Law Commons^™

Will Fda Data Exclusivity Make Biologic Patents Passé?, Vincent J. Roth Esq

Vincent J Roth Esq

Much controversy has ensued over the current 12 year data exclusivity period afforded biosimilars pursuant to the Biologics Price Competition and Innovation Act of 2009 (the “BPCI”) that was recently enacted in March 2010, as part of President Obama’s Patient Protection and Affordable Care Act (the “PPACA”), to create a biosimilar market in the US. In fact, the BPCI, itself, has been controversial and just barely survived judicial scrutiny when the US Supreme Court upheld the PPACA on June 28, 2012 in a 5-4 vote. Many commentators speculate whether data exclusivity will overtake patents as the preferred method of intellectual …