Charles Davis · July 2013
81 GEO. WASH. L. REV. 1255 (2013)
Biologics drugs present great promise for curing deadly diseases such as cancer or neurological disorders. These auspicious drugs are, however, inordinately expensive. The patents on many of these blockbuster biologics treatments will soon expire, creating high demand for cheap generic versions of biologics drugs. Yet until 2010, no FDA approval pathway for follow-on biologics existed in the United States.
As part of the Patient Protection and Affordable Care Act, Congress passed the Biologics Price Competition and Innovation Act. The BPCIA included an approval pathway for follow-on biologics modeled closely after the Hatch-Waxman approval process for generic small molecule drugs. Congress did not sufficiently consider the myriad of abuses that existed under the Hatch-Waxman Act, leaving open multiple avenues for abuse in the BPCIA, particularly in the Act’s novel patent dispute resolution procedures.
This Note analyzes several of the most serious issues with the BPCIA approval process. In particular, the BPCIA does not provide for any third-party input or public notification in the patent dispute provisions. Further, the BPCIA places no limit on abusive pay-to-delay settlements between pioneer and follow-on biologics manufacturers. This Note argues that Congress should amend the BPCIA to provide for greater public notification processes and opportunities for third-party intervention in patent disputes. Congress should also act to significantly limit pay-to-delay settlements by requiring the filing of such settlements with the FTC and DOJ for approval. Through such amendments, Congress will finally achieve a follow-on biologics process that provides significant avenues for both competition and innovation in the biologics industry.
