Life Sciences

  • 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.

  • April 10, 2024

    1st Circ. Says Appellant's Death Erases Conviction

    The First Circuit has vacated the stock fraud conviction of a biotech executive who died in prison, aligning itself with all the other federal circuits in adopting the longstanding principle that a defendant's death during a direct appeal of a conviction wipes out all the criminal proceedings from their inception.

  • April 10, 2024

    Life Sciences Group Of The Year: Morrison Foerster

    Morrison Foerster LLP successfully beat a preliminary injunction that would have thwarted a Sandoz biosimilar for multiple sclerosis from going to market, one achievement among many that earned the firm a spot among Law360's 2023 Life Sciences Groups of the Year.

  • April 10, 2024

    Ginkgo Bioworks SPAC Investors Sue In Del. After Stock Drop

    Investors in the blank check company that took biotech firm Ginkgo Bioworks Inc. public in September 2021 have sued the venture's founders and insiders for unjust enrichment and fiduciary breaches in Delaware's Court of Chancery, alleging that the deal was propped up by false and misleading claims.

  • April 09, 2024

    After Uproar, New MDL Rule Advances With Attys Assuaged

    Following years of debate and months of outcry, a judicial panel Tuesday approved the first formal rule aimed at improving efficiency and fairness in the nation's burgeoning realm of multidistrict litigation, earning plaudits from placated lawyers in the defense and plaintiffs bars.

  • April 09, 2024

    Investor Can't Get Approval Of Hong Kong Award In Calif.

    A California judge has thrown out a petition filed by a biotechnology company investor seeking to enforce a Hong Kong arbitral award that found she is the proper owner of the company's shares, saying the case has an insufficient connection to the Golden State.

  • April 09, 2024

    Philips, Feds Enter Consent Decree Over Sleep Apnea Devices

    Philips Respironics can't make sleep apnea breathing machines until it hires an independent monitor, undergoes inspections and meets its obligations under a plan to remediate patients affected by a 2021 recall of such devices, the U.S. Department of Justice and U.S. Food and Drug Administration announced Tuesday.

  • April 09, 2024

    Pfizer Cancer Drug Way Too Expensive, Biden Told

    The U.S. government is being asked yet again to use patent laws to lower the price of a prostate cancer drug that was developed at UCLA and is being sold by Pfizer for $136 a pill in the U.S.

  • April 09, 2024

    HK Arbitrator Halts Commercialization Of Leukemia Treatment

    A Cayman Islands pharmaceutical company has announced that an emergency arbitrator in Hong Kong has ordered a Chinese biopharma firm to stop commercializing a treatment for leukemia as the two companies arbitrate a dispute over a terminated license agreement.

  • April 09, 2024

    Former Pharma Exec Can't Oust Judge In Contempt Case

    A federal judge in Massachusetts on Tuesday denied what he called a "frivolous" motion to recuse himself from a criminal contempt proceeding against a former pharmaceutical executive who has acknowledged using an alias to flout an injunction banning him from working in the securities field.

  • April 09, 2024

    Endo Sues FDA Over Generic Adrenalin Approvals

    Endo has filed a lawsuit against federal health regulatory authorities, alleging that they are wrongfully giving the go-ahead for a generic version of the Adrenalin epinephrine injection, asking for a stay of the decision.

  • April 09, 2024

    Biotech Co. Insiders Sued In Del. Over $200M PIPE Deal Gain

    Investors of clinical-stage pharmaceutical company Taysha Gene Therapies Inc. sued the company's directors and officers in Delaware Chancery Court to recover more than $200 million in damages on behalf of the company after its insiders allegedly wrongfully profited from a public equity sale.

  • April 09, 2024

    Tech M&A Reigns Supreme In Q1 After Rare Hiccup In Q4

    The technology sector logged the greatest total value of global mergers and acquisitions in the first quarter of 2024, following a rare quarter that saw the industry fall out of the top spot and into third place, data from Dealogic shows.

  • April 09, 2024

    Life Sciences GCs On Tighter Regs, Outside Counsel Advice

    General counsel at life sciences venture capital firms are navigating increased regulation in healthcare and looking to outside counsel to act as true advisers and problem-solvers as the healthcare industry becomes more complex.

  • April 09, 2024

    Jenner & Block Recruits Ex-Sheppard Mullin IP Litigator In SF

    Jenner & Block LLP is boosting its intellectual property practice with the addition of a veteran trial lawyer as of counsel in its San Francisco office who was most recently with Sheppard Mullin Richter & Hampton LLP.

  • April 09, 2024

    Court OKs Decision Clearing Contractor Of Missed IP Deadline

    A patent docketing contractor used by major remote law firm FisherBroyles can't be held liable for a "clerical mistake" that led to a missed patent application deadline and then a neurosurgeon's lawsuit potentially seeking nearly $102 million, with a Georgia appeals court affirming a lower court decision that the surgeon never should have relied on those dates in the first place.

  • April 08, 2024

    Target's Acne Treatments Contain Benzene, Customer Says

    A Target customer in Illinois has launched consumer protection claims in federal court targeting acne treatments the retail giant allegedly manufactures and markets without disclosing benzene among their active ingredients. 

  • April 08, 2024

    Walmart Beats Investor Suit Over Opioid Probe Disclosures

    Walmart beat back an investor class action on Monday alleging it failed to properly disclose that it was the subject of parallel criminal and civil investigations over its opioid sales, with a Delaware federal judge ruling that the suit's challenged statements were not false or misleading.

  • April 08, 2024

    SEC 'Shadow Trading' Victory Could Bring DOJ Knocking

    Now that the U.S. Securities and Exchange Commission has convinced a jury that a pharmaceutical executive committed insider trading by purchasing a competitor's stock in a practice often referred to as "shadow trading," attorneys say federal prosecutors might be tempted to dip their toe into the waters of the previously untested legal theory.

Expert Analysis

  • 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.

  • Series

    ESG Around The World: South Korea

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    Numerous ESG trends have materialized in South Korea in the past three years, with impacts ranging from greenwashing prevention and carbon neutrality measures to workplace harassment and board diversity initiatives, say Chang Wook Min and Hyun Chan Jung at Jipyong.

  • General Counsel Need Data Literacy To Keep Up With AI

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    With the rise of accessible and powerful generative artificial intelligence solutions, it is imperative for general counsel to understand the use and application of data for myriad important activities, from evaluating the e-discovery process to monitoring compliance analytics and more, says Colin Levy at Malbek.

  • Trending At The PTAB: Administrative Procedure

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    A pair of recent Federal Circuit rulings on Patent Trial and Appeal Board inter partes review shed light on applications of the Administrative Procedure Act, adding to an ever-growing body of case law showing the board's final written decision must be based on arguments clearly put forth by the parties, say Robert High and Benjamin Saidman at Finnegan.

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