Life Sciences

  • May 20, 2024

    Ex-IRS Agent, Five Others Sentenced In COVID Fraud Scheme

    A former Internal Revenue Service agent, his brother and four other defendants have pled guilty to participating in a scheme that netted more than $3 million in fraudulent COVID-19 pandemic relief loans.

  • May 20, 2024

    Lab Says GSK Hid Zantac Cancer Risk From Feds For Decades

    A Connecticut laboratory claims that GlaxoSmithKline defrauded federal health insurance programs for billions by hiding for 40 years that Zantac decomposes into a carcinogen even when just sitting on the shelf, in a lawsuit filed Monday in Pennsylvania federal court.

  • May 20, 2024

    Teladoc Faces Suit Over Mental Health Platform's Losses

    Telemedicine giant Teladoc Health Inc. and two of its executives face a proposed investor class action alleging trading prices for Teladoc shares fell after the company disclosed that its flagship mental health counseling platform saw membership and revenue declines despite increased advertising costs.

  • May 20, 2024

    Ultragenyx Must Face Suit Over Use Of Henrietta Lacks' Cells

    The family of the late Henrietta Lacks, a Black woman whose cells were harvested without her knowledge to create the first immortalized human cell line, can purse their suit alleging Ultragenyx Pharmaceutical "made a fortune" using her stolen cells to develop gene therapy treatments, a Maryland federal judge ruled Monday.

  • May 20, 2024

    USPTO Clarifies Means-Plus-Function Claims For Antibodies

    The U.S. Patent and Trademark Office's new Appeals Review Panel clarified the use of means-plus-function claiming when patenting antibodies, while continuing to reject claims of a Xencor Inc. patent application related to treating autoimmune diseases.

  • May 20, 2024

    McKinsey Can't Nix Pregnant Women's Claims In Opioid MDL

    A California federal judge has cut some claims from multidistrict litigation seeking to hold McKinsey & Co. Inc. liable for infant neonatal abstinence syndrome caused by pregnant women's use of opioids, trimming fraud and nuisance-based claims, but allowing conspiracy and aiding-and-abetting claims to proceed against the consulting firm.

  • May 20, 2024

    Judge Tosses Acuitas' COVID Biotech IP Suit

    A New Jersey federal judge on Monday threw out a lawsuit from a maker of a component of a COVID-19 vaccine relating to patent infringement litigation brought by two other companies against Pfizer and BioNTech.

  • May 20, 2024

    Local Governments Seek Sanctions For PBMs In Opioid MDL

    Four municipalities are asking an Ohio federal court overseeing the national opioid litigation to sanction pharmacy benefit managers Express Scripts Inc. and OptumRX Inc., saying they've willfully defied the court's order to provide complete responses to discovery requests.

  • May 20, 2024

    iRhythm Brass Face Suit Over FDA's Heart Monitor Inquiry

    Several current and former directors and executives of medical technology company iRhythm are named in a shareholder derivative suit alleging they failed to disclose an inquiry by the Food and Drug Administration that found iRhythm's heavily touted and high-cost real-time heart monitoring device failed to meet the company's claims.

  • May 20, 2024

    J&J Says Beasley Allen Looking To 'Bias' Vote On $6.5B Plan

    Johnson & Johnson's bankrupt talc unit accused the Beasley Allen Law Firm of attempting to intentionally "bias" the vote against its recently announced proposal to pay out $6.5 billion in a prepackaged reorganization plan to resolve claims that its talc-based baby powder causes ovarian cancer.

  • May 20, 2024

    Latham Hires 2 Skadden Healthcare Partners In DC

    Latham & Watkins LLP has picked up two healthcare and life sciences partners from Skadden Arps Slate Meagher & Flom LLP in Washington, D.C., the firm announced Monday.

  • May 20, 2024

    Catching Up With Delaware's Chancery Court

    Delaware was full of drama last week, as proposed changes to the state's corporate law statutes raised eyebrows and a professor's friend-of-the-court brief sparked a very unfriendly public exchange. Delaware's court of equity banged the gavel on pipeline and social media disputes, and shareholders filed new suits alleging insider trading, vote bungling, unfair stock buybacks and merger shenanigans. In case you missed any of it, here's the recap of all the top news last week from Delaware's Chancery Court.

  • May 20, 2024

    Ga. Judge OKs $5M Atty Fees In $41M Acella Thyroid Deal

    A Georgia federal judge has signed off on a nearly $41.5 million class action settlement with Acella Pharmaceuticals LLC over faulty thyroid medication, while awarding the class attorneys another $5 million in legal fees courtesy of the pharma company.

  • May 20, 2024

    Moderna Fends Off Pfizer's MRNA Patent Challenge

    Moderna has successfully defended a key patent underpinning its COVID-19 vaccine, after rivals Pfizer and BioNTech attempted to convince the European Patent Office that the IP protections should be nixed.

  • May 20, 2024

    Shah Ends Novavax Proxy Fight Following Sanofi Deal

    Hedge fund Shah Capital Management Inc. told fellow Novavax Inc. shareholders Monday that it is ending its fight to remove certain members of the biotech company's board, citing its favorable view of Novavax's licensing deal with Sanofi earlier this month.

  • May 17, 2024

    VA Deal Winner Says Protest Not Based On Common Sense

    The winner of a U.S. Department of Veterans Affairs mail-order pharmacy deal urged the U.S. Court of Federal Claims to toss a competitor's protest of the award, saying the protester's challenge was based on an incorrect reading of applicable regulations.

  • May 17, 2024

    Allergan Says Deserted Drug Rule Weakens $680M Fraud Suit

    Allergan drew a Maryland federal court's attention to the Centers for Medicare & Medicaid Services' abandonment of a regulation clarifying drug pricing, arguing the move undermined a whistleblower's claims that it overcharged Medicaid by over $680 million.

  • May 17, 2024

    Patent Office Gets Another Earful About 'March-In' Plan

    Industry groups of all stripes have lined up at the U.S. Patent and Trademark Office to complain yet again about a Biden administration proposal from last year to potentially use "march-in" rights and seize pharmaceutical patents using the Bayh-Dole Act.

  • May 17, 2024

    Pfizer Unit Wins $107.5M Patent Verdict Against AstraZeneca

    A Delaware federal jury on Friday said that AstraZeneca Pharmaceuticals LP should pay $107.5 million in royalty damages for infringing a Pfizer-brand cancer treatment patent, although a final decision won't be issued until after a bench trial on some of AstraZeneca's additional defenses. 

  • May 17, 2024

    FCA Relators Seek Finders Fee For SpineFrontier Doc Deals

    Three whistleblowers who tipped off the federal government to a medical device company's multimillion-dollar kickback scheme said Friday the Justice Department is refusing to pay them a cut of the $3 million in False Claims Act settlements paid by surgeons who admitted participating in the sham consulting ploy.

  • May 17, 2024

    Judge Won't Bar Thermo Fisher Exec's Jump To Repligen

    A Massachusetts judge won't block a former Thermo Fisher Scientific executive from jumping to smaller rival Repligen, calling a noncompete agreement signed by the employee overbroad and suggesting that it was really aimed at stifling competition in a ruling released Friday.

  • May 17, 2024

    EndoStim Emerges From Delaware Insolvency Proceeding

    Delaware's Court of Chancery has approved the final accounting for medical device company EndoStim Inc.'s state-administered insolvency proceeding after no creditor or other party raised any objections at a final hearing on Friday.

  • May 17, 2024

    Industry Emboldened After Justices Galvanize Agency Attacks

    In the year since the U.S. Supreme Court said "extraordinary" and "far-reaching" attacks on administrative enforcers can skip agency tribunals and go straight to federal district court, ambitious challenges to regulatory powers are rapidly gaining traction, and the high court is poised to put them on an even firmer footing.

  • May 17, 2024

    Texas Justices Let Fen-Phen Atty Malpractice Fight Roll On

    The Texas Supreme Court ruled Friday that roughly 4,000 former clients of a Houston mass tort lawyer can continue pressing their claims that the lawyer improperly kept millions of dollars in fen-phen diet drug settlement money.

  • May 17, 2024

    Winston & Strawn Leads Asia-Focused SPAC $100M IPO

    Shares of RF Acquisition II, a special-purpose acquisition company targeting the technology sector in Asia, began trading publicly on Friday following the company's $100 million initial public offering.

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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