The Changing Face of US Patent Law and its Impact on Business Strategy

The Changing Face of US Patent Law and its Impact on Business Strategy

New Horizons in International Business series

Edited by Daniel R. Cahoy and Lynda J. Oswald

Within the complex global economy, patents function as indispensable tools for fostering and protecting innovation. This fascinating volume offers a comprehensive perspective on the US patent system, detailing its many uses and outlining several critical legislative, administrative and judicial reforms that impact business strategy.

Chapter 9: Biopharmaceuticals under the Patient Protection and Affordable Care Act: determining the appropriate market and data exclusivity periods

Donna M. Gitter

Subjects: business and management, international business


With the enactment of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) in March 2010 as part of the Patient Protection and Affordable Care Act (Patient Protection and Affordable Care Act, 2010), manufacturers of follow-on protein products, meaning biopharmaceuticals that are similar to branded biologic products, will be able to file abbreviated applications for US Food and Drug Administration (FDA) approval for their products. This abbreviated approval process will allow manufacturers of follow-on protein products, also known as biosimilars, to avoid at least some, though not necessarily all, of the costly pre-clinical and clinical testing necessary for regulatory approval by relying on data generated by branded products. Even after enactment of the BPCIA, however, confusion remains regarding two of its most debated provisions, those relating to the periods of market and data exclusivity to which innovator pharmaceutical firms are entitled under the statute. Data exclusivity is defined as the period of time that an innovator pharmaceutical firm’s pre-clinical and clinical data cannot be relied upon by a follow-on competitor in its application for FDA approval.

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