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Life Sciences

  • September 29, 2025

    Catching Up With Delaware's Chancery Court

    A Delaware vice chancellor expressed disappointment and concern over what she says is a "breakdown" in "civility and respect" that has emerged in recent Delaware corporate litigation. A $30 million settlement was approved in the five-year running Match.com reverse spinoff suit, and the top brass of Estée Lauder were hit with a derivative suit for allegedly covering up the company's reliance on prohibited, duty-free "gray market" sales of its products in China.

  • 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.

Expert Analysis

  • How Value-Based Patent Fees May Shape IP Strategies

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    If the U.S. Patent and Trademark Office implements rumored plans to correlate patent fees with patent value, the financial and strategic consequences would largely depend on the specifics of how, when and how often patent values are assessed, say attorneys at Cleary.

  • Agentic AI Puts A New Twist On Attorney Ethics Obligations

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    As lawyers increasingly use autonomous artificial intelligence agents, disciplinary authorities must decide whether attorney responsibility for an AI-caused legal ethics violation is personal or supervisory, and firms must enact strong policies regarding agentic AI use and supervision, says Grace Wynn at HWG.

  • Using Reissue Applications To Strategically Improve Patents

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    Though reissue applications are an often-overlooked consideration in today's patent environment, they can offer powerful tools for correcting errors, strengthening patent protection, or adapting to evolving business and legal landscapes, says Curtis Powell at Wolf Greenfield.

  • FDA Transparency Plans Raise Investor Disclosure Red Flags

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    The U.S. Food and Drug Administration’s recently announced intent to publish complete response letters for unapproved drugs and devices implicates certain investor disclosure requirements under securities laws, making it necessary for life sciences and biotech companies to adopt robust controls going forward, say attorneys at Arnold & Porter.

  • Series

    Being A Professional Wrestler Makes Me A Better Lawyer

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    Pursuing my childhood dream of being a professional wrestler has taught me important legal career lessons about communication, adaptability, oral advocacy and professionalism, says Christopher Freiberg at Midwest Disability.

  • Patent Claim Lessons From Fed. Circ.'s Teva Decision

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    The Federal Circuit's recent decision in Janssen v. Teva is an important precedent for parties drafting patent claims or litigating obviousness where the prior art has potentially overlapping ranges for a claimed element, and may be particularly instructive to patent applicants in the pharmaceutical field, say attorneys at Cooley.

  • Series

    Law School's Missed Lessons: Adapting To The Age Of AI

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    Though law school may not have specifically taught us how to use generative artificial intelligence to help with our daily legal tasks, it did provide us the mental building blocks necessary for adapting to this new technology — and the judgment to discern what shouldn’t be automated, says Pamela Dorian at Cozen O'Connor.

  • Ch. 11 Ruling Voiding $2M Litigation Funding Sends A Warning

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    A recent Texas bankruptcy court decision that a postconfirmation litigation trust has no obligations to repay a completely drawn down $2 million litigation funding agreement serves as a warning for estate administrators and funders to properly disclose the intended financing, say attorneys at Kleinberg Kaplan.

  • DOJ's Novel Cybersecurity FCA Case Is A Warning To Medtech

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    The U.S. Department of Justice's recent False Claims Act settlement with Illumina over alleged cybersecurity deficiencies suggests that enforcement agencies and whistleblowers are focusing attention toward cybersecurity in life sciences and medical tech, but also reveals key unanswered questions about the legal viability of such allegations, say attorneys at Morgan Lewis.

  • Future-Proof Patent Law By Starting Talent Pipelines Early

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    Law firms struggling with a narrow talent pipeline in the intellectual property space should consider beginning their recruitment strategies for potential candidates as early as high school, and raise awareness for career opportunities that do not require a law degree, says Christine Hollis at Marshall Gerstein.

  • Demystifying The Civil Procedure Rules Amendment Process

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    Every year, an advisory committee receives dozens of proposals to amend the Federal Rules of Civil Procedure, most of which are never adopted — but a few pointers can help maximize the likelihood that an amendment will be adopted, says Josh Gardner at DLA Piper.

  • How USPTO Examiner Memo Informs Software Patent Drafting

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    A memorandum recently released by the U.S. Patent and Trademark Office provides useful clues as to how the USPTO and examining corps will evaluate claims in software-implemented inventions for subject matter eligibility going forward, says Michael Lew at Squire Patton.

  • How 2nd Circ. Cannabis Ruling Upends NY Licensing

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    A recent Second Circuit decision in Variscite NY Four v. New York, holding that New York's extra-priority cannabis licensing preference for applicants with in-state marijuana convictions violates the dormant commerce clause, underscores that state-legal cannabis markets remain subject to the same constitutional constraints as other economic markets, say attorneys at Harris Beach.

  • Parenting Skills That Can Help Lawyers Thrive Professionally

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    As kids head back to school, the time is ripe for lawyers who are parents to consider how they can incorporate their parenting skills to build a deep, meaningful and sustainable legal practice, say attorneys at Alston & Bird.

  • Enablement Standard Insights From Fed. Circ. Agilent Ruling

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    The Federal Circuit's recent enablement standard decision in Agilent v. Synthego underscores three critical takeaways for patent practitioners, including reaffirmation that the enablement inquiry under Section 102 of the Patent Act is distinct from the inquiry under Section 112, say attorneys at MoFo.

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