Life Sciences

  • October 14, 2025

    Skinny Labels, Orange Book Take Center Stage In IP Talks

    Patent litigators focused on pharmaceuticals and biotechnology met Tuesday to work through the biggest issues in their industries, including possible reform to skinny label law, frustration with position-switching in litigation, concerns about when to list patents in the U.S. Food and Drug Administration's Orange Book and data on the relatively low impact of new policies at the U.S. Patent and Trademark Office.

  • October 14, 2025

    Full 3rd Circ. Won't Rethink $45M CareDx False Ad Case

    The Third Circuit on Tuesday turned down medical testing company CareDx's request to have a full panel mull whether to reinstate a $45 million jury award in a false advertisement case over genetic testing technology against rival Natera.

  • October 14, 2025

    Relief Concerns Grow As Sectoral Tariff Actions Build

    Importers' hopes for relief from industrywide tariffs are lagging alongside the trade deals President Donald Trump is trying to broker for some goods, while the administration's accelerated rollout of sectoral levies is also stoking concerns the government may be hamstringing its onshoring goals.

  • October 14, 2025

    Embryo Loss Class Claims Hinge On Calif. Suit, Judge Says

    A Connecticut federal judge may pause a proposed class action blaming CooperSurgical Inc. for embryo losses during in vitro fertilization until a class certification motion is decided in a first-filed case in California, but the plaintiff will have until the end of the month to decide if she wants to proceed with only her direct claims instead.

  • October 14, 2025

    6th Circ. Won't Revive Allergy Tester's Antitrust Case

    The Sixth Circuit refused to revive an allergy testing and treatment company's antitrust case accusing an insurer and a medical group of conspiring to squeeze it out of the market, after finding that doctors are the ones being directly harmed by the alleged activity.

  • October 14, 2025

    Meet HHS General Counsel Michael Stuart

    Michael Stuart, a former chief federal prosecutor for West Virginia, has been confirmed by the U.S. Senate to serve as general counsel for the Department of Health and Human Services, where he has promised to make healthcare fraud enforcement a priority. 

  • October 14, 2025

    Attempts To Revive Stroke Treatment Patents Fail At Fed. Circ.

    The Federal Circuit on Tuesday tossed without analysis a challenge to Patent Trial and Appeal Board rulings that invalidated patents covering a stroke treatment system, letting stand one of the decisions deemed precedential by a former U.S. Patent and Trademark Office director.

  • October 14, 2025

    Freshfields Guides J&J's Planned Orthopedics Unit Spinoff

    Johnson & Johnson said Tuesday it intends to separate its orthopedics business into a stand-alone company within the next 18 to 24 months, with Freshfields LLP advising on the planned spinoff of the unit. 

  • October 14, 2025

    Ōura Valuation Soars To $11B After $900M Financing Round

    Fitness-tracking ring maker Ōura on Tuesday revealed it had reached a roughly $11 billion valuation after securing over $900 million in a funding round, which it says will help it develop new technologies, speed up artificial intelligence and product innovation, and expand global distribution.

  • October 14, 2025

    Catching Up With Delaware's Chancery Court

    Last week at the Delaware Chancery Court, Vice Chancellor Lori W. Will ruled that Carlos Vasallo remains the CEO of Caribevision TV Network LLC, finding that majority investors' attempt to remove him under a defective 2019 agreement was invalid for lack of proper notice.

  • October 14, 2025

    Blood Test Co. Can't Escape Willful Infringement Claims

    A company that makes diagnostic medical tests has been denied a bid to escape from a medical research firm's claims that it willfully infringed patents when a judge held that reading the allegations in combination creates a plausible basis that the company had knowledge of the patents.

  • October 14, 2025

    Covington, Sidley Guide $700M BioCryst Allergic Disease Deal

    BioCryst Pharmaceuticals Inc. will purchase Astria Therapeutics Inc., a biopharmaceutical company focused on therapies for allergic and immunologic diseases, in a cash and stock deal worth about $700 million, the companies announced Tuesday.

  • October 14, 2025

    High Court Won't Hear FDA Stem Cell Regulation Fight

    The U.S. Supreme Court on Tuesday declined to review a circuit court holding that a stem cell treatment derived from a patient's own tissue is subject to Food, Drug and Cosmetic Act regulations.

  • October 10, 2025

    Some Cases Advance In Latest Stewart Discretionary Rulings

    Deputy U.S. Patent and Trademark Office Director Coke Morgan Stewart rejected 37 Patent Trial and Appeal Board petitions Friday night, but allowed 17 challenges to proceed.

  • October 10, 2025

    Zantac MDL Suits Were Impropely Tossed, 11th Circ. Told

    Consumers urged the Eleventh Circuit on Friday to revive their claims in a multidistrict litigation alleging that the main ingredient in the heartburn medication Zantac causes cancer, saying the court overseeing the case improperly sided with drugmakers' experts and preempted more claims from coming forward.

  • October 10, 2025

    Federal Worker Unions Press For Immediate Block Of Layoffs

    Unions representing federal workers urged a California federal court Friday to immediately block the Trump administration from laying off workers amid the government shutdown as the administration acknowledged it had begun issuing reduction-in-force notices to thousands of employees.

  • October 10, 2025

    AstraZeneca Strikes 'Most Favored Nation' Price Deal

    Pharmaceutical giant AstraZeneca on Friday cut a deal with the Trump administration to reduce drug prices in the United States, agreeing to provide its medications for Medicaid beneficiaries at discount prices.

  • October 10, 2025

    ATyr Pharma Faces Investor Suit Over Failed Drug Trial

    Rare disease biotech aTyr Pharma Inc. and its CEO have been hit with a proposed shareholder class action accusing them of misleading the public about the efficacy of aTyr's lung disease treatment for several months before announcing its trial had not yielded favorable results.

  • October 10, 2025

    Profs Say Apple Used Copyrighted Material For AI Training

    Two neuroscientists have sued Apple in California federal court, claiming it made use of their copyrighted materials to train its artificial intelligence model Apple Intelligence.

  • October 10, 2025

    Covington, Goodwin Guide Bristol Myers' $1.5B Orbital Buy

    Bristol Myers Squibb plans to acquire privately held Orbital Therapeutics for $1.5 billion in cash, aiming to expand its pipeline in cell- and RNA-based therapies for autoimmune diseases, the companies announced Friday.

  • October 10, 2025

    Pharma Co. Escapes Suit Over Ex-CEO's Alleged Misconduct

    Exscientia PLC on Friday won dismissal of a proposed class action related to the termination of its CEO after claims emerged that he participated in inappropriate workplace relationships, with the court finding the investors failed to show that the company's statements about its culture and governance were anything more than puffery.

  • October 10, 2025

    Clinical Trial Co. Settles Severance Fight With Ex-VP

    A clinical research company has agreed to shutter a lawsuit from an ex-executive who claimed his requests for severance went ignored following his resignation, according to a Friday filing in North Carolina federal court.

  • October 10, 2025

    UK Litigation Roundup: Here's What You Missed In London

    This past week in London has seen Paddington Bear's creators and Studio Canal sue the company behind Spitting Image, Blackpool Football Club's former owner Owen Oyston bring a fresh claim against the club, and Mishcon de Reya sue a Saudi investment group.

  • October 09, 2025

    Justices Urged To Clarify Patent Validity In Entresto Case

    Generic-drug makers, academics and others are urging the U.S. Supreme Court to take a case involving Novartis' blockbuster cardiovascular drug Entresto, saying the justices must bring consistency to conflicting Federal Circuit precedent on the role of later technology in assessing patent validity.

  • October 09, 2025

    Biotronik Wants Full 9th Circ. Review Of Whistleblower Ruling

    Biotronik Inc. urged the full Ninth Circuit to review a panel ruling that revived a whistleblower suit alleging the company used unlawful compensation tactics to boost heart-device sales, saying it should have been tossed based on prior disclosures in news articles.

Expert Analysis

  • 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.

  • 8 Ways Lawyers Can Protect The Rule Of Law In Their Work

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    Whether they are concerned with judicial independence, regulatory predictability or client confidence, lawyers can take specific meaningful actions on their own when traditional structures are too slow or too compromised to respond, says Angeli Patel at the Berkeley Center of Law and Business.

  • Is SEC Moving Away From Parallel Insider Trading Cases?

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    The U.S. Securities and Exchange Commission's apparent lack of follow-up in four recent criminal cases of insider trading brought by the Justice Department suggests the SEC may be reconsidering the expense and effort of bringing parallel civil charges for insider trading, say attorneys at Dentons.

  • Rising Enforcement Stakes For Pharma Telehealth Platforms

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    Two pieces of legislation recently introduced in Congress could transform the structure and promotion of telehealth arrangements as legislators increasingly scrutinize direct-to-consumer advertising platforms, potentially paving the way for a new U.S. Food and Drug Administration policy with bipartisan support, say attorneys at Sheppard Mullin.

  • Series

    Law School's Missed Lessons: Communicating With Clients

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    Law school curricula often overlook client communication procedures, and those who actively teach this crucial facet of the practice can create exceptional client satisfaction and success, says Patrick Hanson at Wiggam Law.

  • 3 Judicial Approaches To Applying Loper Bright, 1 Year Later

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    In the year since the U.S. Supreme Court overturned Chevron deference in its Loper Bright Enterprises v. Raimondo decision, a few patterns have emerged in lower courts’ application of the precedent to determine whether agency actions are lawful, say attorneys at Husch Blackwell.

  • Prepping For SEC's Changing Life Sciences Enforcement

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    By proactively addressing several risk areas, companies in the life sciences sector can position themselves to minimize potential exposure under the U.S. Securities and Exchange Commission's return to back-to-basics enforcement focused on insider trading and fraud, say attorneys at Morgan Lewis.

  • Series

    Adapting To Private Practice: From US Rep. To Boutique Firm

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    My transition from serving as a member of Congress to becoming a partner at a boutique firm has been remarkably smooth, in part because I never stopped exercising my legal muscles, maintained relationships with my former colleagues and set the right tone at the outset, says Mondaire Jones at Friedman Kaplan.

  • How Providers Can Brace For Drug Pricing Policy Changes

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    Though it's uncertain which provisions of the Trump administration's executive order aimed at addressing prescription drug costs will eventually be implemented, stakeholders can reduce potential negative outcomes by understanding pathways that could be used to effectuate the order's directives, say attorneys at McDermott.

  • Discretionary Denial Rulings May Spur Calls For PTAB Reform

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    The U.S. Patent and Trademark Office's recent decision in iRhythm Technologies v. Welch Allyn, denying inter partes review based on the patent owner's settled expectations that the patent would not be challenged, could motivate patent holders to seek Patent Trial and Appeal Board reform to preserve patent quality without burdening owners, say attorneys at Dechert.

  • Comparing New Neural Data Privacy Laws In 4 States

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    Although no federal law yet addresses neural privacy comprehensively, the combined effect of recent state laws in Colorado, California, Montana and Connecticut is already shaping the regulatory future, but a multistate compliance strategy has quickly become a gating item for those experimenting with neuro-enabled workplace tools, says Kristen Mathews at Cooley.

  • Spinoff Transaction Considerations For Biotech M&A

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    Amid current market challenges, boards and management teams of biotech companies can consider several strategies for maximizing value should a spinoff opportunity arise, but not without significant advance planning and careful implementation, particularly in cases that might qualify as tax-free, say attorneys at Paul Hastings.

  • Opinion

    Senate's 41% Litigation Finance Tax Would Hurt Legal System

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    The Senate’s latest version of the Big Beautiful Bill Act would impose a 41% tax on the litigation finance industry, but the tax is totally disconnected from the concerns it purports to address, and it would set the country back to a time when small plaintiffs had little recourse against big defendants, says Anthony Sebok at Cardozo School of Law.

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