Ever since the financial collapse of 2008, American consumer budgets have been increasingly squeezed. 1Household Expenditures and Income, Pew Charitable Trusts (Mar 2016), http://www.pewtrusts.org/-/media/assets/2016/03/household_expenditures_and_income.pdf. This led to increased political pressure to rein in drug prices. In 2009, Congress enacted the BPCIA in an effort to control drug prices. The BPCIA provided an accelerated FDA approval pathway for “biosimilars,” which are biologics with similar pharmacological features to ones already on the market. Those features are similar enough that biosimilars effectively act as generics. Biologics are a class of large molecules, usually derived via recombinant DNA techniques in specialized tissues cultures, producing drugs as complex as monoclonal antibodies and immunoglobins.
Biologics are one of the fastest growing segments of the pharmaceutical industry, with the top 10 products accounting for $73 billion in global sales as of 2017. Unfortunately, intellectual property rights relating to biosimilars, when marketed as generics, are too complex to effectively regulate under the pre-BPCIA framework established by the Hatch-Waxman Act. The BPCIA established such a framework for handling patent infringement disputes by a mechanism that has come to be known as “the patent dance.” This dance involves several rounds of information exchange and negotiation to clearly delineate any infringement claims, and is meant to cut down on the time and expense of discovery and litigation.10
This article outlines the current jurisprudence on some of the major unresolved issues relating to the BPCIA. This article first summarizes the salient elements of the BPCIA and the patent dance, then addressesthree major issuesthat the courts are currently reviewing or have recently reviewed. First, this article assesses whether compliance with the BPCIA patent dance is a required or an optional procedure. This issue will determine how much “bite” the BPCIA legislation has on parties that wish to use the abbreviated approval pathway, but spurn open exchanges of information, and consequently impact how many millions of dollars worth of litigation will play out. Second, and in conjunction with the first issue, the question arises of whether an applicant must wait until after FDA approval to notify a reference product sponsor (“RPS”), the creator of the patented product, of their intent to market their product. The answer will dictate whether patent holders (“innovators”) will be given an extra 180 days of patent exclusivity on top of their existing 12 years. Lastly, this article looks at whether innovators or generic manufacturers must engage with the entire sequence of steps, or may engage more selectively, thereby influencing expensive litigation while still gaining some benefit from the legislation. Each of these three issues are raised in current and pending court actions at varying levels. The analysis of this article is informed by the discussion of these issues in such court cases alongside the legislative history of the BPCIA.