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Data or Market Exclusivity? (Perhaps) Only Congress Knows for Sure

By Donald Zuhn, Kevin Noonan, Chris Singer, Sherri Oslick, and Jason Derry

By Kevin E. Noonan -- A debate has begun on the meaning of the term "exclusivity" in the follow-on biologics pathway provisions of the Patient Protection and Affordable Care Act (P.L. 111-148), § 351(k) of the Public Health Service Act, codified at 42 U.S.C. § 262(k)). The debate centers on the availability of innovator drug company data to be used in support of a follow-on biologic drug application. And the consequences of how the Food and Drug Administration interprets the term (or how Congress amends the law to better define it) will impact how quickly follow-on biologic drugs will be...

Full post as published by Patent Docs on January 27, 2011 (boomark / email).