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Life Sciences

  • July 18, 2025

    Judge Advised Against State AG Intervention In Sandoz Deal

    A special master on Friday advised a Pennsylvania federal court to deny a bid by California and other state attorneys general to intervene in a $275 million settlement resolving generic-drug price-fixing claims against Sandoz, finding they lacked standing to represent the interests of consumers.

  • July 18, 2025

    Stewart Issues Discretion Decisions For 56 More Petitions

    Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart issued 25 more orders on requests for discretionary denial, deciding a total of 56 cases, while the results of earlier proceedings she let move forward have started to roll out.

  • July 18, 2025

    MSN Urges Fed. Circ. To Allow Launch Of Generic Entresto

    MSN Pharmaceuticals asked the Federal Circuit on Friday to lift a temporary injunction and allow the company to launch a generic version of the blockbuster heart drug Entresto, a move MSN says would benefit the public by reducing costs for Medicare and Medicaid.

  • July 18, 2025

    Fed. Circ. Frees Medtronic From $125M Patent Judgment

    The Federal Circuit on Friday overturned a more than $125 million judgment against Medtronic's CoreValve unit for infringing a Colibri Heart Valve LLC patent, saying changes made to the patent during examination mean that Medtronic should not have been found to infringe.

  • July 18, 2025

    Off The Bench: Latest NASCAR Win, Trans Athlete Fights Ban

    In this week's Off The Bench, Michael Jordan's racing team fails to bounce back right away from a tough defeat in its battle with NASCAR, a transgender woman fights a last-minute expulsion from a college women's track and field event, and a football player sees his window to playing an extra college season slammed shut by the NCAA and the Seventh Circuit.

  • July 18, 2025

    Trump Flexes Air Law Power To Delay Compliance Deadlines

    President Donald Trump has postponed deadlines to comply with air pollution standards for companies in the coal power, chemical manufacturing, medical sterilization and iron ore industries, relying on special presidential power contained in the Clean Air Act.

  • July 18, 2025

    Supply Co. Looks To Spur New Judge Amid NC Staff Shortage

    A medical supply procurement company on Friday sought to hasten the assignment of a new judge to its contract suit against a pharmaceutical middleman after the previous judge retired, acknowledging there are staffing issues in the Western District of North Carolina but saying the "serious case" needs attention to stay on track.

  • July 18, 2025

    Taxation With Representation: Wachtell, Slaughter And May

    In this week's Taxation With Representation, Blackstone pours billions into data centers and related infrastructure, Waters Corp. and Becton Dickinson look to form a new life sciences powerhouse, Reckitt sells 70% of its Essential Home business to private equity firm Advent, and Chevron completes its acquisition of Hess following a favorable arbitral award.

  • July 17, 2025

    FDA Signs Off On Juul E-Cig Products After 5-Year Review

    The U.S. Food and Drug Administration on Thursday gave Juul the green light to market five e-cigarette products, although the FDA noted that the long-awaited authorization "does not mean these tobacco products are safe, nor are they FDA-approved."

  • July 17, 2025

    FDA Warns Firms Over Illegal Kratom Product Marketing

    The U.S. Food and Drug Administration has warned seven companies — including a California company facing a proposed class action — that they are illegally marketing products containing a potent kratom-derived compound, in letters that indicate intensified federal scrutiny of the opioid-like supplement.

  • July 17, 2025

    SEC Fraud Suit Against Ex-Online Pharmacy Execs Advances

    A New York federal judge has declined to dismiss a majority of the U.S. Securities and Exchange Commission's claims against former executives of a now-defunct online pharmacy called Medly, finding the agency adequately pleaded that the executives made false statements or acted recklessly, among other misconduct.

  • July 17, 2025

    11th Circ. Says Ex-Quest Diagnostics Worker's FCA Suit Fails

    The Eleventh Circuit declined to revive a former Quest Diagnostics Inc. compliance officer's False Claims Act suit against the lab testing company, ruling she had failed to allege a specific claim of medical billing fraud after some 15 years of litigation.

  • July 17, 2025

    Stanford Trims Roche IP Suit, But Others Face Most Claims

    Stanford University was let out of all but one claim brought by subsidiaries of F. Hoffmann-La Roche AG over alleged trade secret theft, but a California federal judge allowed most claims to move forward against several Stanford professors and a startup they founded.

  • July 17, 2025

    Senators Float 'Patent Thicket' Bill To Limit Generic Litigation

    A bill floated in the U.S. Senate would limit the use of so-called patent thickets that are asserted by major pharmaceutical companies in litigation to restrict generic competition.

  • July 17, 2025

    6 Cases For Patent Attys To Watch In The Second Half Of 2025

    The Federal Circuit is considering major questions about when delays in prosecuting patents become bad faith and whether the acting U.S. Patent and Trademark Office director is legally allowed to apply new rules retroactively. Here's what you need to know about these cases and others that attorneys are keeping an eye on for the rest of the year.

  • July 17, 2025

    Ex-CEO Agrees To $27.5M Judgment In Medicare Fraud Case

    A day before his trial was set to begin, the former CEO and owner of the now-defunct laboratory Premier Medical Inc. agreed to a $27.5 million consent judgment, acknowledging he was likely to be found liable in the suit brought against him by the federal government and three states.

  • July 17, 2025

    Fla. AG, Sandoz Clash With Other Enforcers Over 'Done' Deal

    Sandoz and Florida's attorney general pressed a Connecticut federal judge Wednesday to let them settle out of sweeping price-fixing litigation against generic-drug makers, contending that federal civil procedure rules give no room for objections from other state enforcers worried the Sunshine State deal interferes with their own ability to negotiate settlements.  

  • July 17, 2025

    PE Firm Is Denied FDA Docs For Defense In Deal Challenge

    An Illinois federal court on Wednesday denied a request from private equity firm GTCR BC Holdings LLC to force the U.S. Food and Drug Administration to produce more than a decade's worth of medical device approval applications as the firm fights a merger challenge from enforcers.

  • July 17, 2025

    J&J Loses Bid To DQ Beasley Allen From Talc MDL Committee

    A New Jersey federal judge on Thursday denied Johnson & Johnson's bid to remove the Beasley Allen Law Firm from the plaintiffs steering committee in the multidistrict talc litigation but said that changes would be made to the committee's structure.

  • July 17, 2025

    Iowa Church Says DEA Can't 'Pocket Veto' Drug Exemption

    An Iowa church is asking the D.C. Circuit to force the Drug Enforcement Administration to rule on an application it filed more than six years ago for a religious exemption to use a psychedelic in its services, saying the DEA shouldn't be allowed to "pocket veto" the application and leave the church hanging.

  • July 16, 2025

    Pharmacy Benefit Managers Say Ohio Can't Recast Suit

    The state of Ohio can't "recast its complaint on appeal" in order to convince the Sixth Circuit that its enforcement suit accusing two pharmacy benefit managers of working to raise the cost of prescription drugs belongs in state court, those managers have told the appellate court.

  • July 16, 2025

    Gilgo Beach Killer Case Puts New DNA Science To The Test

    The only physical evidence linking the Gilgo Beach serial killings to the defendant, Rex Heuermann, are five hairs that could only be analyzed via a newer technique known as whole genome sequencing, but as the court decides whether the science is jury ready, experts are divided.

  • July 16, 2025

    Hims & Hers Brass Face Suit Over 'Knockoff' Wegovy Sales

    Executives and directors of telehealth company Hims & Hers Health Inc. have been hit with a shareholder derivative suit in California federal court accusing them of allowing the company to exploit its now-terminated partnership with Novo Nordisk to sell "knockoff" versions of Novo's weight loss drug Wegovy,.

  • July 16, 2025

    Glucose Monitoring Co. LifeScan Hits Ch. 11 With $1.7B Debt

    LifeScan Global Corp., a company that makes blood glucose monitoring devices, has filed for Chapter 11 protection in Texas bankruptcy court with $1.7 billion of debt and a plan supported by its private equity backer to trim more than 75% of debt by handing the business to existing lenders.

  • July 16, 2025

    Novartis Denied Bid To Block Generic Entresto In TM Feud

    A New Jersey federal judge has rethought her initial decision blocking a Novartis competitor from potentially selling a generic version of a heart failure treatment drug, saying she got it wrong when she earlier analyzed a trade dress claim.

Expert Analysis

  • Purdue Case Could Transform Patent Obviousness Analyses

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    If accepted for review by the U.S. Supreme Court, Purdue Pharma v. Accord Healthcare — concerning whether Purdue's abuse-deterrent opioid formulation patents were invalid as obvious — could significantly shift how courts weigh secondary considerations in patent obviousness analyses, say attorneys at Lathrop.

  • Federal Regs Order May Spell Harsher FDCA Enforcement

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    A recent executive order aimed at reducing criminal prosecutions of those who unknowingly violate complex federal regulations may actually lead to more aggressive felony indictments under the Federal Food, Drug and Cosmetic Act, but companies and executives can mitigate risks by following several key principals, say attorneys at McGuireWoods.

  • Series

    Law School's Missed Lessons: Practicing Self-Care

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    Law schools don’t teach the mental, physical and emotional health maintenance tools necessary to deal with the profession's many demands, but practicing self-care is an important key to success that can help to improve focus, manage stress and reduce burnout, says Rachel Leonard​​​​​​​ at MG+M.

  • ABA Opinion Makes It A Bit Easier To Drop A 'Hot Potato'

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    The American Bar Association's recent ethics opinion clarifies when attorneys may terminate clients without good cause, though courts may still disqualify a lawyer who drops a client like a hot potato, so sending a closeout letter is always a best practice, say attorneys at Thompson Hine.

  • IRhythm IPR Denial Raises Key PTAB Discretion Questions

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    By giving the passage of time a dispositive role in denying institution of five inter partes review petitions filed by iRhythm Technologies, the U.S. Patent and Trademark Office has upended the strategic considerations for filing and defending against IPRs, disclosing prior art during prosecution, and engaging in licensing negotiations, say attorneys at Dentons.

  • Canadian Suit Offers Disclosure Lesson For US Cannabis Cos.

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    A Canadian class action asserting that Aurora Cannabis failed to warn consumers about the risk of developing cannabinoid hyperemesis syndrome may spawn copycat filings in the U.S., and is a cautionary tale for cannabis and hemp industries to prioritize risk disclosure, says Ian Stewart at Wilson Elser.

  • Opinion

    IPR Denial In IRhythm Should Not Set A Blanket Rule

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    Though the Patent Trial and Appeal Board's discretionary denial in iRhythm v. Welch Allyn last month raised concerns that mere knowledge of a patent could bar inter partes review institution, a closer look at the facts and reasoning reveals why this case's holdings should not be reflexively applied to all petitioners, says David McCombs at Haynes Boone.

  • What High Court's Tenn. Trans Care Ruling Means Nationally

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    The U.S. Supreme Court's decision in U.S. v. Skrmetti, upholding a Tennessee ban on gender-affirming medical care for minors, is fairly limited in scope and closely tailored to the specific language of Tennessee's law, but it may have implications for challenges to similar laws in other states, say attorneys at Hall Render.

  • How Trump's Trade Policies Are Shaping Foreign Investment

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    Five months into the Trump administration, investors are beginning to see the concrete effects of the president’s America First Investment Policy as it presents new opportunities for clearing transactions more quickly, while sustaining risk aversion related to Chinese trade and potentially creating different political risks, say attorneys at Covington.

  • Series

    My Opera And Baseball Careers Make Me A Better Lawyer

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    Though participating in opera and the world of professional baseball often pulls me away from the office, my avocations improve my legal career by helping me perform under scrutiny, prioritize team success, and maintain joy and perspective at work, says Adam Unger at Herrick Feinstein.

  • Opinion

    Subject Matter Eligibility Test Should Return To Preemption

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    Subject matter eligibility has posed challenges for patentees due to courts' arbitrary and confusing reasoning, but adopting a two-part preemption test could align the applicant, the U.S. Patent and Trademark Office and the courts, says Manav Das at McDonnell Boehnen.

  • 8 Ways Lawyers Can Protect The Rule Of Law In Their Work

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    Whether they are concerned with judicial independence, regulatory predictability or client confidence, lawyers can take specific meaningful actions on their own when traditional structures are too slow or too compromised to respond, says Angeli Patel at the Berkeley Center of Law and Business.

  • Is SEC Moving Away From Parallel Insider Trading Cases?

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    The U.S. Securities and Exchange Commission's apparent lack of follow-up in four recent criminal cases of insider trading brought by the Justice Department suggests the SEC may be reconsidering the expense and effort of bringing parallel civil charges for insider trading, say attorneys at Dentons.

  • Rising Enforcement Stakes For Pharma Telehealth Platforms

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    Two pieces of legislation recently introduced in Congress could transform the structure and promotion of telehealth arrangements as legislators increasingly scrutinize direct-to-consumer advertising platforms, potentially paving the way for a new U.S. Food and Drug Administration policy with bipartisan support, say attorneys at Sheppard Mullin.

  • Series

    Law School's Missed Lessons: Communicating With Clients

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    Law school curricula often overlook client communication procedures, and those who actively teach this crucial facet of the practice can create exceptional client satisfaction and success, says Patrick Hanson at Wiggam Law.

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