Life Sciences

  • October 31, 2024

    Purdue Gets More Time For Deal, 'Substantial' Progress Made

    Bankrupt OxyContin maker Purdue Pharma LP on Thursday won more time to continue mediating a new settlement with its owners — certain members of the Sackler family — and reported that it is nearing a deal, in a bid to avoid having one of the most complex Chapter 11 cases in U.S. history tumble into a litigation free-for-all.

  • October 31, 2024

    Flint Water Case Paused For 'Advanced' Settlement Talks

    Days after a jury trial meant to decide whether a water firm failed to properly warn of the dangers of the city of Flint's water was delayed a second time, a Michigan federal judge paused two bellwether cases because of "advanced settlement negotiations" between individual plaintiffs and the firm.

  • October 31, 2024

    Judge Upholds Sanctions Against Ex-Stimwave CEO

    A Delaware federal judge has upheld a decision by the bankruptcy judge overseeing the Chapter 11 case of medical device maker Stimwave Technologies to screen the filings of the company's ex-CEO and two of her relatives.

  • October 31, 2024

    The 2024 Law360 Pulse Leaderboard

    Check out the Law360 Pulse Leaderboard to see which firms made the list of leaders in all-around excellence this year.

  • October 31, 2024

    Firms' Hiring Strategies Are Evolving In Fight For Top Spot

    Competition for top talent among elite law firms shows no signs of slowing down, even amid economic uncertainty, with financially strong firms deploying aggressive strategies to attract and retain skilled professionals to solidify their market position.

  • October 31, 2024

    Teva Fined €463M For Blocking Rival MS Drug Launch

    The European Union antitrust enforcer hit pharmaceutical giant Teva with a €463 million ($502 million) fine Thursday for launching a smear campaign against a rival multiple sclerosis drug and misusing the patent system to thwart the competitor's attempt to enter the market.

  • October 30, 2024

    FDA Didn't Flub Approval In Orphan Drug Case, DC Court Says

    The U.S. Food and Drug Administration didn't err in determining that a rival narcolepsy treatment is not the "same drug" as Jazz Pharmaceuticals' exclusive treatment, a D.C. federal judge ruled Wednesday, holding that the FDA's approval of the rival drug didn't run afoul of the Orphan Drug Act.

  • October 30, 2024

    Alleged Kickback Plotters Can Waive Conflict Over Attorney

    A Colorado federal judge on Wednesday concluded that a lab testing company owner charged with participating in a kickback scheme to defraud Medicare and a man who pled guilty to participating in a connected conspiracy could waive any conflicts that might arise from both using the same attorney.

  • October 30, 2024

    Cigna Wants $16.1M, Florida Labs Seek $5.1M In Benefits Feud

    Cigna should pay $5.1 million for harming three Florida laboratories by wrongfully declaring thousands of substance abuse treatment tests medically unnecessary, the labs told a Connecticut jury Wednesday, while Cigna asked to recoup $16.1 million in payouts to the labs for what it called "wasteful" tests.

  • October 30, 2024

    LA Times Owner Faces Investor Suit Over Drug Co.'s Woes

    Officers and directors of biotechnology company ImmunityBio Inc., including L.A. Times owner Patrick Soon-Shiong, face a shareholder's derivative complaint alleging the company concealed issues affecting a path to regulatory approval for one of its key product candidates.

  • October 30, 2024

    After Exeltis Win, Judge Won't Allow Suits On Dropped Patents

    A Delaware federal judge has shot down a request that seven patents Insud Pharma's New Jersey-based division Exeltis USA Inc. dropped in patent litigation against Lupin Pharmaceuticals Inc. be dismissed in a way where they could be refiled later.

  • October 30, 2024

    Publix Denied Early Win Over Opioid Coverage Defense

    A Florida federal court rejected Publix's bid for defense cost coverage for dozens of public nuisance lawsuits related to the opioid crisis, finding that the damages sought are too far removed from particular bodily injuries caused "because of" opioid addiction, as required in Publix's policies.

  • October 30, 2024

    3rd Circ. Told Medicare Drug Price Talks Not Voluntary

    Three pharmaceutical companies told the Third Circuit on Wednesday the Medicare drug price negotiation program is anything but voluntary, arguing the appeals court should revive their challenges to the program because it is unconstitutional.

  • October 30, 2024

    Biopharma Co. Can't Knock Ex-CFO's Bias Suit Out Of Court

    A biopharmaceutical development company can't kick a fired executive's bias suit to arbitration, a California federal judge said, ruling that the harassment she said she faced on the job was gendered enough to invoke a federal law curbing out-of-court-resolutions of sex harassment claims.

  • October 30, 2024

    Ex-Takeda Exec. Gets Nearly 4 Years For Fake Invoice Scam

    A former Takeda Pharmaceuticals executive was sentenced Wednesday to 46 months in prison for stealing millions from the drug company through a fake invoice scam that a Boston federal judge characterized as "utterly unnecessary and pointless" and carried out for no other reason than to fund a luxurious lifestyle.

  • October 30, 2024

    Yale Researcher's Suit Over Loss Of 'Life's Work' Transferred

    A Connecticut state court judge in Fairfield is passing on a researcher's lawsuit accusing Yale School of Medicine of destroying two decades of research worth $28 million, transferring the case to the complex litigation docket in Hartford.

  • October 30, 2024

    Ohio PBM Case Will Wait For High Court Ruling

    The Sixth Circuit agreed to pause a case from Ohio state enforcers accusing Express Scripts and Prime Therapeutics of driving up prescription drug prices while the U.S. Supreme Court decides another case dealing with federal versus state jurisdiction.

  • October 30, 2024

    DLA Piper's FDA Regulation Vice Chair Joins White & Case

    The former vice chair of DLA Piper's FDA regulatory practice has joined White & Case LLP's global life sciences and healthcare group and intellectual property practice.

  • October 29, 2024

    NY Judge Tosses $14B Decongestant MDL

    A New York federal judge threw out a streamlined complaint in a multidistrict litigation accusing companies such as Target and Bayer of making and selling ineffective over-the-counter decongestants, finding Tuesday the state claims are expressly preempted, and the proposed class lacks standing on a federal racketeering claim as indirect purchasers.

  • October 29, 2024

    Y-mAbs Therapeutics Investors Get Final OK For $19.7M Deal

    A New York federal judge has granted final approval to a $19.7 million settlement between Y-mAbs Therapeutics and investors who claim the company misrepresented the likelihood that the U.S. Food and Drug Administration would approve the company's signature pediatric nerve cancer treatment, giving class counsel a $6.5 million cut of the deal.

  • October 29, 2024

    Retired Fed. Circ. Judge Backs Invisalign In Monopoly Cases

    Retired Federal Circuit Judge Paul R. Michel warned the Ninth Circuit on Tuesday that reversing a lower court's decision to toss a pair of class actions accusing Invisalign of monopolizing the clear braces and teeth scanners market by illegally refusing to deal with a rival would increase patent owners' legal uncertainties.

  • October 29, 2024

    Patent Partner Moves From King & Spalding To Steptoe

    A former King & Spalding LLP partner has made the jump to Steptoe LLP, filling out the firm's team of California-based litigators who take on patent cases.

  • October 29, 2024

    4th Circ. Quizzes Drugmaker Challenging W.Va. Abortion Law

    An attorney arguing that West Virginia is preempted by federal law from restricting access to an abortion medication faced skeptical questions Tuesday from two judges who suggested it's entirely normal for states to regulate the practice of medicine.

  • October 29, 2024

    Biopharma Co. Escapes Investor Suit Over Drug Approval Lies

    Biopharmaceutical company Spero Therapeutics Inc. has escaped a proposed investor class action accusing it of concealing warning signs that it would not secure regulatory approval of one of its drugs, with the court ruling that Spero's interactions with the U.S. Food and Drug Administration do not indicate Spero should have known its application would be rejected.

  • October 29, 2024

    Medical Co. Gets No Coverage For Toxic Tort

    An insurer for B. Braun Medical Inc. has no duty to defend or indemnify the company against numerous lawsuits accusing B. Braun of exposing residents near one of its medical device manufacturing plants to a carcinogenic gas, a Pennsylvania federal court ruled, finding a pollution exclusion applicable.

Expert Analysis

  • How High Court Approached Time Limit On Reg Challenges

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    The U.S. Supreme Court's decision in Corner Post v. Federal Reserve Board effectively gives new entities their own personal statute of limitations to challenge rules and regulations, and Justice Brett Kavanaugh's concurrence may portend the court's view that those entities do not need to be directly regulated, say attorneys at Snell & Wilmer.

  • Fed. Circ. Skinny Label Ruling Guides On Infringement Claims

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    The Federal Circuit's recent decision in Amarin v. Hikma shows generic drug manufacturers must pay close attention to the statements in their abbreviated new drug application labels to put themselves in the best position in defending against an induced infringement claim, say Luke Shannon and Roshan Shrestha at Taft Stettinius.

  • 4 Takeaways From Biotech Patent Invalidity Ruling

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    The recent Patents Court decision in litigation between Advanced Cell Diagnostics and Molecular Instruments offers noteworthy commentary on issues related to experiments done in the ordinary course of business, joint importation, common general knowledge and mindset, and mosaicking for anticipation, say Nessa Khandaker and Darren Jiron at Finnegan.

  • How To Clean Up Your Generative AI-Produced Legal Drafts

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    As law firms increasingly rely on generative artificial intelligence tools to produce legal text, attorneys should be on guard for the overuse of cohesive devices in initial drafts, and consider a few editing pointers to clean up AI’s repetitive and choppy outputs, says Ivy Grey at WordRake.

  • Calif. Ruling Heightens Medical Product Maker Liability

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    The California Supreme Court's decision in Himes v. Somatics last month articulates a new causation standard for medical product manufacturer liability that may lead to stronger product disclosures nationwide and greater friction between manufacturers and physicians, say attorneys at Cooley.

  • Constitutional Protections For Cannabis Companies Are Hazy

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    Cannabis businesses are subject to federal enforcement and tax, but often without the benefit of constitutional protections — and the entanglement of state and federal law and conflicting judicial opinions are creating confusion in the space, says Amber Lengacher at Purple Circle.

  • USPTO Disclaimer Rule Would Complicate Patent Prosecution

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    The U.S. Patent and Trademark Office's proposed changes to terminal disclaimer practice could lead to a patent owner being unable to enforce a valid patent simply because it is indirectly tied to a patent in which a single claim is found anticipated or obvious in view of the prior art, say attorneys at Sterne Kessler.

  • Series

    Boxing Makes Me A Better Lawyer

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    Boxing has influenced my legal work by enabling me to confidently hone the skills I've learned from the sport, like the ability to remain calm under pressure, evaluate an opponent's weaknesses and recognize when to seize an important opportunity, says Kirsten Soto at Clyde & Co.

  • Purdue Ch. 11 Ruling Reinforces Importance Of D&O Coverage

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    The U.S. Supreme Court's recent decision in Harrington v. Purdue Pharma, holding that a Chapter 11 reorganization cannot discharge claims against a nondebtor without affected claimants' consent, will open new litigation pathways surrounding corporate insolvency and increase the importance of robust directors and officers insurance, says Evan Bolla at Harris St. Laurent.

  • Opinion

    Industry Self-Regulation Will Shine Post-Chevron

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    The U.S. Supreme Court's Loper decision will shape the contours of industry self-regulation in the years to come, providing opportunities for this often-misunderstood practice, says Eric Reicin at BBB National Programs.

  • 3 Ways Agencies Will Keep Making Law After Chevron

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    The U.S. Supreme Court clearly thinks it has done something big in overturning the Chevron precedent that had given deference to agencies' statutory interpretations, but regulated parties have to consider how agencies retain significant power to shape the law and its meaning, say attorneys at K&L Gates.

  • After Chevron

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    Since the U.S. Supreme Court overturned the Chevron deference standard in June, this Expert Analysis series has featured attorneys discussing the potential impact across 37 different rulemaking and litigation areas.

  • Series

    After Chevron: Expect Few Changes In ITC Rulemaking

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    The U.S. Supreme Court's opinion overruling the Chevron doctrine will have less impact on the U.S. International Trade Commission than other agencies administering trade statutes, given that the commission exercises its congressionally granted authority in a manner that allows for consistent decision making at both agency and judicial levels, say attorneys at Polsinelli.

  • 6 PTAB Events To Know From The Last 6 Months

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    The first half of 2024 brought a flurry of Patent Trial and Appeal Board developments that should be considered in post-grant strategies, including proposed rules on discretionary denial and director review, and the first decisions of the Delegated Rehearing Panel, say attorneys at Fish & Richardson.

  • Opinion

    Atty Well-Being Efforts Ignore Root Causes Of The Problem

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    The legal industry is engaged in a critical conversation about lawyers' mental health, but current attorney well-being programs primarily focus on helping lawyers cope with the stress of excessive workloads, instead of examining whether this work culture is even fundamentally compatible with lawyer well-being, says Jonathan Baum at Avenir Guild.

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