By Verne A. Luckow, PhD, JD
Volume 11, Issue 2 (Summer 2012)
The Leahy-Smith America Invents Act (AIA) and the Biologics Price Competition and Innovation Act (BPCIA) are dramatically reshaping business strategies designed to protect intellectual property and regulatory exclusivity rights granted by the United States Patent and Trademark Office (PTO) and the Federal Drug Administration (FDA) to the sponsors of new and follow-on versions of many biopharmaceutical products. The AIA alters many provisions in the U.S. patent statutes, most notably long-standing policies and practices relating to the conditions for patentability of an invention, particularly 35 USC §§ 102 and 103 relating to novelty and non-obviousness, respectively, and introduces new provisions relating to post-grant review proceedings and prioritized examination that will affect the business plans of academic and corporate institutions seeking to discover and develop health care products that serve unmet medical needs or provide consumers with safe sources of drug products at a low cost. The BPCIA implements many new provisions relating to the abbreviated review and approval of follow-on biopharmaceutical products. Important aspects of the BPCIA, particularly issues identified in draft guidance documents that were released by the FDA in February 2012 concerning the characterization, comparison, and evaluation of reference and follow-on macromolecules, will be discussed in this article. Political issues that may jeopardize the BPCIA, economic considerations faced by drug product sponsors, and public reaction to the guidance documents are also discussed in this final article of a three-part series describing key provisions of the AIA and the BPCIA that affect intellectual property and regulatory exclusivity rights of institutions having an interest in developing novel or follow-on versions of biopharmaceutical drug products…
Citation: Luckow VA. Recent Statutes, Regulations, and Court Cases Affecting Intellectual Property Rights of Life Sciences Institutions: Key Provisions of the Leahy-Smith America Invents Act and the Biologics Price Competition and Innovation Act; Part III: Analysis of the BPCIA: FDA Guidelines Concerning the Characterization of Reference and Follow-On Macromolecules. BioProcess J, 2012; 11(2): 14-28. https://dx.doi.org/10.12665/J112.Luckow
Posted online July 20, 2012