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Bio Law Blog

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  • Welcome to the Bio Law Blog. Our blog shares insights into intellectual property law for biologic medicines and related regulatory and legislative developments. We started this blog to engage in a conversation about the rapidly developing U.S. biosimilars pathway (the Biologics Price Competition and Innovation Act) and the recent surge in approvals for cutting-edge biologic products, such as siRNAs and cell-based and gene therapies. These new biologic products are changing medicine and posing new intellectual property questions and challenges. We also analyze developments in written description and enablement law for antibodies, the impact of Section 101 on biotech discoveries, and the increasing role of the Patent Trial and Appeal Board in reviewing biotech patents. We share a perspective as trial lawyers immersed in biology and biotech patent law.

    We are excited to be part of these transformative times for biologic medicines and to discuss them with you. We hope you enjoy our blog, and we welcome any questions, comments or suggestions.

    Subscribe for updates here.

    Featured Posts

    • Category
      Bio Law Blog
      Date
      Aug. 15, 2024
      Title
      Less Is More — the Premise of the Biosimilar ‘Patent Thicket’ Bill
      Read More
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    Author
    • Author
    • Jonathan S. Caplan
    • Jeffrey Coleman, Ph.D.
    • Kenneth Mueller ,Ph.D.
    • André Pineda, Ph.D.
    Topic
    • Topic
    • BCPIA
    • BPCIA
    • Biologics
    • Biosimilars
    • Biotechnology
    • FDA
    • Healthcare
    • IPRs
    • Inflation Reduction Act
    • Inflation Reduction Act (IRA)
    • Orphan Drug Act of 1983
    • Orphan Drugs
    • Patent Litigation

    Recent Posts

    • Category
      Bio Law Blog
      Date
      Aug. 15, 2024
      Name
      Less Is More — the Premise of the Biosimilar ‘Patent Thicket’ Bill
      Read More
    • Category
      Bio Law Blog
      Date
      July 19, 2024
      Name
      Just Opt Out! Boehringer Ingelheim’s IRA Challenge Is Latest To Fail
      Read More
    • Category
      Bio Law Blog
      Date
      May 01, 2024
      Name
      Potential Effects of the Inflation Reduction Act on Orphan Drug Development
      Read More
    • Category
      Bio Law Blog
      Date
      Nov. 30, 2020
      Name
      Third-Generation Vaccines Take Center Stage in Battle Against COVID-19
      Read More
    • Category
      Bio Law Blog
      Date
      July 01, 2020
      Name
      In Two Life Sciences Cases, the Supreme Court Declines to Address the Constitutionality of IPRs of Pre-AIA Patents
      Read More
    • Category
      Bio Law Blog
      Date
      May 01, 2020
      Name
      10 Years of Biosimilars: Lessons and Trends
      Read More

    Featured Perspectives

    • Category
      Announcements
      Date
      July 28, 2021
      Title
      Lisa Kobialka Named to Managing IP's 2021 Top 250 Women in IP List
      Read More
    • Category
      Announcements
      Date
      June 01, 2021
      Title
      Hannah Lee, Josh Winefsky Named Law360 Rising Stars
      Read More

    Editors

      • Jonathan S. Caplan

        • Partner
        • Partner, Co-Chair, Intellectual Property
        • New York
        • jcaplan@kramerlevin.com
        • T 212.715.9488
        • F 212.715.7718
      • vcard

    Archive | August 2024

    • People

        • Jonathan S. Caplan

          • Partner
          • Partner, Co-Chair, Intellectual Property
          • New York
          • jcaplan@kramerlevin.com
          • T 212.715.9488
          • F 212.715.7718
        • vcard
        • Marcus A. Colucci

          • Special Counsel
          • New York
          • mcolucci@kramerlevin.com
          • T 212.715.9148
          • F 212.715.8248
        • vcard
        • Jenna Fuller

          • Associate
          • New York
          • jfuller@kramerlevin.com
          • T 212.715.9398
          • F 212.715.8000
        • vcard
        • Timothy Layden

          • Associate
          • Silicon Valley
          • tlayden@kramerlevin.com
          • T 650.752.1783
          • F 650.752.1800
        • vcard
        • André Pineda, Ph.D.

          • Scientific Advisor
          • New York
          • apineda@kramerlevin.com
          • T 212.715.9593
          • F 212.715.8000
        • vcard
        • Jeffrey H. Price

          • Special Counsel
          • New York
          • jprice@kramerlevin.com
          • T 212.715.7502
          • F 212.715.8302
        • vcard
    • Perspectives

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      • Patent Litigation
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