Life Sciences

  • 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.

  • April 11, 2024

    Medtronic Can't Ditch Ex-Sales Rep's Retaliation Claim

    Medical device maker Medtronic can't avoid a whistleblower retaliation claim by a former sales rep who says he was pushed out after reporting what he suspected to be a kickback scheme to the U.S. Food and Drug Administration, a federal judge said Wednesday.

  • April 11, 2024

    Kirkland, Jones Day Build $787.5M Sale Of Steris' Dental Unit

    Medical device company Steris, advised by Jones Day, on Thursday announced plans to sell its dental segment to Kirkland & Ellis LLP-advised middle market private equity shop Peak Rock Capital for $787.5 million.

  • April 11, 2024

    Life Sciences Group Of The Year: Sullivan & Cromwell

    Sullivan & Cromwell LLP helped Bayer defeat Merck in litigation over asbestos-containing talc liability and guided mega pharma deals such as Pfizer's $43 billion acquisition of Seagen and Amgen's $27.8 billion acquisition of Horizon Therapeutics, earning the firm a spot among Law360's 2023 Life Sciences Groups of the Year.

  • April 10, 2024

    Pfizer Unit Cuts $39M Deal Ending Effexor Antitrust Claims

    A proposed class of direct buyers asked a New Jersey federal judge on Tuesday to approve a $39 million settlement to end allegations that Pfizer Inc. unit Wyeth engaged in a scheme with Teva Pharmaceuticals to delay generic competition for the antidepressant drug Effexor XR.

  • April 10, 2024

    DOJ Hits Regeneron With False Claims Act Suit Over Eylea

    The federal government has brought a False Claims Act intervenor complaint in Massachusetts against Regeneron, alleging the pharmaceutical giant fraudulently withheld information from its Medicare reports seeking reimbursement for its drug Eylea, the U.S. Department of Justice announced Wednesday. 

  • April 10, 2024

    Del. Justices Probe Validity Of Advance Notice Bylaws

    The appeal of a Delaware Chancery Court decision voiding a biopharmaceutical company's "onerous" advance notice requirements for director nominations while upholding the rejection of an activist shareholder's nominees boiled down to one basic legal question at Delaware's Supreme Court Wednesday: Is this a facial or an as-applied challenge?

  • April 10, 2024

    9th Circ. Mostly Affirms Industry Ban For COVID PPE Delays

    A Ninth Circuit panel on Tuesday largely upheld a district court's ruling requiring personal protective equipment suppliers to pay over $3 million after finding that they misrepresented the shipping times of hand sanitizer products at the start of the COVID-19 pandemic, while reversing the Federal Trade Commission's injunction against one of the companies' owners.

  • April 10, 2024

    Dems Introduce Bill To Codify Policy Barring Judge Shopping

    Senate Majority Leader Chuck Schumer, D-N.Y., along with 37 other Democratic and two independent senators, introduced legislation on Wednesday to codify the new Judicial Conference of the United States policy against judge shopping after pushback from Republicans and a Texas court.

  • April 10, 2024

    4th Circ. Sides With CMS' Definition Of 'Line-Extension Drug'

    The Fourth Circuit on Wednesday affirmed a summary judgment ruling in favor of the Centers for Medicare & Medicaid Services in a rule challenge by Vanda Pharmaceuticals, which took issue with the agency's criteria for what constitutes a line-extension drug.

  • April 10, 2024

    Skadden, Fenwick Lead $4.9B Alpine Immune Sciences Sale

    Biotechnology company Alpine Immune Sciences Inc., advised by Fenwick & West LLP, on Wednesday revealed that it has agreed to be bought by Vertex Pharmaceuticals Inc., led by Skadden Arps Slate Meagher & Flom LLP, in a $4.9 billion cash deal.

  • April 10, 2024

    Pharmacy Gets Eli Lilly's Mounjaro Suit Tossed

    A Florida federal judge has thrown out Eli Lilly & Co.'s suit accusing an online pharmacy of wrongly selling a compounded version of its drug Mounjaro, saying Eli Lilly was "using state law to enforce the terms of" federal law.

  • April 10, 2024

    Justices Asked To Ban FCA Suits Relying On Patent Reviews

    Valeant Pharmaceuticals is going to the U.S. Supreme Court to argue that information cited in Patent Trial and Appeal Board reviews cannot later be used by whistleblowers in False Claims Act lawsuits.

  • April 10, 2024

    Moderna Says Pfizer Is PTAB 'Tea-Leaf-Reading' In Vax IP Row

    Moderna Inc. asked a Boston federal judge to deny Pfizer Inc.'s bid to pause a COVID-19 vaccine patent trial while the Patent Trial and Appeal Board reviews the validity of two of the three patents at issue.

Expert Analysis

  • Understanding Discovery Obligations In Era Of Generative AI

    Excerpt from Practical Guidance
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    Attorneys and businesses must adapt to the unique discovery challenges presented by generative artificial intelligence, such as chatbot content and prompts, while upholding the principles of fairness, transparency and compliance with legal obligations in federal civil litigation, say attorneys at King & Spalding.

  • Kochava Ruling May Hint At Next Privacy Class Action Wave

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    The Southern District of California's recent ruling in Greenley v. Kochava and increasing complaints alleging that a consumer website is an illegal “pen register” due to the use of third-party marketing software tools foreshadow a new theory of liability for plaintiffs in privacy litigation, say attorneys at Crowell & Moring.

  • Forecasting The Impact Of High Court Debit Card Rule Case

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    John Delionado and Aidan Gross at Hunton consider how the U.S. Supreme Court's forthcoming ruling in a retailer's suit challenging a Federal Reserve rule on debit card swipe fees could affect agency regulations both new and old, as well as the businesses that might seek to challenge them.

  • Series

    ESG Around The World: Mexico

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    ESG has yet to become part of the DNA of the Mexican business model, but huge strides are being made in that direction, as more stakeholders demand that companies adopt, at the least, a modicum of sustainability commitments and demonstrate how they will meet them, says Carlos Escoto at Galicia Abogados.

  • Opinion

    FDA And Companies Must Move Quickly On Drug Recalls

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    When a drug doesn't work as promised — whether it causes harm, like eyedrops recalled last month by the U.S. Food and Drug Administration, or is merely useless, like a widely used decongestant ingredient recently acknowledged by the agency to be ineffective — the public must be notified in a timely manner, says Vineet Dubey at Custodio & Dubey.

  • The Case For Post-Bar Clerk Training Programs At Law Firms

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    In today's competitive legal hiring market, an intentionally designed training program for law school graduates awaiting bar admission can be an effective way of creating a pipeline of qualified candidates, says Brent Daub at Gilson Daub.

  • Opinion

    A Telecom Attorney's Defense Of The Chevron Doctrine

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    The Chevron doctrine, which requires judicial deference to federal regulators, is under attack in two U.S. Supreme Court cases — and while most telecom attorneys likely agree that the Federal Communications Commission is guilty of overrelying on it, the problem is not the doctrine itself, says Carl Northrop at Telecommunications Law Professionals.

  • What's At Stake In Bystolic 'Side Deals' Litigation

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    In re: Bystolic Antitrust Litigation, which has oral argument set for next month, will likely shed light on how the U.S. Court of Appeals for the Second Circuit views side deals, and could create a circuit split in pleading standards for reverse payment cases, say attorneys at Axinn.

  • 2 HHS Warnings Highlight Anti-Kickback Risks For Physicians

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    Two recent advisory opinions issued by the U.S. Department of Health and Human Services' Office of Inspector General involve different scenarios and rationales, but together they illustrate the OIG's focus on and disapproval of contractual joint ventures and other revenue-maximizing physician arrangements, say Robert Threlkeld and Elliott Coward at Morris Manning.

  • Attorneys Have An Ethical Duty To Protect The Judiciary

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    The tenor of public disagreement and debate has become increasingly hostile against judges, and though the legislative branch is trying to ameliorate this safety gap, lawyers have a moral imperative and professional requirement to stand with judges in defusing attacks against them and their rulings, says Deborah Winokur at Cozen O'Connor.

  • Cross-Market Implications In FTC's Anesthesia Complaint

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    The Federal Trade Commission's recent complaint against a private equity firm's acquisition of anesthesiology practices highlights the controversial issue of cross-market harm in health care provider mergers, and could provide important insights into how a court may view such theories of harm, say Christopher Lau and Dina Older Aguilar at Cornerstone Research.

  • FTC Orange Book Move Signals New Pharma Patent Scrutiny

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    The Federal Trade Commission's recent dispute against improper listing of drug patents in the U.S. Food and Drug Administration's Orange Book indicates heightened surveillance of the pharmaceutical industry, particularly where competition-related consequences of patent or regulatory processes are concerned, say attorneys at Fenwick.

  • AI Can Help Lawyers Overcome The Programming Barrier

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    Legal professionals without programming expertise can use generative artificial intelligence to harness the power of automation and other technology solutions to streamline their work, without the steep learning curve traditionally associated with coding, says George Zalepa at Greenberg Traurig.

  • How Legal Teams Can Prep For Life Sciences' Tech Revolution

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    The life sciences and health care industries are uniquely positioned to take advantage of new efficiencies created by cloud computing and generative artificial intelligence, but the sensitivity of their data also demands careful navigation of an expanding legislative and regulatory landscape, say Kristi Gedid, Zack Laplante and Lisa LaMotta at Ernst & Young.

  • Preparing Law Students For A New, AI-Assisted Legal World

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    As artificial intelligence rapidly transforms the legal landscape, law schools must integrate technology and curricula that address AI’s innate challenges — from ethics to data security — to help students stay ahead of the curve, say Daniel Garrie at Law & Forensics, Ryan Abbott at JAMS and Karen Silverman at Cantellus Group.

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