Life Sciences

  • 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.

  • June 24, 2024

    Judge Mulls BioXcel's Duty To Tell Investors Of FDA Troubles

    A Connecticut federal judge wondered Monday if executives at the artificial intelligence-driven drugmaker BioXcel Therapeutics Inc. had an opportunity to correct problems that government regulators identified with a key clinical trial and, if so, whether their statements on the subject to investors could be considered false or misleading.

  • June 24, 2024

    NYC Pharmacy Owners Get Jail Time For $18M Med Fraud

    Two brothers who own several New York pharmacies will each have to pay over $18 million in restitution in addition to serving jail time for submitting fraudulent claims to Medicare for pricey cancer medication and funneling illicit proceeds through several shell companies, the U.S. Department of Justice announced Monday.

  • June 24, 2024

    Justices Undo Terror Victims' Win, Citing Twitter Decision

    The U.S. Supreme Court on Monday swept aside a D.C. Circuit ruling that threatened to expose major pharmaceutical companies to liability for terrorist attacks that injured or killed hundreds of U.S. soldiers and civilians in Iraq.

  • June 24, 2024

    LA Schools Says Pseudoscience Infected 9th Circ. Vax Ruling

    The Los Angeles Unified School District said Friday that a split Ninth Circuit panel leaned on pseudoscience when ruling that a rescinded employee COVID-19 vaccination mandate implicated the right of district employees to refuse medical treatment, urging an en banc panel to correct the "fatally flawed" decision.

  • June 24, 2024

    Ark. AG Sues Pharmacy Benefit Managers Over Opioids

    The Arkansas attorney general said Monday that he had sued pharmacy benefit managers Optum Inc. and Express Scripts Inc. in state court, claiming they contributed to the opioid crisis and profited from the drug epidemic.

  • June 24, 2024

    Suit Over Medical Screws Filed Too Late, Texas Panel Finds

    A Texas appeals court won't revive a woman's suit against BioPro Inc. alleging that surgical screws used in her feet were defective, saying the evidence establishes that she filed her suit after the two-year statute of limitations had expired.

  • June 24, 2024

    Jurisdictional Discovery Ordered In NJ COVID Test Fraud Suit

    A New Jersey federal court has denied without prejudice a dismissal bid and ordered "tightly-targeted and prompt jurisdictional discovery" in a Garden State medical supply business' complaint accusing a Texas attorney and his solo practice of aiding in an alleged $2.45 million fraud scheme involving COVID-19 test kits that were never delivered.

  • June 24, 2024

    Catching Up With Delaware's Chancery Court

    Amendments to Delaware's General Corporation Law topped the news out of the Court of Chancery again last week, as the hotly contested measure sailed through the state's legislature. Tesla and its shareholders continued their tug-of-war over attorney fees for Chancery litigation about Elon Musk's pay package, and new cases were filed involving biotechs, car rental companies, workout platforms, telecom towers, and a cargo ship fire in Brazil.

  • June 24, 2024

    Justices Pass On Conn. School Vaccine Mandate Fight

    The U.S. Supreme Court on Monday declined to review a Second Circuit decision that largely upheld the dismissal of a suit challenging a Connecticut law passed during the COVID-19 pandemic that revoked religious exemptions to student vaccine mandates.

Expert Analysis

  • Mitigating Incarceration's Impacts On Foreign Nationals

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    Sentencing arguments that highlighted the disparate impact incarceration would have on a British national recently sentenced for insider training by a New York district court, when compared to similarly situated U.S. citizens, provide an example of the advocacy needed to avoid or mitigate problems unique to noncitizen defendants, say attorneys at Lankler Siffert.

  • Contract Disputes Recap: Saying What Needs To Be Said

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    Edward Arnold and Bret Marfut at Seyfarth Shaw examine three recent decisions that delve into the meaning and effect of contractual releases, and demonstrate the importance of ensuring that releases, as written, do what the parties intend.

  • Lessons On Challenging Class Plaintiffs' Expert Testimony

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    In class actions seeking damages, plaintiffs are increasingly using expert opinions to establish predominance, but several recent rulings from California federal courts shed light on how defendants can respond, say Jennifer Romano and Raija Horstman at Crowell & Moring.

  • Exploring An Alternative Model Of Litigation Finance

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    A new model of litigation finance, most aptly described as insurance-backed litigation funding, differs from traditional funding in two key ways, and the process of securing it involves three primary steps, say Bob Koneck, Christopher Le Neve Foster and Richard Butters at Atlantic Global Risk LLC.

  • Del. IP Ruling May Mark Limitation-By-Limitation Analysis Shift

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    A Delaware federal court's recent ruling in Lindis Biotech v. Amgen, which involved complex technology where the complaint contained neither facts nor a specific allegation directed to a claim limitation, might spark a shift away from requiring a limitation-by-limitation analysis, say Ted Mathias and Ian Swan at Axinn.

  • Cell Therapy Cos. Must Beware Limits Of Patent Safe Harbors

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    Though developers of gene and cell therapy products commonly assume that a legal safe harbor protects them from patent infringement suits, recent case law shows that not all preapproval uses of patented technology are necessarily protected, say Natasha Daughtrey and Joshua Weinger at Goodwin.

  • Series

    Teaching Yoga Makes Me A Better Lawyer

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    Being a yoga instructor has helped me develop my confidence and authenticity, as well as stress management and people skills — all of which have crossed over into my career as an attorney, says Laura Gongaware at Clyde & Co.

  • How Clinical Trials Affect Patentability In US And Europe

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    A comparison of recent U.S. and European patent decisions — concerning the effect of disclosures in clinical trials on the patentability of products — offers guidance on good practice for companies dealing with public use issues and prior art documents in these commercially important jurisdictions, say lawyers at Finnegan.

  • A Vision For Economic Clerkships In The Legal System

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    As courts handle increasingly complex damages analyses involving vast amounts of data, an economic clerkship program — integrating early-career economists into the judicial system — could improve legal outcomes and provide essential training to clerks, say Mona Birjandi at Data for Decisions and Matt Farber at Secretariat.

  • Opinion

    State-Regulated Cannabis Can Thrive Without Section 280E

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    Marijauna's reclassification as a Schedule III-controlled substance comes at a critical juncture, as removing marijuana from being subjected to Section 280E of the Internal Revenue Code is the only path forward for the state-regulated cannabis industry to survive and thrive, say Andrew Kline at Perkins Coie and Sammy Markland at FTI Consulting.

  • 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.

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