Intellectual Property

  • Read more: The Rise of Biosimilars: Success of the BPCIA? (Part III)

    The Rise of Biosimilars: Success of the BPCIA? (Part III)

    By Jonathan Darrow This is Part III in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already approved biological medicines.  Part III considers a path forward in the regulation of biologics.  For Part I, click here.  For Part II click here.…

    Graph with number of biosimilar approvals on the X axis and years from 1970 until 2018 on the Y axis. The line on the graph represents a generally upward trend.
  • Read more: The Rise of Biosimilars: Success of the BPCIA? (Part II)

    The Rise of Biosimilars: Success of the BPCIA? (Part II)

    By Jonathan Darrow This is Part II in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already approved biological medicines.  Part II covers some key considerations and factors that impact the biologics market and regulation.  For Part I, click here. Reference…

    Graph with number of biosimilar approvals on the X axis and years from 1970 until 2018 on the Y axis. The line on the graph represents a generally upward trend.
  • Read more: The Rise of Biosimilars: Success of the BPCIA? (Part I)

    The Rise of Biosimilars: Success of the BPCIA? (Part I)

    By Jonathan Darrow This is Part I in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already-approved biological medicines.  This Part briefly covers the history of American regulation of biologics and touches briefly on the European experience. The Biologics Price Competition…

    Graph with number of biosimilar approvals on the X axis and years from 1970 until 2018 on the Y axis. The line on the graph represents a generally upward trend.
  • Read more: Do Pharmaceutical Patents Generate Unique Global Health Duties?

    Do Pharmaceutical Patents Generate Unique Global Health Duties?

    By Govind Persad Imagine a Harvard MBA graduate trying to decide between jobs at Pfizer and at Snapchat. Both are immensely wealthy firms. Many of Pfizer’s products benefit global health. Snapchat’s are at best neutral and may even harm health. Yet many see Pfizer as distinctively culpable for global health deficits. These arguments often depend…

    Researcher works at a lab bench
  • Read more: Laws and Facts of Patent Eligibility and Medical Diagnostics

    Laws and Facts of Patent Eligibility and Medical Diagnostics

    This post is part of our Eighth Annual Health Law Year in P/Review symposium. You can read all of the posts in the series here. Review the conference’s full agenda and register for the event on the Petrie-Flom Center’s website. By Jacob S. Sherkow For this year’s Health Law Year in P/Review, I’ll be talking…

    U.S. Patent and Trademark Office building
  • Read more: What Google Isn’t Saying About Your Health Records

    What Google Isn’t Saying About Your Health Records

    By Adrian Gropper Google’s semi-secret deal with Ascension is testing the limits of HIPAA as society grapples with the future impact of machine learning and artificial intelligence. I. Glenn Cohen points out that HIPAA may not be keeping up with our methods of consent by patients and society on the ways personal data is used.…

    Close up of a computer screen displaying code
  • Read more: Novartis, Dana Farber, Oregon Health & Science University Wait 18 Years to Disclose NIH Funding in Key Gleevec Patent

    Novartis, Dana Farber, Oregon Health & Science University Wait 18 Years to Disclose NIH Funding in Key Gleevec Patent

    By James Love This is a story about U.S. patent number 6,958,335, and how it took more than 18 years for Novartis to acknowledge National Institutes of Health (NIH) funding in a key patent for Gleevec, allowing Novartis to shape the narrative regarding its role in the development of Gleevec, and also to avoid demands…

    Pipette and test tubes in a rack