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Life Sciences

  • 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.

  • September 04, 2025

    Sanofi Settles Conn. Zantac Suits Alleging Cancer Risks

    After more than a year of indicating settlement talks would likely be successful, Sanofi-Aventis US LLC and Sanofi US Services Inc. on Thursday announced accords in two Connecticut state court lawsuits that asserted that generic forms of brand name heartburn and acid reflux drug Zantac degraded into a substance that caused cancer.

  • September 04, 2025

    Purdue Pharma Approved For $17.5M In Ch. 11 Bonus Plans

    Bankrupt pharmaceutical company Purdue Pharma LP received approval from a New York judge Thursday to pay more than $17.5 million in employee bonuses, mirroring the bonus structures of the last few years since the company commenced its Chapter 11 case.

  • September 04, 2025

    Ohio Cannabis Card Network Sued Over Faulty Cybersecurity

    An Ohio man is suing Ohio Medical Alliance LLC in federal court, alleging that its lackluster cybersecurity measures exposed more than 950,000 records containing private health information for its users.

  • September 03, 2025

    7th Circ. Backs AbbVie's Win Against Ex-Sales Rep's FCA Suit

    The Seventh Circuit declined to revive a former AbbVie employee's False Claims Act retaliation suit alleging he faced repercussions for refusing to push Vraylar's off-label use to treat major depressive disorder, ruling Wednesday he didn't put AbbVie on notice that he reasonably believed it was defrauding the government. 

Expert Analysis

  • Data Undermines USPTO's 'Settled Expectations' Doctrine

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    An analysis of inter partes review proceedings filed since 2012 appears to refute the U.S. Patent and Trademark Office's recent stance that patent owners develop a strong settled expectation that their patents will not be challenged after being in force for six years, say Jonathan DeFosse and Samuel Smith at Sheppard Mullin, and Kenzo Kasai at NGB Corp.

  • Advice For 1st-Gen Lawyers Entering The Legal Profession

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    Nikki Hurtado at The Ferraro Law Firm tells her story of being a first-generation lawyer and how others who begin their professional journeys without the benefit of playbooks handed down by relatives can turn this disadvantage into their greatest strength.

  • High Court E-Cig Ruling Opens Door For FDA Challenges

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    There will likely be more challenges to marketing denial orders brought before the Fifth Circuit following the Supreme Court's recent ruling in U.S. Food and Drug Administration v. R.J. Reynolds Vapor Co., where litigants have generally had greater success, say attorneys at Troutman Pepper.

  • Fed. Circ. In July: Instability In IPR Requirements

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    The Federal Circuit's decision in Shockwave v. Cardiovascular last month provided an important, albeit short-lived, clarification to the type of evidence that can be used in an inter partes review challenge, say attorneys at Knobbe Martens.

  • Structuring Noncompetes In License And Collaboration Deals

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    As companies grappling with coming patent cliffs look to mergers and acquisitions to compensate, contracting parties assessing biopharma license and collaboration agreements should prepare to agree on noncompetes that ensure the parties' respective objectives are met and that their incentives are aligned, both under their collaboration and beyond, says Jeff Jay at Freshfields.

  • Series

    Coaching Cheerleading Makes Me A Better Lawyer

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    At first glance, cheerleading and litigation may seem like worlds apart, but both require precision, adaptability, leadership and the ability to stay composed under pressure — all of which have sharpened how I approach my work in the emotionally complex world of mass torts and personal injury, says Rashanda Bruce at Robins Kaplan.

  • 7 Ways To Fetch Patents In The World Of Working Animals

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    Though developers rarely file patents related to working animals, and animal training techniques are generally considered unpatentable, certain aspects of training and developing animals may be ripe for patent protection, say Matthew Avery at Baker Botts, Makenzi Galvan at Perkins Coie and Lute Yang at Orrick.

  • 9th Circ.'s Kickback Ruling Strengthens A Prosecutorial Tool

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    The Ninth Circuit's decision last month in U.S. v. Schena, interpreting the Eliminating Kickbacks in Recovery Act to prohibit kickback conduct between the principal and individuals who do not directly interact with patients, serves as a wake-up call to the booming clinical laboratory testing industry, say attorneys at Kendall Brill.

  • Series

    Law School's Missed Lessons: How To Make A Deal

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    Preparing lawyers for the nuances of a transactional practice is not a strong suit for most law schools, but, in practice, there are six principles that can help young M&A lawyers become seasoned, trusted deal advisers, says Chuck Morton at Venable.

  • From Clerkship To Law Firm: 5 Transition Tips For Associates

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    Transitioning from a judicial clerkship to an associate position at a law firm may seem daunting, but by using knowledge gained while clerking, being mindful of key differences and taking advantage of professional development opportunities, these attorneys can flourish in private practice, say attorneys at Lowenstein Sandler.

  • 9th Circ.'s Trade Secrets Ruling Is A Win For DTSA Plaintiffs

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    The Ninth Circuit's recent decision in Quintara v. Ruifeng shifts the balance in federal trade secret litigation toward a more flexible, discovery-driven process, meaning that plaintiffs may be more likely to pursue claims under the Defend Trade Secrets Act, and early motions to strike or dismiss will face steep odds, say attorneys at Cooley.

  • Associates Can Earn Credibility By Investing In Relationships

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    As the class of 2025 prepares to join law firms this fall, new associates must adapt to office dynamics and establish credible reputations — which require quiet, consistent relationship-building skills as much as legal acumen, says Kyle Forges at Bast Amron.

  • Puzzling Out When Similar Insurance Claims Are Related

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    A recent decision in Virginia federal court shows that more than identical allegations of negligent business practices across two lawsuits may be necessary to satisfy the strict definition of relatedness under claims-made liability insurance policies, say attorneys at Hunton.

  • A Shifting Trend In FDA Form 483 Disclosure Obligations

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    A New York federal court's Checkpoint Therapeutics decision extends a recent streak of dismissals of securities class actions alleging that pharmaceutical companies failed to disclose U.S. Food and Drug Administration Form 483 inspection reports, providing critical guidance for companies during the FDA approval process, say attorneys at Alston & Bird.

  • Trending At The PTAB: IPR Memo And Its Fed. Circ. Backdrop

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    There are new rules for when and how evidence other than patents or printed publications can be considered in inter partes reviews, and while this change is intended to reflect current Federal Circuit precedent, the U.S. Patent and Trademark Office's memo seems to acknowledge tension with last month's Shockwave decision, say attorneys at Finnegan.

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