Life Sciences

  • 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.

  • October 09, 2025

    Pharma Co. Looks To Nix 'Absurd' Award Over Acne Drug

    Sun Pharmaceutical Industries is urging a New York federal court to partially undo an arbitral award issued in a dispute over intellectual property for an acne drug, saying the award, if allowed to stand, could interfere with a medication that's been available in Canada for years.

  • October 09, 2025

    9th Circ. Probes Buyers On HIV Drug Antitrust Claims

    Insurers and health plans told a Ninth Circuit panel on Thursday that a lower court was wrong to toss their claims that Gilead orchestrated a product-hop scheme for its HIV drugs ahead of trial and for not seeing a price drop as evidence of an alleged agreement with Teva to delay generics.

  • October 09, 2025

    NJ Justices Probe Insurer's Role In $12M Settlement Fight

    The New Jersey Supreme Court zeroed in Thursday on how far insurers can go in reserving their rights without taking a definitive position on coverage, as Mist Pharmaceuticals LLC accused Berkley Insurance Co. of stonewalling a $12 million settlement by hiding behind ambiguity in its "capacity exclusion" clause.

  • October 09, 2025

    Mich. Justice Eyes Scope Of Judge-As-Grand-Jury Issue

    Michigan's chief Supreme Court justice on Thursday pondered the real-world implications of retroactively applying a 2022 ruling that judges cannot act as a one-person grand jury to issue indictments, saying the practice seems to have grown more prevalent.

  • October 09, 2025

    Judge Axes Cell Analysis Patent In Case Against Parse

    A federal magistrate judge in Delaware has trimmed a suit accusing biotechnology company Parse Biosciences of infringing patents covering a way of detecting target molecules in cell samples, finding one of the patents was invalid.

  • October 09, 2025

    Hemp Co. Asks Del. Court To Defer Ex-Exec's Suit To Australia

    An Australian hemp manufacturer and its U.S. subsidiaries asked a Delaware federal judge Thursday to dismiss or pause a lawsuit filed by a former executive-turned-whistleblower, arguing the case should be deferred under international comity principles.

  • October 09, 2025

    Tivity Health Investors Seek Final OK Of $17M Settlement

    An investor in fitness program administrator Tivity Health Inc. has asked a Nashville federal judge for a final nod for an over $17 million deal ending claims the company misled investors about its financial prospects after its $1.3 billion acquisition of troubled weight-loss meal delivery company Nutrisystem.

  • October 09, 2025

    Pet Owner Keeps State, But Not Fed., Elanco Tick Meds Suit

    Advantix flea-and-tick medication maker Elanco Animal Health Inc. partially ducked a consumer proposed class action by convincing an Indiana federal judge to cut federal antitrust claims, but still must face state law allegations accusing it of paying off PetSmart, Petco and Chewy not to carry generic versions.

  • October 09, 2025

    Patient Asks 4th Circ. To Revive Faulty Ethicon Stapler Suit

    A surgery patient is asking the Fourth Circuit to reinstate his suit against Johnson & Johnson subsidiary Ethicon Endo-Surgery LLC over faulty staples used in his procedure, saying the district court was wrong to deny his request to extend an expert deadline after he finally narrowed down the type of stapler used.

  • October 09, 2025

    Ropes, Kirkland Guide $5.2B Novo Nordisk Liver Disease Deal

    Novo Nordisk said on Thursday it will acquire U.S.-based Akero Therapeutics for up to $5.2 billion in cash, expanding its portfolio into metabolic liver disease in a deal steered by Ropes & Gray LLP and Kirkland & Ellis LLP. 

  • October 09, 2025

    Munck Wilson Taps Texas Atty To Lead Life Sciences Practice

    Munck Wilson Mandala LLP has chosen a Lone Star State lawyer who joined the firm earlier this year to lead the technology-focused firm's life sciences practice group.

  • October 08, 2025

    Senate IP Leader Plans Push To Pass Patent Eligibility Bill

    Sen. Thom Tillis, R-N.C., the leader of the Senate's intellectual property subcommittee, said Wednesday that before he leaves Congress in just over a year, one of his primary goals will be to advance his long-gestating bill to make more inventions eligible for patents.

Expert Analysis

  • How To Prep For Potential Passage Of SAFER Banking Act

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    The Secure and Fair Enforcement Regulation, or SAFER, Banking Act, could fundamentally reshape how financial institutions interact with cannabis businesses, so operators that move now to get their house in order will be best positioned to capitalize if and when change comes, says Alex Leonowicz at Howard & Howard.

  • A Former PTAB Judge Weighs The End Of Remote Hearings

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    Former Patent Trial and Appeal Board Judge Amanda Wieker, now at McGuireWoods, examines the costs and benefits of the PTAB's impending in-person hearing requirement, and offers suggestions for making the most out of this new regime.

  • The Future Of Lab-Test Regs After FDA Rescinds Rule

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    The U.S. Food and Drug Administration recently rescinded its laboratory-developed tests rule in response to a Texas federal court decision this spring, reinforcing a separation of authority between the FDA and the Centers for Medicare & Medicaid Services, and calling into question the FDA's role in overseeing such tests without congressional action, say attorneys at Venable.

  • SDNY Ruling Reinforces Joint Steering Committee Obligations

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    The recent Southern District of New York decision in ChemImage v. Johnson & Johnson makes joint steering committees a valuable tool in strategic relationships, as provisions for such committees can now be wielded to demand attention to core issues, say Lisa Bernstein at the University of Chicago Law School, and Reginald Goeke and Brad Peterson at Mayer Brown.

  • What 2 Profs Noticed As Transactional Law Students Used AI

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    After a semester using generative artificial intelligence tools with students in an entrepreneurship law clinic, we came away with numerous observations about the opportunities and challenges such tools present to new transactional lawyers, say professors at Cornell Law School.

  • What Patent Claim 'Invalidity' Means In Different Forums

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    A recent Federal Circuit order allowing a patent suit to proceed despite similar claims being invalidated in an inter partes review underscores how fractured the patent litigation landscape has become, leading to critical nuances in how district courts, the U.S. International Trade Commission and Patent Trial and Appeal Board treat invalidity, says Jason Hoffman at BakerHostetler.

  • Rebuttal

    BigLaw Settlements Should Not Spur Ethics Deregulation

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    A recent Law360 op-ed argued that loosening law firm funding restrictions would make BigLaw firms less inclined to settle with the Trump administration, but deregulating legal financing ethics may well prove to be not merely ineffective, but counterproductive, says Laurel Kilgour at the American Economic Liberties Project.

  • How Big Pharma Has Responded To FTC Delisting Demands

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    Looking at some statistics concerning how pharmaceutical companies have responded to the Federal Trade Commission's recent challenges to Orange Book listings raises several possible hypotheses about the FTC's strategy and effectiveness, say Ratib Ali and Celia Lu at Competition Dynamics.

  • 5 Ways Lawyers Can Earn Back The Public's Trust

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    Amid salacious headlines about lawyers behaving badly and recent polls showing the public’s increasingly unfavorable view of attorneys, we must make meaningful changes to our culture to rebuild trust in the legal system, says Carl Taylor at Carl Taylor Law.

  • USPTO's AI Tool Redefines Design Patent Landscape

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    The U.S. Patent and Trademark Office's newly introduced DesignVision tool for artificial intelligence-powered image searching represents a dramatic shift in how design patent applications are examined, necessitating new strategies for patent practitioners, says Matthew Epstein at Dinsmore.

  • Class Actions At The Circuit Courts: August Lessons

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    In this month's review of class action appeals, Mitchell Engel at Shook Hardy discusses key takeaways from federal appellate decisions involving topics including antitrust, immigration, consumer fraud, birthright citizenship under the Fourteenth Amendment, and product defects.

  • Series

    Hiking Makes Me A Better Lawyer

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    On the trail, I have thought often about the parallels between hiking and high-stakes patent litigation, and why strategizing, preparation, perseverance and joy are important skills for success in both endeavors, says Barbara Fiacco at Foley Hoag.

  • What US-India Trade Deal Will Mean For Indian Pharma

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    Complicated by newly imposed tariffs from the U.S., the outcome of the U.S.-India trade talks is poised to reshape not just trade policy, but also the strategic alignment of the two countries' pharmaceutical ecosystems, says Jashaswi Ghosh at Holon Law Partners.

  • Opinion

    Time For Full Disclosure Of Third-Party Funding In MDLs

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    It is appropriate that the Federal Advisory Committee on Civil Rules is considering a rule to require disclosure of third-party litigation funding in civil litigation — something that is particularly needed in multidistrict litigation, which now comprises more than half of all civil cases in the federal courts, says Eric Hudson at Butler Snow.

  • Series

    Law School's Missed Lessons: Negotiation Skills

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    I took one negotiation course in law school, but most of the techniques I rely on today I learned in practice, where I've discovered that the process is less about tricks or tactics, and more about clarity, preparation and communication, says Grant Schrantz at Haug Barron.

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