Life Sciences

  • September 25, 2026

    SEC Says Mich. Atty Tipped Family About Pharma Co. Merger

    The U.S. Securities and Exchange Commission on Friday accused a Michigan tax lawyer of insider trading, alleging he told his brother and cousin about a planned but not-yet-announced merger between Y-mAbs Therapeutics Inc. and SERB Pharmaceuticals.

  • September 25, 2026

    SEC Says Md. Woman Illegally Traded On FDA Approval Info

    The SEC accused a Maryland resident of trading on nonpublic information she received from an insider ahead of the FDA's 2023 denial of a new drug application for a depression treatment submitted by Sage Therapeutics Inc. that caused the company's shares to lose over half of their value.

  • September 25, 2026

    Teva, Apotex Don't Infringe Sleep Drug Patents, Judge Finds

    Generic drugmakers Teva Pharmaceuticals and Apotex Inc. have secured an order from a Delaware federal court that they do not infringe patents asserted by Vanda Pharmaceuticals that cover the sleep drug Hetlioz.

  • September 25, 2026

    PTAB Invalidates Challenged Claims In Breast Pump Patent

    The Patent Trial and Appeal Board on Friday ruled that all claims Shenzhen Root Technology Co. Ltd. challenged in a Willow Blossom wearable breast pump patent are invalid on numerous grounds.

  • September 25, 2026

    AbbVie Says Botox Exempt From Medicare Price Negotiations

    AbbVie largely backed away from its constitutional challenges to the Inflation Reduction Act's Drug Price Negotiation Program in D.C. federal court Friday, but still insisted that its suite of Botox drugs can't be forced into negotiations with Medicare over price because they feature enough human plasma to fit into a congressional exemption.

  • September 25, 2026

    Alkermes Must Face Bulk Of Addiction Treatment Drug Suit

    A Massachusetts federal judge largely refused Thursday to let Alkermes duck a proposed class action alleging it tricked the U.S. Patent and Trademark Office into granting a patent for the addiction treatment therapy Vivitrol, crediting allegations a missing study was intentionally omitted from the patent application to win approval.

  • September 25, 2026

    Squires Says Biocon Challenge To Eylea Patent Filed Too Late

    U.S. Patent and Trademark Office Director John Squires has explained why he rejected Biocon Biologics' challenge to a Regeneron Pharmaceuticals Inc. patent covering the eye disorder drug Eylea — because Biocon waited too long to bring the challenge.

  • September 25, 2026

    COVID Testing Co.'s Ex-COO Pleads Guilty In $500M Fraud

    The former chief operating officer of a COVID-19 testing company pled guilty in Michigan federal court to a healthcare fraud conspiracy allegedly involving more than $500 million in fraudulent insurance claims for services that were not performed as billed.

  • September 25, 2026

    Del. Chancery Says Curonix Owns Stimwave Shares

    The medical device company Curonix LLC has won its lawsuit against the founder of Stimwave Technologies Inc., with Delaware's Court of Chancery finding that the plaintiff is the rightful holder of 75,000 shares of the company it purchased in bankruptcy.

  • September 25, 2026

    Cooley, Latham Steer RNA Drugmaker's Upsized $446M IPO

    San Diego-based biotechnology company ADARx Pharmaceuticals began trading publicly on Friday after raising $446 million in its initial public offering steered by Cooley LLP and Latham & Watkins LLP, adding to the growing list of biotech IPOs recently.

  • September 25, 2026

    Novo Bets $1.3B On Nanexa Drug Tech Amid Obesity Push

    Novo Nordisk has agreed to pay up to about €1.165 billion ($1.3 billion) under an exclusive license and collaboration agreement for Swedish drug-delivery company Nanexa's PharmaShell technology.

  • September 25, 2026

    Taxation With Representation: Kirkland, Latham, McDermott

    In this week's Taxation With Representation, Royal Caribbean invests billions in a joint venture with Sandals, Telix Pharmaceuticals buys ITM Isotope Technologies Munich, and Priority Technology makes a go-private deal with an investor group helmed by the company's chair and CEO.

  • September 24, 2026

    Jurisdictional Skepticism Puts Eli Lilly Appeal On Thin Ice

    Eli Lilly & Co.'s bid to unwind the U.S. Food and Drug Administration's refusal to classify a developing obesity treatment as a biological product appears to suffer from jurisdictional issues that might sink the company's appeal before its resolved, a Seventh Circuit judge signaled Thursday.

  • September 24, 2026

    ITC Takes On Patents, Trade Secrets In Large Decision Drop

    The U.S. International Trade Commission issued a flood of decisions this week on investigations in which imports are being evaluated to see if they infringe patents or misappropriate secrets, including three cases where it will reconsider holdings from administrative law judges.

  • September 24, 2026

    Squires Grants 5 Patent Review Bids, Rejects 6 Others

    In his latest round of decisions, U.S. Patent and Trademark Office Director John Squires has granted five petitions seeking reviews of patents, while turning down six other requests: three for discretionary reasons and three on the merits.

  • September 24, 2026

    FDA Nom Says Vaccines Safe, Won't Call IUDs Birth Control

    President Donald Trump's nominee to lead the U.S. Food and Drug Administration faced a Senate committee Thursday morning, where she affirmed the safety of vaccines when pressed but refused to directly contradict the president's false claim that the measles vaccine could be "quite lethal," and declined to affirm that IUDs are birth control and not abortifacients.

  • September 24, 2026

    Mylan Wants Del. Judge To Clear Wegovy Generic Drug

    Mylan Pharmaceuticals Inc. has launched a lawsuit in Delaware federal court asking for a finding that its proposed generic version of Novo Nordisk Inc.'s blockbuster weight loss drug Wegovy does not infringe a patent, the latest salvo in a larger intellectual property fight over the GLP-1.

  • September 24, 2026

    Novartis Beats Patent Listing Suit Over Entresto

    A New York federal judge gave Novartis permanent relief from a proposed class action alleging it monopolistically delayed generic competition for its blockbuster heart failure drug Entresto, concluding that the drugmaker properly used a patent to ensure exclusivity.

  • September 24, 2026

    Eli Lilly Hit With $90M Verdict In Nektar's Rezpeg Breach Suit

    A California federal jury on Thursday found Eli Lilly breached the implied covenant of good faith and fair dealing in an agreement to co-develop Nektar Therapeutics' autoimmune-disease drug Rezpeg, awarding Nektar $90 million — a considerable sum that fell short of the $1 billion the clinical-stage biotech company had sought.

  • September 24, 2026

    Labcorp Inks $2.3M Deal To Resolve Multistate Data Breach

    Labcorp will pay nearly $2.3 million and adopt data security changes under a multistate settlement resolving investigations into a 2019 breach at its former debt collection vendor, a group of state attorneys general announced Thursday.

  • September 24, 2026

    EPA Cuts Deal To Partially Settle U. Of Calif. Grant Fight

    University of California researchers urged a California federal judge Wednesday to preliminarily sign off on their proposed deal to resolve claims against the U.S. Environmental Protection Agency in broader litigation challenging the Trump administration's termination of thousands of UC grants.

  • September 24, 2026

    Thriving Rivals Disprove Hillrom Antitrust Suit, 3rd Circ. Told

    Hill-Rom Holdings Inc. told the Third Circuit on Thursday a Pennsylvania hospital had no evidence the equipment supplier illegally sidelined competitors from the hospital bed market, noting its deals tying discounts to exclusivity hadn't put multiple rivals out of business.

  • September 23, 2026

    Organ Network Says Kidney Race Bias Claims Can't Proceed

    The United Network for Organ Sharing is seeking to exit a proposed class action claiming it prolonged wait times for Black patients seeking kidney transplants by encouraging hospitals to use a flawed race-based adjustment when measuring kidney function, saying the network's policy was "silent" as to how such scores were calculated.

  • September 23, 2026

    Colo. Judge Declines To Sanction Hospital In Gender Care Suit

    Children's Hospital Colorado properly complied with an injunction prohibiting it from refusing to provide medically necessary gender-affirming care to transgender youth patients, a state judge ruled, rejecting a request by a class of patients to hold the hospital in contempt.

  • September 23, 2026

    Patients Drop Fertility Fraud Suits Against Yale Medical School

    Five plaintiffs have dropped two related court actions against Yale School of Medicine, Yale New Haven Hospital and the estate of a Connecticut doctor accused of fraudulently using his own sperm to inseminate fertility patients, state court records show.

Expert Analysis

  • Cannabis Policy Shift May Reshape Banking, Insolvency Risks

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    The Trump administration's cannabis rescheduling initiative aims to correct classification that had rendered federal banking, tax administration and insolvency law incoherent, and will begin to restore some alignment between federal law and the economic reality of the marijuana industry, says Richard Ormond at Buchalter.

  • Opinion

    International Patent Licensing System Must Be Maintained

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    As foreign approaches to patent enforcement threaten to distort the licensing markets that underpin modern technology, courts and policymakers must take action to ensure that the standard essential patent framework is preserved, says Brian O'Shaughnessy at Dinsmore.

  • Series

    Studying Foreign Languages Makes Me A Better Lawyer

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    Studying Italian and Japanese has shown me that learning a new language can benefit a legal career in several ways, including by demonstrating the importance of approaching problems from a fresh perspective and the value of practicing patience with colleagues and clients, says Anna King at Genworth Financial.

  • 10 US Patent Pressure Points For EU Life Sciences Cos.

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    U.S.-specific patent issues can be challenging for European life sciences companies because they require decisions at the intersection of legal, scientific, regulatory and commercial functions, necessitating proactive, cross-functional steps from EU patent counsel, says Paul Calvo at Sterne Kessler.

  • Sizing Up The Rescheduling Hurdles Medical Pot Cos. Face

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    The Justice Department’s recent lowering of certain medical marijuana products to Schedule III means operators — particularly those simultaneously offering federally illegal adult-use cannabis — must implement greater structural discipline to navigate an increasingly fragmented legal landscape if they hope to benefit from new tax deductions and access to capital, say attorneys at Akerman.

  • Series

    NY Times Word Puzzles Make Me A Better Lawyer

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    Every morning I let The New York Times humble me with word games, which offer a chance to recalibrate my brain before the day's chaos arrives and remind me that a solution — whether to a puzzle or employment law issue — almost always exists once I find the right angle, says Amy Epstein Gluck at Pierson Ferdinand.

  • Engaging With FDA's New Complete Response Letter Policy

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    A citizen petition filed with the U.S. Food and Drug Administration last month puts renewed focus on the agency's practice of releasing complete response letters in near real time, materially altering the context in which life sciences companies communicate with investors regarding regulatory developments, say attorneys at Debevoise.

  • Series

    Law School's Missed Lesson: Diagnose Before Arguing

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    Law school often skips over explicitly teaching students how to determine what kind of problem a case presents before they commit to a particular doctrinal path, which risks building arguments that are internally coherent but externally misaligned, says Melanie Oxhorn at Kobre & Kim.

  • Trump's Psychedelics EO Creates A Regulatory Collision

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    Sponsors pursuing U.S. Food and Drug Administration approval for psychedelic drug access must tackle how to generate regulatory-grade safety and efficacy data in controlled trials when President Donald Trump's recent executive order on psychedelics mandates uncontrolled access through Right to Try, say Kimberly Chew at Husch Blackwell and Odette Hauke at Odette Alina.

  • A Fed. Circ. Blueprint For Drafting Medical Device Patents

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    The Federal Circuit's decision in Constellation Designs v. LG last month, among other recent rulings, underscores the importance of emphasizing engineering, rather than clinical goals, when drafting patent claims for medical devices and software as a medical device, says Brandon Theiss at Volpe Koenig.

  • DTSA Data Shows Hidden Value Of Ex Parte Seizure Filings

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    Ten years of Defend Trade Secrets Act data indicate that although there is a low success rate for civil seizure applications, intellectual property litigators should continue filing them anyway in order to better their odds of obtaining other provisional relief, say attorneys at Reed Smith.

  • Becoming The Biz-Savvy GC That Portfolio Companies Need

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    Candidates for general counsel roles at private equity-backed portfolio companies should prioritize proving their sector-specific experience, commercial judgment and ease with uncertainty — and attorneys hoping to be candidates in five to 10 years should start working on those skills now, says Dimitri Mastrocola at Major Lindsey.

  • AI Regulatory Gaps May Fuel FCA Enforcement Action

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    The intersection of artificial intelligence and False Claims Act enforcement presents legal risk for government contractors across several industries, particularly in the absence of a federal regulatory framework explicitly governing its development and use, say attorneys at O’Melveny.

  • Series

    Judges On AI: How Courts Can Survive The Tech Revolution

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    Colorado Supreme Court Justice Maria Berkenkotter and Colorado Court of Appeals Judge Lino Lipinsky de Orlov discuss how artificial intelligence has already fundamentally altered the legal system and offer tips for courts navigating deepfakes, hallucinations and a gap in access to AI tools.

  • 'Skinny Label' Arguments Spotlight Induced Infringement Risk

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    Recent oral arguments before the U.S. Supreme Court in Hikma Pharmaceuticals v. Amarin Pharma highlight the uncertain boundary between lawful generic competition through so-called skinny labels and induced patent infringement, with potential implications for patent holders’ communication, enforcement and causation strategies across industries, says Anton Hopen at Trenam.

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