Life Sciences

  • April 15, 2024

    Hold This COVID Vax Patent Case, Judge Recommends

    One of the suits over Pfizer's blockbuster COVID-19 vaccine hit a snag in Virginia federal court Friday when a judge recommended pausing the case to wait for a ruling in a related dispute over patent ownership involving one of BioNTech's other partners.

  • April 15, 2024

    Catching Up With Delaware's Chancery Court

    Last week, Delaware justices mulled whether one Chancery Court vice chancellor properly voided four company bylaws — just as another vice chancellor voided one more. Fights among Truth Social investors continued, and shareholders launched new cases involving Macy's, United Airlines, and Clayton Dubilier & Rice LLC and Stone Point Capital LLC.

  • April 15, 2024

    Orrick Adds Kramer Levin Life Sciences Head In NY

    The former head of Kramer Levin Naftalis & Frankel LLP's life sciences practice has jumped to the intellectual property litigation team at Orrick Herrington & Sutcliffe LLP in New York, Orrick said Monday. 

  • April 15, 2024

    Pharmacy, Courier Co. Settle Driver's Classification Suit

    A delivery driver and a CVS-owned pharmacy and a logistics and courier firm told an Illinois federal court that they have reached a settlement resolving claims that the company misclassified workers as independent contractors and paid them neither minimum nor overtime premium wages. 

  • April 15, 2024

    Justices Won't Nix FDA Labeling Preemption For State Claims

    The Supreme Court on Monday let stand lower court findings that the unique authority of the federal Food and Drug Administration preempted and, therefore, justified dismissing a proposed class action that alleged a Johnson & Johnson subsidiary broke Massachusetts law by misbranding Lactaid drug products as dietary supplements.

  • April 15, 2024

    Life Sciences Group Of The Year: Cooley

    Cooley LLP advised Horizon Therapeutics during its massive sale to Amgen Inc. — defeating an antitrust challenge along the way — and helped Moderna Inc. win a patent case centering on its COVID-19 vaccine, earning the firm a place among Law360's 2023 Life Sciences Groups of the Year.

  • April 12, 2024

    Moderna, Pfizer COVID Vax IP Suit Paused Amid PTAB Review

    A Massachusetts federal judge on Friday agreed to pause Moderna Inc.'s COVID-19 vaccine patent infringement suit against Pfizer Inc. and BioNTech until the Patent Trial and Appeal Board weighs in on a pair of patents, issuing a stay despite objections from Moderna.

  • April 12, 2024

    Ex-Biotech CEO Gets 7 Years In Fake COVID Test Case

    A former biotech CEO accused of defrauding investors by touting a phony rapid finger-prick COVID test was sentenced to seven years in prison in D.C. federal court Friday.

  • April 12, 2024

    DEA Unlawfully Pushing Psychedelics Ban, Researcher Says

    A psychedelic research company has asked a Washington federal judge to block the Drug Enforcement Administration from proceeding with its plan to ban two psychedelic substances, saying the agency's process for bringing the matter before an administrative judge has been unlawful.

  • April 12, 2024

    Abbott Labs Gets Price Claims Tossed In Baby Formula MDL

    An Illinois federal judge on Friday threw out a suit from parents alleging that Abbott Laboratories benefited from increased prices during a shortage of baby formula kicked off when one of its facilities was shut down, saying they haven't shown that the company's profits during that time were unjustly retained.

  • April 12, 2024

    Ex-Pfizer Worker's Pal Avoids Prison In Insider Trading Case

    An electrical engineer was sentenced to probation Friday for trading Pfizer Inc.'s stock using confidential tips about the efficacy of its COVID-19 drug, after a Manhattan federal court recognized his decision to voluntarily assist prosecutors with the trial conviction of his friend, a former Pfizer employee who leaked insider information.

  • April 12, 2024

    Trade Groups Urge Senators To Advance Patent Reform Bills

    Groups representing inventors, startups and medical technology companies are putting pressure on U.S. senators to pass bills that would prospectively limit the ability of courts to throw out patent lawsuits, a month after tech industry groups argued the legislation would trigger an onslaught of patent litigation.

  • April 12, 2024

    Woman Pleads Guilty To $1.3M COVID Tax Credit Fraud

    A California woman pled guilty to fraudulently obtaining $2 million in COVID-19 government loans and falsely claiming $1.3 million in tax credits, crimes that could result in a 20-year prison sentence, the U.S. Department of Justice said.

  • April 12, 2024

    Life Sciences Group Of The Year: Latham

    Latham & Watkins LLP marshaled its considerable depth and breadth of experience to score a major Federal Circuit victory and to shepherd biotechnology deals that reached into the 11 figures, earning the firm a nod as one of Law360's 2023 Life Sciences Groups of the Year.

  • April 12, 2024

    US-based MSD Broke Ban On Using 'Merck' In UK, Court Finds

    U.S.-based Merck Sharp & Dohme LLC's use of the "Merck" name on websites and social media breached the terms of a court order barring it from using the name in the U.K. to protect German drugmaker Merck KGaA's rights, a London court ruled Friday.

  • April 12, 2024

    Zoll Says 'Cookie-Cutter' Hack Claims Don't Show Harm

    Zoll Medical Corp. is asking a Boston federal judge to toss a proposed class action brought by medical device customers whose personal information was released during a ransomware attack last year and an earlier data breach in 2019, arguing the consumers weren't actually injured.

  • April 12, 2024

    EU Approves Biotech Co. Illumina's Plan To Divest Grail

    European Union antitrust authorities on Friday approved Illumina's plan to sell off Grail, the latest development in a saga that saw the biotech company reverse course and agree to offload the cancer-screening company after authorities claimed the reacquisition was completed "unlawfully."

  • April 12, 2024

    Asbury Park Escapes Pot Co.'s Zoning Board Conspiracy Suit

    A New Jersey federal court has dismissed a medical cannabis company's suit alleging Asbury Park and its zoning board conspired with a rival to block it from operating a treatment center, saying the complaint fails to support its allegations of the scheme.

  • April 11, 2024

    Sandoz Says Feds Misclassified Generics As 'Innovator Drugs'

    Pharmaceutical company Sandoz Inc. sued the Centers for Medicare & Medicaid Services in Washington, D.C., federal court on Wednesday, alleging the agency ignored the company's objection to classifying two of its generics as "innovator drugs," which could impact Sandoz's rebate obligations under Medicaid.

  • April 11, 2024

    Fed. Circ. Blocks Alvogen Generic Of Bausch Diarrhea Drug

    The Federal Circuit upheld a decision Thursday that prevents Alvogen from releasing a generic version of Bausch Health's blockbuster diarrhea and brain disease drug Xifaxan until 2029, rejecting Alvogen's bid to launch sooner because it was cleared of infringing some patents.

  • April 11, 2024

    FDA Commissioner Says Congress Must Act On Hemp, CBD

    The commissioner of the U.S. Food and Drug Administration said Thursday that the agency did not consider hemp-derived CBD safe enough to be sold lawfully as a dietary supplement, and urged Congress to create a new pathway to regulate the substance.

  • April 11, 2024

    9th Circ. Nixes 'Super Snap Removals' In Dexcom Suits

    The Ninth Circuit won't let Dexcom Inc. remove three suits alleging its glucose monitoring system is defective to federal court, saying its "super snap removal" motions were premature as they were filed before any of the cases actually commenced.

  • April 11, 2024

    Birth Control Injury Claims Barred From Conn., Court Told

    Connecticut state courts have no basis to exercise jurisdiction over three of the four companies targeted in product liability lawsuits brought by 103 women who claim their Filshie Clip birth control devices migrated within their bodies and caused injuries, counsel for the defendants told a Waterbury judge Thursday.

  • April 11, 2024

    Deals Rumor Mill: US Steel, Germany's Stada, Paramount

    The DOJ opens a probe into Nippon’s proposed $14.9 billion takeover of US Steel, German drugmaker Stada explores a sale, and Paramount and Skydance are hashing out potential deal terms. Here, Law360 breaks down these and other notable deal rumors from the past week.

  • April 11, 2024

    Del. Justices OK Denial Of Icahn-Illumina Midcase Appeal Bid

    Billionaire investor Carl Icahn may not put his Chancery Court litigation against biotechnology company Illumina Inc.'s board on hold for a review of a decision that struck portions of the complaint that were based on confidential information, Delaware's Supreme Court said Thursday, upholding the lower court's rejection of the midcase appeal.

Expert Analysis

  • Top Considerations For Retailers Using AI To Combat Theft

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    The Federal Trade Commission's recent enforcement action against Rite Aid indicates a significant evolution in the landscape surrounding biometric information and artificial intelligence data collection by retailers, meaning retailers should take reasonable measures to prevent harm to customers, say attorneys at Dentons.

  • 2 FCPA Settlements Illuminate Self-Disclosure, Disgorgement

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    Two of last year’s Foreign Corrupt Practices Act settlements — with biomedical company Lifecore and mining company Corsa Coal — suggest that the government will be much more flexible in negotiating disgorgement amounts if an entity voluntarily self-discloses misconduct, say Michael Gilbert and Lucas Amodio at Sheppard Mullin.

  • Opinion

    Anti-Kickback Statute Does Not Require But-For Causation

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    A proper interpretation of the Anti-Kickback Statute clearly indicates that but-for causation is not required for False Claims Act Liability, and courts that hold otherwise will make it significantly easier for fraudsters to avoid accountability, says Kenneth Capesius at Baron & Budd.

  • 5 Litigation Funding Trends To Note In 2024

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    Over the next year and beyond, litigation funding will continue to evolve in ways that affect attorneys and the larger litigation landscape, from the growth of a secondary market for funded claims, to rising interest rates restricting the availability of capital, says Jeffery Lula at GLS Capital.

  • Medtronic's Cautionary Tale Of Fed. Circ. Word Limits

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    The Federal Circuit's ruling in Medtronic v. Teleflex that Medtronic waived an argument that it had sought to incorporate by reference illustrates the pitfalls facing parties in complex patent cases involving numerous issues that cannot all be addressed within the strict word limits for appellate briefs, say Sean Murray and Jeremiah Helm at Knobbe Martens.

  • Key Legal Trends For Healthcare And Life Sciences In 2024

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    Due to the impact of contentious legal battles over drug pricing negotiations, the growing integration of artificial intelligence into drug development and manufacturing, and the publication of industry segment-specific guidance, the year ahead promises to be a dynamic period of changes and challenges, say Xin Tao and Lois Liu at Baker McKenzie.

  • Series

    ESG Around The World: South Africa

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    While South Africa has yet to mandate the reporting of nonfinancial and environmental, social, and corporate governance issues, policy documents and recent legislative developments are likely to have a material impact in the country's transition to a low-carbon economy and in meeting its international obligations, say Glynn Kent at Eversheds Sutherland.

  • FOIA Exemption Questions On Redacted HHS Cannabis Letter

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    The U.S. Department of Health and Human Services' recent recommendation letter concerning the rescheduling of cannabis was heavily redacted, and based on an analysis on the applicability of Freedom of Information Act Exemption 5 to the letter, it's likely that we will see successful legal challenges to those redactions, say attorneys at Troutman Pepper.

  • Fed. Circ. Ruling Seemingly Offers PTAB Deadline Immunity

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    The Federal Circuit's recent Purdue Pharma v. Collegium Pharmaceutical Inc. decision that the Patent Trial and Appeal Board had authority to issue a final written decision in a post grant review after the prescribed statutory deadline underscores how courts should consider the overall objective of the statutory scheme when balancing the classic conflict between bright-line rules and flexible standards, says Matthew Dowd at Dowd Sheffel.

  • Evaluating Retroactivity Of Mich. Drugmaker Immunity Repeal

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    In assessing whether a new Michigan law lifting drugmakers' blanket immunity from product liability suits will apply retroactively, there are four key factors that Michigan courts will likely consider, say Sherry Knutson and Brenda Sweet at Tucker Ellis.

  • 4 Legal Ethics Considerations For The New Year

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    As attorneys and clients reset for a new year, now is a good time to take a step back and review some core ethical issues that attorneys should keep front of mind in 2024, including approaching generative artificial intelligence with caution and care, and avoiding pitfalls in outside counsel guidelines, say attorneys at HWG.

  • FTC Rite Aid Order Holds Biometrics And AI Compliance Tips

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    The Federal Trade Commission's recent enforcement action against Rite Aid over its use of facial biometric technology on customers provides lessons that can be leveraged to reduce and manage the risk of regulatory scrutiny of biometrics and artificial intelligence, says David Oberly at Baker Donelson.

  • Bribery Settlement Gives Insight On DOJ Policies

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    Chemical company Albemarle’s recent $218 million settlement with the government to resolve foreign bribery claims provides valuable data points for companies on the U.S. Department of Justice’s voluntary self-disclosure policy and its clawback pilot program, say Michael DeBernardis and Tiauna Mathieu at Hughes Hubbard.

  • SEC Case May Expand Scope Of Insider Trading Liability

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    The U.S. Securities and Exchange Commission's first-of-its-kind enforcement action against an individual in a case involving "shadow trading" demarcates an expansion of insider trading liability to circumstances in which there is a market connection between the source of information and the issuer of the securities traded, say attorneys at Steptoe.

  • Opinion

    Waiving COVID-19 IP Protections Would Harm US Industry

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    President Joe Biden should turn down a World Trade Organization proposal to waive crucial intellectual property protections behind COVID-19 tests and diagnostics — protections that allow U.S. companies to sustain millions of jobs and develop life-saving treatments that benefit patients in every country, says former U.S. Circuit Judge Paul Michel, now at the Council for Innovation Promotion.

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