Life Sciences

  • September 05, 2025

    DC Circ. Won't Halt Order Releasing Billions In Foreign Aid

    Both a divided D.C. Circuit panel and a district court judge Friday refused to hit pause on the judge's recent order requiring the Trump administration to release billions of dollars in frozen foreign aid.

  • September 05, 2025

    Stewart Tackles Markets, Injunctions In Newest PTAB Reviews

    Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart released 14 institution decisions in the last week, providing more insight on the scope of settled expectations and the impact of a district court preliminary injunction.

  • September 05, 2025

    Federal Agencies Push To Toss Masimo's Apple Watch Suit

    U.S. Customs and Border Protection and the U.S. International Trade Commission have again urged a federal judge to throw out Masimo's suit seeking to block a decision allowing imports of redesigned Apple Watches, saying Congress barred court review of such findings.

  • September 05, 2025

    2nd Circ. Backs Ex-Pfizer Worker's Insider Trading Conviction

    The Second Circuit on Friday affirmed a former Pfizer Inc. statistician's insider trading conviction for making $272,000 in options trades from nonpublic news about the success of trials for the COVID-19 therapy drug Paxlovid, rejecting his arguments that prosecutors improperly shifted their legal theory at trial and pursued the case in the wrong venue.

  • September 05, 2025

    DOJ Pushes To DQ Attorney Over Conflict In Fraud Case

    Federal prosecutors in Georgia are seeking to disqualify an attorney from representing a defendant accused of making false statements in relation to a criminal fraud investigation of Hi-Tech Pharmaceuticals Inc., arguing the lawyer was previously disqualified from representing the company's CEO for a conflict and that "the same is true now."

  • September 05, 2025

    Merck Shakes Off Some Claims From Cholesterol Drugs Suit

    A New Jersey federal judge has partly granted a request from Merck & Co. to dismiss claims brought by Humana over an alleged anticompetitive scheme to control distribution of cholesterol drugs Zetia and Vytorin, tossing several proposed theories of monopolization but allowing unjust enrichment claims and state law antitrust claims to survive.

  • September 05, 2025

    Vein Tech Maker Wants Suit Over DOJ Kickback Probe Tossed

    Vein disease device maker Inari Medical Inc. and its former top brass have asked a New York federal judge to toss a proposed investor class action over claims the company's share price fell after it disclosed an investigation into its compliance with federal anti-kickback laws, arguing the suit fails to allege any specific kickbacks or false statements.

  • September 05, 2025

    FDA Explains Rejection Of MDMA Therapy For Treating PTSD

    The U.S. Food and Drug Administration rejected a historic new drug application to treat post-traumatic stress disorder with the psychedelic MDMA due to concerns with the drug's safety and effectiveness and with the design of the clinical trials behind the bid, according to an agency letter made public Thursday.

  • September 05, 2025

    Casper Can't Escape Innovator-Liability Drug Label Suit

    A California federal judge won't let Casper Pharma LLC escape an innovator-liability suit alleging that its failure to provide adequate warnings on its gout treatment led to the death of a man who used its generic version.

  • September 05, 2025

    Conn. Biotech Hits Ch. 11 With $2.7M Debt After Patent Suit

    A Connecticut biotech company has filed a voluntary Chapter 11 petition claiming at least $2.7 million in liabilities, mostly debts to Quinn Emanuel Urquhart & Sullivan LLP and Verrill Dana LLP, after both law firms represented it in a since-settled Massachusetts stem cell patent lawsuit.

  • September 05, 2025

    Motley Rice Fights OptumRx DQ Bid In Utah Opioid Suit

    Pharmacy benefit manager OptumRx cannot disqualify Motley Rice LLC from representing Utah in a lawsuit over the opioid crisis, since any information the firm obtained during its involvement in earlier government investigations is available to all other parties in the multidistrict litigation and so isn't confidential, the state has told a federal court.

  • September 04, 2025

    Feds Seek Stay On Court Order Releasing Foreign Aid Billions

    The Trump administration urged the D.C. Circuit on Thursday to stay a federal judge's order that it release billions in frozen foreign aid pending its appeal, saying the disbursement will likely be "impossible" to recover according to the international aid organization plaintiffs' "own description of their financial condition."

  • September 04, 2025

    Split 3rd Circ. Rejects Janssen, Bristol Myers Pricing Appeal

    A split Third Circuit panel Thursday shot down another challenge to the Medicare drug pricing negotiation, this time rejecting a consolidated appeal from Bristol Myers Squibb and Janssen and upholding a lower court's finding that the program is indeed voluntary and therefore constitutional.

  • September 04, 2025

    Doc Tells 1st Circ. Acquitted Conduct Marred Drug Sentence

    A Massachusetts psychiatrist convicted over an alleged scheme to import and dispense nonapproved forms of addiction medication on Thursday told the First Circuit the trial judge wrongly ran afoul of limitations on the consideration of acquitted conduct in federal sentencings when handing him a three-year prison term.

  • September 04, 2025

    4th Circ. Affirms Gardasil's Vaccine Table Inclusion

    A unanimous Fourth Circuit panel affirmed Thursday that adding the human papillomavirus vaccine Gardasil to the Vaccine Act's injury table did not violate the U.S. Constitution, rejecting three plaintiffs' arguments that the Secretary of Health and Human Services lacks the authority to make additions to the table without an act of Congress.

  • September 04, 2025

    Generic Drug Org Backs MSN In High Court Entresto Appeal

    The Association for Accessible Medicines has thrown its weight behind MSN Pharmaceuticals in the company's U.S. Supreme Court challenge to a Federal Circuit decision blocking its generic version of Novartis' blockbuster cardiovascular drug Entresto, saying Wednesday that the appeals court took the wrong approach to patent validity.

  • September 04, 2025

    GSK Adds Moderna's New COVID Vaccine To Del. IP Suit

    GlaxoSmithKline Biologicals is broadening its patent infringement suit against Moderna Inc. to include the latter's new family of COVID-19 vaccines, mNEXSPIKE.

  • September 04, 2025

    Why The Harvard Funding Case Is 'Clear As Mud' On Appeal

    A sweeping Harvard University victory in a suit challenging President Donald Trump's block on $2.2 billion in grant funding tees up a high-stakes appeal that experts say may turn on a wonky jurisdictional issue on which the U.S. Supreme Court seems to lack any sort of consensus.

  • September 04, 2025

    Sterne Kessler Adds Ex-Deputy Chief PTAB Judge

    The former acting head of the U.S. Patent and Trademark Office's unit that reexamines patents after they have been granted has made the move to Sterne Kessler Goldstein & Fox PLLC, amid a series of personnel changes at the agency.

  • September 04, 2025

    DOJ Moves To End Challenge To RFK Jr.'s Vaccine Directive

    The Justice Department is seeking a quick exit from a suit challenging Robert F. Kennedy Jr.'s directive recommending against the COVID-19 vaccine for pregnant women and children, telling a Massachusetts federal court Thursday that the three women and coalition of medical associations behind the suit can't demonstrate a link between the directive and any potential injuries.

  • September 04, 2025

    Monthly Merger Review Snapshot

    The Justice Department settled a challenge to UnitedHealth's $3.3 billion home hospice acquisition while Democrats called for a judge to reject a different government settlement and the Federal Trade Commission moved against medical technologies transactions for heart valves and device coatings.

  • September 04, 2025

    Robitussin Maker Must Face Woman's Lung Infection Suit

    A Pennsylvania judge has refused to dismiss a suit against the maker of Robitussin cough syrup by a woman who alleged she developed a severe lung infection from a contaminated product, saying her allegations are sufficient to plead causation.

  • September 04, 2025

    PBMs Look To Toss FTC's Insulin Pricing Case

    Caremark Rx, Express Scripts and OptumRx have asked to dismiss the Federal Trade Commission's in-house case accusing the pharmacy benefit managers of artificially inflating insulin prices, saying the agency is exceeding its authority to address "unfairness."

  • September 04, 2025

    RFK Renews Attacks On CDC At Fiery Capitol Hill Appearance

    U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. faced intense questioning from lawmakers on Capitol Hill on Thursday, with a handful of Republicans joining Democratic senators in voicing alarm over recent turmoil in vaccine policy and in leadership at the Centers for Disease Control and Prevention.

  • September 04, 2025

    3rd Circ. Preview: Sept. Features Biosimilars, Gambling Cases

    The Third Circuit's September argument lineup is packed with cases centering on the biosimilars segment of the pharmaceutical industry and gambling companies embroiled in disputes originating from New Jersey.

Expert Analysis

  • Opinion

    Congress Must Restore IP Protection To Drive US Innovation

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    Congress should pass the RESTORE Patent Rights Act to enforce patent holders' exclusive rights and encourage American innovation, and undo the decades of patent rights erosion caused by the U.S. Supreme Court's 2006 decision in eBay v. MercExchange, says former Chief U.S. Circuit Judge Paul Michel.

  • How Focus On Menopause Care Is Fueling Innovation, Access

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    Recent legislative developments concerning the growing field of menopause care are creating opportunities for increased investment and innovation in the space as they increase access to education and coverage, say attorneys at Kirkland.

  • Opinion

    The BigLaw Settlements Are About Risk, Not Profit

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    The nine Am Law 100 firms that settled with the Trump administration likely did so because of the personal risk faced by equity partners in today's billion‑dollar national practices, enabled by an ethics rule primed for modernization, says Adam Forest at Scale.

  • Neb.'s Cannabis Regulatory Void Poses Operational Risks

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    With the Nebraska Legislature recently declining to advance any cannabis legislation, leaving the state without a regulatory framework for voter-passed initiatives, the risks of operating without clear rules will likely affect patients, providers and caregivers, says John Cartier at Omnus Law.

  • Opinion

    Courts Must Revitalize Robust Claim Construction

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    Two Federal Circuit decisions from earlier this year illustrate the rarity of robust claim construction and the underused reverse doctrine of equivalents — a dual problem that prevents courts from clearly delineating and correctly cabining the scope of rights conferred by patent claims, say attorneys at Klarquist Sparkman.

  • What Gene Findings Mean For Asbestos Mesothelioma Claims

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    Recent advances in genetic research have provided substantial evidence that significant numbers of malignant mesothelioma cases may be caused by inherited mutations rather than asbestos exposure — a finding that could fundamentally change how defendants approach personal injury litigation over mesothelioma, say David Schwartz at Lumanity and Kirk Hartley at LSP Group.

  • Series

    Brazilian Jiujitsu Makes Me A Better Lawyer

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    Competing in Brazilian jiujitsu – often against opponents who are much larger and younger than me – has allowed me to develop a handful of useful skills that foster the resilience and adaptability necessary for a successful legal career, says Tina Dorr of Barnes & Thornburg.

  • Fed. Circ. In April: Introducing New Evidence During IPR

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    The Federal Circuit's decision in Sage Products v. Stewart last month upheld the Patent Trial and Appeal Board's decision to allow a petitioner to rely on case-dispositive evidence beyond prior art references, affording petitioners in inter partes review proceedings greater latitude in the timing of evidence presentation, say attorneys at Knobbe Martens.

  • FDA Commissioner Speech Suggests New Vision For Agency

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    In his first public remarks as U.S. Food and Drug Administration commissioner, Marty Makary outlined an ambitious framework for change centered around cultural restoration, scientific integrity, regulatory flexibility and selective modernization, and substantial enforcement shifts for the food and tobacco sectors, say attorneys at Arnall Golden.

  • DOJ Export Declination Highlights Self-Reporting Benefits

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    The U.S. Department of Justice's recent decision not to prosecute a NASA contractor, despite a former employee pleading guilty to facilitating unlicensed exports, underscores the advantages available to companies that self-report sanctions violations, cooperate with investigations and implement timely remediation, say attorneys at Cleary.

  • AG Watch: Texas Expands Use Of Consumer Protection Laws

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    In recent years under Attorney General Ken Paxton, Texas has demonstrated the breadth of its public interest authority by bringing actions in areas not traditionally associated with consumer protection law, including recent actions involving sports and public safety, say attorneys at Kelley Drye.

  • Series

    Power To The Paralegals: An Untapped Source For Biz Roles

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    Law firms looking to recruit legal business talent should consider turning to paralegals, who practice several key skills every day that prepare them to thrive in marketing and client development roles, says Vanessa Torres at Lowenstein Sandler.

  • A Path Forward For Colo. Pot Products After Failed Safety Test

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    As cannabis products in Colorado face increasingly rigorous contamination testing, decontamination and remediation can be an alternative to destruction after a failed safety check, in certain circumstances, so understanding the nuances of these procedures is vital, say attorneys at Troutman Pepper.

  • Series

    Playing Poker Makes Me A Better Lawyer

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    Poker is a master class in psychology, risk management and strategic thinking, and I’m a better attorney because it has taught me to read my opponents, adapt when I’m dealt the unexpected and stay patient until I'm ready to reveal my hand, says Casey Kingsley at McCreadyLaw.

  • What EU 'Killer Acquisition' Study Means For Pharma Deals

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    The European Commission’s recent study of pharmaceutical companies' acquisitions of emerging competitive threats, the first of its kind globally, has important implications for the industry, and may lead to increased awareness of merger control risks in collaborative agreements, say lawyers at Paul Weiss.

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