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MBHB Partner Kevin Noonan Authors DDNEWS Article Entitled, "Patent Docs: Will the 12-year biologic drug exclusivity period survive?”

Kevin E. Noonan, Ph.D.November 9, 2013

McDonnell Boehnen Hulbert & Berghoff LLP partner Dr. Kevin E. Noonan authored an article entitled, “Patent Docs: Will the 12-year biologic drug exclusivity period survive?” that appears in the November 9, 2013 online edition of DDNEWS. One of the signal achievements of the Obama Administration is the healthcare law, the Patient Protection and Affordable Care Act (PPACA, commonly known as Obamacare).  One important part of this law is the Biologics Price Competition and Innovation Act (BPCIA) that, for the first time, provides a regulatory approval pathway for generic biologic drugs, also known as “follow-on biologics” or biosimilars. The latter name acknowledges what the act expressly states: the reality that generic biologic drugs are, at best, similar but not identical to the branded biologic drug (termed the “reference product” in the act) to which they correspond.  View the article