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Life Sciences

  • June 13, 2025

    DC Circ. Urged To Reject Approval For Braille-Free Drug Label

    Vanda Pharmaceuticals Inc. is urging the D.C. Circuit to reverse a lower court decision upholding the U.S. Food and Drug Administration's approval of a generic sleep-disorder drug without Braille labeling, a move the company argues jeopardizes patient safety.

  • June 13, 2025

    Ga. Medical Co. Accused Of Infringing Swedish Co.'s Patents

    A Swedish medical device company has sued Georgia-based MedWay Group Inc. in federal court for allegedly infringing its patents for foam dressings used in wound care and management.

  • June 13, 2025

    2024 Patent Litigation: A Year In Review

    The Eastern District of Texas held onto its newly regained title as the busiest patent venue in the U.S., with nearly three times as many cases in 2024 as the once-dominant Western District of Texas. In addition, Patent Trial and Appeal Board filings bounced back after falling to a record low in 2023.

  • June 13, 2025

    AstraZeneca Inks Up To $5.3B AI Drug Deal With Chinese Firm

    AstraZeneca said Friday it has entered into a strategic artificial intelligence-driven research partnership with China's CSPC Pharmaceutical Group in a deal worth as much as $5.3 billion, expanding the British drugmaker's commitments in the country following a shakeup of the company's local leadership.

  • June 12, 2025

    Roundup Plaintiffs' Rip Of Expert Was Off Base, Jury Hears

    A Missouri jury weighing a Roundup cancer case heard expert testimony Thursday that plaintiffs offered a "remarkable mischaracterization" of a defense expert witness on cancer causation when they said in openings that he was "discredited."

  • June 12, 2025

    Holmes Seeks 2 Year Cut, Commits To Criminal Justice Work

    Elizabeth Holmes has asked a California federal judge to knock two years off her 11-year prison sentence, arguing she's eligible for the adjustment under sentencing guidelines and has spent her time behind bars tutoring and advocating for her fellow prisoners.

  • June 12, 2025

    Florida, Sandoz Say They've Fixed Generic Drug Price-Fix Deal

    The Florida Attorney General's Office and Sandoz Inc. have told a Connecticut federal court they've fixed the problems the court identified with a generic drug price-fixing settlement after other states with claims in the case objected to a clause in the deal.

  • June 12, 2025

    23andMe Ombudsman Not Confident Sale Is Lawful

    The privacy expert probing 23andMe's proposed sale of customers' genetic data in bankruptcy told a Missouri federal judge Wednesday that he couldn't determine the deal wouldn't violate state privacy laws and recommended the company be required to obtain consent from its customers before handing over the data.

  • June 12, 2025

    8th Circ. Upholds Block On Minn. Generic-Drug Price Law

    The Eighth Circuit on Thursday backed a lower court's preliminary injunction blocking a Minnesota law that prohibits pharmaceutical manufacturers from imposing an "excessive" price increase on generic or biosimilar drugs, agreeing that the law is likely unconstitutional in regulating prices charged nationwide.

  • June 12, 2025

    'Forum Shopping' Center Stage At 6th Circ. Drug Pricing Args

    As part of an expansive effort to tee up U.S. Supreme Court review, pharmaceutical industry-backed opponents of Medicare's drug price negotiations entered less-than-hospitable territory at the Sixth Circuit, where judges pointedly questioned a local business group's basis for challenging a national healthcare program.

  • June 12, 2025

    USPTO Tells Fed. Circ. Not To Review Ruling In Xencor Case

    The U.S. Patent and Trademark Office has found that the full Federal Circuit doesn't need to review a decision rejecting Xencor Inc.'s application for an antibody patent, saying that a panel of the appellate court applied the right standard.

  • June 12, 2025

    GlaxoSmithKline Settles Conn. Generic Zantac Suits

    GlaxoSmithKline on Thursday agreed to settle two Connecticut lawsuits, one by seven plaintiffs and the other by 11, that claimed generic forms of the brand name heartburn and acid reflux drug Zantac degraded into a substance that caused cancer.

  • June 12, 2025

    These Firms Are Landing The Most PTAB Work

    Intellectual property powerhouse Fish & Richardson again secured the top spot on a list of firms appearing in the most trials over the past three years in front of the Patent Trial and Appeal Board.

  • June 12, 2025

    Fla.-Based Med Spa Chain Files For Ch. 11 After Expansion

    Contour Spa LLC, a Florida-based chain of fat-burning med spas, filed for Chapter 11 protection after a rapid expansion and a sprawling and decentralized operational system led to financial challenges that ate into revenues.

  • June 12, 2025

    8th Circ. Stubs Out Challenge To FDA Menthol Vape Denial

    The Eighth Circuit on Thursday threw out a challenge from SWT Global Supply Inc. to the U.S. Food and Drug Administration's denial of its application to market menthol-flavored e-cigarettes, saying the agency didn't arbitrarily or capriciously find that the company's sales plan failed to meet its standards for promoting public health.

  • June 12, 2025

    Rising PTAB Filings Follow Surge In Patent Cases

    The number of petitions filed with the Patent Trial and Appeal Board ticked up last year, following a similar increase in federal court litigation and suggesting that activity at the board has somewhat stabilized, according to a new report.

  • June 12, 2025

    Harvard Researcher Held By ICE Over Specimens Released

    A Harvard Medical School researcher and Russian national who has been detained by U.S. immigration authorities since February, when frog embryo specimens were found in her luggage at Logan Airport, was released from custody Thursday while she awaits trial on a smuggling charge.

  • June 12, 2025

    Judiciary Committee Clears Squires For Full Senate Vote

    The U.S. Senate Judiciary Committee approved former Goldman Sachs intellectual property attorney John Squires to serve as U.S. Patent and Trademark Office director on Thursday, putting his nomination in the hands of the full Senate.

  • June 12, 2025

    Greenberg Traurig Adds IP Atty From Kilpatrick In NY

    Greenberg Traurig LLP has boosted its intellectual property offerings in New York with the addition of an experienced litigator from Kilpatrick Townsend & Stockton LLP.

  • June 12, 2025

    5 Firms Guide $1.25B BioNTech, CureVac Oncology Deal

    German biotech firm BioNTech SE said Thursday that it will acquire CureVac NV, a clinical-stage mRNA specialist, in an all-stock oncology-focused deal valuing it at about $1.25 billion and involving five legal advisers. 

  • June 12, 2025

    Chancery Tags AstraZeneca Unit For $180M 'Expectation' Loss

    Rejecting calls for a $755 million award, a Delaware vice chancellor ruled late Wednesday that a biopharmaceutical company's shareholders are due $180.9 million in post-merger "expectation damages" plus interest after an AstraZeneca PLC unit's failure to reasonably pursue an acquired drug prospect.

  • June 11, 2025

    9th Circ. Doubts Kleenex Ad Fight Belongs In District Court

    Two judges on a Ninth Circuit panel doubted Wednesday that they have jurisdictional authority to revive a putative class action alleging Kimberly-Clark Corp.'s Kleenex Wet Wipes Germ Removal products mislead consumers about its ability to kill germs, saying repeatedly that the consumers' complaint has not met their burden to establish jurisdiction.

  • June 11, 2025

    PTAB Issues Mixed Group Of Discretionary Denial Decisions

    The Patent Trial and Appeal Board has invoked its discretion to free Nike Inc. and Cleveland Medical Devices from having their patents scrutinized, but refused to do so for Vermeer Manufacturing Co.

  • June 11, 2025

    RFK Jr. Picks Vaccine Critics As Part Of CDC Panel Overhaul

    Robert F. Kennedy Jr., secretary of the U.S. Department of Health and Human Services, announced Wednesday he appointed eight new members to a vaccine advisory panel, just two days after he removed 17 existing members of the panel, which provides advice and guidance on the use of vaccines to the Centers for Disease Control and Prevention.

  • June 11, 2025

    IP, Health Law Scholars Object To 23andMe Ch. 11 Data Sale

    A number of university scholars urged a Missouri bankruptcy judge to require that DNA testing company 23andMe Holding Co.'s asset sale be contingent on the final buyer maintaining policies that benefit biomedical researchers.

Expert Analysis

  • Mastering The Fundamentals Of Life Sciences Due Diligence

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    As life sciences transactions continue to gain tremendous momentum, companies participating in these transactions must conduct effective and strategic regulatory due diligence, which involves extensive amounts of information and varies by manifold factors, says Anna Zhao at GunnerCooke.

  • Beware Risks Of Arguing Multiple Constructions In IP Cases

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    Defendants accused of patent infringement often argue for different, potentially contradictory, claim constructions before district courts and the Patent Trial and Appeal Board, but the board may be clamping down on this strategy, say attorneys at Dechert.

  • What's At Stake In High Court Transgender Care Suit

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    The outcome of U.S. v. Skrmetti will have critical implications for the rights of transgender youth and their access to gender-affirming care, and will likely affect other areas of law and policy involving transgender individuals, including education, employment, healthcare and civil rights, say attorneys at ArentFox Schiff.

  • 6th Circ. Ruling Paves Path Out Of Loper Bright 'Twilight Zone'

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    The U.S. Supreme Court’s Loper Bright ruling created a twilight zone between express statutory delegations that trigger agency deference and implicit ones that do not, but the Sixth Circuit’s recent ruling in Moctezuma-Reyes v. Garland crafted a two-part test for resolving cases within this gray area, say attorneys at Wiley.

  • A Reminder On Avoiding Improper Venues In Patent Cases

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    A Texas federal court's recent decision in the Symbology and Quantum cases shows that baseless patent venue allegations may be subject to serious Rule 11 sanctions, providing venue-vetting takeaways for plaintiffs and defendants, say attorneys at Bond Schoeneck.

  • NIH Cuts To Indirect Costs May Stifle IP Generation

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    Although currently blocked by a preliminary injunction, the National Institutes of Health's new policy to cut down on indirect cost funding creates challenges for university research projects, and may hamper the development of intellectual property — which is considered an indirect cost — for years to come, say attorneys at Snell & Wilmer.

  • Recent Cases Clarify FCA Kickback Pleading Standards

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    Two recently resolved cases involving pharmaceutical manufacturers may make it more difficult for False Claims Act defendants facing kickback scheme allegations to get claims dismissed for lack of evidence, say Li Yu at Bernstein Litowitz, Ellen London at London & Noar, and Gregg Shapiro at Gregg Shapiro Law.

  • Opinion

    Antitrust Analysis In Iowa Pathologist Case Misses The Mark

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    An Iowa federal court erred in its recent decision in Goldfinch Laboratory v. Iowa Pathology Associates by focusing exclusively on market impacts and sidestepping key questions that should be central to antitrust standing analysis, says Daniel Graulich at Baker McKenzie.

  • Opinion

    State FCAs Should Cover Local Fund Misuse, State Tax Fraud

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    New Jersey and other states with similar False Claims Acts should amend them to cover misappropriated municipal funding, and state and local tax fraud, which would encourage more whistleblowers to come forward and increase their recoveries, says Kenneth Levine at Stone & Magnanini.

  • 7 Tips For Associates To Thrive In Hybrid Work Environments

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    As the vast majority of law firms have embraced some type of hybrid work policy, associates should consider a few strategies to get the most out of both their in-person and remote workdays, says James Argionis at Cozen O’Connor.

  • Series

    Playing Beach Volleyball Makes Me A Better Lawyer

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    My commitment to beach volleyball has become integral to my performance as an attorney, with the sport continually reminding me that teamwork, perseverance, professionalism and stress management are essential to both undertakings, says Amy Drushal at Trenam.

  • What To Expect From 'Make America Healthy Again' Actions

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    The Make America Healthy Again Commission recently established by President Donald Trump and chaired by Robert F. Kennedy Jr. will potentially bring energy and attention to important public health topics, and stakeholders should be aware of pathways for sharing their input and proactively informing proceedings, says Nicholas Manetto at Faegre Drinker.

  • How Law Firms Can Counteract The Loneliness Epidemic

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    The legal industry is facing an urgent epidemic of loneliness, affecting lawyer well-being, productivity, retention and profitability, and law firm leaders should take concrete steps to encourage the development of genuine workplace connections, says Michelle Gomez at Littler and Gwen Mellor Romans at Herald Talent.

  • What's At Stake In High Court's Class Member Standing Case

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    The U.S. Supreme Court’s eventual decision in Labcorp v. Davis could significantly alter how parties prosecute and defend class actions in federal court, particularly if the court determines some proof of member standing is required before a class may be certified, say attorneys at Reed Smith.

  • How Citizen Petitions Have Affected Drug Competition

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    In light of recent citizen petitions and proposed legislation regulating such petitions, Omar Robles at Managing Health analyzes the statistics of the extent to which citizen petitions have been filed, and to what extent they have delayed competition in prescription pharmaceuticals.

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