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.
The consequences of the BPCIA came to the forefront when at least one company challenged the biosimilars approval process. On April 2, 2012, Abbott Laboratories filed a citizen petition asking the Food and Drug Administration (FDA) not to accept biosimilars applications referencing BLA 125057, for its multibillion-dollar drug Humira (adalimumab), or any other BLA submitted to the FDA before March 23, 2010. The basis for that petition rests on the Fifth Amendment. Essentially, the petition asserts that accepting a biosimilars application referencing a pre-enactment BLA constitutes a taking in violation of the Fifth Amendment.
In comments and letters submitted to the FDA in response to Abbott’s petition, opponents argue that the FDA should deny the petition for at least these reasons: