Life Sciences

  • January 21, 2025

    What IP Attorneys Need To Know From Trump's First Days

    Since the Trump administration took over on Monday, a new acting director for the U.S. Patent and Trademark Office has been sworn in, federal workers have been mandated to return to working in person and the Biden administration's artificial intelligence executive order has been rescinded. Here's what IP attorneys should know.

  • January 17, 2025

    Law360 Names Practice Groups Of The Year

    Law360 would like to congratulate the winners of its Practice Groups of the Year awards for 2024, which honor the attorney teams behind litigation wins and significant transaction work that resonated throughout the legal industry this past year.

  • January 17, 2025

    Law360 Names Firms Of The Year

    Eight law firms have earned spots as Law360's Firms of the Year, with 54 Practice Group of the Year awards among them, steering some of the largest deals of 2024 and securing high-profile litigation wins, including at the U.S. Supreme Court.

  • January 20, 2025

    Trump, Musk Sued By Nonprofits Over DOGE Transparency

    Public Citizen and other nonprofits hit the Trump administration with multiple lawsuits seeking to shut down the new Department of Government Efficiency in D.C. federal court Monday, alleging the Elon Musk-led advisory committee targeting government waste lacks requisite transparency guardrails to prevent DOGE from solely advancing private interests.

  • January 17, 2025

    Walgreens Knowingly Filled Invalid Prescriptions, Feds Say

    The U.S. Department of Justice has accused Walgreens of knowingly filling millions of prescriptions for opioids and other controlled substances that did not have a legitimate medical purpose or were not valid, intervening in cases brought by four whistleblowers in Illinois federal court.

  • January 17, 2025

    MSN Wants Generic Entresto Launch After Patent Expired

    MSN Pharmaceuticals asked the Federal Circuit Friday to let it launch its generic version of Novartis' blockbuster heart drug Entresto while the drugmakers continue their litigation over a newly expired patent, by lifting a temporary injunction barring that launch.

  • January 17, 2025

    Bayer, J&J Minimized Drug Reaction Data, 3rd Circ. Told

    A doctor urged the Third Circuit on Friday to revive his whistleblower suit against Bayer Corp. and Johnson & Johnson, arguing that the drugmakers' regulatory approval applications played down the side effects of the antibiotics Cipro and Levaquin.

  • January 17, 2025

    Up Next At High Court: Forum Shopping & TCPA Definitions

    The U.S. Supreme Court will return to the bench Tuesday for a short argument session, during which the justices will consider the U.S. Food and Drug Administration's bid to limit forum shopping by manufacturers challenging agency decisions and how much deference district courts must give to Federal Communications Commission orders.

  • January 17, 2025

    NC Biotech Co. Can't Restrain Co-Founder's Rival Biz Yet

    A biotechnology company can't stop its co-founder from conducting research and soliciting customers at his new company using what it believes is stolen confidential information, a North Carolina state court judge said Friday, pointing to a lack of urgency and glaring holes in the record.

  • January 17, 2025

    3rd Circ. Vexed By Remedies For Defunct Vax Mandate

    The Third Circuit wrestled Friday with how it could remedy injuries claimed to be suffered by nurses who lost their jobs for not complying with New Jersey Gov. Phil Murphy's vaccine mandate for healthcare workers, asking what order it could give about something that is no longer in effect and about jobs they no longer have.

  • January 17, 2025

    Duke U. Strikes Deal In Female Scientist's Pay Bias Suit

    Duke University and a female scientist have brokered an agreement to end her suit claiming she was paid less than her male counterparts and was threatened with demotions after complaining about it, according to a Friday filing in North Carolina federal court.

  • January 17, 2025

    Crown Labs Tops Rival Bid In Quest To Buy Biotech Revance

    Skincare product company Crown Laboratories Inc. has offered to raise its all-cash bid to buy healthcare biotech company Revance Therapeutics Inc. from $3.10 per share to $3.65 per share as it seeks to beat out a surprise bid from a Revance shareholder, according to a securities filing on Friday. 

  • January 17, 2025

    1st Circ. Revives Biotech Worker's COVID-19 Vax Challenge

    The First Circuit on Thursday resuscitated religious discrimination claims brought by a former pharmaceutical company employee who alleged her employer's COVID-19 vaccination mandate during the pandemic was in conflict with her sincerely held religious beliefs.

  • January 17, 2025

    Taxation With Representation: Simpson Thacher, Covington

    In this week's Taxation With Representation, Eli Lilly and Co. buys a precision breast cancer program, Applied Digital Corp. enters a financing agreement for its high-performance computing business, Clearwater Analytics buys Enfusion, and Lantheus Holdings Inc. buys Life Molecular Imaging Ltd.

  • January 16, 2025

    Texas Judge Says 3 States Can Pursue Mifepristone Suit

    A Texas federal judge said Thursday that Idaho, Missouri and Kansas can continue to challenge federal approvals for the abortion medication mifepristone in Texas federal court after private plaintiffs dropped their claims.

  • January 16, 2025

    ITC Commissioner Heading To WilmerHale In DC

    One of the commissioners of the U.S. International Trade Commission, who had served as the agency's leader for a year and a half, has decided to leave and make the move to WilmerHale, according to the ITC.

  • January 16, 2025

    EpiPen Direct Buyers, Mylan Ink $75M Antitrust Deal

    Mylan Pharmaceuticals has agreed to pay $73.5 million to resolve claims it worked with Pfizer to inflate the price of the latter's popular auto-injecting emergency allergy medication EpiPen, a proposed class of direct purchasers told a Kansas federal judge Wednesday, bringing the total settlement to $123.5 million.

  • January 16, 2025

    USPTO Seeks Views On 'Traditional Knowledge' IP Treaty

    The U.S. Patent and Trademark Office requested comments Thursday on whether the U.S. should sign an international treaty that could require patent applicants to disclose if an invention draws on the traditional knowledge of indigenous people, which has concerned business groups.

  • January 16, 2025

    Expert Witnesses Limited In J&J Talc Ch. 11 Dismissal Try

    A Texas bankruptcy judge limited Thursday the number of expert witnesses that can provide testimony in an upcoming hearing on talc claimants' attempt to dismiss the Chapter 11 case of Johnson & Johnson's talc unit.

  • January 16, 2025

    Merck Defends 3rd Circ. Win In Mumps Vaccine Antitrust Case

    Merck urged the Third Circuit not to reconsider a ruling that immunized the company from antitrust claims over submissions it made to federal regulators for its mumps vaccine, arguing the appeals court was right to find the submissions were protected.

  • January 16, 2025

    Fed. Circ. Urged To Keep Block Of Sun Pharma Alopecia Drug

    Incyte Corp. has urged the Federal Circuit to leave in place an injunction a New Jersey judge imposed in November blocking Sun Pharmaceutical from launching the alopecia drug Leqselvi, saying the lower court was correct that the launch would give Sun an improper "head start."

  • January 16, 2025

    NC Biz Court Bulletin: Judge Bids Adieu, TikTok Wants Out

    The North Carolina Business Court's former chief judge hung up his robes for the last time as the court entered the new year with a ruling that shapes the fate of beset real estate company MV Realty's consumer fraud trial and arguments by TikTok Inc. that its platform being "too engaging" isn't enough for the state to begin an enforcement action.

  • January 16, 2025

    Chamber Slams Opioid Judge's PBM Audit Privilege Ruling

    The Sixth Circuit must step in to prevent a pharmacy benefit manager from being forced to turn over internal compliance audit documents, the U.S. Chamber of Commerce has said, arguing a lower court's decision threatens to undermine the existence of in-house counsel's attorney-client privilege. 

  • January 15, 2025

    Novartis Wins Temporary Stay Of MSN's Generic Heart Drug

    The D.C. Circuit late Wednesday temporarily halted the U.S. Food and Drug Administration's approval of MSN Pharmaceuticals' generic version of Novartis' blockbuster heart failure drug Entresto, just after federal judges in D.C. and Delaware declined to block the launch of MSN's product.

  • January 15, 2025

    Gilead, Feds Resolve HIV Drug Patent Dispute Amid Appeal

    Gilead Sciences and the federal government have agreed to dismiss all claims and counterclaims in a yearslong intellectual property and contract battle over HIV prevention drugs Truvada and Descovy, according to stipulations of voluntary dismissal filed Wednesday in both the Federal Circuit and Delaware federal court.

Expert Analysis

  • It's No Longer Enough For Firms To Be Trusted Advisers

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    Amid fierce competition for business, the transactional “trusted adviser” paradigm from which most firms operate is no longer sufficient — they should instead aim to become trusted partners with their most valuable clients, says Stuart Maister at Strategic Narrative.

  • Vertex Suit Highlights Issues For Pharma Fertility Support

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    Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.

  • Opinion

    CMS' New 'Breakthrough' Device Policy Shows Little Promise

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    The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.

  • New Lessons On Managing Earnout Provision Risks

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    Earnout provisions can be a useful tool for bridging valuation gaps in M&A, particularly in developmental-stage pharmaceutical transactions, but the Delaware Chancery Court’s recent decision in Shareholder Representative Services v. Alexion sheds new light on the inherent risks and best practices for managing them, say attorneys at Cleary.

  • 3 Patent Considerations For America's New Quantum Hub

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    Recent developments signal an incredibly bright future for Chicago as the new home of quantum computing, and it is crucial that these innovators — whose technology has the potential to transform many industries — prioritize intellectual property strategy, says Andrew Velzen at McDonnell Boehnen.

  • A Preview Of AI Priorities Under The Next President

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    For the first time in a presidential election, both of the leading candidates and their parties have been vocal about artificial intelligence policy, offering clues on the future of regulation as AI continues to advance and congressional action continues to stall, say attorneys at Mintz.

  • How Companies Are Approaching Insider Trading Policies

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    An analysis of insider trading policies recently disclosed by 49 S&P 500 companies under a new U.S. Securities and Exchange Commission rule reveals that while specific provisions vary from company to company, certain common themes are emerging, say attorneys at Gibson Dunn.

  • 11 Patent Cases To Watch At Fed. Circ. And High Court

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    As we head into fall, there are 11 patent cases to monitor, touching on a range of issues that could affect patent strategy, such as biotech innovation, administrative rulemaking and patent eligibility, say Edward Lanquist and Wesley Barbee at Baker Donelson.

  • Opinion

    3rd. Circ. Got It Right On Cancer Warning Claims Preemption

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    The Third Circuit's recent, eminently sensible ruling in a failure-to-warn case against Roundup manufacturer Monsanto, holding that the Federal Insecticide, Fungicide and Rodenticide Act preempts state law claims, provides a road map that other courts should adopt, says Lawrence Ebner at the Atlantic Legal Foundation.

  • 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.

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