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Life Sciences

  • September 26, 2025

    Stewart Keeps Discretion Duty As Squires Takes On RPIs, AI

    In John Squires' first week as U.S. Patent and Trademark Office director, he walked back precedent from the first Trump administration, claimed machine learning should be patent-eligible, and designated Deputy Director Coke Morgan Stewart to continue handling discretionary denial reviews.

  • September 26, 2025

    Semler Scientific, Bard To Pay $37M To End FCA Claims

    The Department of Justice announced on Friday that two companies have agreed to pay nearly $37 million to resolve claims that they knowingly recommended healthcare providers submit erroneous Medicare claims for tests for diagnosing artery disease.

  • September 26, 2025

    Judge Criticizes Push For Harsher Sentence In CytoDyn Case

    A Maryland judge on Friday blasted federal prosecutors for seeking an enhanced sentence for a former biotech executive convicted of fraud for his role in the CytoDyn stock inflation scheme, saying the government wanted a harsher sentence for allegations he was already acquitted of at trial.

  • September 26, 2025

    CareDx Asks 3rd Circ. To Rethink $45M False Ad Case

    Medical testing company CareDx has asked the Third Circuit for a panel rehearing or a rehearing before the entire circuit to consider reinstating a $45 million jury award in a false advertisement case over genetic testing technology against rival Natera.

  • September 26, 2025

    Inotiv Inks $8.75M Investor Deal Over Animal Welfare Claims

    Medical research services provider Inotiv Inc. and its shareholders asked an Indiana federal court to approve an $8.75 million settlement to resolve investors' claims the company concealed that its subsidiaries were under investigation by the U.S. Department of Justice for animal welfare and smuggling violations.

  • September 26, 2025

    Bayer Investors Seek Final OK Of $38M Settlement, Atty Fees

    Bayer AG shareholders have asked a California federal judge to give final approval of its $38 million settlement with the German multinational to end claims it downplayed litigation risks related to the weedkiller Roundup, saying the deal, which seeks over $10 million in attorney fees, is fair.

  • September 26, 2025

    Illumina And Grail Nix Investor Suit Over Failed Deal, For Now

    Illumina and Grail on Friday defeated a proposed class action alleging they lied to investors who bought artificially inflated Illumina stock whose prices plunged following several purported disclosures, after a California federal judge said the investors hadn't adequately pled which disclosures corrected any alleged misstatements that caused their losses. 

  • September 26, 2025

    Cellectis, AstraZeneca Face IP Suit From Cell Engineering Co.

    A cell engineering company sued pharmaceutical giant Cellectis Inc. on Friday, claiming it had used patented gene-editing protein research technology and purported to license it for use to AstraZeneca.

  • September 26, 2025

    DC Circ. Won't Stop FDA From Approving Entresto Generic

    The D.C. Circuit on Friday shot down Novartis' attempt to block the U.S. Food and Drug Administration's approval of a generic version of its most lucrative drug, the heart disease medication Entresto.

  • September 26, 2025

    Chemical Plant Spat Must Unfold In NY, NC Court Is Told

    A Swiss chemical technology company urged a North Carolina state judge Friday to toss a suit alleging that it bungled work on a $200 million plant, arguing during a hearing that it is not a construction company as defined in a state law undergirding where the claims can be litigated.

  • September 26, 2025

    High Court Pauses Distribution Of $4B Foreign Aid

    The U.S. Supreme Court ruled Friday that the Trump administration can hold onto $4 billion in frozen foreign aid funding while Congress considers a proposal to cut it, pausing a lower court order that required the federal government to spend the money before the end of the month.

  • September 26, 2025

    Trump Announces 100% Tariff On Drug Imports Starting Oct. 1

    President Donald Trump announced a slew of new Section 232 tariffs to be imposed beginning Oct. 1, including a 100% tariff on drug imports and new rates for semi trucks, kitchen cabinets, bathroom vanities and upholstered furniture.

  • September 26, 2025

    Taxation With Representation: De Brauw, Hengeler Mueller

    In this week's Taxation With Representation, power grid operator TenneT Holding sells a stake in its German transmission business to institutional investors, Pfizer Inc. acquires biotechnology company Metsera Inc., and Dutch brewer Heineken NV buys most of Costa Rica's FIFCO beverage and retail operations.

  • September 25, 2025

    COVID-19 Orders Could Save Embryo Loss Case, Court Hears

    Responding to last-minute arguments during a summary judgment hearing, a Connecticut Superior Court judge Thursday ordered attorneys to brief whether COVID-19 executive orders might save a Massachusetts woman's claims that her fertility doctors misplaced or destroyed her frozen embryos.

  • September 25, 2025

    Judge Plans To Let ITC Take Lead In Apple Watch Patent Fight

    A D.C. federal judge said Thursday that she is not inclined to block a U.S. Customs and Border Protection decision permitting Apple Watch imports amid a patent dispute with Masimo Corp., because the U.S. International Trade Commission will soon address the same issue.

  • September 25, 2025

    Perrigo Mostly Beats US In $163M Tax Refund Dispute

    A Michigan federal court largely sided Thursday with pharmaceutical company Perrigo in a $163 million tax refund case, rejecting the government's claim that the company's transactions with a foreign entity lacked economic substance and were meant only to avoid taxes.

  • September 25, 2025

    MiMedx, FDA Ordered To Rework Args In Wound Care Case

    Biomedical company MiMedx Group Inc. and the U.S. Food and Drug Administration have been ordered to reframe their briefs in a suit in which the company seeks to overturn the agency's classification of a wound care treatment as a biological product.

  • September 25, 2025

    Pa. High Court Backs Two-Lab Rule For Medical Pot Products

    The Pennsylvania Supreme Court on Thursday upheld a state rule requiring medical marijuana businesses to test their products at two separate laboratories, finding that the state law's emphasis on public safety empowered regulators to impose the requirement.

  • September 25, 2025

    Dr. Reddy's To Keep Generic Cancer Drug Off Market Until 2030

    Indian pharmaceutical group Dr. Reddy's Laboratories Inc. has agreed to keep its generic version of a cancer drug made by Eisai Ltd. off the market until 2030 as part of a deal to settle the Japanese drugmaker's lawsuit in New Jersey federal court alleging patent infringement.

  • September 25, 2025

    AstraZeneca Asks High Court To 'Unscramble' Drug Price Law

    As legal losses pile up for drug manufacturers in their fight to overturn the Medicare Drug Price Negotiation program, pharma giant AstraZeneca is asking the U.S. Supreme Court to decide if the program infringes on its constitutional rights. 

  • September 25, 2025

    Labcorp Workers Balk At Paying For Expert's Biz Class Airfare

    Labcorp shouldn't be reimbursed for its expert witness's round-trip business class flight and other ancillary costs it wants a group of employees to pay after fending off claims that it mismanaged their retirement savings, the workers have told a North Carolina federal judge.

  • September 25, 2025

    SmartLabs Accused Of Dodging Rent On Cambridge Lab

    Boston-headquartered SmartLabs is facing a lawsuit over millions in unpaid rent owed to the landlord of one of its Cambridge facilities, according to a complaint filed in Massachusetts state court.

  • September 25, 2025

    Depo-Provera MDL Plaintiff Numbers Balloon To 1,300

    The plaintiffs in a multidistrict litigation claiming Pfizer failed to warn consumers of a link between brain tumors and the hormonal contraceptive Depo-Provera now number more than 1,300, with more expected to file suits ahead of a hearing Monday on whether their claims are preempted by federal law.

  • September 25, 2025

    In-House Life Sciences Lawyer Joins WilmerHale In Boston

    An attorney specializing in the life sciences will be returning to private practice next month after more than nine years as an in-house counsel for several pharmaceutical and biotechnology companies, joining WilmerHale's Boston office.

  • September 25, 2025

    Families Cite Trump In Bid To Revive Tylenol Autism Claims

    Families suing the maker of Tylenol quickly cited President Donald Trump's words this week as they pushed the Second Circuit to overturn a lower-court ruling that barred their expert witnesses from testifying that prenatal exposure to the medicine can cause autism.

Expert Analysis

  • 3rd Circ. Clarifies Ch. 11 3rd-Party Liability Scope Post-Purdue

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    A recent Third Circuit decision that tort claims against the purchaser of a debtor's business belong to the debtor's bankruptcy estate reinvigorates the use of Chapter 11 for the resolution of nondebtor liability in mass tort bankruptcies following last year's U.S. Supreme Court ruling in Purdue Pharma, say attorneys at Sullivan & Cromwell.

  • Texas Suit Marks Renewed Focus On Service Kickback Theory

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    After a dormant period at the federal level, a theory of kickback enforcement surrounding nurse educator programs and patient support services resurfaced with a recent state court complaint filed by Texas against Eli Lilly, highlighting for drugmakers the ever-changing nature of enforcement priorities and industry landscapes, say attorneys at Sheppard Mullin.

  • Series

    Power To The Paralegals: How And Why Training Must Evolve

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    Empowering paralegals through new models of education that emphasize digital fluency, interdisciplinary collaboration and human-centered lawyering could help solve workforce challenges and the justice gap — if firms, educators and policymakers get on board, say Kristine Custodio Suero and Kelli Radnothy.

  • Series

    Playing Softball Makes Me A Better Lawyer

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    My time on the softball field has taught me lessons that also apply to success in legal work — on effective preparation, flexibility, communication and teamwork, says Sarah Abrams at Baleen Specialty.

  • 5 Years In, COVID-19 Fraud Enforcement Landscape Is Shifting

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    As the government moves pandemic fraud enforcement from small-dollar individual prosecutions to high-value corporate cases, and billions of dollars remain unaccounted for, companies and defense attorneys must take steps now to prepare for the next five years of scrutiny, says attorney David Tarras.

  • Fed. Circ. In August: A Framework For AIA Derivation Disputes

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    In Global Health Solutions v. Selner, the Federal Circuit established how to assess derivation challenges under the America Invents Act's first-to-file system, making it easier for petitioners to determine a challenge's odds of success, say attorneys at Knobbe Martens.

  • USPTO's Track One A Reliable Patent Pathway Amid Backlog

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    As the U.S. Patent and Trademark Office faces a backlog of unexamined utility, plant and reissue patent applications, patent applicants should consider utilizing the USPTO's Track One Program, which not only expedites the process but also increases the likelihood of working with more senior examiners, says Ryan Schermerhorn at Marshall Gerstein.

  • Vanda Ruling Opens Door For Contesting FDA Drug Denials

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    The D.C. Circuit's recent decision in Vanda Pharmaceuticals v. U.S. Food and Drug Administration creates new opportunities and considerations for drug companies navigating the FDA approval process, establishing that litigation is an option when the FDA refuses to hold a hearing, say attorneys at Polsinelli.

  • Series

    Law School's Missed Lessons: Mastering Time Management

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    Law students typically have weeks or months to prepare for any given deadline, but the unpredictability of practicing in the real world means that lawyers must become time-management pros, ready to adapt to scheduling conflicts and unexpected assignments at any given moment, says David Thomas at Honigman.

  • Rare Del. Oversight Ruling Sends Governance Wake-Up Call

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    An unusual ruling from the Delaware Court of Chancery recently allowed Caremark oversight claims to proceed against former executives of a company previously known as Teligent, sending a clear reminder that boards and officers must actively monitor and document oversight efforts when addressing mission-critical risks, say attorneys at WilmerHale.

  • How Hyperlinks Are Changing E-Discovery Responsibilities

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    A recent e-discovery dispute over hyperlinked data in Hubbard v. Crow shows how courts have increasingly broadened the definition of control to account for cloud-based evidence, and why organizations must rethink preservation practices to avoid spoliation risks, says Bree Murphy at Exterro.

  • Pharma Copay Programs Raise Complex Economic Questions

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    The growing prevalence of copay accumulator and maximizer programs in the pharmaceutical industry is drawing increased scrutiny from patients, advocacy groups, lawmakers and courts, bringing complex questions about how financial responsibility for prescription drug purchases is determined and complicating damages assessments in litigation, say analysts at Analysis Group.

  • State False Claims Acts Can Help Curb Opioid Fund Fraud

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    State versions of the federal False Claims Act can play an important role in policing the misuse of opioid settlement funds, taking a cue from the U.S. Department of Justice’s handling of federal fraud cases involving pandemic relief funds, says Kenneth Levine at Stone & Magnanini.

  • Beaming Up Lessons From William Shatner's Failed Patent Bid

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    In a tale that boldly goes where few celebrity inventors have gone before, William Shatner's unsuccessful attempt to patent a smartphone file organization system offers insights about potential pitfalls to avoid in patent applications, say attorneys at King & Spalding.

  • The Pros And Cons Of Levying Value-Based Fees On Patents

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    The potential for a recurring, value-based maintenance fee on patents, while offering some benefits, raises several complications, including that it would likely exceed the U.S. Patent and Trademark Office's statutory authority and reduce research and development activities in the U.S., says Sandip Patel at Marshall Gerstein.

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