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Life Sciences

  • June 02, 2025

    4 Mass. Rulings You May Have Missed In May

    Massachusetts judges grappled with accusations of fraud in the sale of a struggling life sciences company and gave the benefit of the doubt to a vendor who allegedly sold the state gallons of ineffective hand sanitizer, among other notable rulings last month.

  • June 02, 2025

    Judge Denies UTC Bid To Block Liquidia's Lung Drug

    A North Carolina federal judge has refused to temporarily block Liquidia Technologies Inc. from selling its own version of United Therapeutics Corp.'s blockbuster lung disease treatment Tyvaso.

  • June 02, 2025

    Allergan Entities Get Booted From Botox Patent Suit In Del.

    A Delaware federal judge has dismissed a pair of Allergan units from a suit alleging two biotechnology companies infringed patents related to Botox products, finding one unit had not shown it was actually the exclusive licensee to the disputed patents, while another agreed to be dismissed.

  • June 02, 2025

    Foley & Lardner Opens In Nashville With 3 Holland & Knight Attys

    Foley & Lardner LLP has chosen Nashville as the location for its 27th office worldwide, bringing on three attorneys who had been at Holland & Knight LLP to work on regulatory, tax and transactional matters, the firm announced Monday.

  • June 02, 2025

    J&J Again Seeks To Block Beasley Allen In NJ Talc Litigation

    Johnson & Johnson has opposed a New Jersey talc claimant's motion for the pro hac vice admission of two attorneys from The Beasley Allen Âé¶¹´«Ã½ Firm, claiming the partners' conduct in its talc unit's bankruptcy proceedings warrants denial of the application.

  • June 02, 2025

    Defamation Litigation Roundup: Cheetos, NASCAR, OpenAI

    In this month's review of ongoing defamation fights, Âé¶¹´«Ã½360 looks back on developments in a man's case against Frito-Lay Inc. over what he called the company's defamatory statements disputing his role in the invention of a flavor of Cheetos.

  • June 02, 2025

    High Court Rejects Bard Patent Misuse Dispute

    The U.S. Supreme Court on Monday said it won't consider the Ninth Circuit's decision to revive a $53 million breach of contract suit C.R. Bard Inc. filed against Atrium Medical Corp. over patent royalties and patent misuse.

  • May 30, 2025

    Pharma Co. Hid Cancer Study Method Problems, Investor Claims

    Biotechnology company UroGen Pharma Ltd. and three current and former executives are facing a proposed investor class action in New Jersey federal court alleging the company failed to disclose methodology flaws affecting a study of its lead drug candidate that ultimately doomed its bid for U.S. Food and Drug Administration approval.

  • May 30, 2025

    $5.2M Generic Drug Price-Fixing MDL Deal Gets Final OK

    Apotex Corp. will be paying $5.2 million to settle claims from a class of indirect purchasers alleging the drugmaker was working with other pharmaceutical companies to hike up the price of certain generic medications.

  • May 30, 2025

    Wheeling & Appealing: The Latest Must-Know Appellate Action

    Saying that June's circuit court calendars include important arguments in all practice areas would be hyperbolic — but just slightly. That's because significant showdowns are imminent involving appellate procedure principles, "click-to-cancel" rules, government procurement protests, judiciary employment protections and litigation risk insurance — as well as President Donald Trump's felony convictions and extraordinary deportation measures.

  • May 30, 2025

    Crowdfunding, Reg A Deals Grow Slowly As SEC Weighs Ideas

    Equity crowdfunding and expanded Regulation A offerings have grown slowly since going live over the past decade, according to new data, leaving open questions on whether regulators will ease rules to bolster these alternatives to traditional capital raising.

  • May 30, 2025

    TopCo Settles Suit Over Cough Syrup Billed As 'Non-Drowsy'

    The parties in a lawsuit alleging Tussin cough syrup's "non-drowsy" label is deceptive because the syrup makes users sleepy told an Illinois federal judge that they've reached a binding settlement that would end the case.

  • May 30, 2025

    ITC Issues Import Block On Ascletis Liver Disease Drugs

    The U.S. International Trade Commission has issued an order blocking a Hong Kong-listed drug developer from importing treatments for a type of liver disease for the next seven years.

  • May 30, 2025

    Generic-Drug Makers Near Exit From Depo-Provera MDL

    Attorneys for the plaintiffs in a multidistrict litigation claiming Pfizer Inc. failed to adequately warn patients and doctors about the risk of brain tumors associated with the hormonal contraceptive Depo-Provera told a Florida federal judge that they are close to dismissing claims against three manufacturers of generic versions of the drug.

  • May 30, 2025

    DLA Piper Adds Healthcare Regulatory Atty In DC Office

    DLA Piper strengthened its healthcare regulatory resources in Washington, D.C., with the recent addition of an attorney who previously served as acting general counsel for the U.S. Department of Health and Human Services.

  • May 30, 2025

    Former Pfizer Atty, Motley Rice Adviser Joins DiCello Levitt

    A former Pfizer vice president and assistant general counsel, who last June entered into a consulting agreement with Motley Rice LLC, is joining DiCello Levitt as a partner as part of the firm's Washington, D.C., public client practice group, the firm recently announced.

  • May 29, 2025

    AstraZeneca Inks $51.4M Settlement In Pay-For-Delay Case

    AstraZeneca Pharmaceuticals LP and Handa Pharmaceuticals LLC have agreed to shell out a combined $51.4 million to put to rest allegations AstraZeneca paid off generic-drug makers, including Handa, to protect its brand antipsychotic drug Seroquel XR, according to a filing Thursday in Delaware federal court.

  • May 29, 2025

    CMS Seeks Hospital Responses On Gender Dysphoria Care

    The Centers for Medicare & Medicaid Services is asking hospitals to produce information on gender dysphoria care provided to children and adolescents, noting in an oversight letter that the U.S. government has "serious concerns" surrounding hormone therapy and other gender-affirming medical interventions.

  • May 29, 2025

    Monsanto-Funded Researcher Influenced Panel, Jury Hears

    A Missouri jury hearing the latest trial over cancer claims related to Monsanto's glyphosate pesticides heard Thursday that a Monsanto-funded researcher was able to change the course of a prestigious international panel weighing the chemical's carcinogenicity.

  • May 29, 2025

    Express Scripts Says Arkansas Can't Ban PBM Pharmacies

    Pharmacy benefits manager Express Scripts sued the state of Arkansas in federal court Thursday, alleging that the state's recently enacted law banning PBMs from owning pharmacies in the state violated the U.S. Constitution and ran afoul of federal law governing military employee benefits.

  • May 29, 2025

    Delaware Justices Asked To Review Corporate Âé¶¹´«Ã½ Rework

    A biopharmaceutical company stockholder has sought direct certification of a derivative suit to Delaware's Supreme Court, asking for state constitutional review of legislation approved in March that limits avenues for challenges to some corporate acts.

  • May 29, 2025

    Judge Favors Vanda But Seeks Deal Over Drug Approval

    A D.C. federal judge on Thursday seemed ready to rule for Vanda Pharmaceuticals Inc. in its challenge to the U.S. Food and Drug Administration's timelines for approving new drugs but asked both sides to first try negotiating remedies to resolve the dispute.

  • May 29, 2025

    Ex-USPTO Solicitor Says He's Against Squires Nomination

    A former solicitor for the U.S. Patent and Trademark Office has come out against the nomination of John A. Squires to be the next director of the agency, saying in a letter Thursday that he's concerned about the nominee's desire to make existing patents stronger.

  • May 29, 2025

    Drugstores Say Texas Flouted Rules To Update Pharmacy Regs

    The National Association of Chain Drug Stores Inc. told the Texas Supreme Court that updates to statewide policy governing how pharmacies report drug prices flouted Texas rulemaking procedures, telling the state's high court that even if the updates were "good policy" they weren't lawful.

  • May 29, 2025

    Ex-United Therapeutics Exec Can't Dodge IP Suit

    A former United Therapeutics Corp. executive lost his bid to toss his former employer's suit alleging he used stolen intellectual property to develop a lung disease drug for a competitor, with the North Carolina Business Court ruling that it was too soon to determine if the complaint was untimely.

Expert Analysis

  • Series

    Adapting To Private Practice: From DOJ Leadership To BigÂé¶¹´«Ã½

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    The move from government service to private practice can feel like changing one’s identity, but as someone who has left the U.S. Department of Justice twice, I’ve learned that a successful transition requires patience, effort and the realization that the rewards of practicing law don’t come from one particular position, says Richard Donoghue at Pillsbury.

  • Fed. Circ. Ruling Reaffirms Listing Elements Separately Is Key

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    The Federal Circuit's decision last month in Regeneron v. Mylan reaffirms a critical principle in patent law: When a claim lists elements separately, the clear implication is that they are distinct elements, say attorneys at Taft.

  • State Extended Producer Responsibility Âé¶¹´«Ã½s: Tips For Cos.

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    As states increasingly shift the onus of end-of-life product management from consumers and local governments to the businesses that produce, distribute or sell certain items, companies must track the changing landscape and evaluate the applicability of these new laws and regulations to their operations, say attorneys at Alston & Bird.

  • Âé¶¹´«Ã½ Firm Executive Orders Create A Legal Ethics Minefield

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    Recent executive orders targeting BigÂé¶¹´«Ã½ 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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    Âé¶¹´«Ã½makers 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 Âé¶¹´«Ã½yer

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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 BigÂé¶¹´«Ã½

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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.

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