Life Sciences

  • October 30, 2025

    Fed. Circ. Explains Rule While Upholding Merck PTAB Loss

    The Federal Circuit sided with generics makers Thursday and upheld the Patent Trial and Appeal Board's invalidation of claims in two Merck KGaA patents on the blockbuster multiple sclerosis drug Mavenclad, while clarifying how to treat invalidity arguments that involve overlapping inventors.

  • October 30, 2025

    2nd Ex-Magellan Exec Avoids Jail Over Faulty Lead Tests

    A second former Magellan Diagnostics executive ducked prison time Thursday for his role in an alleged scheme to hide a defect in the company's lead-testing devices ahead of its sale in 2016.

  • October 30, 2025

    Lawmakers Slam Value-Based Patent Fee Proposal

    Six members of the U.S. House of Representatives wrote to U.S. Secretary of Commerce Howard Lutnick on Thursday expressing concern over the proposal to charge patent holders fees based on their patent's value, saying that will harm innovation and economic growth.

  • October 30, 2025

    J&J's Janssen Says 3rd Circ. Should Reverse $1.6B FCA Win

    Johnson & Johnson's Janssen Products LP urged the Third Circuit to overturn a $1.6 billion False Claims Act judgment over two of its HIV drugs, arguing the district court allowed whistleblowers to prove fraud based solely on "off-label" marketing rather than any false claim actually submitted to the government.

  • October 30, 2025

    Generic-Drug Firms Want To Fast-Track Conn. Price Cap Fight

    An industry group for generic and biosimilar pharmaceutical companies has asked a Connecticut federal judge to fast-track its lawsuit seeking to block the state's new drug price cap, claiming it will suffer "imminent harm" if the case is delayed.

  • October 30, 2025

    McCarter & English Used Doctrine As 'Whipsaw,' Panel Hears

    A biotech company on Thursday urged a New Jersey appellate panel to revive its legal malpractice suit against McCarter & English LLP, arguing that the claims were distinct from the firm's own suit seeking unpaid fees.

  • October 30, 2025

    Mich. Top Court Upholds Gilead Immunity In COVID Drug Case

    The Michigan Supreme Court on Wednesday said it won't consider an appeal from a man who was injected with a COVID-19 treatment made by Gilead Sciences Inc. that was later recalled for containing glass shards, a few months after a lower appellate court found the company immune because of a federal health emergency law.

  • October 30, 2025

    Judge Unpauses 'Important' Suit Over Vax Guidelines

    A Massachusetts federal judge agreed Thursday to lift a government shutdown-related stay of litigation challenging new COVID-19 vaccine recommendations for children and pregnant women, calling the case a "matter of national importance" that warrants keeping the case moving over the U.S. Department of Justice's objection.

  • October 30, 2025

    Novo Nordisk Bids $9B For Metsera, Jeopardizing Pfizer Deal

    Metsera Inc. said Thursday that Novo Nordisk has put forth a $9 billion buyout proposal that is "superior" to its existing agreement to sell itself to Pfizer, prompting a response from Pfizer stating that it is prepared to "pursue all legal avenues" to keep its agreement intact.

  • October 29, 2025

    DOJ Subpoena Called 'Pressure' To Ax Gender-Affirming Care

    The U.S. Department of Justice issued a subpoena to intimidate a telehealth organization into ending gender-affirming medical care, a Seattle federal judge said in a ruling that found the agency is using the guise of an investigation to further the Trump administration's stated goal of eliminating transgender and gender-diverse patients' access to healthcare.

  • October 29, 2025

    DexCom Misled Investors About Its Diabetes Tech, Suit Says

    Medical device maker DexCom is facing a proposed investor class action in Manhattan federal court alleging the company hurt shareholders by failing to disclose changes to a glucose monitoring device affecting the reliability of the device's readings.

  • October 29, 2025

    Conn. Med Spa Says Ex-Workers Poaching Clients, Employees

    Two former employees of a Connecticut medical spa violated their employment contract when they lured a co-worker to join them at a nearby competitor and began soliciting the spa's clients, a state court lawsuit alleges.

  • October 29, 2025

    Where PTAB Institution Reviews Stand As Squires Takes Lead

    U.S. Patent and Trademark Office Director John Squires will be maintaining the agency leader's new role of gatekeeper at the Patent Trial and Appeal Board. Here's what to know about his plans and the pushback on them.

  • October 29, 2025

    Taro Pharma Beats Investor Suit Over $43-Per-Share Buyout

    A New York federal judge tossed a proposed class action brought by minority shareholders of Taro Pharmaceutical Industries Ltd. that alleged the company and its majority shareholder misled them during the approval process for a $43-per-share buyout, finding the minority shareholders have failed to plead any actionable misstatements or omissions.

  • October 29, 2025

    Ga. Panel Backs Sanctions For 'Delaying Tactic' In Pot Dispute

    The Georgia Court of Appeals on Wednesday backed sanctions rulings against two companies that filed litigation after they were denied cannabis licenses by Georgia, only to draw out the proceedings for years before dropping their claims at "quite literally the last minute."

  • October 29, 2025

    FDA Unveils Plan To Speed Biosimilar Drugs To Market

    The Trump administration on Wednesday said it plans to slash the cost of biologics by shortening the time required to bring a biosimilar drug to market and making it easier for patients to switch to the cheaper products.

  • October 29, 2025

    3 Pharmaceutical Firms Will Pay $4M To Tribes In Opioid MDL

    Indivior, Sun Pharmaceuticals and Zydus Pharmaceuticals have inked deals to compensate tribes for their role in the opioid crisis, according to stipulated dismissals entered on Wednesday in Ohio federal court.

  • October 29, 2025

    Brothers Found Guilty Of $100M HIV Drug Fraud

    A Florida federal jury on Wednesday convicted two Maryland brothers accused of conspiring to distribute about $100 million worth of misbranded HIV drugs, finding them guilty of fraud charges related to selling the medication with fake tracing documents. 

  • October 29, 2025

    PE-Backed Medical Supplies Giant Medline Files For IPO

    Private equity-backed medical supplies giant Medline has filed for its long-awaited initial public offering, eyeing a return to public markets four years after being taken private through a large buyout. 

  • October 29, 2025

    'Smart Drugs' Amphetamine Suit Moves Forward Minus Execs

    A Washington federal judge declined to trim claims from a former army nurse's suit alleging that Thesis "smart drugs" contained amphetamines without warning consumers, while dismissing her claims against two executives for the company.

  • October 29, 2025

    3 Firms Guide Thermo Fisher On $8.9B Clario Deal

    Thermo Fisher Scientific Inc. said on Wednesday it will acquire Clario Holdings Inc., a provider of endpoint data solutions for clinical trials, from a shareholder group led by Astorg, Nordic Capital, Novo Holdings and Cinven for $8.875 billion in cash.

  • October 28, 2025

    Off-Label Prescribing Was Common, Novo Nordisk Tells Jury

    A whistleblower suing drugmaker Novo Nordisk for allegedly defrauding Washington state's Medicaid system acknowledged from the witness stand Tuesday that she previously prescribed hemophilia drugs for off-label use in her own practice — despite concerns she raised in her lawsuit about other doctors' off-label prescription of Novo Nordisk's drug NovoSeven.

  • October 28, 2025

    Apple Spared From Some Masimo Patent Claims Before Trial

    A California federal judge issued a mixed ruling in Masimo's case claiming Apple infringed its patents covering pulse oximetry technology for smartwatches, dismissing certain infringement theories but preserving other parts of the case for next week's trial.

  • October 28, 2025

    Perceptive Asks Chancery To Block Kindbody Ex-CEO's NY Suit

    Attorneys for senior lenders to nationwide fertility clinic chain Kindbody Inc. told a Delaware vice chancellor Tuesday that amendments to a former CEO's suit against the company's controlling lenders and directors in New York triggered a right to pull the dispute into Delaware's Court of Chancery.

  • October 28, 2025

    Trump Admin Ordered To Halt Some Shutdown-Linked Layoffs

    A California federal judge on Tuesday granted a preliminary injunction to eight unions for federal workers who lost their jobs during the government shutdown, saying they were likely to succeed on their claims that the Trump administration's actions were "political retribution" and unlawful.

Expert Analysis

  • 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.

  • 3 Judicial Approaches To Applying Loper Bright, 1 Year Later

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    In the year since the U.S. Supreme Court overturned Chevron deference in its Loper Bright Enterprises v. Raimondo decision, a few patterns have emerged in lower courts’ application of the precedent to determine whether agency actions are lawful, say attorneys at Husch Blackwell.

  • Prepping For SEC's Changing Life Sciences Enforcement

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    By proactively addressing several risk areas, companies in the life sciences sector can position themselves to minimize potential exposure under the U.S. Securities and Exchange Commission's return to back-to-basics enforcement focused on insider trading and fraud, say attorneys at Morgan Lewis.

  • Series

    Adapting To Private Practice: From US Rep. To Boutique Firm

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    My transition from serving as a member of Congress to becoming a partner at a boutique firm has been remarkably smooth, in part because I never stopped exercising my legal muscles, maintained relationships with my former colleagues and set the right tone at the outset, says Mondaire Jones at Friedman Kaplan.

  • How Providers Can Brace For Drug Pricing Policy Changes

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    Though it's uncertain which provisions of the Trump administration's executive order aimed at addressing prescription drug costs will eventually be implemented, stakeholders can reduce potential negative outcomes by understanding pathways that could be used to effectuate the order's directives, say attorneys at McDermott.

  • Discretionary Denial Rulings May Spur Calls For PTAB Reform

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    The U.S. Patent and Trademark Office's recent decision in iRhythm Technologies v. Welch Allyn, denying inter partes review based on the patent owner's settled expectations that the patent would not be challenged, could motivate patent holders to seek Patent Trial and Appeal Board reform to preserve patent quality without burdening owners, say attorneys at Dechert.

  • Comparing New Neural Data Privacy Laws In 4 States

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    Although no federal law yet addresses neural privacy comprehensively, the combined effect of recent state laws in Colorado, California, Montana and Connecticut is already shaping the regulatory future, but a multistate compliance strategy has quickly become a gating item for those experimenting with neuro-enabled workplace tools, says Kristen Mathews at Cooley.

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