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Life Sciences

  • July 17, 2025

    Fla. AG, Sandoz Clash With Other Enforcers Over 'Done' Deal

    Sandoz and Florida's attorney general pressed a Connecticut federal judge Wednesday to let them settle out of sweeping price-fixing litigation against generic-drug makers, contending that federal civil procedure rules give no room for objections from other state enforcers worried the Sunshine State deal interferes with their own ability to negotiate settlements.  

  • 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.

Expert Analysis

  • Series

    Law School's Missed Lessons: Rejecting Biz Dev Myths

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    Law schools don’t spend sufficient time dispelling certain myths that prevent young lawyers from exploring new business opportunities, but by dismissing these misguided beliefs, even an introverted first-year associate with a small network of contacts can find long-term success, says Ronald Levine at Herrick Feinstein.

  • Move Beyond Surface-Level Edits To Master Legal Writing

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    Recent instances in which attorneys filed briefs containing artificial intelligence hallucinations offer a stark reminder that effective revision isn’t just about superficial details like grammar — it requires attorneys to critically engage with their writing and analyze their rhetorical choices, says Ivy Grey at WordRake.

  • Observations On 5 Years Of Non-Notified CFIUS Inquiries

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    Since 2020, the Committee on Foreign Investment in the United States has identified and investigated covered cross-border transactions not formally notified to CFIUS, and a look at data from 50 non-notified matters during that time reveals the general dynamics of this enforcement function, say attorneys at Cooley.

  • 9th Circ. Has Muddied Waters Of Article III Pleading Standard

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    District courts in the Ninth Circuit continue to apply a defunct and especially forgiving pleading standard to questions of Article III standing, and the circuit court itself has only perpetuated this confusion — making it an attractive forum for disputes that have no rightful place in federal court, say attorneys at Gibson Dunn.

  • An Underused Tariff Exemption For Medical Product Importers

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    Medical device importers may be able to reduce tariff exposure by leveraging an often-overlooked Nairobi Protocol duty exemption for products specially designed to benefit those with qualifying medical conditions, says Samuel Finkelstein at LMD Trade Law.

  • Series

    Competing In Modern Pentathlon Makes Me A Better Lawyer

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    Opening myself up to new experiences through competing in modern Olympic pentathlon has shrunk the appearance of my daily work annoyances and helps me improve my patience, manage crises better and remember that acquiring new skills requires working through your early mistakes, says attorney Mary Zoldak.

  • Prepare For Increased FDA Inspections Of Foreign Facilities

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    In light of the U.S. Food and Drug Administration's recently announced plans to expand use of unannounced inspections of foreign drug manufacturing factories, foreign firms should implement best practices in anticipation of an imminent increase in enforcement activity, say attorneys at McGuireWoods.

  • Series

    Law School's Missed Lessons: Teaching Yourself Legal Tech

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    New graduates often enter practice unfamiliar with even basic professional software, but budding lawyers can use on-the-job opportunities to both catch up on technological skills and explore the advanced legal and artificial intelligence tools that will open doors, says Alyssa Sones at Sheppard Mullin.

  • Navigating Potential Sources Of Tariff-Related Contract Risk

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    As the tariff landscape continues to shift, companies must anticipate potential friction points arising out of certain common contractual provisions, prepare to defend against breach claims, and respond to changing circumstances in contractual and treaty-based relationships, say attorneys at Debevoise.

  • How AI May Reshape The Future Of Adjudication

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    As discussed at a recent panel at Texas A&M, artificial intelligence will not erase the human element of adjudication in the next 10 to 20 years, but it will drive efficiencies that spur private arbiters to experiment, lead public courts to evolve and force attorneys to adapt, says Christopher Seck at Squire Patton.

  • When Legal Advocacy Crosses The Line Into Incivility

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    As judges issue sanctions for courtroom incivility, and state bars advance formal discipline rules, trial lawyers must understand that the difference between zealous advocacy and unprofessionalism is not just a matter of tone; it's a marker of skill, credibility and potentially disciplinary exposure, says Nate Sabri at Perkins Coie.

  • Should Patent Disputes Be Filed In The ITC Or UPC?

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    When companies must choose between initiating patent litigation in the U.S. International Trade Commission or the European Union's Unified Patent Court, the ITC may offer a few distinct advantages, but ultimately the decision requires consideration of case-specific factors, say attorneys at White & Case.

  • Opinion

    NJ Should Align With Federal Rule On Expert Testimony

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    The time is right to amend Rule 702 of the New Jersey Rules of Evidence to align it with the recently amended Rule 702 of the Federal Rules of Evidence and clarify the standard for admissibility of expert testimony, says Timothy Freeman at Tanenbaum Keale.

  • 2 NY Rulings May Stem Foreign Co. Derivative Suits

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    In recent decades, shareholders have challenged the internal affairs doctrine by bringing a series of derivative actions in New York state court on behalf of foreign corporations, but the New York Court of Appeals' recent rulings in Ezrasons v. Rudd and Haussmann v. Baumann should slow that trend, say attorneys at Cleary.

  • Recent Reports Shed Light On Section 340B's Effectiveness

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    Recent analyses of the Section 340B program's effectiveness in helping patients afford drugs in Minnesota reinforce concerns about the program's lack of transparency and underscore the need for further evaluation of whether legislative reform should be enacted, say William A. Sarraille at the University of Maryland, and Andrée-Anne Fournier and Molly Frean at Analysis Group.

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