Life Sciences

  • July 10, 2024

    ​GOP Bombards Agencies With Demands After Chevron's End

    Republican leaders of major congressional committees Wednesday demanded details from dozens of agencies on policies suddenly shrouded in uncertainty after U.S. Supreme Court conservatives overturned the so-called Chevron doctrine, which for 40 years gave regulators flexibility in rulemaking and advantages in related litigation.

  • July 10, 2024

    Meijer Says Takeda Can't Force Antitrust Suit Into Arbitration

    Meijer argued before a Massachusetts federal court that Takeda waited far too long to try to force the supermarket chain to arbitrate its proposed class action accusing the Japanese pharmaceutical company of conspiring to delay a generic version of its anti-constipation drug Amitiza.

  • July 10, 2024

    Skin Care Tech Co. Says Suit Shows 'Rough' Year, Not Fraud

    Skin care and beauty technology company Cutera Inc. asked a federal judge to toss a shareholder lawsuit that alleged the company exaggerated its financial sustainability and hid compliance issues, saying the company's "rough" year does not establish securities fraud.

  • July 10, 2024

    Buyers Say Teva Had Multipart Scheme To Delay Inhaler Rivals

    Employee benefit funds accusing Teva of orchestrating a decadelong scheme to delay generic competition for its QVAR asthma inhalers told a Massachusetts federal court the drugmaker is trying to end the case by addressing merely one aspect of a multipart scheme.

  • July 10, 2024

    RJ Reynolds Urges Toss Of Menthol Suit Against FDA

    Tobacco giant R.J. Reynolds has come to the support of the U.S. Food and Drug Administration in a friend-of-the-court brief, arguing that the court should toss a federal lawsuit against the agency over its purported delays in implementing a ban on menthol cigarettes.

  • July 10, 2024

    Ex-FDA Regulator Joins Chicago Boutique Amin Wasserman

    A former high-level attorney within the U.S. Food and Drug Administration is joining Chicago-based boutique Amin Wasserman Gurnani LLP, which specializes in representing food and dietary supplement companies.

  • July 10, 2024

    Longtime Axinn Atty To Chair Polsinelli's Hatch-Waxman Team

    A practice leader from Axinn Veltrop & Harkrider LLP, known in part for his high-profile work on behalf of pharmaceutical clients, is joining Polsinelli PC to chair its Hatch-Waxman and biologics practice, the firm announced on Tuesday.

  • July 10, 2024

    Ex-CEO Convicted In COVID Test Kit Fraud Case

    A former healthcare software executive was found guilty of securities fraud Wednesday by a New Jersey federal jury in the retrial of a case that ended in a hung jury in December.

  • July 09, 2024

    Pharma Co. Fined $16.9M For Fake Scripts, Ex-VP Arrested

    A subsidiary of bankrupt DMK Pharmaceuticals Corp. faces a $16.9 million criminal fine after pleading guilty to conspiring in a scheme to ship drugs using false prescriptions, federal prosecutors announced Tuesday, adding that the subsidiary's former vice president of sales was also arrested.

  • July 09, 2024

    Bard Fights 'Patent Misuse' Ruling In $53M Suit At 9th Circ.

    Bard urged the Ninth Circuit on Tuesday to reverse a lower court's finding that its attempt to collect $53 million in licensing payments from a medical-device company was a clear case of "patent misuse," arguing that the parties' licensing agreement allows for Bard to collect payments even after the patents-in-suit expired.

  • July 09, 2024

    South Africa Drops J&J Probe After TB Drug Price Cuts

    South Africa's antitrust office has said it's going to drop its investigation over whether Johnson & Johnson engaged in anticompetitive conduct by filing a patent there for a tuberculosis drug, after the drugmaker agreed to lower the cost of bedaquiline by 40% and allow generic versions of the drug on the market.

  • July 09, 2024

    Fla. Judge Won't Nix Antitrust Claims Against Alcon

    The Florida federal judge presiding over the multidistrict litigation alleging disposable contact lens sellers conspired to fix prices refused Tuesday to let Alcon escape antitrust claims by an online contact lens reseller and sent the suit back to New York.

  • July 09, 2024

    HEC Can't Get Damages Over Injunction In Novartis Feud

    A Delaware federal court on Tuesday shot down HEC Pharm Co.'s bid for damages stemming from a preliminary injunction against it over the launch of a generic version of Novartis Pharmaceuticals' blockbuster multiple sclerosis treatment Gilenya.

  • July 09, 2024

    BCBS Unit Fails To Stop Religious Vaccine Objector Suits

    A Blue Cross Blue Shield of Michigan subsidiary can't escape claims it treated differently employees who sought accommodations from a COVID-19 vaccine mandate, a Michigan federal judge ruled Tuesday, finding it plausible that religious discrimination "was at least a motivating factor" in the way the workers were dealt with.

  • July 09, 2024

    3rd Circ. Rips 2nd Circ. In Asset Freeze Ruling For SEC

    The Third Circuit is standing by a lower court's decision to freeze a private equity executive's assets as he fights insider trading claims brought by the U.S. Securities and Exchange Commission, criticizing its sister circuit's approach to handling such issues in a precedential ruling Tuesday.

  • July 09, 2024

    NJ Panel Revokes Coverage For Pharma Co. In Fraud Row

    A pharmaceutical company isn't covered for underlying accusations that it was a middleman in a self-dealing scheme orchestrated by its now-deceased board chairman, a New Jersey state appeals court ruled Tuesday, reversing a decision that a capacity exclusion in the company's directors and officers policy didn't apply.

  • July 09, 2024

    Purdue Plans 'High-Speed' Bid For New Ch. 11 Plan

    Purdue Pharma told a New York bankruptcy judge Tuesday that it plans a two-month "high-speed, high-stakes" attempt to replace the Chapter 11 plan shot down by the U.S. Supreme Court last month before unleashing litigation on its former owning family.

  • July 09, 2024

    NJ Jury Begins Deliberating COVID Test Kit Fraud Case

    Jurors began deliberating Tuesday in the retrial of a securities fraud case that ended with a dramatic mistrial after a juror announced in open court last December that he disagreed with the guilty verdict that had just been delivered by the jury forewoman.

  • July 09, 2024

    Terrorism Victims Push To Keep Pharma Suit In DC Circ.

    Terrorism victims warned the D.C. Circuit against sending to a lower court a lawsuit seeking to link pharmaceutical companies to the attacks that injured them, saying a remand could delay the case and frustrate their efforts to collect evidence.

  • July 09, 2024

    FTC Says Drug Middlemen Inflate Costs, Squeeze Pharmacies

    The Federal Trade Commission said Tuesday that its study of pharmacy benefit managers has shown that six large companies now control 95% of all prescriptions filled in the U.S., allowing them to profit at the expense of patients and independent pharmacies.

  • July 09, 2024

    Gov't Missed Merck Vax Potency Problem, 3rd Circ. Told

    Two whistleblowers claiming that Merck & Co. had exaggerated the potency of its mumps vaccine told a Third Circuit panel Tuesday that the U.S. Centers for Disease Control and Prevention's continued purchasing of the vaccine was not proof that the agency knew but didn't care about the alleged deception.

  • July 08, 2024

    Emergent, J&J Reach $50M Deal In COVID Vax Supply Fight

    Johnson & Johnson has agreed to pay Emergent BioSolutions $50 million to resolve claims stemming from a now-terminated COVID-19 vaccine manufacturing deal, according to a disclosure filed with the U.S. Securities and Exchange Commission on Monday.

  • July 08, 2024

    Biotech Slaps Intellia With IP Suit Over $100M Regeneron Deal

    Biotechnology company BlueAllele Corp. sued Intellia Therapeutics Inc. in Delaware federal court Monday, claiming the rival has infringed on three of its patents related to gene editing and using its invented technology to reap over $100 million under a deal with another biotech, Regeneron Pharmaceuticals Inc.

  • July 08, 2024

    Jurors Told To Decide Who Is Lying In COVID Test Fraud Case

    The task for jurors in the retrial of a securities fraud case over a COVID test kit deal that never materialized will be to determine not whether lies were told but who told them, according to closing arguments delivered Monday in New Jersey federal court.

  • July 08, 2024

    Blank Check Co. Sagaliam Gets Shareholder Suit Trimmed

    A Delaware federal judge on Monday trimmed a shareholder suit brought against blank check company Sagaliam Acquisition Corp. over its planned tie-up with biotech company Enzolytics Inc., saying the plaintiffs failed to adequately plead a breach of fiduciary duty claim.

Expert Analysis

  • Patent Lessons From 4 Federal Circuit Reversals In April

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    Four Federal Circuit decisions in April that reversed or vacated underlying rulings provide a number of takeaways, including that obviousness analysis requires a flexible approach, that an invalidity issue of an expired patent can be moot, and more, say Denise De Mory and Li Guo at Bunsow De Mory.

  • Opinion

    USPTO's Proposed Disclaimer Rule Would Harm Inventors

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    The U.S. Patent and Trademark Office’s recently proposed rule on terminal disclaimers will make the patent system less available to inventors and will unfairly favor defendants in litigation, say Stephen Schreiner at Carmichael IP and Sarah Tsou at Omni Bridgeway.

  • Series

    Being An EMT Makes Me A Better Lawyer

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    While some of my experiences as an emergency medical technician have been unusually painful and searing, the skills I’ve learned — such as triage, empathy and preparedness — are just as useful in my work as a restructuring lawyer, says Marshall Huebner at Davis Polk.

  • 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.

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