Life Sciences

  • July 31, 2024

    Inhaler Patents 'Must Be' In Orange Book, Teva Tells Fed. Circ.

    Teva Pharmaceuticals USA Inc. urged the Federal Circuit to upend a lower court decision ejecting inhaler device patents from an important government database, arguing that the delisting, won by Amneal Pharmaceuticals Inc. in an infringement lawsuit, ignores broad protection envisioned under intellectual property law.

  • July 31, 2024

    1st Circ. Mostly Backs $5M Award In Biotech Recruiting Spat

    The First Circuit left intact the vast majority of a $5 million post-trial award against a life sciences recruiting firm found to have misappropriated trade secrets from a rival involving placements at Takeda and Vedanta Biosciences.

  • July 31, 2024

    5 Trials To Watch In The 2nd Half Of 2024

    Upcoming high-profile trials over star lawyer Tom Girardi's alleged fraud, Hunter Biden's taxes and Washington state's "patent troll" law are among the cases to watch in the latter half of the year.

  • July 31, 2024

    AIG Units Off Hook In Defending McKesson Opioid Suits

    Two AIG insurers have no duty to defend McKesson Corp. over claims it intentionally over-distributed opioids, a California federal court ruled, saying the three underlying suits do not allege a potentially covered occurrence under policies issued between 1999 and 2004.

  • July 30, 2024

    Life Sciences Cases To Watch 2024: A Midyear Report

    From the U.S. Supreme Court down to the federal district courts, judges and lawmakers are grappling with questions crucial to the life sciences industry. Here are some of the biggest life sciences cases to watch in the second half of 2024. 

  • July 30, 2024

    2024 Product Liability Areas To Watch

    The growing movement in state laws about whether consumers can repair their own products is catching attorneys' eyes, as well as recent changes in rules that govern multidistrict litigation, which often involve pharmaceuticals and medical devices.

  • July 30, 2024

    Cook Medical Vein Filter Claims Came Too Late, 7th Circ. Says

    The Seventh Circuit on Tuesday upheld Cook Medical LLC's win in a woman's lawsuit claiming the company's inferior vena cava filter caused her to develop abdominal pain and that the device fractured when it was removed, saying the suit was filed after the statute of limitations had expired.

  • July 30, 2024

    DC Circ. Finds NIH's Comment Restrictions Unconstitutional

    The National Institutes of Health violated the First Amendment when the agency used keyword filters to hide comments from animal rights activists on its official Facebook and Instagram pages, a D.C. Circuit panel ruled Tuesday.

  • July 30, 2024

    AIDS Org Sues Express Scripts For PBM Monopoly

    The world's largest HIV/AIDS healthcare organization is joining the slew of litigants suing pharmacy benefit manager Express Scripts, claiming in a new complaint that the pharmacy giant has leveraged monopoly power in Louisiana to suppress competition among independent specialty pharmacies that focus on rare and complex medical conditions.

  • July 30, 2024

    Judge Wants Device Warning Answers From Mich. Justices

    A Michigan federal judge ruled Tuesday that medical device manufacturer NuVasive Inc. must face a patient suit alleging its limb-lengthening device caused metal poisoning, while also asking the Michigan Supreme Court to break its silence on medical manufacturers' duty to warn patients directly. 

  • July 30, 2024

    Chancery Rejects Forte-Camac Deal As 'Not Fair' To Class

    A Delaware Chancery Court judge on Tuesday rejected a settlement between Forte Biosciences Inc. and Camac Partners LLC that would have ended the activist investor's class action over Forte's alleged board entrenchment, finding that the proposed deal gave Camac "unique and personal benefits" that weren't shared with the rest of the class.

  • July 30, 2024

    Psychedelics And The Law: A Midyear Review

    A groundbreaking effort to secure federal approval for a psychedelic medication hit an unexpected snag. Religious groups asserting the right to access controlled substances had mixed success in federal court. Physicians seeking to administer psilocybin to terminally ill patients will finally have their day in court. Here are the major developments in psychedelics law from the first half of 2024.

  • July 30, 2024

    DOD Contractors Must Face Suit Over 'Made In U.S.A.' Label

    A pair of whistleblowers who claim that tourniquets and other medical equipment sold to the U.S. Department of Defense was mislabeled as "made in U.S.A." can continue with most of their False Claims Act suit against two contractors, a Pennsylvania federal judge said.

  • July 30, 2024

    Litigator Rejoins Faegre Drinker From Medical Device Co.

    Faegre Drinker Biddle & Reath LLP's newest lateral hire is stepping back into private practice after two years as associate general counsel for orthopedic implant company Exactech, and should be a familiar face around the firm's Indianapolis office.

  • July 30, 2024

    What Mass. Attys Will Be Watching In The 2nd Half Of 2024

    Two potentially sweeping Massachusetts high court rulings and a long-awaited employment bill lingering in the State House are among the issues Bay State attorneys say they are monitoring closely heading into the latter half of 2024.

  • July 29, 2024

    Genzyme Says Sarepta's Dystrophy Gene Therapy Infringes IP

    Sanofi's biotechnology company Genzyme Corp. hauled Sarepta Therapeutics into Delaware federal court on Friday, alleging Sarepta's gene therapy treatment for Duchenne muscular dystrophy infringed two of its patents for manufacturing certain therapeutics.

  • July 29, 2024

    Medical Co. Can't Get Alleged Fraudulent Arbitral Award Nixed

    A New York federal judge has declined to vacate an arbitral award issued by a Swiss tribunal to a Singapore company in a dispute over a medical imaging joint venture, rejecting arguments that an agreement struck by the parties meant that a New York court could decide the issue.

  • July 29, 2024

    NIST Lays Out 200+ Ways To Tackle Generative AI Risks

    The National Institute of Standards and Technology has recommended hundreds of actions that can be taken to address issues of data privacy, intellectual property, environmental impact and more raised by generative artificial intelligence.

  • July 29, 2024

    Wash. Says At-Home Rape Kit Law Targets Harm, Not Speech

    Washington pushed back against a company's bid to pause enforcement of a ban on the sale of "DIY" DNA collection kits to sexual assault survivors, saying the prohibition is meant to prevent victims from being tricked into thinking the kit results will stand up in court.

  • July 29, 2024

    Gilstrap Finds Nothing Between The Lines Of Barcode Patents

    A handful of barcode scanning patents issued to prolific litigant Leigh Rothschild met their fate in Texas, with U.S. District Judge Rodney Gilstrap deciding they "recite no more than generic computer operations."

  • July 29, 2024

    Vaccine Co. Was Sanctioned For Deliberately Hiding Testing

    U.S. Patent and Trademark Office Director Kathi Vidal backed sanctions for Longhorn Vaccines & Diagnostics' "egregious abuse" of the Patent Trial and Appeal Board system because of the patent owner's "deliberate scheme to hide" harmful evidence from the board, she said in an opinion made public Friday.

  • July 29, 2024

    Boehringer Appeals HHS Win In Medicare Drug Price Suit

    Boehringer Ingelheim Pharmaceuticals Inc. notified a Connecticut federal court Friday that it will appeal its loss in a lawsuit challenging a new Medicare drug price negotiation program on the grounds that it unlawfully compels the pharmaceutical giant to declare prices "fair," takes its property and imposes an excessive fine.

  • July 29, 2024

    Kirkland-Led Amulet Closes $1.2B Health-Focused Fund

    Kirkland & Ellis LLP-advised private equity shop Amulet Capital Partners LP on Monday announced that it successfully closed its third healthcare-focused private equity fund with roughly $1.2 billion in tow.

  • July 29, 2024

    Legalization Org Taps Cannabis Atty As New Treasurer

    The pro-legalization advocacy organization Marijuana Policy Project announced Monday that a preeminent member of the cannabis bar had been tapped as the group's newest treasurer.

  • July 29, 2024

    GSK Settles Ill. Zantac Cancer Suit

    GlaxoSmithKline said Monday it has settled a lawsuit brought by an Illinois man who took the heartburn medication Zantac or its generic counterpart for more than 20 years and claimed the drug caused his prostate cancer.

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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