Law School's Missed Lessons: Skillful Persuasion

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    In many ways, law school teaches us how to argue, but when the ultimate goal is to get your client what they want, being persuasive through preparation and humility is the more likely key to success, says Michael Friedland at Friedland Cianfrani.

  • FCA Working Group Reboot Signals EHR Compliance Risk

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    The revival of the False Claims Act working group is an aggressive expansion of enforcement efforts by the Justice Department and the U.S. Department of Health and Human Services targeted toward technology-enabled fraud involving electronic health records and other data, say attorneys at ArentFox Schiff.

  • Litigation Inspiration: How To Respond After A Loss

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    Every litigator loses a case now and then, and the sting of that loss can become a medicine that strengthens or a poison that corrodes, depending on how the attorney responds, says Bennett Rawicki at Hilgers Graben.

  • While On Firmer Ground, Uncertainty Remains For SEC's ALJs

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    The U.S. District Court for the District of Columbia's recent opinion in Lemelson v. U.S. Securities and Exchange Commission affirmed the legitimacy of the SEC's administrative proceedings, but pointedly left unanswered the constitutional merits of tenure protection enjoyed by SEC administrative law judges — potentially the subject of future U.S. Supreme Court review, says Dean Conway at Carlton Fields.

  • FDA's Hasty Policymaking Approach Faces APA Challenges

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    Though the U.S. Food and Drug Administration has abandoned its usual notice-and-comment process for implementing new regulatory initiatives, two recent district court decisions make clear that these programs are still susceptible to Administrative Procedure Act challenges, says Rachel Turow at Skadden.

  • Legal Considerations Around Ibogaine As Addiction Therapy

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    Recent funding approval in Texas pertaining to the use of ibogaine for the potential treatment of substance use disorders signals a growing openness to innovative addiction treatments, but also underscores the need for rigorous compliance with state and federal requirements and ethical research standards, say attorneys at Husch Blackwell.

  • How Patent Attys Can Carefully Integrate LLMs Into Workflows

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    With artificial intelligence-powered tools now being developed specifically for the intellectual property domain, patent practitioners should monitor evolving considerations to ensure that their capabilities are enhanced — rather than diminished — by these resources, say attorneys at McDonnell Boehnen.

  • The Metamorphosis Of The Major Questions Doctrine

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    The so-called major questions doctrine arose as a counterweight to Chevron deference over the past few decades, but invocations of the doctrine have persisted in the year since Chevron was overturned, suggesting it still has a role to play in reining in agency overreach, say attorneys at Crowell & Moring.

  • New PTAB Denial Processes Grow More And More Confusing

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    Guidance from the U.S. Patent and Trademark Office about the Patent Trial and Appeal Board's new workload management and discretionary denial processes has been murky and inconsistent, and has been further muddled by the acting director's seemingly contradictory decisions, say attorneys at Finnegan.

  • Arguing The 8th Amendment For Reduction In FCA Penalties

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    While False Claims Act decisions lack consistency in how high the judgment-to-damages ratio in such cases can be before it becomes unconstitutional, defense counsel should cite the Eighth Amendment's excessive fines clause in pre-trial settlement negotiations, and seek penalty decreases in post-judgment motions and on appeal, says Scott Grubman at Chilivis Grubman.

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