By Stacie Ropka, Ted Mathias and Drew Hillier ( February 4, 2019, 2:36 PM EST) -- Much like the Hatch-Waxman Act provides a pathway for approving generic small-molecule drugs and litigating patent disputes about those drugs, the Biologics Price Competition and Innovation Act provides the same for follow-on biologic drugs. Although the BPCIA was enacted in 2010, to date only a handful of biologics have been the subject of BPCIA litigation. Much of that early litigation has focused on the availability of declaratory judgments as a mechanism to resolve patent disputes concerning follow-on biologics. In addressing those issues, courts have affirmed the primacy of the BPCIA's processes for framing patent disputes, commonly known as the "patent dance," and limited the use of declaratory judgments to avoid the patent dance. Below we discuss why these decisions leave applicants filing abbreviated biologics license applications, or aBLAs, with a clear strategic choice that they must make soon after filing their applications....