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Life Sciences

  • July 17, 2025

    PE Firm Is Denied FDA Docs For Defense In Deal Challenge

    An Illinois federal court on Wednesday denied a request from private equity firm GTCR BC Holdings LLC to force the U.S. Food and Drug Administration to produce more than a decade's worth of medical device approval applications as the firm fights a merger challenge from enforcers.

  • July 17, 2025

    J&J Loses Bid To DQ Beasley Allen From Talc MDL Committee

    A New Jersey federal judge on Thursday denied Johnson & Johnson's bid to remove the Beasley Allen Law Firm from the plaintiffs steering committee in the multidistrict talc litigation but said that changes would be made to the committee's structure.

  • July 17, 2025

    Iowa Church Says DEA Can't 'Pocket Veto' Drug Exemption

    An Iowa church is asking the D.C. Circuit to force the Drug Enforcement Administration to rule on an application it filed more than six years ago for a religious exemption to use a psychedelic in its services, saying the DEA shouldn't be allowed to "pocket veto" the application and leave the church hanging.

  • July 16, 2025

    Pharmacy Benefit Managers Say Ohio Can't Recast Suit

    The state of Ohio can't "recast its complaint on appeal" in order to convince the Sixth Circuit that its enforcement suit accusing two pharmacy benefit managers of working to raise the cost of prescription drugs belongs in state court, those managers have told the appellate court.

  • July 16, 2025

    Gilgo Beach Killer Case Puts New DNA Science To The Test

    The only physical evidence linking the Gilgo Beach serial killings to the defendant, Rex Heuermann, are five hairs that could only be analyzed via a newer technique known as whole genome sequencing, but as the court decides whether the science is jury ready, experts are divided.

  • July 16, 2025

    Hims & Hers Brass Face Suit Over 'Knockoff' Wegovy Sales

    Executives and directors of telehealth company Hims & Hers Health Inc. have been hit with a shareholder derivative suit in California federal court accusing them of allowing the company to exploit its now-terminated partnership with Novo Nordisk to sell "knockoff" versions of Novo's weight loss drug Wegovy,.

  • July 16, 2025

    Glucose Monitoring Co. LifeScan Hits Ch. 11 With $1.7B Debt

    LifeScan Global Corp., a company that makes blood glucose monitoring devices, has filed for Chapter 11 protection in Texas bankruptcy court with $1.7 billion of debt and a plan supported by its private equity backer to trim more than 75% of debt by handing the business to existing lenders.

  • July 16, 2025

    Novartis Denied Bid To Block Generic Entresto In TM Feud

    A New Jersey federal judge has rethought her initial decision blocking a Novartis competitor from potentially selling a generic version of a heart failure treatment drug, saying she got it wrong when she earlier analyzed a trade dress claim.

  • July 16, 2025

    CooperSurgical Wants Conn. Embryo Loss Claims Tossed

    CooperSurgical Inc. should not have to face a Connecticut federal lawsuit over embryos lost to its recalled culture medium for in vitro fertilization, the company said in motions to dismiss or pause the litigation based in part on "significant briefing and discovery" in a first-filed case in California.

  • July 15, 2025

    GTCR Seeks Rival's Sales Data To Counter FTC Challenge

    The private equity firm looking to buy medical device coating company Surmodics is seeking Salesforce data from another competitor in the space, saying the information is crucial to showing that the industry will still be competitive if its acquisition is cleared.

  • July 15, 2025

    Biohaven's Drug Prospects Were Overhyped, Suit Says

    Biopharmaceutical company Biohaven Ltd. was hit with an investor suit claiming it overstated the odds that two of its product candidates would receive regulatory approval, hurting investors as it announced disappointing results.

  • July 15, 2025

    Trump Admin Seeks Win In Harvard $2B Funding Freeze Case

    The Trump administration urged a Massachusetts federal judge Monday to grant it summary judgment in Harvard University's lawsuit challenging the government's effort to freeze $2.2 billion in funding, arguing the dispute is a contract fight that belongs in the Federal Claims Court and the allegations fail on the merits.

  • July 15, 2025

    Patent Fight Over Xtandi Erupts Anew Before RFK Jr.

    A new dispute is playing out over the price of a prostate cancer drug that was developed at University of California, Los Angeles, and is being sold by Pfizer, with the federal government being pushed on the issue of using its authority to allow early entry of generics.

  • July 15, 2025

    Court Blocks Generic Selenium Products Amid Patent Suit

    A New Jersey federal judge has temporarily blocked a group of generic-drug companies from selling versions of a selenium injection treatment covered by patents owned by American Regent Inc., which accused the group of patent infringement.

  • July 15, 2025

    The Biggest IP Agency Developments Of 2025: Midyear Report

    The U.S. Patent and Trademark Office and the U.S. Copyright Office have not been spared from the Trump administration's shake-ups and changes across the federal government in the first half of the year.

  • July 15, 2025

    Split 4th Circ. Rejects GenBioPro Abortion Ban Challenge

    A split Fourth Circuit panel on Tuesday rejected GenBioPro's challenge to a West Virginia law banning medication abortion with narrow exceptions, with the majority finding the ban does not conflict with federal regulators' statutory authority to impose safety requirements on drug manufacturers.

  • July 15, 2025

    9th Circ. Backs Nature's Way Loss In Supplements TM Suit

    The Ninth Circuit on Tuesday upheld a lower court's finding that a Doctor's Best Inc. brand of supplements didn't infringe a trademark of competitor Nature's Way Products LLC because the Doctor's Best products were all sold outside the U.S.

  • July 15, 2025

    Abbott Brass Ignoring Call For Formula Plant Probe, Suit Says

    An Abbot shareholder has launched a derivative lawsuit in Illiniois state court accusing the company's leaders of improperly sitting on her demand to investigate a baby formula shortage caused by safety and regulatory violations that she said executives and officers hid from the public.

  • July 15, 2025

    Fed. Circ. Temporarily Blocks MSN's Entresto Generic

    The Federal Circuit gave Novartis Pharmaceuticals Corp. a temporary reprieve Tuesday from having to face generic competition for its top-selling drug, Entresto, after losing a bench trial in Delaware.

  • July 15, 2025

    J&J Demands Sanctions Over Atty's 'Frivolous' Bias Suit In NJ

    Johnson & Johnson has blasted a former in-house data privacy attorney's discrimination suit against the company as "baseless and defamatory" and demanded sanctions against the ex-employee in New Jersey federal court.

  • July 15, 2025

    PTAB Knocks Out Claims In 3 Nasal Airway Patents

    The Patent Trial and Appeal Board has invalidated a host of claims across a trio of nasal airway treatment patents owned by Aerin Medical, agreeing with challenger Neurent Medical that the claims were obvious.

  • July 14, 2025

    DOJ Drops Vax Card Case Against Plastic Surgeon Mid-Trial

    The Justice Department dismissed charges against a Utah plastic surgeon accused of leading a conspiracy to forge COVID-19 vaccination cards for over 1,500 people, ending the case less than a week after trial began in Salt Lake City federal court.

  • July 14, 2025

    USPTO Acting Director Spurns 'Traditional Knowledge' Treaty

    The U.S. Patent and Trademark Office's acting director has come out against an international treaty that could require patent applicants to report if an invention uses the traditional knowledge of indigenous people, suggesting in remarks that such a rule would undermine the global patent system's effectiveness.

  • July 14, 2025

    Judge Says Med Device 401(k) Fee Suit Should Get A Trim

    A Massachusetts federal magistrate judge recommended narrowing a proposed class action claiming a medical technology company saddled its retirement plan with excessive fees and abused forfeited funds, ruling the workers failed to show the business violated the plan's terms.

  • July 14, 2025

    Fed. Circ. Upholds PTAB Ax Of J&J Unit's Catheter Patent

    The Federal Circuit on Monday upheld the Patent Trial and Appeal Board's invalidation of a Johnson & Johnson unit's patent on a device for clearing blocked arteries, saying an Abbott Laboratories unit's challenge was not improperly based on what the patent admitted was an earlier invention.

Expert Analysis

  • Opinion

    We Must Allow Judges To Use Their Independent Judgment

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    As two recent cases show, the ability of judges to access their independent judgment crucially enables courts to exercise the discretion needed to reach the right outcome based on the unique facts within the law, says John Siffert at Lankler Siffert & Wohl.

  • Series

    Performing Stand-Up Comedy Makes Me A Better Lawyer

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    Whether I’m delivering a punchline on stage or a closing argument in court, balancing stand-up comedy performances and my legal career has demonstrated that the keys to success in both endeavors include reading the room, landing the right timing and making an impact, says attorney Rebecca Palmer.

  • Unpacking The Illicit E-Cigarette Crackdown By State AGs

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    A bipartisan coalition of attorneys general for nine states and the District of Columbia announced a coordinated effort to curb illicit electronic cigarette sales, illustrating the rising prominence of state attorneys general using consumer protection laws to address issues of national scope, especially when federal efforts prove ineffective, say attorneys at Troutman.

  • Lawmakers Shouldn't Overlook Rare Disease Therapies' Value

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    As the ORPHAN Cures Act is pending in Congress, policymakers assessing the value of certain drugs for price regulation should consider data beyond what is collected in clinical trials, say Alice Chen at the University of Southern California, and Molly Frean and Yao Lu at Analysis Group.

  • Series

    Adapting To Private Practice: From SEC To BigLaw

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    As I adjusted to the multifaceted workflow of a BigLaw firm after leaving the U.S. Securities and Exchange Commission, working side by side with new colleagues on complex matters proved the fastest way to build a deep rapport and demonstrate my value, says Jennifer Lee at Jenner & Block.

  • China High Court Ruling Could Encourage Antitrust Litigation

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    Practitioners defending U.S. companies in China should take note of a Chinese Supreme Court ruling that plaintiffs can file suits based on either where the alleged action, or where the result of such action, occurred — which will promote civil litigation by minimizing procedural battles over forum selection, says Yang Yang at Leaqual Law Firm.

  • Making The Case For Rest In The Legal Profession

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    For too long, a culture of overwork has plagued the legal profession, but research shows that attorneys need rest to perform optimally and sustainably, so legal organizations and individuals must implement strategies that allow for restoration, says Marissa Alert at MDA Wellness, Carol Ross-Burnett at CRB Global, and Denise Robinson at The Still Center.

  • How Amended Rule 702 Affects Testimony In Patent Litigation

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    In 2023, Federal Rule of Evidence 702 was amended to address the apparent failure of some courts to prevent unreliable expert evidence from reaching a jury, but a statistical analysis of Daubert decisions in 2022 and 2024 shows that courts remain divided about how to apply consistent evidence standards, say attorneys at Perkins Coie.

  • What Trump's Order Means For The Legal Status Of IVF

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    An executive order signed by President Donald Trump last month signals the administration's potential intention to increase protections for in vitro fertilization services, though more concrete actions would be needed to resolve the current uncertainty around IVF access or bring about a binding legal change, says Jeanne Vance at Weintraub Tobin.

  • Mitigating Tariff Risks For Healthcare In US And Canada

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    Healthcare stakeholders should take steps to evaluate the impact of cross-border tariffs, as the historically strong ties between Canada and the U.S. demonstrate the potential for real disruption and harm to the healthcare industry in both countries, say attorneys at Norton Rose.

  • 4 Ways Women Attorneys Can Build A Legal Legacy

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    This Women’s History Month, women attorneys should consider what small, day-to-day actions they can take to help leave a lasting impact for future generations, even if it means mentoring one person or taking 10 minutes to make a plan, says Jackie Prester, a former shareholder at Baker Donelson.

  • A Judge's Pointers For Adding Spice To Dry Legal Writing

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    U.S. District Judge Fred Biery shares a few key lessons about how to go against the grain of the legal writing tradition by adding color to bland judicial opinions, such as by telling a human story and injecting literary devices where possible.

  • Preparing For Disruptions To Life Sciences Supply Chains

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    Life sciences companies must assess how new and escalating tariffs — combined with other restrictions on cross-border activity singling out pharmaceutical products and medical devices — will affect supply chains, and they should proactively prepare for antitrust and foreign direct investment regulatory review processes, say attorneys at Weil.

  • Mastering The Fundamentals Of Life Sciences Due Diligence

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    As life sciences transactions continue to gain tremendous momentum, companies participating in these transactions must conduct effective and strategic regulatory due diligence, which involves extensive amounts of information and varies by manifold factors, says Anna Zhao at GunnerCooke.

  • Beware Risks Of Arguing Multiple Constructions In IP Cases

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    Defendants accused of patent infringement often argue for different, potentially contradictory, claim constructions before district courts and the Patent Trial and Appeal Board, but the board may be clamping down on this strategy, say attorneys at Dechert.

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