Life Sciences

  • March 05, 2026

    Top Patent Officials To Review Sanofi's Double Patenting Win

    U.S. Patent and Trademark Office Director John Squires on Thursday announced he'll be reviewing whether the Patent Trial and Appeal Board properly approved Sanofi's patent application after an obviousness-type double patenting rejection.

  • March 05, 2026

    Pharma Co. Investors Secure Class Cert. Over FDA Obstacles

    A Pennsylvania federal judge has granted certification to a group of Verrica Pharmaceuticals Inc. investors who claim the company defrauded them by hiding obstacles it faced in obtaining approval from the U.S. Food and Drug Administration for its lead product, though she made a slight change to the class definition to avoid what she called a "heads I win, tails you lose strategy."

  • March 05, 2026

    Drugmaker Aquestive Hit With Suit Over FDA Approval Delay

    Pharmaceutical company Aquestive Therapeutics Inc. has been hit with a proposed class action accusing it of harming investors by failing to disclose the likelihood that the U.S. Food and Drug Administration would delay approval of the company's drug application for its allergic reaction treatment.

  • March 05, 2026

    Pfizer Gets OK For $29M SEC Payout From Insider Case

    A New York federal judge on Thursday approved a request from the U.S. Securities and Exchange Commission and Pfizer to have $29 million paid out to a Pfizer subsidiary from the roughly $75.2 million distribution left over from a $602 million insider trading deal.

  • March 05, 2026

    Progenity Investors' $1M Billing Fraud Suit Deal Gets Final OK

    Genetic test distributor Progenity Inc., now known as Biora Therapeutics Inc., has received final approval of a $1 million settlement with investors, resolving claims that it made misleading statements ahead of its June 2020 initial public offering about its practice of overbilling the government.

  • March 05, 2026

    Fed. Circ. Mulls Patents In Penile Implant Trade Secret Win

    A Federal Circuit panel on Thursday grilled both sides in a trade secret dispute over penile implants that resulted in an $18.3 million judgment against defendants, repeatedly questioning attorneys about whether existing patents doomed the trade secrets claimed by International Medical Devices and its founder, Dr. James Elist.

  • March 05, 2026

    9th Circ. Judge 'Frustrated' At DOJ Position On Anti-Trans EOs

    A Ninth Circuit judge said Thursday he's "very frustrated" with the Trump administration's argument that a district court judge acted prematurely by partly blocking executive orders to end funding for gender-affirming care, saying it's "pretty clear" the government was poised to do exactly that.

  • March 05, 2026

    Squires' Newest Quick Order Grants 5 Petitions, Rejects 4

    The latest bulk order from U.S. Patent and Trademark Office Director John Squires on America Invents Act patent challenges instituted five petitions while denying four others on discretionary grounds, including three brought by Samsung.

  • March 05, 2026

    Fla. Lab Pays $980K To Settle Kickback Allegations

    A laboratory in Florida agreed to pay $980,000 to resolve allegations that it provided kickbacks to marketers for referring Medicare beneficiaries to use its services, according to a Thursday statement from the U.S. Department of Justice.

  • March 05, 2026

    Insurer Seeks Win In $6.3M Coverage Row With Pot Tester

    James River Insurance Co. is asking a Mississippi federal court to grant it a win in its suit to deny coverage of a $6.3 million default judgment against a cannabis testing company, saying the company breached its policy by not cooperating with the insurer.

  • March 04, 2026

    Wheeling & Appealing: The Latest Must-Know Appellate Action

    If this month's circuit calendars were a March Madness bracket, we'd struggle to pick the top-seeded showdown. Big Pharma against the False Claims Act, or big business against President Donald Trump's visa fees? A big bank's view of "human life wagers," or en banc review in a State Farm class action?

  • March 04, 2026

    CVS Beats Antitrust Suit Over 340B Drug Program, For Good

    CVS Health Corp. permanently defeated a proposed antitrust class action alleging it forced hospitals in a discount drug program to use its third-party administrator for savings, when a Pennsylvania federal judge ruled Tuesday that hospitals aren't required to contract with CVS and can pick Walgreens or other participating pharmacies to contract with.

  • March 04, 2026

    Del. Judge Mocks IP Owner, But Still: 'Defendants Win? No!'

    U.S. District Judge Richard G. Andrews has refused to dismiss New Directions Technology Consulting's patent infringement litigation over pacemakers and glucose monitors against Abbott Laboratories, but he had choice words for both parties when doing so.

  • March 04, 2026

    Regeneron, Sanofi Didn't Warn About Cancer Risk, Suit Says

    Regeneron Pharmaceuticals and Sanofi-Aventis were sued Tuesday in Georgia federal court by a woman who said she experienced rapid progression of cutaneous T-cell lymphoma after getting injections of dupilumab, a medication the companies sell as Dupixent as a treatment for inflammation.

  • March 04, 2026

    Zantac Investor Class Action Time-Barred, Pa. Judge Rules

    The maker of heartburn and acid reflux relief tablet Zantac has defeated a securities fraud class action claiming the company hid for decades the cancer risks associated with the drug, causing a stock price drop when the truth was revealed, after a Pennsylvania federal judge ruled Wednesday that the claims were untimely.

  • March 04, 2026

    GAO Denies Protest Of $39.5M Defense Logistics Contract

    The Defense Logistics Agency reasonably concluded that a pharmaceutical company was at fault for any missubmitted bids, the U.S. Government Accountability Office said, denying the company's protest of a $39.5 million contract for potassium chloride tablets.

  • March 04, 2026

    9th Circ. Hesitant To Revive Implant Suit Against Medtronic

    A Ninth Circuit panel cast doubt Wednesday on a Washington man's attempt to revive a negligence lawsuit against Medtronic for allegedly not assisting him when his spinal implant malfunctioned, hinting that his failure to find an expert witness to testify the device caused his pain may be fatal to the case.

  • March 04, 2026

    DC Judge Strikes Down 340B Drug Discount Registration Rule

    The U.S. Health Resources and Services Administration cannot reinstate a pre-pandemic policy requiring covered hospitals' offsite facilities to register with the agency in order to access discounted drugs under the 340B program, a D.C. federal judge ruled.

  • March 04, 2026

    Sandoz Parent Targets Walmart, Southwest Generic Drug Suits

    Sandoz parent company Sandoz AG contested generic drug price-fixing complaints from Southwest Airlines, Walmart, Walgreen and United Healthcare, arguing that the direct action plaintiffs cannot pursue the company in the wider Pennsylvania federal court multidistrict litigation because the Swiss firm is too far removed from its Sandoz Inc. subsidiary.

  • March 04, 2026

    Buyers Finalize $58M Generic-Pricing Deal With 3 Drugmakers

    Purchasers of certain generic drugs asked a Pennsylvania federal court for final approval of settlements worth a total of at least $58 million with Glenmark Pharmaceutical Inc., Greenstone LLC and Pfizer Inc. over claims the companies colluded with others to keep drug prices high.

  • March 04, 2026

    Judge Sets 'Hard Deadline' To Rule On Childhood Vax Policy

    A Massachusetts federal judge said Wednesday he will rule within two weeks on a closely watched request to block the Centers for Disease Control and Prevention from paring back the recommended childhood vaccine schedule.

  • March 03, 2026

    Moderna To Pay At Least $950M To End COVID-19 Vax IP Fight

    Moderna announced Tuesday that it will pay $950 million to resolve global patent litigation brought by Arbutus and Genevant Sciences over Moderna's COVID-19 vaccines, with no future royalties, but the company could pay as much as $2.25 billion if it loses an appeal at the Federal Circuit.

  • March 03, 2026

    EPA Fights Fluoridated Water IQ Risk Finding At 9th Circ.

    The U.S. Environmental Protection Agency urged the Ninth Circuit on Tuesday to reverse a ruling that the EPA's current "optimal" level of fluoride in drinking water poses an unreasonable risk of lowering children's IQ, arguing that the trial judge improperly held his ruling in abeyance for years to await more scientific evidence.

  • March 03, 2026

    Calif. Sued Over Cancer Warning Law For Personal Care

    Forcing makeup and personal care companies to place Proposition 65 warning labels on products containing the chemical diethanolamine, or DEA, violates the First Amendment, according to a California federal lawsuit, which argues the practice is costing companies millions.

  • March 03, 2026

    BioAge Investors Lose Last Bid At Obesity Drug-Linked Suit

    Biopharmaceutical company BioAge Labs Inc. has escaped a suit accusing it of damaging investors by unexpectedly halting a clinical trial for a weight loss drug, with a California federal judge finding that the court already dismissed the claim that BioAge's risk disclosures were lacking.

Expert Analysis

  • Opinion

    Punitive Damages Awards Should Be Limited To 1st Instance

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    Recent verdicts in different cases against Johnson & Johnson and Monsanto showcase a trend of multiple punitive damages being awarded to different plaintiffs for the same course of conduct by a single defendant, a practice that should be deemed unconstitutional by the U.S. Supreme Court, says Jacob Mihm at Polales Horton.

  • How Calif. High Court Is Rethinking Forum Selection Clauses

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    Two recent cases before the California Supreme Court show that the state is shifting toward greater enforcement of freely negotiated forum selection clauses between sophisticated parties, so litigators need to revisit old assumptions about the breadth of California's public policy exception, says Josh Patashnik at Perkins Coie.

  • AI Litigation Tools Can Enhance Case Assessment, Strategy

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    Civil litigators can use artificial intelligence tools to strengthen case assessment and aid in early strategy development, as long as they address the risks and ethical considerations that accompany these uses, say attorneys at Barnes & Thornburg.

  • Attys Beware: Generative AI Can Also Hallucinate Metadata

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    In addition to the well-known problem of AI-generated hallucinations in legal documents, AI tools can also hallucinate metadata — threatening the integrity of discovery, the reliability of evidence and the ability to definitively identify the provenance of electronic documents, say attorneys at Law & Forensics.

  • Lessons From Fed. Circ. On Expert Testimony In Patent Cases

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    Several recent decisions from the Federal Circuit are notable for their treatment of expert testimony, with relevance to the three pillars of every patent case — infringement, invalidity and damages — and offer lessons on ensuring that expert testimony is both admissible and sufficient to support the jury's verdict, say attorneys at Honigman.

  • When Atty Ethics Violations Give Rise To Causes Of Action

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    Though the Model Rules of Professional Conduct make clear that a violation of the rules does not automatically create a cause of action, attorneys should beware of a few scenarios in which they could face lawsuits for ethical lapses, says Brian Faughnan at Faughnan Law.

  • What's New In FDA's Latest Cell And Gene Therapy Guidance

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    New draft guidance from the U.S. Food and Drug Administration, along with other recent initiatives, come together to promote cell and gene therapy product development by streamlining development and review pathways, say attorneys at Holland & Knight.

  • Trending At The PTAB: A Potential Barrier To Serial Challenges

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    New rules proposed by the U.S. Patent and Trademark Office may appear similar to previous rules at first glance, but are actually much broader in how they would limit petitioners' ability to challenge a patent more than once, say attorneys at Finnegan.

  • What's Changing For Cos. In New Calif. Hazardous Waste Plan

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    While the latest hazardous waste management plan from California's Department of Toxic Substances Control still awaits final approval, companies can begin aligning internal systems now with the plan's new requirements for environmental justice, waste and disposal reduction, waste criteria, and capacity planning, says Thierry Montoya at Frost Brown.

  • Fed. Circ. In September: The Printed Matter Doctrine Expands

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    The Federal Circuit’s recent decision in Bayer v. Mylan represents an extension of the doctrine that adding new words to an existing product or method will not support patentability unless there is a functional relationship, bringing new considerations for both patent holders and challengers, say attorneys at Knobbe Martens.

  • Justices' LabCorp Punt Leaves Deeper Class Cert. Circuit Split

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    In its ruling in LabCorp v. Davis, the U.S. Supreme Court left unresolved a standing-related class certification issue that has plagued class action jurisprudence for years — and subsequent conflicting decisions among federal circuit courts have left district courts and litigants struggling with conflicting and uncertain standards, say attorneys at Cozen O'Connor.

  • Series

    Practicing Stoicism Makes Me A Better Lawyer

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    Practicing Stoicism, by applying reason to ignore my emotions and govern my decisions, has enabled me to approach challenging situations in a structured way, ultimately providing advice singularly devoted to a client's interest, says John Baranello at Moses & Singer.

  • Broader Eligibility For AI-Related Patents May Be Coming

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    A series of recent developments from the U.S. Patent and Trademark Office appears to signal that claims involving improvement in the operation of a machine learning model are now more likely to be considered patent-eligible, and that patent examiners may focus on questions of novelty and nonobviousness and less so on subject matter eligibility, say attorneys at Kilpatrick.

  • Series

    The Biz Court Digest: Texas, One Year In

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    A year after the Texas Business Court's first decision, it's clear that Texas didn't just copy Delaware and instead built something uniquely its own, combining specialization with constitutional accountability and creating a model that looks forward without losing touch with the state's democratic and statutory roots, says Chris Bankler at Jackson Walker.

  • AI Product Safety Insights May Expand Foreseeability

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    Product liability law has long held that companies are responsible for risks they knew about or should have known about — and with AI systems now able to assess and predict hazards during the design process, companies should expect that courts will likely treat such hazards as foreseeable, says Donald Fountain at Clark Fountain.

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