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Venable’s Ha Kung Wong and April Breyer Menon break down the issues that digital health and precision medicine face with IP and the history of case law that has created the current landscape for the Center for Biosimilars.

Precision medicine is changing the treatment landscape for countless patients, but with the transformational advances come a host of intellectual property (IP) issues that must be overcome to ensure the continued evolution of these life changing technologies. With a focus on digital health, we will discuss what precision medicine is and the IP hurdles it faces, such as patent subject matter eligibility, proving infringement, and software licensing.

View the full article here.


    Methodology

    Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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