In a quarterly Special Report piece, Andrew Williams, patent law expert, partner at Chicago-based IP law firm McDonnell Boehnen Hulbert & Berghoff and chairman of its Patent Trial and Appeal Board (PTAB) Trials Practice Group, writes about a crucial case affecting the marketing of biosimilars in the USA.
Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) in 2010 in an effort to expedite the approval of generic biological drugs, known as biosimilars.
It took several years, however, for anyone to take advantage of the abbreviated approval pathway contained therein. This delay likely stemmed, at least in part, from the accompanying patent-resolution scheme.
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