Life Sciences

  • 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.

  • 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."

Expert Analysis

  • 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.

  • 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.

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