Life Sciences

  • June 26, 2024

    Conn. Zantac Ruling To Include Sanofi As Settlement Looms

    A Connecticut state judge will include Sanofi-Aventis US LLC and a related corporate entity in a forthcoming decision on whether Zantac makers must face novel innovator liability claims in the Constitution State, the judge revealed after the pharmaceutical giant suggested a ruling would help finalize a nascent settlement.

  • June 26, 2024

    Justices Leave Blurry Line In Place On Misinformation Fight

    The U.S. Supreme Court's decision Wednesday to reverse a Fifth Circuit order prohibiting the Biden administration from joining with social media platforms to fight misinformation leaves an important First Amendment question unanswered and left Missouri's attorney general promising a continuing fight against what he called a "censorship regime."

  • June 26, 2024

    Moms For America Sues Biden Admin Over Vax Liability Law

    Conservative nonprofit Moms for America has sued the Biden administration over a law that shields companies from COVID-19 vaccine injury lawsuits, saying the law is unconstitutional because it circumvents judicial review and violates fundamental rights, including due process and trial by jury.

  • June 26, 2024

    Design Patent Attys Wary Of Applicant Disclosure Proposal

    Various intellectual property trade groups are expressing some skepticism toward a proposal over the United Nations using a new treaty to force design patent applicants to disclose more details in their applications.

  • June 26, 2024

    Justices Chide 5th Circ. In Biden Social Media Case

    The Fifth Circuit relied on "clearly erroneous" facts and an overgeneralized view of standing when it ordered the Biden administration to stop working with social media platforms to combat COVID-19 and election misinformation, the U.S. Supreme Court ruled Wednesday as it threw out a challenge to the government's actions.

  • June 26, 2024

    Ga. High Court Told To Skip Inventor's 'Clerical Mistake' Fight

    A unit of the analytics giant Clarivate is telling Georgia's highest court that a neurosurgeon's $102 million legal malpractice case over "a clerical mistake" in a patent filing from an aggrieved former FisherBroyles client is definitely "not a cert-worthy case."

  • June 26, 2024

    State Data Privacy Law Patchwork: Midyear Report

    States jumped on the consumer data privacy law bandwagon at a brisk clip in the first half of 2024, although it remains unclear if this push will be enough to encourage Congress to finally enact a nationwide framework this year. 

  • June 26, 2024

    Choctaw Nation Wants 9th Circ. Rehearing In CVS Arb. Dispute

    The Choctaw Nation has asked the Ninth Circuit for a rehearing in an effort to undo the court's decision forcing it to arbitrate a dispute over prescription drug reimbursements with subsidiaries of CVS Health Corp., arguing it never waived sovereign immunity and did not agree to such proceedings on its Recovery Act claims.

  • June 26, 2024

    Apple Watch Improvement Is 'Inferior,' Docs Tell 9th Circ.

    Four cardiac specialists backed medical monitoring startup AliveCor against Apple in a Ninth Circuit amicus brief Tuesday arguing a district court wrongly nixed antitrust claims by crediting the phaseout of a heart rate monitoring algorithm as an improvement when all it did was deny patient access to "potentially life-saving" technology.

  • June 26, 2024

    House GOP Gears Up For The End Of Chevron Deference

    A new memo outlines how House Republicans are gearing up for the U.S. Supreme Court to potentially overturn the decades-old precedent that courts defer to agencies' interpretations of ambiguous statutes, as an opportunity to roll back the Biden administration's policies and reclaim Congress' power.

  • June 26, 2024

    Squire Patton Adds Epstein Becker Healthcare Atty In DC

    An experienced healthcare and life sciences industries attorney has jumped from Epstein Becker Green PC to Squire Patton Boggs LLP in Washington, D.C., the latter firm has announced.

  • June 26, 2024

    Pharma Co. PhaseBio Can Exit Ch. 11 With Wind-Down Plan

    A Delaware bankruptcy judge on Wednesday gave her blessing for pharmaceutical developer PhaseBio Pharmaceuticals Inc. to liquidate its assets and wind down after settlement agreements with creditors and a business partner cleared a path for it to exit Chapter 11 after roughly 19 months.

  • June 26, 2024

    High Court 'Inadvertently' Posts Order Punting Abortion Case

    The U.S. Supreme Court mistakenly released a draft order Wednesday that would allow emergency abortions in Idaho, with a majority saying the court was wrong to consider a state challenge at this time.

  • June 26, 2024

    High Court Axes Challenge To Biden Admin's Social Media Work

    The U.S. Supreme Court wiped out a Fifth Circuit order prohibiting the Biden administration and several federal agencies from working with social media platforms to combat the spread of misinformation Wednesday, finding the states and individuals challenging the collaboration don't have standing to sue.

  • June 25, 2024

    Riley Safer Expands IP Practice With Chicago Partner

    Chicago firm Riley Safer Holmes & Cancila LLP has bolstered its intellectual property practice by bringing on board an experienced litigator from Goldman Ismail Tomaselli Brennan & Baum, the law firm announced Tuesday.

  • June 25, 2024

    PTAB Wipes Out UMass Skin Disease Treatment Patent

    The Patent Trial and Appeal Board has sided with Forte Biosciences in invalidating a University of Massachusetts patent on treating the skin disease vitiligo, ruling that the patent does not adequately describe the invention or enable a skilled person to make and use it.

  • June 25, 2024

    Fed. Circ. Restores Amarin's Skinny Label Suit Against Hikma

    The Federal Circuit revived litigation Tuesday accusing Hikma Pharmaceuticals USA Inc. of inducing physicians to infringe patents covering Amarin Pharma Inc.'s blockbuster cardiovascular drug Vascepa in a case over limited-use generics.

  • June 25, 2024

    Sarissa Capital, Founder Settle Bioverativ Suit In Del. For $40M

    Remaining parties in a Delaware Court of Chancery class action over the $11.6 billion sale of biotech venture Bioverativ Inc. to Sanofi Inc. in 2018 have agreed to settle their outstanding claims for $40 million in cash, according to a stipulation filed with the court Tuesday.

  • June 25, 2024

    Indiana U Settles Ricin-Carrying Fruit Fly Export Violations

    Indiana University has escaped fines, but it must instead educate the broader academic community at large on export controls under a settlement with the U.S. Department of Commerce after the institution sent unlicensed shipments overseas, of fruit flies carrying a subunit of ricin.

  • June 25, 2024

    Plaintiffs Firms Appealing $2.1B Fee Order In Opioid Case

    Motley Rice LLC, Weisman Kennedy & Berris Co. LPA, Stranch Jennings & Garvey PLLC, Crueger Dickinson LLP, Goldstein & Russell PC, Kelley & Ferraro LLP, Spangenberg Shibley & Liber LLP and Meyers & Flowers LLC are appealing $2.13 billion in attorney fees stemming from opioid settlements awarded earlier this month.

  • June 25, 2024

    Chancery OKs $71M Premier Deal, $14M Four-Firm Fee

    Shareholder attorneys led by Friedlander & Gorris who negotiated a $71 million settlement to end derivative Delaware Chancery Court litigation with healthcare-purchasing giant Premier Inc. will get $14 million for their efforts, the total fee award they sought.

  • June 25, 2024

    UK Billionaire's Pilot Avoids Prison For Insider Trading

    A Manhattan federal judge sentenced a former private jet pilot to house arrest Tuesday for insider trading on stock tips from his billionaire boss Joe Lewis, finding that a prison term would be unfair in comparison to Lewis' non-incarceratory sentence.

  • June 25, 2024

    Lye Buyers Can't Get Court OK For $38.5M Antitrust Deals

    A federal judge in Buffalo has rejected three settlements totaling $38.5 million for a proposed class of lye purchasers who alleged producers of the chemical colluded to inflate prices, ruling exceptions to who qualifies for the class make it impossible to determine membership.

  • June 25, 2024

    Litigation Pro Rejoins GRSM50 In Calif. From DeHay & Elliston

    Gordon Rees Scully Mansukhani LLP has strengthened its litigation bench with a partner in Walnut Creek, California, who arrived from DeHay & Elliston LLP and who worked for six years earlier in his career as a senior counsel for GRSM50.

  • June 24, 2024

    Alleged Contract Killing Sparks Delaware Chancery Lawsuit

    Los Angeles biotech firm Renovaro Inc. has sued a former, purported scientific adviser and his husband in Delaware's Court of Chancery for damages tied to an assortment of fraudulent schemes allegedly shielded in part by a contract killing linked to a separate alleged international oil trading scam.

Expert Analysis

  • Key Takeaways From FDA Final Rule On Lab-Developed Tests

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    Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.

  • Assessing HHS' Stance On Rare Disease Patient Assistance

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    The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.

  • Opinion

    Feds' Biotech Enforcement Efforts Are Too Heavy-Handed

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    The U.S. Department of Justice's recent actions against biotech companies untether the Anti-Kickback Statute from its original legislative purpose, and threaten to stifle innovation and undermine patient quality of care, say attorneys at Ropes & Gray.

  • Regulating Resurrected Species Under The ESA

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    As the prospect of extinct species being resurrected from DNA and reintroduced into the wild grows closer, an analysis of the Endangered Species Act suggests that it could provide a thoughtful, flexible governance framework for such scenarios, say Caroline Meadows and Shelby Bobosky at the SMU Dedman School of Law.

  • E-Discovery Quarterly: Recent Rulings On Text Message Data

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    Electronically stored information on cellphones, and in particular text messages, can present unique litigation challenges, and recent court decisions demonstrate that counsel must carefully balance what data should be preserved, collected, reviewed and produced, say attorneys at Sidley.

  • What CRA Deadline Means For Biden Admin. Rulemaking

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    With the 2024 election rapidly approaching, the Biden administration must race to finalize proposed agency actions within the next few weeks, or be exposed to the chance that the following Congress will overturn the rules under the Congressional Review Act, say attorneys at Covington.

  • 5 Takeaways From FDA's Biosimilars Promotion Guidance

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    New draft guidance from the U.S. Food and Drug Administration expands upon other recent efforts to clarify expectations for biosimilar and interchangeable labeling, highlighting a number of potential missteps that could draw attention from regulators, say attorneys at Arnold & Porter.

  • Dual-Track IPO-M&A Exit Strategies For Life Science Cos.

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    A dual-track process for life sciences companies offers a proven path to securing favorable deal terms for an exit, and strategic moves can include running a crossover financing round in the lead-up, say attorneys at McDermott.

  • Does Expert Testimony Aid Preliminary IPR Responses?

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    Dechert attorneys analyze six years of patent owners' preliminary responses to inter partes review petitions to determine whether the elimination of the presumption favoring the petitioner as to preinstitution testimonial evidence affected the usefulness of expert testimony in responses.

  • Are Concessions In FDA's Lab-Developed Tests Rule Enough?

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    Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.

  • Rebuttal

    Double-Patenting Ruling Shows Terminal Disclaimers' Value

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    While a recent Law360 guest article seems to argue that the Federal Circuit’s Cellect decision last year robs patent owners of lawful patent term, the ruling actually identifies how terminal disclaimers are the solution to the problem of obviousness-type double patenting, say Jane Love and Robert Trenchard at Gibson Dunn.

  • Series

    Swimming Makes Me A Better Lawyer

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    Years of participation in swimming events, especially in the open water, have proven to be ideal preparation for appellate arguments in court — just as you must put your trust in the ocean when competing in a swim event, you must do the same with the judicial process, says John Kulewicz at Vorys.

  • Mid-2024 FCA Enforcement And Litigation Trends To Watch

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    Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.

  • What 100 Federal Cases Suggest About Changes To Chevron

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    With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.

  • Why High Court May Have Rejected IP Obviousness Appeal

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    Attorneys at Womble Bond analyze possible reasons the U.S. Supreme Court rejected Vanda Pharmaceuticals' request to review the Federal Circuit’s reasonable expectation of success standard for determining obviousness, including that the court was unpersuaded by the company's argument that Amgen v. Sanofi places a bind on drug developers.

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