Life Sciences

  • December 19, 2024

    Judge Says Some Paraquat Plaintiffs Being Left In Dark

    Amid a hearing targeting fall 2025 for a first bellwether trial over the alleged link between the pesticide paraquat and Parkinson's disease, an Illinois federal judge told plaintiffs' lawyers to keep in better touch with their clients after her chambers received calls from plaintiffs wondering what's happening with their cases.

  • December 19, 2024

    PhRMA Wins Bid To Halt W.Va. Drug Discount Expansion Law

    The country's biggest pharmaceutical lobbying group has won preliminary injunctions against a West Virginia law that the Pharmaceutical Research and Manufacturers of America claims unconstitutionally expands a federal drug discount program, with a federal judge finding that the law threatens to create a situation where "the fox guards the henhouse."

  • December 19, 2024

    FTC Says PBMs Can't Get Preliminary Block In Insulin Case

    The Federal Trade Commission urged a Missouri federal judge Thursday not to temporarily block its in-house case accusing pharmacy benefits managers of artificially inflating insulin prices through unfair rebate schemes, arguing Congress clearly empowered such in-house adjudications and the officials who handle them.

  • December 19, 2024

    Foley Adds Tech, Life Sciences Partner From IP Boutique

    Foley & Lardner LLP has hired a longtime partner from intellectual property boutique Lerner David LLP to strengthen both the transactional and litigation arms of its technology and life science practices in New York.

  • December 19, 2024

    Judge Wrongly Axed $107M IP Verdict, Pfizer Tells Fed. Circ.

    A Pfizer unit has told the Federal Circuit that a federal judge got it wrong when he overturned a Delaware jury verdict that AstraZeneca owes $107.5 million for infringing two cancer drug patents.

  • December 19, 2024

    Biotech Co. Hid Eye Drug's Safety Risks, Investor Says

    A biotech company concealed the potential risks that emerged during clinical trials of a drug meant to treat age-related vision degradation, according to an investor complaint filed in Massachusetts federal court Thursday.

  • December 19, 2024

    Medical Supplies Giant, Drone Operator File Confidential IPOs

    Private equity-backed medical supplies giant Medline Inc. and drone operator Airo Group Holdings Inc. said Thursday that they confidentially filed plans for initial public offerings with regulators, joining a growing pipeline of IPO prospects for 2025.

  • December 19, 2024

    McKesson Urges Justices To Keep Hobbs Act's 'Exclusivity'

    McKesson Corp. is urging the U.S. Supreme Court to preserve circuit courts' "exclusive" jurisdiction for Federal Communications Commission orders, warning that regulatory consistency nationwide could be undermined if lower courts are allowed to step in.

  • December 19, 2024

    Medical Device Investors Get Final OK On $15M Deal

    A North Carolina federal judge has given final approval to a $15.25 million settlement that will resolve a suit claiming Bioventus Inc. misled investors about its internal controls and financial health and its readiness to implement new Medicare regulations, leading to inflated stock prices, along with $5 million in attorney fees.

  • December 19, 2024

    Generic-Drug Cos. Get State AGs' Trial Order Flipped

    A Connecticut federal court has sided with the generic-drug makers accused of price-fixing by state-level enforcers and will allow a narrower case involving 15 drugs to move ahead prior to a much broader case involving more than 100 medications.

  • December 19, 2024

    Labcorp Settles Competition Suit Against Ex-Sales Exec

    Less than two weeks after Laboratory Corp. of America Holdings sued its former sales marketing executive and his new employer in North Carolina federal court for allegedly violating noncompete and nonsolicitation agreements, a deal has been reached to end the lawsuit.

  • December 19, 2024

    FDA Declaration May Restart Compounders' Shortage Suit

    Federal regulators pulled Eli Lilly's lucrative weight-loss and diabetes drug off the national shortage list Thursday and gave compounding pharmacists two months to stop making copycat versions of the injectable medication, a move with the potential to reignite a Texas legal clash.

  • December 19, 2024

    Fresenius Loses Invalidity Argument In Nausea Drug IP Fight

    Fresenius Kabi USA LLC has lost its arguments in Delaware federal court that claims in a pair of Heron Therapeutics patents for a nausea drug were invalid, keeping Fresenius' generic from entering the market for around a decade.

  • December 19, 2024

    Philips CPAP Suits Against SoClean Tossed From MDLs

    A Pennsylvania federal judge has tossed two complaints from Philips RS North America against SoClean Inc. from multidistrict litigation stemming from a CPAP machine recall, saying one would disrupt the wrap-up of the MDL surrounding Philips' products, while the other should not have been filed directly into the SoClean MDL.

  • December 18, 2024

    Pharma Trial Consultant To Pay SEC $3M Over Insider Trading

    An oncologist and clinical professor at the University of California, Irvine agreed to pay the U.S. Securities and Exchange Commission $3 million to resolve allegations he purchased shares in a Massachusetts biotech company based on insider information regarding a clinical trial he was overseeing, the SEC announced Wednesday.

  • December 18, 2024

    Vaxart Investors Win Class Cert. Over COVID Shot On 2nd Try

    A California federal judge has certified a class of Vaxart investors accusing the biotechnology company's onetime controlling shareholder of dumping stock at inflated prices following deceptive headlines about a COVID-19 vaccine, saying the investors' revised motion fixes issues of predominance and the damages model.

  • December 18, 2024

    Patent Limits For Biosimilar Litigation Lands In Spending Bill

    Congress' spending package to keep the government open through March would also limit how many patents a biologics maker can assert when trying to prevent a competitor from getting on the market.

  • December 18, 2024

    FDA's Gastro Drug Fast-Track Denial Survives DC Circ.

    A D.C. Circuit panel upheld federal regulators' refusal to streamline approval of a drug to treat nausea in patients with a chronic gastric condition, ruling that the U.S. Food and Drug Administration was right to consider the drug's development plan when deciding whether it qualified for fast tracking.

  • December 18, 2024

    J&J Unit Beats Schizophrenia Drug IP Challenge On Remand

    Teva Pharmaceuticals USA Inc. has failed to invalidate claims in a patent for a Johnson & Johnson unit's blockbuster schizophrenia medicine, according to a New Jersey federal judge who rejected the generic-drug maker's assertions that the formula was obvious.

  • December 18, 2024

    State AGs, Generic Cos. Fight Over Price-Fixing Trial Order

    A contingent of state-level enforcers told a Connecticut federal court there is no need to reconsider prioritizing a sprawling generic drug price-fixing case that involves more than 100 medications over a narrower case the drugmakers are asking to have tried first.

  • December 18, 2024

    Judge Eyes Limits To Medical Device Co.'s Poaching Verdict

    A Boston federal judge on Wednesday considered interpreting twin $5 million jury awards against medical device sales employees as a subset of the $15 million in damages awarded against their employer in a rival company's poaching case.

  • December 18, 2024

    CVS Fueled Opioid Epidemic In Rush For Profits, Feds Say

    The U.S. Department of Justice unveiled a suit Wednesday accusing CVS, the nation's largest pharmacy chain, of knowingly filling invalid prescriptions for powerful opioids and ignoring internal pleas from its pharmacists as it allegedly put profits over safety. 

  • December 18, 2024

    Amgen Hit With $50M Infringement Verdict Over Leukemia Drug

    Germany's Lindis Biotech has persuaded a Delaware federal jury that Amgen should pay $50.3 million in damages for encouraging healthcare providers to infringe the Munich company's immunotherapy patents through administering the leukemia drug Blincyto.

  • December 18, 2024

    FTC Wants Express Scripts' Defamation Suit Tossed

    The Federal Trade Commission told a Missouri federal court that Express Scripts Inc. has no basis to challenge an interim agency report that only offered "qualified conclusions" from an ongoing study about how pharmacy benefit managers affect prescription drug prices.

  • December 18, 2024

    RJ Reynolds Asks Justices To Toss Forum Shopping Argument

    R.J. Reynolds Vapor Co. is urging the U.S. Supreme Court to reject the U.S. Food and Drug Administration's argument that the vape company engaged in forum shopping when it challenged denial of one of its applications in the Fifth Circuit, saying its Texas- and Mississippi-based co-petitioners make the Fifth Circuit the proper venue.

Expert Analysis

  • Opinion

    To Lower Drug Prices, Harris Must Address Patent Thickets

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    If Vice President Kamala Harris is serious about her pledge to address high drug prices, she must begin by closing loopholes that allow pharmaceutical companies to develop patent thickets that can deter generic or biosimilar companies from entering the market, says Tahir Amin at the Initiative for Medicines, Access & Knowledge.

  • How Methods Are Evolving In Textualist Interpretations

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    Textualists at the U.S. Supreme Court are increasingly considering new methods such as corpus linguistics and surveys to evaluate what a statute's text communicates to an ordinary reader, while lower courts even mull large language models like ChatGPT as supplements, says Kevin Tobia at Georgetown Law.

  • Trending At The PTAB: Obviousness In Director Reviews

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    Three July decisions from the U.S. Patent and Trademark Office favoring petitioners indicate a willingness by the director to review substantive issues, such as obviousness, particularly in cases where the director believes the Patent Trial and Appeal Board provided incorrect or inadequate rationale to support its decisions, say attorneys at Finnegan.

  • Why Attorneys Should Consider Community Leadership Roles

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    Volunteering and nonprofit board service are complementary to, but distinct from, traditional pro bono work, and taking on these community leadership roles can produce dividends for lawyers, their firms and the nonprofit causes they support, says Katie Beacham at Kilpatrick.

  • Opinion

    Agencies Should Reward Corporate Cyber Victim Cooperation

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    The increased regulatory scrutiny on corporate victims of cyberattacks — exemplified by the U.S. Securities and Exchange Commission's case against SolarWinds — should be replaced with a new model that provides adequate incentives for companies to come forward proactively and collaborate with law enforcement, say attorneys at McDermott.

  • Firms Must Offer A Trifecta Of Services In Post-Chevron World

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    After the U.S. Supreme Court’s Loper Bright Enterprises v. Raimondo decision overturning Chevron deference, law firms will need to integrate litigation, lobbying and communications functions to keep up with the ramifications of the ruling and provide adequate counsel quickly, says Neil Hare at Dentons.

  • Takeaways From UPC's Amgen Patent Invalidity Analysis

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    The Unified Patent Court Central Division's decision in Regeneron v. Amgen to revoke a patent for lack of inventive step is particularly clear in its reasoning and highlights the risks to patentees of the new court's central revocation powers, say Jane Evenson and Caitlin Heard at CMS.

  • 5 Ways Life Sciences Cos. Can Manage Insider Trading Risk

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    In light of two high-profile insider trading jury decisions against life sciences executives this year, public companies in the sector should revise their policies to account for regulators' new and more expansive theories of liability, says Amy Walsh at Orrick.

  • 5 Tips To Succeed In A Master Of Laws Program And Beyond

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    As lawyers and recent law school graduates begin their Master of Laws coursework across the country, they should keep a few pointers in mind to get the most out of their programs and kick-start successful careers in their practice areas, says Kelley Miller at Reed Smith.

  • Bayer Antitrust Case Hinged On Evolving Market Definition

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    Generic flea and tick medication manufacturer Tevra's evolving market definition played a key role in the development and outcome of its five-year antitrust litigation against Bayer Healthcare, highlighting challenges that litigants may face when a proposed definition is assessed at trial, say Amy Vegari and Colleen Anderson at Patterson Belknap.

  • IP Hot Topic: The Intersection Of Trademark And Antitrust Law

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    Antitrust claims – like those in the U.S. Department of Justice’s recent case against Apple – are increasingly influencing trademark disputes and enforcement practices, demonstrating how antitrust law can dilute the power of a trademark, say attorneys at Dentons.

  • Series

    Being An Opera Singer Made Me A Better Lawyer

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    My journey from the stage to the courtroom has shown that the skills I honed as an opera singer – punctuality, memorization, creativity and more – have all played a vital role in my success as an attorney, says Gerard D'Emilio at GableGotwals.

  • What Drug Cos. Must Know About NY Price Transparency Law

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    Drug manufacturers must understand the contours of New York's recently implemented law requiring self-reporting of drug price increases, as well as best practices for compliance and challenges against similar laws in other states, say Elizabeth Bierut and Angie Garcia at Friedman Kaplan.

  • How Law Firms Can Avoid 'Collaboration Drag'

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    Law firm decision making can be stifled by “collaboration drag” — characterized by too many pointless meetings, too much peer feedback and too little dissent — but a few strategies can help stakeholders improve decision-making processes and build consensus, says Steve Groom at Miles Mediation.

  • What BIPA Reform Law Means For Biometrics Litigation

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    A recently signed Illinois law amending the Biometric Information Privacy Act limits defendants' liability exposure on a per-scan basis and clarifies that electronic signatures constitute a valid written release, establishing additional issues that courts will need to address in future BIPA litigation, say attorneys at Faegre Drinker.

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