Life Sciences

  • September 10, 2025

    Splenda Maker Says Scientist's Counterclaims Are Too Late

    The company behind artificial sweetener Splenda is urging a North Carolina federal court to deny a scientist's bid to amend her counterclaims in a suit over whether Splenda contains cancer-causing chemicals, saying her claims are either outside the statute of limitations or retreads of claims she already dropped.

  • September 09, 2025

    4th Circ. Debates Whether 'Silence' In 340B Empowers States

    Two states told a Fourth Circuit panel on Tuesday that "silence" in the law governing the federal government's drug discount program permits state enforcers to step in and regulate the delivery of those drugs to their communities.

  • September 09, 2025

    CVS Says Takeda Tried To Block Heartburn Drug Competition

    Drugmaker Takeda Pharmaceutical Co. Ltd. and other entities engaged in a "horizontal conspiracy and agreement" to restrain competition in the U.S. market for the acid reflux drug Dexilant and its generic equivalents, CVS Pharmacy Inc. alleged in a complaint filed in California federal court Tuesday.

  • September 09, 2025

    PTAB Leader Urges Specificity In Discretionary Denial Briefs

    The Patent Trial and Appeal Board's acting chief judge urged litigants Tuesday to support the arguments they make in the board's new discretionary denial process with specific details about their cases, during a panel where lawyers expressed both frustration about and praise for the system.

  • September 09, 2025

    Zantac Buyers Will Appeal Sanofi Dismissal From Conn. Suit

    Hundreds of out-of-state purchasers of the heartburn drug ranitidine, the generic form of Zantac, have signaled plans to appeal a Connecticut judge's dismissal of negligent design claims against Sanofi-Aventis U.S. LLC, challenging the conclusion that they had no right to sue the company in the Constitution State.

  • September 09, 2025

    Omni Must Pay Atty Fees Over 'Troubling' Conduct In FCA Suit

    A Massachusetts federal judge has ordered a medical practice to pay legal fees to a lab it accused of False Claims Act violations, ruling its claims were "clearly vexatious" because the provider knowingly ordered medically unnecessary tests to support its suit.

  • September 09, 2025

    MAHA Report Calls For Increased Scrutiny Of Drug Advertising

    The Trump administration on Tuesday pledged to ramp up federal oversight of drug advertising, update dietary guidelines and slash unnecessary regulations as part of its strategy to boost the health of America's children and curb the rise in childhood chronic disease.

  • September 09, 2025

    Gilgo Beach DNA Evidence Ruling May Propel New Methods

    A recent ruling from the New York judge overseeing the Gilgo Beach serial killer case finding that the newer DNA testing method known as whole genome sequencing clears rigorous admissibility standards is a laudable decision that could help solve cold cases, according to proponents of the technology.

  • September 09, 2025

    Sandoz, Regeneron Settle Eye Drug Patent Claims

    Sandoz Inc. and Regeneron Pharmaceuticals Inc. have reached a settlement to resolve patent claims Regeneron had asserted over a biosimilar alternative to its Eylea ophthalmic disorder drug.

  • September 09, 2025

    Particle's Antitrust Battle With Epic: 3 Things To Know

    Epic Systems Corp. must face allegations it violated federal law by attempting to monopolize a segment of the electronic health records market to the exclusion of competitor Particle Health Inc. Here's what you need to know about the case.

  • September 09, 2025

    Roberts Pauses Foreign Aid Distribution For Now

    Chief Justice John Roberts on Tuesday temporarily stayed a lower court's order requiring the Trump administration to release roughly $4 billion in frozen foreign aid while the U.S. Supreme Court considers a longer-term solution. 

  • September 09, 2025

    Kidney Care Co. Strive Health Secures $550M In New Funding

    Kidney care company Strive Health, led by Goodwin Procter LLP, on Tuesday revealed that it has completed a $550 million capital raise, which will be used to help the company enhance its "value-based" care model through advanced technology such as artificial intelligence-driven tools and analytics.

  • September 09, 2025

    DOJ, FTC Urged To Probe Drugmakers' Rebate Models

    The American Hospital Association asked the Trump administration to investigate whether major pharmaceutical companies violated antitrust laws as they push out new rebate models for a program that offers discounted drugs to healthcare providers serving low-income patients.

  • September 09, 2025

    3rd Circ. Told Cigna's 'Private Label' Stelara May Alter Market

    A Johnson & Johnson subsidiary told a Third Circuit panel it would be "difficult" to calculate its potential monetary losses if a Cigna subsidiary were to launch its own version of an anti-inflammatory treatment, particularly if it permanently changed the market by giving the insurance giant a "private label" version that pharmacies would give preference over the original.

  • September 08, 2025

    NY AG To Fight Texas Bid To Enforce Abortion Ban Ruling

    New York Attorney General Letitia James on Monday moved to intervene in a lawsuit brought by the state of Texas that seeks to enforce a money judgment against a New York doctor for providing abortion-inducing drugs to a woman via telemedicine in the Lone Star state.

  • September 08, 2025

    Oura Domestic Labor Investment Won Import Ban, ITC Says

    The U.S. International Trade Commission has found that Ouraring Inc.'s commitments in the U.S. to producing its smart ring warranted the agency's decision to block Ultrahuman and RingConn from importing products it held infringed a wearable computing device patent.

  • September 08, 2025

    FisherBroyles Can't Nix Stem Cell Patent Malpractice Claim

    A California judge on Monday denied FisherBroyles LLP's motion to toss a claim in a $10 million malpractice suit brought against it by a stem cell treatment center, ruling the firm missed a deadline to file the motion. 

  • September 08, 2025

    Whisper Not Enough To Sustain Worker's Harassment Suit

    A Pennsylvania federal judge tossed a Merck Sharp & Dohme worker's suit Monday claiming his boss sexually harassed him by whispering in his ear at a staff meeting, ruling the singular incident did not create a hostile work environment at the pharmaceutical company.

  • September 08, 2025

    Trump Returns To High Court In Foreign Aid Freeze Dispute

    President Donald Trump asked the U.S. Supreme Court on Monday to pause a lower court's order requiring the administration to release roughly $4 billion in frozen foreign aid, claiming the ruling interferes with his attempt to lawfully rescind the funding.

  • September 08, 2025

    FibroGen To Pay SEC $1.25M Over Drug Mistatements

    Biopharmaceutical company FibroGen Inc. has agreed to pay a $1.25 million penalty to the U.S. Securities and Exchange Commission to resolve claims that its former chief medical officer fudged results for its primary drug, Roxadustat, which treats anemia in kidney disease patients.

  • September 08, 2025

    Catching Up With Delaware's Chancery Court

    Last week at the Delaware Court of Chancery, a bankruptcy administrator for a generic drugmaker formerly known as Teligent was told he can proceed with duty of oversight claims against most former officers and directors of the company, who the administrator said was complicit in the company's collapse. In an opinion, the Court of Chancery cites its 1996 decision In re Caremark International Inc. Derivative Litigation, which refined director duties of care and oversight.

  • September 08, 2025

    23andMe's Ch. 11 Sale Flouted State Privacy Law, Calif. Says

    The state of California has asked a Missouri federal judge to undo the $305 million bankruptcy sale of consumer DNA testing group 23andMe, arguing it sidestepped state consumer data protections.

  • 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.

Expert Analysis

  • 2 NY Rulings May Stem Foreign Co. Derivative Suits

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    In recent decades, shareholders have challenged the internal affairs doctrine by bringing a series of derivative actions in New York state court on behalf of foreign corporations, but the New York Court of Appeals' recent rulings in Ezrasons v. Rudd and Haussmann v. Baumann should slow that trend, say attorneys at Cleary.

  • Recent Reports Shed Light On Section 340B's Effectiveness

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    Recent analyses of the Section 340B program's effectiveness in helping patients afford drugs in Minnesota reinforce concerns about the program's lack of transparency and underscore the need for further evaluation of whether legislative reform should be enacted, say William A. Sarraille at the University of Maryland, and Andrée-Anne Fournier and Molly Frean at Analysis Group.

  • Opinion

    Congress Should Pass IP Reform, Starting With 3 Patent Bills

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    Congress is considering a trio of bipartisan bills to fix patent law problems that have cropped up over the past two decades, and it shouldn't stop there — addressing two other intellectual property issues is critical for America's economy, says retired Judge Kathleen O'Malley at the Council for Innovation Promotion.

  • Class Standing Issues Still Murky After Justices Punt LabCorp

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    While litigants and district courts had hoped the U.S. Supreme Court's ruling in LabCorp v. Davis would provide much-needed clarity on the interplay between Article III standing and class certification, the court's failure to rule on the issue leaves disagreement, confusion and uncertainty for stakeholders, says Erica Rutner at Cozen O'Connor.

  • When Reshoring, IP Issues Require A Strong Action Plan

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    With recent headlines highlighting tariffs as high as 3,521%, more firms will contemplate reshoring manufacturing to the U.S., and they will need to consider important intellectual property issues as part of this complex, expensive and lengthy undertaking, say attorneys at Norton Rose.

  • Series

    Volunteering At Schools Makes Me A Better Lawyer

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    Speaking to elementary school students about the importance of college and other opportunities after high school — especially students who may not see those paths reflected in their daily lives — not only taught me the importance of giving back, but also helped to sharpen several skills essential to a successful legal practice, says Guillermo Escobedo at Constangy.

  • 5 Open Questions About FDA's AI-Assisted Review Plans

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    The U.S. Food and Drug Administration recently touted the completion of a generative artificial intelligence program for scientific reviewers and plans for agencywide deployment to speed up reviews of premarket applications, but there is considerable uncertainty surrounding the tools' ability to protect trade secrets, avoid bias and more, say attorneys at King & Spalding.

  • Prospects And Challenges For Expert Evidence At The UPC

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    Expert testimony on economic or damages-related issues will likely play a larger part in Unified Patent Court proceedings in the near future, potentially presenting unique challenges for experts, counsel and judges alike, say analysts at Charles River.

  • Attacks On Judicial Independence Tend To Manifest In 3 Ways

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    Attacks on judicial independence now run the gamut from gross (bald-faced interference) to systemic (structural changes) to insidious (efforts to undermine public trust), so lawyers, judges and the public must recognize the fateful moment in which we live and defend the rule of law every day, says Jim Moliterno at Washington and Lee University.

  • Series

    Law School's Missed Lessons: Appreciating Civil Procedure

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    If you’re like me, law school’s often complex and theoretical approach to teaching civil procedure may have contributed to an early struggle with the topic, but when seen from a practical perspective, new lawyers may find they enjoy mastering these rules, says Chloe Villagomez at Foster Garvey.

  • Calif. Bar Exam Fiasco Shows Why Attys Must Disclose AI Use

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    The recent revelation that a handful of questions from the controversial California bar exam administered in February were drafted using generative artificial intelligence demonstrates the continued importance of disclosure for attorneys who use AI tools, say attorneys at Troutman.

  • In 2nd Place, Va. 'Rocket Docket' Remains Old Reliable

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    The U.S. District Court for the Eastern District of Virginia was again one of the fastest civil trial courts in the nation last year, and an interview with the court’s newest judge provides insights into why it continues to soar, says Robert Tata at Hunton.

  • Parsing A Lack Of Antitrust Info-Sharing Enforcement Clarity

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    Information sharing among competing firms has recently faced dramatic changes in antitrust agency guidance, while courts grapple with the permissible scope of pricing algorithms, leaving companies in limbo, but potential Trump administration changes could offer some reprieve, say attorneys at Axinn.

  • What FCA Liability Looks Like In The Cybersecurity Realm

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    ​Two recent settlements highlight how whistleblowers and the U.S. Department of Justice have been utilizing the False Claims Act to allege fraud predicated on violations of cybersecurity standards — timely lessons given new bipartisan legislation introducing potential FCA liability for artificial intelligence use, say​ attorneys Rachel Rose and Julie Bracker.

  • Foreign Sovereign Entities Should Heed 9th Circ. IP Ruling

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    After the Ninth Circuit recently held that four Chinese state-controlled companies were not immune from criminal indictment for alleged economic espionage, foreign sovereign-controlled entities should assess whether their operations and affiliation with their parent states qualify for sovereign immunity under the common law, say attorneys at Cleary.

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