Life Sciences

  • September 30, 2024

    J&J Exec Accused Of File Heist Wants Pause Amid DOJ Case

    A former competitive strategy director for Johnson & Johnson accused of stealing confidential files as he left the company to work for Pfizer asked a New Jersey federal court to pause the suit after learning he is under criminal investigation.

  • September 27, 2024

    Kappos' Bayh-Dole Warning To Clients Draws Debate

    An advocate for lowering drug prices squared off Friday against a former U.S. Patent and Trademark Office director about the potential risk of accepting government funds to develop drugs, as part of a discussion at New York University School of Law.

  • September 27, 2024

    9th Circ. Says Stem Cell Treatment Not Exempt From FDA Rule

    Two California clinics' experimental stem cell treatments are "drugs" subject to Food, Drug and Cosmetic Act regulations, the Ninth Circuit ruled Friday, reviving the federal government's bid to stop the clinic from marketing the products as cures for certain diseases without U.S. Food and Drug Administration review.

  • September 27, 2024

    Why Many Drugs Remain Pricey 40 Years After Hatch-Waxman

    In the four decades since Congress passed the Hatch-Waxman Act in an effort to make generic drugs more available, the pharmaceutical industry has used patent thickets, "evergreening" and pay-for-delay tactics to block competition and keep prices of life-saving specialty drugs astronomical, several legal experts told Law360, while the industry argues other parties shoulder more of the blame.

  • September 27, 2024

    Pharma Co. Amarin Beats Class Action Over Patent Issues

    A New Jersey federal judge has tossed a proposed class action against pharmaceutical company Amarin and its top brass, alleging they misled shareholders about their products and the prospects of related patent litigation, saying the investors have failed to plead any actionable misleading statements or omissions made by the defendants.

  • September 27, 2024

    Life Sciences Firms Energize IPO Market As Recovery Builds

    Initial public offerings are closing the year's third quarter on an upswing, led mostly by pre-revenue drug developers and select large companies that are seizing opportunities in friendlier capital markets buoyed by interest-rate cuts, generating momentum that experts say could carry over into next year.

  • September 27, 2024

    Advil Owner Haleon Paying $637M To Up Stake In China JV

    British consumer healthcare giant Haleon plc said Friday that it has agreed to pay the equivalent of roughly $637 million to increase its stake in a Chinese joint venture, Tianjin TSKF Pharmaceutical Co., from 55% to 88%. 

  • September 27, 2024

    Medical Equipment Co., Founder Settle FCA Suit For $20M

    A Florida-based medical equipment company and its founder will pay $20 million to settle claims under the federal False Claims Act that they improperly billed government healthcare plans for duplicated and unnecessary sales of devices meant to offer pain relief through electrical stimulation, Pennsylvania prosecutors said Friday.

  • September 26, 2024

    SEC Fines Cassava $40M Over Alzheimer's Treatment Claims

    Neuroscience-focused biopharmaceutical company Cassava Sciences Inc. and two of its former executives agreed to pay over $40 million to resolve U.S. Securities and Exchange Commission claims related to allegedly misleading statements about clinical trial results for a potential Alzheimer's disease therapeutic, the regulator announced on Thursday.

  • September 26, 2024

    11th Circ. Affirms Convictions In Fla. Shark Rescue Case

    The Eleventh Circuit upheld felony theft convictions for two Florida tour boat divers who were prosecuted for freeing sharks they believed were illegally poached, but turned out to be part of a research project conducted with a permit granted by the National Oceanic and Atmospheric Administration.

  • September 26, 2024

    2nd Circ. Denies Jury Trial In Abbott Labs Gray Market Case

    A man and his wife involved in the sale of gray market diabetes test strips on Tuesday were unable to persuade the Second Circuit to undo the $33.4 million judgment they owe to Abbott Laboratories after a federal judge stripped them of their right to a jury trial.

  • September 26, 2024

    New Report Urges Feds To Take Larger Role In Pot Policy

    The rise of state-sanctioned cannabis markets amid the absence of federal regulation has prioritized policies intended to launch marijuana sales over those focused on public health, according to a government-sponsored report made public Thursday.

  • September 26, 2024

    Walgreens Struggles To Exit 'Non-Drowsy' Label Suit In Wash.

    The Washington State Supreme Court questioned Thursday whether Walgreens could avoid state consumer protection claims over its "non-drowsy" cough medicine label by pointing to a lack of federal labeling requirements for the drug, with one justice calling the argument a non sequitur.

  • September 26, 2024

    NC Medical Equipment Maker Can't Ditch Unfair Biz Suit

    The North Carolina Business Court has denied a medical equipment maker's bid to get a win based on the pleadings in a fraudulent concealment and unfair trade practices lawsuit alleging that it stole the business model and a pregnancy support garment design from a rival.

  • September 26, 2024

    Obesity Drug Developer Leads 2 Upsized IPOs Totaling $310M

    Obesity-focused drug developer BioAge Labs Inc. gained in debut trading Thursday after raising $198 million through an upsized initial public offering, leading one of two new listings that netted a combined $310 million under the guidance of four law firms.

  • September 26, 2024

    Virtua Discriminates Against Pregnant Patients, NJ Alleges

    Virtua Health discriminates against pregnant patients by forcing them to undergo drug testing for inpatient admission to its hospitals — a policy that does not apply universally to other patients, New Jersey Attorney General Matthew J. Platkin alleged in a lawsuit filed Thursday in New Jersey state court.

  • September 26, 2024

    Senate Patent Bill Markups Delayed Until After Election

    Congressional hearings scheduled for Thursday to mark up several bills related to patents, including measures dealing with patent eligibility, validity challenges and drug patents, have been postponed until after Election Day due to the Senate's adjournment.

  • September 26, 2024

    Nobel Winners Behind Gene Editor Seek To Nix Own Patents

    The scientists credited with inventing the gene-editing tool CRISPR have voluntarily requested that two key patents be revoked in Europe, after officials suggested they might get nixed over technical issues.

  • September 26, 2024

    Quest Diagnostics Escapes 401(k) Mismanagement Suit

    A New Jersey federal judge tossed a proposed class action alleging Quest Diagnostics Inc. mismanaged its $5 billion retirement plan by failing to chop under performing investment funds from its lineup, pointing to proof that the company acted to rein in questionable funds.

  • September 25, 2024

    In-House Counsel To Play Central Role At AI Cos., VCs Say

    Venture capital firms expect in-house counsel at artificial intelligence companies to play a bigger role in their businesses due to regulatory uncertainties around AI, while a professor who helped pioneer the technology warned that transparency of commercial AI businesses should be "top of mind," attorneys heard at the seventh annual Berkeley Law AI Institute Wednesday.

  • September 25, 2024

    NY Judge Pauses Abortion 'Reversal' Case As AG Files Appeal

    A New York federal judge has ruled that two more anti-abortion pregnancy centers are free to promote abortion pill "reversal" while a legal clash continues over whether the First Amendment protects their right to market the treatment, which is doubted by major medical groups.

  • September 25, 2024

    Ascension Must Face Additional Suit Over Vaccine Mandate

    Ascension Health Alliance must face another proposed class action challenging its 2021 COVID-19 vaccination policy, an Indiana federal judge ruled Wednesday, holding that a group of workers who were suspended or fired after refusing the vaccine on religious grounds have a case against the Catholic healthcare system.

  • September 25, 2024

    Generics Group Names Ex-BIO, PhRMA Exec As New CEO

    The generic drug industry group the Association for Accessible Medicines on Wednesday announced it has appointed a new chief executive officer who brings over a decade of experience in the branded drug industry.

  • September 25, 2024

    3rd Circ. Preserves Monsanto's Win In Cancer Warning Suit

    The Third Circuit refused to reconsider its ruling that federal law preempts a more stringent Pennsylvania statute that mandates cancer warnings on chemicals, preserving Monsanto's win against a man who alleged the company's Roundup herbicide caused his illness.

  • September 25, 2024

    7th Circ. Judge Surprised Key Argument Left In Footnote

    A Seventh Circuit judge seemed unsure Wednesday whether an insurer for Sterigenics could avoid a $75 million legal bill for defending the company from pollution suits, noting that the insurer addressed "the biggest issue in the case" in just a single, vague footnote. 

Expert Analysis

  • 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.

  • Opinion

    Litigation Funding Disclosure Key To Open, Impartial Process

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    Blanket investor and funding agreement disclosures should be required in all civil cases where the investor has a financial interest in the outcome in order to address issues ranging from potential conflicts of interest to national security concerns, says Bob Goodlatte, former U.S. House Representative for Virginia.

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