After many years of patent litigation on small molecule drugs under the Hatch-Waxman Act, drug companies and their counsel are now starting to explore patent litigation on biosimilars under the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

Biologic drugs are much more complex than small molecule drugs, which typically contain 50 to 100 atoms and are prepared using conventional chemical synthesis methods. Specifically, biologic drugs are usually proteins composed of tens to hundreds of thousands of atoms. They cannot usually be prepared by chemical synthesis and instead must be produced in a cell genetically engineered to make them. Most biologic drugs are unusually expensive due to the cost of developing and making them. Indeed, while bringing a conventional generic drug to market may cost around $5 million, merely building the facility necessary to produce commercially useful amounts of a biosimilar drug could cost several hundreds of millions of dollars.

These complexities and high costs motivated the passage of the BPCIA, which was part of the omnibus healthcare reform legislation commonly known as Obamacare and was incorporated into Title VII of the Patient Protection and Affordable Care Act (Pub. L. No. 111-148, 124 Stat. 119 (2010)). The three main changes created by the BPCIA are:

Biosimilar applications and patent litigation under the BPCIA are relatively new, and the BPCIA's provisions governing these activities are complex. As these activities become more common, pharmaceutical companies and their counsel should understand the key features of the BPCIA, including:

Practical Law asked Kevin E. Noonan of McDonnell Boehnen Hulbert & Berghoff LLP to explain these key features of the BPCIA. To learn more, see Article, Expert Q&A on Biosimilar Patent Litigation under the BPCIA.