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Venable Fitzpatrick partner Ha Kung Wong commented on the Terminating the Extension of Rights Misappropriated Act, or TERM Act, H.R. 3199, as part of the Law360 article “New Bill Would Reshape Drug Patent Cases in Uncertain Ways,” available here.

The TERM Act was introduced in the House of Representatives on June 12, 2019 by Rep. Hakeem Jeffries, D-N.Y., to address drug companies obtaining multiple patents on the same drug to prevent generic competition, referred to as “evergreening.”  In patent litigations, the bill states that “the patentee shall be presumed to have disclaimed the patent term for each of the listed patents after the date on which the term of the first patent expires.”  Wong expressed concern that the bill was more than a “significant change” to patent law that is “effectively undoing the presumption of validity for later-issued drug patents.”


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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