Life Sciences

  • May 28, 2024

    Edwards Urges Full Fed. Circ. To Limit FDA Safe Harbor

    Edwards Lifesciences has petitioned the full Federal Circuit to narrow its interpretation of a U.S. Food and Drug Administration safe harbor that essentially allows patent infringement during drug development, arguing that if Congress wanted the statute to be interpreted broadly, "it would have said exactly that."

  • May 28, 2024

    Beasley Allen, J&J Trade Barbs Over DQ Bid In Talc Litigation

    Johnson & Johnson and the Beasley Allen Law Firm have accused each other by turns of "gamesmanship" and "unscrupulous conduct" in New Jersey courts in a fight over whether the firm should be disqualified from talcum powder litigation for allegedly collaborating in secret with a former J&J outside counsel.

  • May 24, 2024

    Esperion Launches Suits Over Cholesterol Drug Patents

    Esperion Therapeutics has sued Dr. Reddy's, Sandoz, Hetero and MSN in New Jersey, alleging that their planned generic versions of cholesterol drugs infringe a variety of patents on its treatments.

  • May 24, 2024

    Treaty Wants Patents To Cite Ties To 'Traditional Knowledge'

    Members of the United Nations announced a treaty Friday that would potentially change mandatory patent disclosure rules in order to require applicants to cite "traditional knowledge" developed by "indigenous peoples," requirements that have drawn concerns from lawyers for the pharmaceutical industry in the U.S. and at least one former federal judge.

  • May 24, 2024

    Petition Watch: Forum Shopping, Monopolies & Gun Safety

    Law360 looks at four U.S. Supreme Court petitions filed in the past two weeks, including the FDA's request that the justices curb an increase in forum shopping at the Fifth Circuit, and two veterinarians who want the justices to allow plaintiffs to pursue antitrust claims for actions allegedly leading to the creation of a monopoly.

  • May 24, 2024

    Fla. Lab Owner Will Pay $27M To End False Billing Suit

    A Florida medical lab owner who pled guilty to charges related to accusations he billed Medicare for $53 million in unnecessary genetic cancer screening tests has agreed to pay more than $27 million to resolve three whistleblower suits over the same conduct, according to an announcement Friday from the U.S. Department of Justice.

  • May 24, 2024

    Shuttered Paper Mill Flouted $12M Incentive Deal, NC AG Says

    The state of North Carolina is suing food and beverage packaging company Pactiv Evergreen to recoup $12 million in economic incentives the company allegedly accepted to keep a local mill up and running after it abruptly shuttered the facility last year.

  • May 24, 2024

    NY AG Sues Over Illegal Long Island Wetland Construction

    New York prosecutors on Friday sued to force a contractor to pay nearly $600,000 and restore a Long Island wetland area the company has been using as a storage site after illegally clearing vegetation and building a parking lot more than a decade ago.

  • May 24, 2024

    Biden's Judicial Impact And What's Left On The Wish List

    President Joe Biden secured confirmation of his 200th federal judge Wednesday and has transformed the judiciary by picking more women and people of color than any other president. But the upcoming election season could derail his hopes of confirming many more judges.

  • May 24, 2024

    NYSE Companies Could Face Heat If Business Focus Changes

    A New York Stock Exchange proposal seeking additional authority to delist companies that enact wholesale business changes after going public could subject certain companies to more scrutiny, attorneys say, though such drastic actions are expected to be rare.

  • May 24, 2024

    UK Litigation Roundup: Here's What You Missed In London

    This past week in London has seen an IT engineer seek permission to search a landfill hiding a hard drive supposedly storing millions of pounds in bitcoin, Glencore take on legal action by American Century Investments, gold payment app Glint bring a breach of duty claim against FRP Advisory, and an ongoing dispute between a solicitor and the Solicitors Regulation Authority. Here, Law360 looks at these and other new claims in the U.K.

  • May 23, 2024

    NJ Justices Toss Direct Appeals Over Hospital Contract Bid

    The New Jersey Supreme Court ruled Thursday that an independent state-owned teaching hospital's conduct cannot be challenged directly in the state's intermediate appellate court because it isn't considered an administrative agency, affirming the dismissal of two protests over the hospital's selection of a pharmacy vendor.

  • May 23, 2024

    Fed. Circ. Upends Inventors' Interference Win Over Time-Bar

    The Patent Trial and Appeal Board wrongly chose inventors tied to Cook Medical, rather than ones tied to Medtronic, when determining who should prevail in an interference proceeding over catheters, the Federal Circuit held Thursday.

  • May 23, 2024

    Ex-Judge Pushed False Narrative On Atty Romance, Firm Says

    U.S. Bankruptcy Judge David R. Jones of Texas, who resigned last year after his secret relationship with a Jackson Walker LLP partner was revealed, attempted to head off rumors about the relationship by asking the firm to file a false, partial disclosure in 2022, the firm alleged.

  • May 23, 2024

    Merck To Pay $600M For KKR-Backed Life Sciences Biz

    Menlo Park, California-based Gamma Biosciences said Thursday it has agreed to sell its operating company Mirus Bio for $600 million in cash to Merck KGaA, inking the deal under the guidance of Sidley Austin LLP. 

  • May 23, 2024

    Just 57% Of Complex Global Deals Closed Since 2020

    About 43% of complex cross-border global deals have failed to close since the start of 2020, while the remaining 57% did close but were highly likely to involve remedies, according to a new report from Weil Gotshal & Manges LLP.

  • May 23, 2024

    J&J Loses Expedited Bid For Beasley Allen Docs In Talc MDL

    Johnson & Johnson has lost its bid in New Jersey federal court to have the Beasley Allen Law Firm quickly produce documents related to what J&J said seems to be an "intentional effort" by the firm to "bias the vote" against a proposed $6.5 billion reorganization plan for its talc subsidiary.

  • May 23, 2024

    GSK, Boehringer Prevail In 1st Zantac Cancer Trial

    A Chicago jury found Thursday that Zantac heartburn medication and its generic counterparts sold by GlaxoSmithKline and Boehringer Ingelheim are not responsible for an Illinois woman's colon cancer and her subsequent, debilitating symptoms, handing the drug companies a decisive victory in the first of hundreds of such cases to go to trial.

  • May 22, 2024

    Inventor To Take $102M IP Malpractice Row To Ga. High Court

    A neurosurgeon pursuing a nearly $102 million legal malpractice case against FisherBroyles LLP and a legal services contractor over a missed patent filing deadline said Wednesday that he is planning to take the dispute to the highest court in the Peach State.

  • May 22, 2024

    Cancer Patients Target J&J Talc Unit's Asset Shuffles

    Cancer patients who have sued Johnson & Johnson alleging that its talcum powder caused their illness alleged Wednesday that the company has tried to intentionally prevent tort victims from getting their day in court through a scheme of fraudulent corporate transactions.

  • May 22, 2024

    Justices' CFPB Alliance May Save SEC Courts, Not Chevron

    A four-justice concurrence to the U.S. Supreme Court's decision upholding the Consumer Financial Protection Bureau's unique funding scheme last week carries implications for other cases pending before the court that challenge the so-called administrative state, or the permanent cadre of regulatory agencies and career government enforcers who hold sway over vast swaths of American economic life.

  • May 22, 2024

    FDA Must Act On Sexual Side Effects Of SSRIs, Suit Says

    The Food and Drug Administration should be forced to warn the public about the serious sexual side effects of a certain class of depression medications after sitting on a petition asking it to do just that for more than six years, a new lawsuit says.

  • May 22, 2024

    Evidence Shaky In First Zantac Cancer Trial, Drugmakers Say

    Attorneys for GlaxoSmithKline and Boehringer Ingelheim told a Chicago jury Wednesday that no one besides a plaintiff's paid witnesses have said publicly that Zantac heartburn medication causes colon cancer, calling on the jurors to reject claims that the companies owe $640 million for a woman's cancer diagnosis.

  • May 22, 2024

    Doc Gets 3 Mos. For Alexion Trades Despite 'Meaningful Job'

    A doctor was sentenced to three months in prison Wednesday for insider trading on an Alexion Pharmaceuticals acquisition, with a Manhattan federal judge saying the defendant's treatment of critically ill, underserved kidney disease patients does not amount to a "get out of jail free card."

  • May 22, 2024

    DuPont 'Document Dump' Rattles NC In PFAS Suit

    North Carolina and DuPont on Wednesday battled over what the state called a roughly 5 million-page "document dump" ahead of a looming June 3 discovery deadline in its contamination lawsuit, irking a business court judge in the process.

Expert Analysis

  • Judge-Shopping Policy Revisal May Make Issue Worse

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    The Judicial Conference at its March meeting unveiled a revised policy with the stated goal of limiting litigants’ ability to judge-shop in patent cases, but the policy may actually exacerbate the problem by tying the issue to judge-shopping in polarizing political cases, making reform more difficult, say Robert Niemeier and William Milliken at Sterne Kessler.

  • 2nd Circ. Baby Food Ruling Disregards FDA's Expertise

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    The Second Circuit's recent decision in White v. Beech-Nut Nutrition, refusing to defer litigation over heavy metals in baby food until the U.S. Food and Drug Administration weighs in on the issue, provides no indication that courts will resolve the issue with greater efficiency than the FDA, say attorneys at Phillips Lytle.

  • Assessing FDA Pathways For Genome-Edited Plant Foods

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    The U.S. Food and Drug Administration's recent clarification of the regulatory pathways for foods produced from genome-edited plants seeks to strike a balance between public health and innovation, and may hold broader significance for developers of novel human foods subject to voluntary notification programs, say Emily Marden and Diane McEnroe at Sidley Austin.

  • Opinion

    Proposed MDL Management Rule Needs Refining

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    Proponents of the recently proposed Federal Rule of Civil Procedure 16.1 believe it may enhance efficiency in multidistrict litigation proceedings if adopted, but there are serious concerns that it could actually hinder plaintiffs' access to justice through the courts — and there are fundamental flaws that deserve our attention, says Ashleigh Raso at Nigh Goldenberg.

  • Why Oncology Deal Making Continues To Fuel Biotech M&A

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    The biotech sector's potential for advancements in cancer care continues to attract deal-maker interest, and the keys to successful mergers and acquisitions include the ability to integrate innovative therapies, leverage technological advancements and respond to the dynamic needs of patients, say Bryan Luchs and Mike Weir at White & Case.

  • Opinion

    Judicial Independence Is Imperative This Election Year

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    As the next election nears, the judges involved in the upcoming trials against former President Donald Trump increasingly face political pressures and threats of violence — revealing the urgent need to safeguard judicial independence and uphold the rule of law, says Benes Aldana at the National Judicial College.

  • Opinion

    NIST March-In Framework Is As Problematic As 2021 Proposal

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    While the National Institute of Standards and Technology's proposed march-in framework on when the government can seize patents has been regarded as a radical departure that will support lowering prescription drug costs, the language at the heart of it is identical to a failed 2021 notice of proposed rulemaking, says attorney Kelly Morron.

  • Document Retention Best Practices To Lower Litigation Risks

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    As new technologies emerge and terabytes of data can be within the purview of a single discovery request, businesses small and large should take four document management steps to effectively minimize risks of litigation and discovery sanctions long before litigation ensues, says Kimbrilee Weber at Norris McLaughlin.

  • Series

    Riding My Peloton Bike Makes Me A Better Lawyer

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    Using the Peloton platform for cycling, running, rowing and more taught me that fostering a mind-body connection will not only benefit you physically and emotionally, but also inspire stamina, focus, discipline and empathy in your legal career, says Christopher Ward at Polsinelli.

  • Ala. Frozen Embryo Ruling Creates Risks for Managed Care Orgs

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    The Alabama Supreme Court's decision in LePage v. Center for Reproductive Medicine last month, declaring that frozen embryos count as children, has not only upended the abortion debate but also raised questions for managed care organizations and healthcare providers that provide, offer or facilitate fertility treatment nationwide, say attorneys at Reed Smith.

  • Spartan Arbitration Tactics Against Well-Funded Opponents

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    Like the ancient Spartans who held off a numerically superior Persian army at the Battle of Thermopylae, trial attorneys and clients faced with arbitration against an opponent with a bigger war chest can take a strategic approach to create a pass to victory, say Kostas Katsiris and Benjamin Argyle at Venable.

  • Uncertainty Surrounds Patent Eligibility Restoration Bill

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    A recent U.S. Senate hearing regarding the Patent Eligibility Restoration Act, a bill that aims to overhaul patent eligibility law and establish clearer statutory exclusions, marks a pivotal moment in the ongoing patent eligibility debate, but the law’s fate remains uncertain as discussions continue, say attorneys at Marshall Gerstein.

  • CSA Case Could Shift Intrastate Commercial Cannabis

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    In Canna Provisions v. Merrick Garland, cannabis companies argue that the Controlled Substances Act is unconstitutional as applied to intrastate commercial cannabis activity; the Massachusetts federal court's eventual decision will be important to the cannabis industry for several reasons, including that the threat of federal enforcement would disappear overnight, says Hilary Bricken at Husch Blackwell.

  • How AI May Be Used In Fintech Fraud — And Fraud Detection

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    Recent enforcement actions in the fintech and finance industries show that the government is increasingly pursuing fraud enabled by artificial intelligence — at the same time it’s using AI innovations to enforce regulations and investigate fraud, say attorneys at ArentFox Schiff.

  • What Recent Study Shows About AI's Promise For Legal Tasks

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    Amid both skepticism and excitement about the promise of generative artificial intelligence in legal contexts, the first randomized controlled trial studying its impact on basic lawyering tasks shows mixed but promising results, and underscores the need for attorneys to proactively engage with AI, says Daniel Schwarcz at University of Minnesota Law School.

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