Life Sciences

  • September 16, 2025

    Exactech Enters $8M Deal To Resolve Implant Failure Claims

    Orthopedic implant-maker Exactech Inc. agreed to pay $8 million to resolve allegations it marketed and sold faulty components of its knee-replacement systems that were to be used on patients on Medicare, Medicaid and U.S. Department of Veterans Affairs assistance, federal prosecutors in Maryland and Alabama announced Tuesday.

  • September 16, 2025

    Merck Says Vaccine Case 'Poor Vehicle' For Antitrust Review

    Merck & Co. told the U.S. Supreme Court to reject a bid from physicians looking to revive antitrust claims over submissions the pharmaceutical giant made to federal regulators concerning its mumps vaccine, arguing that the case is "an exceptionally poor vehicle" for review.

  • September 16, 2025

    BrainStorm Can't Shed Investors' ALS Treatment Trial Claims

    Biopharmaceutical company BrainStorm Cell Therapeutics Inc. must face a proposed investor class alleging it misrepresented feedback from the U.S. Food and Drug Administration regarding clinical trials for an ALS product candidate that failed to get approval, though a Manhattan federal judge has tossed the suit's insider trading allegations and certain fraud claims.

  • September 16, 2025

    The Patent Workforce Is Attracting Fewer Attys, More Agents

    The pool of patent practitioners registered with the U.S. Patent and Trademark Office has undergone a dramatic shift over the past few decades, with the number of attorneys taking the bar exam decreasing at the same time more patent agents are entering the field.

  • September 16, 2025

    Jazz Can't Escape Antitrust Claims Over Sleep Disorder IP

    A Delaware federal judge has refused to let Jazz Pharmaceuticals dodge antitrust claims that it wrongly listed a patent covering a way to distribute a narcolepsy drug in the U.S. Food and Drug Administration's Orange Book.

  • September 16, 2025

    CVS Caremark Takes $290M Overbilling Judgment To 3rd Circ.

    CVS's pharmacy benefits manager will appeal a judgment against the company that was recently increased from $95 million to $290 million in a suit alleging it overbilled Medicare Part D-sponsored drugs, according to a notice of appeal filed in Pennsylvania federal court.

  • September 16, 2025

    FTC Chair Pledges 'Action' Against Late Merger Fixes

    Federal Trade Commission Chairman Andrew Ferguson vowed Tuesday to take unspecified "action" against tactics by merging companies to propose fixes only after antitrust enforcers bring a transaction challenge, a strategy he called "bad for the system."

  • September 16, 2025

    Jones Day Adds FDA Regulatory Expert As Of Counsel In DC

    Jones Day on Tuesday announced the arrival of an attorney who brings over a decade of experience at the U.S. Food and Drug Administration advising on drug regulation.

  • September 16, 2025

    For Cahill Atty, Rare Disease Pro Bono Work Is Personal

    John MacGregor of Cahill Gordon & Reindel LLP didn't have any experience in healthcare law before taking on a pro bono client that supports people with a rare form of epilepsy. MacGregor's son is one of them.

  • September 16, 2025

    VarmX Partners With Biotech CSL In Deal Worth Up To $2.2B

    European life sciences venture capital firm EQT Life Sciences on Tuesday announced that its portfolio company VarmX, a Netherlands-based biotech, has entered into an exclusive option agreement to be bought by global biotech CSL in a deal worth up to $2.2 billion.

  • September 15, 2025

    Jazz Loses Bid To Block Avadel From Seeking Sleep Drug OK

    Jazz Pharmaceuticals Inc. cannot block Avadel CNS Pharmaceuticals LLC from seeking U.S. Food and Drug Administration approval for its sleep disorder treatment, a Delaware federal judge ruled, saying the act of seeking FDA approval is not an infringing activity that can be enjoined.

  • September 15, 2025

    AbbVie Settles Rinvoq Litigation, Blocks Generics Until 2037

    AbbVie Inc. has settled litigation with drug manufacturers, blocking generic versions of its immunosuppressant Rinvoq drug from the market for just over a decade and closing out litigation that accused generic-drug makers of infringing a slew of its patents.

  • September 15, 2025

    Ch. 11 Plan Faces Blowback From 23andMe Breach Claimants

    More than 30,000 individuals who elected to pursue arbitration rather than sign on to a proposed class settlement over a data breach at 23andMe are urging a Missouri bankruptcy judge to reject the DNA testing company's notice of its reorganization plan, arguing that the disclosure provides misleading and inflated information about the company's agreement with these claimants.

  • September 15, 2025

    Bayer Urges 9th Circ. Not To Revive Tevra Flea, Tick Meds Suit

    Bayer is urging the Ninth Circuit not to grant a new trial over claims that it locked up the market for pet flea and tick treatment, saying the only evidence that rival Tevra showed a jury at trial was "highly dubious."

  • September 15, 2025

    Ex-PTAB Leader Reflects On USPTO After Leaving Agency

    One of the Patent Trial and Appeal Board's most senior judges has left the U.S. Patent and Trademark Office after more than 13 years, and soon after joining private practice she spoke with Law360 about her history at the agency and the current dynamics playing out at the office.

  • September 15, 2025

    Investor Says $16M Ouraring Fight Shouldn't Go To Finland

    An early investor in the Oura health and fitness tracker is fighting Ouraring Inc.'s attempt to send his $16 million dispute to arbitration in Finland, saying there is no underlying agreement to arbitrate and his lawsuit should stay in California federal court.

  • September 15, 2025

    Stewart Says New Policies Seek Fairness For Patent Owners

    Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart said Monday the numerous changes to patent reviews she has implemented are intended to provide "more balance and fairness" for patent owners, and bring the reviews "back to how they were originally intended."

  • September 15, 2025

    Eli Lilly Fights $278M Drug Royalties Ruling At 9th Circ.

    Eli Lilly urged the Ninth Circuit at a hearing on Monday to reverse a finding that it owes an Arizona company $278 million from insulin-brands sales under their royalty agreement, arguing it is off the hook because Eli Lilly only used that company's technology in manufacturing, not in the final product.

  • September 15, 2025

    Corcept Can't Escape Teva's Mifepristone Antitrust Suit

    Corcept Therapeutics must face most of Teva Pharmaceuticals' lawsuit alleging it suppressed generic competition for its brand-name medication used to treat a rare cortisol disorder, a California federal judge ruled, saying the claims are not time-barred and Teva has adequately alleged unlawful monopolization.

  • September 15, 2025

    Exactech Gets OK For Ch. 11 Plan Ditching Sponsor Deal

    A Delaware bankruptcy judge on Monday approved Exactech's Chapter 11 sale and liquidation plan that drops a previous deal with the joint implant maker's equity sponsor in favor of funding the pursuit of potential legal claims against the sponsor on behalf of creditors.

  • September 15, 2025

    Novartis, Monte Rosa Ink Up To $5.7B 'Molecular Glue' Deal

    Novartis is placing a potential $5.7 billion bet on Monte Rosa Therapeutics, a clinical-stage biotech company, to develop new treatments for immune-related diseases, Monte Rosa said on Monday. 

  • September 12, 2025

    Ex-Investor Relations Exec Gets 15 Months For Inside Trades

    A former managing director for LifeSci Advisors LLC was sentenced to 15 months in prison on Friday for passing confidential information about several of the investor relations firm's clients to two friends who used it to make over $500,000 in illicit profits.

  • September 12, 2025

    AbbVie Can't Halt Miss. Discount Drug Law, 5th Circ. Says

    AbbVie and other pharmaceutical manufacturers that participate in Medicaid cannot preliminarily block a Mississippi law barring their interference with the distribution of discounted prescriptions to pharmacies serving low-income patients, the Fifth Circuit ruled Friday, saying the drugmakers haven't shown that the statute likely effectuates a taking of their property.

  • September 12, 2025

    Stewart Issues New Slate Of Discretionary Denials

    Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart rejected 18 petitions for Patent Trial and Appeal Board review based on discretionary factors on Friday, but didn't introduce new elements to her analysis.

  • September 12, 2025

    23AndMe Inks $3.25M Data Breach Deal With Canadian Users

    23andMe has asked a Missouri bankruptcy judge to approve a $3.25 million settlement reached with a class of 300,000 Canadian citizens whose information was compromised following a cybersecurity breach, touting the deal as an "excellent result" considering limited funds available and other issues implicated by the company's bankruptcy proceedings.

Expert Analysis

  • How DOJ's New Data Security Rules Leave HIPAA In The Dust

    Author Photo

    The U.S. Department of Justice's recently effective data security requirements carry profound implications for how healthcare providers collect, store, share and use data — and approach vendor oversight — that go far beyond the Health Insurance Portability and Accountability Act, say attorneys at Nelson Mullins.

  • Opinion

    Section 1983 Has Promise After End Of Nationwide Injunctions

    Author Photo

    After the U.S. Supreme Court recently struck down the practice of nationwide injunctions in Trump v. Casa, Section 1983 civil rights suits can provide a better pathway to hold the government accountable — but this will require reforms to qualified immunity, says Marc Levin at the Council on Criminal Justice.

  • Trump's 2nd Term Puts Merger Remedies Back On The Table

    Author Photo

    In contrast with the Biden administration, the second Trump administration has signaled a renewed willingness to resolve merger enforcement concerns through remedies from the outset, particularly when the proposed fix is structural, clearly addresses the harm and does not require burdensome oversight, say attorneys at Cooley.

  • Patent Ambiguity Persists After Justices Nix Eligibility Appeal

    Author Photo

    The Supreme Court recently declined to revisit the contentious framework governing patent eligibility by denying certiorari in Audio Evolution Diagnostics v. U.S., suggesting a necessary recalibration of both patent application and litigation strategies, say attorneys at Skadden.

  • Texas Med Spas Must Prepare For 2 New State Laws

    Author Photo

    Two new laws in Texas — regulating elective intravenous therapy and reforming healthcare noncompetes — mark a pivotal shift in the regulatory framework for medical spas in the state, which must proactively adapt their operations and contractual practices, says Brad Cook at Munsch Hardt.

  • Fed. Circ. In June: Transitional Phrases In Patent Claims

    Author Photo

    The Federal Circuit's recent decision in Eye Therapies v. Slayback Pharma takes on the rarely addressed topic of transitional phrases in patent claims, providing some useful lessons regarding restating claim language and broadly distinguishing prior art, say attorneys at Knobbe Martens.

  • Series

    Playing Soccer Makes Me A Better Lawyer

    Author Photo

    Soccer has become a key contributor to how I approach my work, and the lessons I’ve learned on the pitch about leadership, adaptability, resilience and communication make me better at what I do every day in my legal career, says Whitney O’Byrne at MoFo.

  • Strategies For Cos. Navigating US-Indian Pharma Partnerships

    Author Photo

    Recent policy adjustments implemented by the U.S. government present both new opportunities and heightened regulatory scrutiny for the Indian life sciences industry, amplifying the importance of collaboration between the Indian and U.S. pharmaceutical sectors, say Bryant Godfrey at Foley Hoag and Jashaswi Ghosh at Holon Law Partners.

  • DOJ-HHS Collab Crystallizes Focus On Health Enforcement

    Author Photo

    The recently announced partnership between the U.S. Department of Justice and U.S. Department of Health and Human Services to combat False Claims Act violations, following a multiyear trend of high-dollar DOJ recoveries, signals a long-term enforcement horizon with major implications for healthcare entities and whistleblowers, say attorneys at RJO.

  • Series

    Law School's Missed Lessons: Learning From Failure

    Author Photo

    While law school often focuses on the importance of precision, correctness and perfection, mistakes are inevitable in real-world practice — but failure is not the opposite of progress, and real talent comes from the ability to recover, rethink and reshape, says Brooke Pauley at Tucker Ellis.

  • 23andMe Fine Signals ICO's New GDPR Enforcement Focus

    Author Photo

    Many of the cybersecurity failures identified by the Information Commissioner’s Office in its investigation of 23andMe, recently resulting in a £2.3 million fine, were basic lapses, but the ICO's focus on several new U.K. General Data Protection Regulation considerations will likely carry into the future, say lawyers at Womble Bond.

  • Eye Drop Ruling Clarifies Importance Of Patent Phrasing

    Author Photo

    The Federal Circuit's recent ruling in Eye Therapies v. Slayback, rejecting the Patent Trial and Appeal Board's interpretation of "consisting essentially of," highlights the importance of using clear and consistent terms throughout a patent's filing history to shield it against future challenges, says Liliana Di Nola-Baron at Panitch Schwarze.

  • How The Healthline Privacy Settlement Redefines Ad Tech Use

    Author Photo

    The Healthline settlement is the first time California has drawn a clear line in the sand around how website tracking must function in practice, so if your site uses tracking technologies, especially around sensitive content like health or finance, regulators are inspecting your website's back end, not just its banner, say attorneys at Baker Donelson.

  • How Sweeping Budget Bill Shakes Up Health Industry

    Author Photo

    With the recently passed One Big Beautiful Bill Act marking one of the most significant overhauls of federal health policy since the passage of the Affordable Care Act, providers, managed care organizations and life sciences companies must now shift focus from policy review to implementation planning, say advisers at Holland & Knight.

  • Series

    Adapting To Private Practice: From ATF Director To BigLaw

    Author Photo

    As a two-time boomerang partner, returning to BigLaw after stints as a U.S. attorney and the director of the Bureau of Alcohol, Tobacco, Firearms and Explosives, people ask me how I know when to move on, but there’s no single answer — just clearly set your priorities, says Steven Dettelbach at BakerHostetler.

Want to publish in Law360?


Submit an idea

Have a news tip?


Contact us here
Can't find the article you're looking for? Click here to search the Life Sciences archive.