Life Sciences

  • May 23, 2025

    Ballard Spahr Adds IP Transactions Pro From DLA Piper

    Ballard Spahr LLP announced Thursday that its New York office has gained a life science and climate change-focused corporate lawyer with a background in licensing and other intellectual property transactions from DLA Piper.

  • May 23, 2025

    Insulet Foe Rips $30M Atty Fee Ask As 'Over-Lawyered'

    A South Korean medical device maker told a Massachusetts federal judge that rival Insulet's request for $30 million in attorney fees following a $60 million trade secrets judgment should be denied, calling that amount "exorbitant" and saying Insulet "consistently over-lawyered disputes."

  • May 22, 2025

    Fed. Circ. Backs Pfizer Win Against Gene Therapy Patents

    The Federal Circuit on Thursday sided with the Patent Trial and Appeal Board's findings that a pair of patents covering a new kind of experimental gene therapy to treat hemophilia were invalid, handing a win to patent challenger Pfizer.

  • May 22, 2025

    Senators Unveil DNA Privacy Bill Amid 23andMe's Ch. 11 Sale

    A bipartisan group of U.S. senators on Thursday introduced a bill designed to safeguard customers' genetic information in bankruptcy cases, saying 23andMe's plan to sell users' DNA data to a pharmaceutical company during its Chapter 11 raises new concerns surrounding consumer privacy.

  • May 22, 2025

    Calif. Docs Bring FDA Stem Cell Regulation Fight To Top Court

    Two California clinics that provide stem cell treatments are urging the U.S. Supreme Court to review a Ninth Circuit panel's finding that their treatments are "drugs" subject to Food, Drug and Cosmetic Act regulations.

  • May 22, 2025

    Justices Urged To Undo Denial Of Fast Track For Gastro Drug

    Vanda Pharmaceuticals Inc. is asking the U.S. Supreme Court to reverse the Food and Drug Administration's decision denying fast-track approval for its gastroparesis drug tradipitant, saying it meets the statutory standard for fast-track review as a new treatment with the "potential to address unmet medical needs."

  • May 22, 2025

    EpiPen Direct Buyers, Mylan Get Final OK On Antitrust Deal

    Mylan Pharmaceuticals' $73.5 million settlement with a class of direct EpiPen buyers has received final approval from a Kansas federal judge, closing out claims from institutional drug resellers that Mylan worked with Pfizer to forestall an EpiPen generic from hitting the market and artificially inflating prices for the emergency injectable.

  • May 22, 2025

    Manufacturer Seeks Over $19M In Beryllium Release Coverage

    A medical device manufacturer accused a Zurich unit of breach of contract and bad faith in Massachusetts federal court, seeking at least $19 million in damages after it said storms caused an "unprecedented dispersal" of beryllium at one of its plants in the United Kingdom.

  • May 22, 2025

    Judge Asks If DEI Is Now 'Homogeneity, Inequity And Exclusion'

    A Massachusetts federal judge considering a challenge to the Trump administration's cuts to hundreds of National Institutes of Health grants pressed the U.S. Department of Justice on Thursday for its definition of diversity, equity and inclusion, at one point asking hypothetically whether the government's policy is now "homogeneity, inequity and exclusion."

  • May 22, 2025

    Conn. AG Targets 'Bootleg' Weight Loss Drug Sellers

    Connecticut has launched a consumer protection lawsuit in state court against a Florida-based company and its owner, accusing them of peddling untested and unsafe, research-level, "bootleg" GLP-1 weight loss drugs to customers.

  • May 22, 2025

    Sanofi To Acquire Goodwin-Led US Biotech Biz For $470M

    Drugmaker Sanofi said Thursday that it has agreed to acquire Vigil Neuroscience, a biotechnology company specializing in neurodegenerative diseases, for approximately $470 million to give it a potential new medicine for Alzheimer's disease in a deal guided by Goodwin Procter.

  • May 21, 2025

    FTC Urges 8th Circ. Not To Pause In-House PBM Case

    The Eighth Circuit should once again say no to a request to pause the Federal Trade Commission's in-house case accusing three pharmacy benefit managers of hiking up the price of insulin to line their own pockets, the agency has told the appellate court.

  • May 21, 2025

    Squires Talks Fortress, PTAB Invalidations In Senate Hearing

    The Trump administration's nominee for U.S. Patent and Trademark Office director had his moment before the Senate Judiciary Committee on Wednesday, where he downplayed his controversial connections to litigation finance giant Fortress Investment Group and raised concerns that too many bad patents were being issued.

  • May 21, 2025

    9th Circ. Judge Asks If Apple's Watch Updates 'Ice Out' Rivals

    Two Ninth Circuit judges appeared skeptical Wednesday of Apple Inc.'s arguments against reviving an antitrust suit brought by medical monitoring startup AliveCor Inc. after Apple blocked third-party access to medical data on the Apple Watch, with one judge asking rhetorically whether a "marginal" improvement by Apple could actually be a way to "ice out" competition.

  • May 21, 2025

    Judge Mulls National Scope Of Bid To Restore COVID Grants

    A Washington, D.C., federal judge Wednesday mulled whether it would be appropriate to issue a nationwide injunction blocking the termination of $11 billion public health grants set aside under COVID-era laws in a lawsuit brought by four local governments and a public sector union.

  • May 21, 2025

    AbbVie Gets Victory In Allergan Shareholder Suit Upheld

    An Illinois state appellate panel said Wednesday that a trial court properly dismissed a shareholder class action against biopharmaceutical company AbbVie Inc. that accused the drugmaker of issuing unregistered shares to investors after acquiring Irish pharmaceutical company Allergan.

  • May 21, 2025

    GOP FTC Renews Calls For Orange Book Patent Delistings

    The now-Republican controlled Federal Trade Commission again called on Teva, Novartis, Mylan and other drugmakers to remove patents from a key federal database that partially insulates their drugs from generic competition, arguing Wednesday the patents cover "devices," not drugs, and thus don't warrant such protection.

  • May 21, 2025

    Kronos Bio Shareholder Says Sale Unfairly Benefits Execs

    Kronos Bio is facing a new shareholder suit claiming its plan to be acquired by another biopharmaceutical company will unfairly entitle Kronos executives to "lucrative" benefits unavailable to public shareholders.

  • May 21, 2025

    Device Maker Who Evaded Tax Gets 2 Years In Prison

    A Florida man who sold millions of dollars worth of medical devices that federal prosecutors said were unproven to work was sentenced to two years in prison for evading taxes and ordered to pay $2.3 million in restitution to the Internal Revenue Service.

  • May 21, 2025

    Walgreens Ducks False Ad Suit Over Mucus Relief Meds

    An Illinois federal judge on Tuesday dismissed a potential class action accusing Walgreens of misleading customers by selling them over-the-counter mucus relief medicine containing benzene without warning them of that risk, saying the claims are preempted by a federal drug safety law.

  • May 20, 2025

    Flo Users Get Class Cert. In Google, Meta Data-Sharing Suit

    A California federal judge has granted class status to users of the menstrual cycle tracking app developed by Flo Health Inc. in a suit accusing the company of unlawfully sharing their personal health information with Google and Meta, finding that the defendants' opposition to this move lacked clarity and support.

  • May 20, 2025

    Barclays Officials Beat Shareholder's Suit At NY High Court

    New York's highest court on Tuesday rejected arguments that current and former officials of London-based Barclays PLC can be sued under New York law over a series of scandals that have rocked the bank, a decision that sparked rebuke from the court's chief judge.

  • May 20, 2025

    Novo Fights To Keep Info Bid In $800M Fraud Dispute Alive

    Novo Nordisk is urging a North Carolina federal court not to dismiss its order permitting the Danish drugmaker to seek information bolstering its $800 million fraud claims stemming from a hypertension drug deal, saying the testimony is needed to preserve assets as it pursues arbitration of its claims.

  • May 20, 2025

    Cancer Drug Co. Beats Investor Suit Over FDA Rejection

    Cancer drug company Checkpoint Therapeutics Inc. has permanently escaped a shareholder suit alleging it understated the likelihood the U.S. Food and Drug Administration would refuse approving Checkpoint's lead product candidate, with a New York federal judge ruling company statements were not shown to be false or made with scienter.

  • May 20, 2025

    Medical Organizations Sue Feds For Removing Health Data

    The U.S. Department of Health and Human Services and several constituent agencies are accused of violating the Administrative Procedure Act by illegally purging websites containing critical public health information related to trans and HIV care, vaccines and the prevention of outbreaks of communicable diseases, according to a lawsuit filed Tuesday in Washington federal court.

Expert Analysis

  • Law Firm Executive Orders Create A Legal Ethics Minefield

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    Recent executive orders targeting BigLaw firms create ethical dilemmas — and raise the specter of civil or criminal liability — for the government attorneys tasked with implementing them and for the law firms that choose to make agreements with the administration, say attorneys at Buchalter.

  • Firms Must Embrace Alternative Billing Models Or Fall Behind

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    As artificial intelligence tools eliminate inefficiencies and the Big Four accounting firms enter the legal market, law firms that pivot from the entrenched billable hour model to outcomes-based pricing will see a distinct competitive advantage, says attorney William Brewer.

  • Key Issues To Watch As USPTO Changes Abound

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    As 2025 continues to unfold, changes at the U.S. Patent and Trademark Office — including new leadership, operational reforms, legislative initiatives and AI-related policies — have potential to influence proceedings, including efforts to prosecute patents and adversarial proceedings before the Patent Trial and Appeal Board, say attorneys at Morgan Lewis.

  • Trending At The PTAB: A Pivot On Discretionary Denials

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    Following the U.S. Patent and Trademark Office's rescission of the 2022 Vidal memorandum and a reversion to the standards under Apple v. Fintiv, petitioners hoping to avoid discretionary denials should undertake holistic review of all Fintiv factors, rather than relying on certain fail-safe provisions, say attorneys at Finnegan.

  • How Attorneys Can Master The Art Of On-Camera Presence

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    As attorneys are increasingly presented with on-camera opportunities, they can adapt their traditional legal skills for video contexts — such as virtual client meetings, marketing content or media interviews — by understanding the medium and making intentional adjustments, says Kerry Barrett.

  • Patent Drafting Pointers From Fed. Circ. COVID Test Ruling

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    The Federal Circuit's recent decision in DNA Genotek v. Spectrum Solutions provides several best practice pointers for drafting and prosecuting patent applications, highlighting how nuances in wording can potentially limit the scope of claims or otherwise affect claim constructions, says Irah Donner at Manatt.

  • Opinion

    Congress Must Reform The PTAB To Protect Small Innovators

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    Lawmakers must reintroduce the Promoting and Respecting Economically Vital American Innovation Leadership Act or similar legislation to prevent larger companies from leveraging the Patent Trial and Appeal Board to target smaller patent holders, says Schwegman Lundberg's Russell Slifer, former deputy director of the U.S. Patent and Trademark Office.

  • Series

    Baseball Fantasy Camp Makes Me A Better Lawyer

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    With six baseball fantasy experiences under my belt, I've learned time and again that I didn't make the wrong career choice, but I've also learned that baseball lessons are life lessons, and I'm a better lawyer for my time at St. Louis Cardinals fantasy camp, says Scott Felder at Wiley.

  • Series

    Adapting To Private Practice: From Fed. Prosecutor To BigLaw

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    Making the jump from government to private practice is no small feat, but, based on my experience transitioning to a business-driven environment after 15 years as an assistant U.S. attorney, it can be incredibly rewarding and help you become a more versatile lawyer, says Michael Beckwith at Dickinson Wright.

  • What To Expect For Stem Cell Regulation Under Trump Admin

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    The new administration's push for deregulation, plus the post-Chevron legal landscape, and momentum from key political and industry players to facilitate stem cell innovation may create an opportune backdrop for a significant reduction in the U.S. Food and Drug Administration's regulatory framework for stem cells, say attorneys at Sheppard Mullin.

  • Firms Still Have Lateral Market Advantage, But Risks Persist

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    Partner and associate mobility data from the fourth quarter of 2024 shows that we’re in a new, stable era of lateral hiring where firms have the edge, but leaders should proceed cautiously, looking beyond expected revenue and compensation analyses for potential risks, say Julie Henson and Greg Hamman at Decipher Investigative Intelligence.

  • 10 Practical Takeaways From FDA's Biopharma AI Guidance

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    Recent guidance from the U.S. Food and Drug Administration provides much-needed insight on the usage of artificial intelligence in producing information to support regulatory decision-making regarding drug safety, with implications ranging from life cycle maintenance to AI tool acquisition, say attorneys at Covington.

  • Opinion

    We Must Allow Judges To Use Their Independent Judgment

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    As two recent cases show, the ability of judges to access their independent judgment crucially enables courts to exercise the discretion needed to reach the right outcome based on the unique facts within the law, says John Siffert at Lankler Siffert & Wohl.

  • Series

    Performing Stand-Up Comedy Makes Me A Better Lawyer

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    Whether I’m delivering a punchline on stage or a closing argument in court, balancing stand-up comedy performances and my legal career has demonstrated that the keys to success in both endeavors include reading the room, landing the right timing and making an impact, says attorney Rebecca Palmer.

  • Unpacking The Illicit E-Cigarette Crackdown By State AGs

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    A bipartisan coalition of attorneys general for nine states and the District of Columbia announced a coordinated effort to curb illicit electronic cigarette sales, illustrating the rising prominence of state attorneys general using consumer protection laws to address issues of national scope, especially when federal efforts prove ineffective, say attorneys at Troutman.

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