Enactment of the Patient Protection and Affordable Care Act (commonly known as the PPACA or Obamacare) resulted in barrage of media coverage that has endured as the law nears its 2014 implementation date. An important aspect of the PPACA that is rarely discussed, however, is the impact this law will most certainly have on patents and the concomitant, but unintended consequences that will invariably follow. In particular, patent issues arise from a portion of the PPACA known as the Biologics Price Competition and Innovation Act (BPCIA). Under the BPCIA, applicants can file a biologics license application (BLA), commonly known as a biosimilars application, under 351(k) of the Public Health Service Act. The BPCIA creates an abbreviated licensure pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference product. In essence, this pathway creates a more efficient route for cheaper drugs to enter the market. Certain entities, however, believe that this abbreviated licensure pathway tramples not only their intellectual property rights, but also their constitutional rights.
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