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Life Sciences

  • 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.

  • June 11, 2025

    Fed. Circ. Backs PTAB Invalidation Of Agilent CRISPR Patents

    The Federal Circuit on Wednesday affirmed Patent Trial and Appeal Board decisions finding every claim invalid in two Agilent Technologies patents on the gene-editing tool CRISPR, sealing a win for Synthego Corp., which has been accused of infringing them.

  • June 11, 2025

    PepGen Faces Investor Suit Over Muscular Dystrophy Drug

    Clinical-stage biotech company PepGen Inc. has been hit with a proposed shareholder class action alleging it misled investors about the efficacy and commercial prospects of its muscular dystrophy drug, causing share price declines as investors learned of the drug's clinical trials' shortcomings.

  • June 11, 2025

    These Firms Are Landing The Most Patent Litigation Work

    Rabicoff Law LLC reclaimed its status as the most active firm for patent plaintiffs, having filed more than twice as many cases in 2024 as it did in 2023, according to a new report from Lex Machina.

  • June 11, 2025

    New Patent Cases Rebound As EDTX Seals Top Venue Spot

    The number of new patent suits filed in 2024 increased 22.2% over 2023, bouncing back from a historically slow year, and the Eastern District of Texas further cemented its status as the most popular patent venue after a rule change made another Texas district less attractive to plaintiffs.

  • June 11, 2025

    Vedder Price Boosts IP, Exec Compensation Teams In NY

    Vedder Price PC has bulked up its New York office with the addition of an intellectual property attorney from Vinson & Elkins LLP and an executive compensation and employee benefits pro from Schulte Roth & Zabel LLP.

  • June 11, 2025

    J&J's Beasley Allen DQ Bid Based On 'Innuendo,' Court Told

    A California couple ripped Johnson & Johnson's renewed bid to block two Beasley Allen Law Firm attorneys from representing them in their suit accusing the company of selling carcinogenic talc-based baby powder, arguing the company's opposition is based largely on "innuendo" rather than proof of misconduct by the lawyers.

  • June 10, 2025

    Stewart's Newest Discretionary Denial Has Attys On Edge

    The acting U.S. Patent and Trademark Office director's decision on Friday to reject patent challenges due to the petitioner's long-standing knowledge of a patent has many attorneys bracing for either a massive rise or dip in Patent Trial and Appeal Board filings.

  • June 10, 2025

    States Sue To Block 23andMe From Selling DNA Data In Ch. 11

    A bipartisan coalition of 28 attorneys general has sued 23andMe Inc. in Missouri bankruptcy court seeking to block the genetic-testing company from auctioning off its 15 million customers' personal genetic information without their explicit consent in its ongoing Chapter 11 proceeding.

  • June 10, 2025

    IT Co. Urges 1st Circ. To Affirm It's Blameless For Data Breach

    An information security technology company urged the First Circuit on Tuesday to affirm that it isn't liable for a 2018 data breach that exposed confidential information of more than 277,000 of the medical device maker's patients, arguing that the insurer assignee of the device maker had no valid points.

Expert Analysis

  • Drug Pricing Policy Trends To Expect In 2025 And Beyond

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    Though 2025 may bring more of the same in the realm of drug pricing policy, business as usual entails a sustained, high level of legal and policy developments across at least six major areas, say attorneys at Ropes & Gray.

  • Imagine The Possibilities Of Openly Autistic Lawyering

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    Andi Mazingo at Lumen Law, who was diagnosed with autism about midway through her career, discusses how the legal profession can create inclusive workplaces that empower openly autistic lawyers and enhance innovation, and how neurodivergent attorneys can navigate the challenges and opportunities that come with disclosing one’s diagnosis.

  • Top 10 Healthcare And Life Sciences Issues To Watch In 2025

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    Under the new Trump administration, this coming year may benefit some healthcare and life sciences stakeholders, while creating new challenges for others amid an increasingly complex regulatory environment, say attorneys at Debevoise.

  • Parsing 3rd Circ. Ruling On Cannabis, Employee Private Suits

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    The Third Circuit recently upheld a decision that individuals don't have a private right of action for alleged violations of New Jersey's Cannabis Regulatory, Enforcement Assistance and Marketplace Modernization Act, but employers should stay informed as the court encouraged the state Legislature to amend the law, say attorneys at Mandelbaum Barrett.

  • 4 Keys To Litigating In An Active Regulatory Environment

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    For companies facing litigation influenced by government regulatory action — a recent trend that a politically charged atmosphere will exacerbate — there are a few principles that can help to align litigation strategy with broader public positioning in the regulatory and oversight context, say attorneys at Jenner & Block.

  • Kiromic SEC Order Shows Importance Of Self-Reporting

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    The U.S. Securities and Exchange Commission's recently filed settled charges against Kiromic BioPharma illustrate the critical intersection between U.S. Food and Drug Administration regulatory processes and investor disclosures under the securities laws, and showcase how responding promptly to internal whistleblower reports may reap benefits, say attorneys at Arnold & Porter.

  • Series

    Documentary Filmmaking Makes Me A Better Lawyer

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    Becoming a documentary filmmaker has allowed me to merge my legal expertise with my passion for storytelling, and has helped me to hone negotiation, critical thinking and problem-solving skills that are important to both endeavors, says Robert Darwell at Sheppard Mullin.

  • Litigation Funding Disclosure Debate: Strategy Considerations

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    In the ongoing debate over whether courts should require disclosure of litigation funding, funders and plaintiffs tend to argue against such mandates, but voluntarily disclosing limited details about a funding arrangement can actually confer certain benefits to plaintiffs in some scenarios, say Andrew Stulce and Marc Cavan at Longford Capital.

  • 2025 May Be A Breakout Year For The Cannabis Industry

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    The cannabis industry faced a slow and frustrating 2024, but consumer trends continue to shift in favor of cannabis, and the new administration may provide the catalyst that the industry needs, says Lynn Gefen at TerrAscend.

  • FDA's Red No. 3 Ban Reshapes Food Safety Legal Landscape

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    The U.S. Food and Drug Administration's recent ban on Red No. 3 represents more than the end of a controversial dye — it signals a shift in regulatory priorities, consumer expectations, intellectual property strategy, compliance considerations and litigation risk, says Dino Haloulos at Foley Mansfield.

  • Scope And Nature Of Judicial Relief Will Affect Loper's Impact

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    The practical result of post-Loper Bright rulings against regulatory actions will depend on the relief courts grant — and there has been controversy in these types of cases over whether the ruling is applied just to the parties or nationwide, and whether the action can be left in place while it's corrected, says Steven Gordon at Holland & Knight.

  • The Implications Of E-Cigarette Cos. Taking Suits To 5th Circ.

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    The U.S. Supreme Court recently heard oral arguments in U.S. Food and Drug Administration v. R.J. Reynolds over the definition of an "adversely affected" person under the Tobacco Control Act, and the justices' ruling will have important and potentially wide-ranging implications for forum shopping claims, says Trillium Chang at Zuckerman Spaeder.

  • Series

    Adventure Photography Makes Me A Better Lawyer

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    Photographing nature everywhere from Siberia to Cuba and Iceland to Rwanda provides me with a constant reminder to refresh, refocus and rethink the legal issues that my clients face, says Richard Birmingham at Davis Wright.

  • What Vinyl Acetate's Prop 65 Listing Means For Cos.

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    California's recent move to add vinyl acetate to the Proposition 65 list of carcinogens, with enforcement starting later this year, will have sweeping compliance and risk implications for businesses in the retail, food and beverage, paint, adhesive, industrial manufacturing, and personal care product industries, say attorneys at Alston & Bird.

  • Fed. Circ. Inherency Ruling Refines Obviousness Framework

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    The Federal Circuit's December decision in Cytiva v. JSR has definitively eliminated the requirement of "reasonable expectation of success" analysis for inherent properties in obviousness determinations, while providing some key clarifications for patent practitioners, says Lawrence Kass at Steptoe.

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