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Venable’s Ha Kung Wong, along with Daisy R. Muzzio, Shane Brunner, Joshua Resiburg, Jeffrey Lewis, and Neill Clark, discusses antitrust issues relating to IP litigations in the pharmaceutical industry.  This is the first webinar in a three-part series, discussing pre-litigation strategies from the perspectives of innovators, generics, and biosimilars.  Topics include information on the Orange and Purple Books, selecting products to develop as a generic/biosimilar, the CREATES Act, skinny labels, and preparing for Paragraph IV letters and other pre-litigation exchanges in the BPCIA patent dance.

View the LES Life Science webinar here.


    Methodology

    Information contained in the Venable 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 BiologicsHQ database.

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