Legal Issues and BPCI Act

The Patient Protection and Affordable Care Act (PPAC Act) was signed into law in March 2010 in addition to the amendments in the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biosimilars and follow on biologics.  These new statutory provisions are often referred as the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This track concentrates upon such legal bindings and the aspects of the BPCI Act that pertain to the biosimilars and biologics. This session on legal issues shall be very beneficial to research scientists from both academic backgrounds and also those from industry R&D.

 

  • Implimentation of the BPCI Act
  • Patent protection and infringement issues
  • Patent negotiation and litigation phase
  • Market exclusivities
  • Patent protection and infringement issues
  • Patent negotiation and litigation phase
  • Market exclusivities

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