December 8, 2014
An expert Q&A with Kevin E. Noonan of McDonnell Boehnen Hulbert & Berghoff LLP on the key features of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), including the regulatory requirements for biosimilar approval under the BPCIA, the requirements and implications of patent litigation under the BPCIA, and how it differs from the Hatch-Waxman Act.
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 comprise 50 to 100 atoms and are prepared using conventional chemical synthesis methods. Specifically, biologic drugs are usually proteins comprised 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, it has been estimated that 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:
- An expedited licensure pathway for new versions of previously marketed biologic drugs.
- Data protection and marketing exclusivity periods for biologic drugs.
- Patent dispute resolution procedures.
Biosimilar applications and patent litigation under the BPCIA are relatively new, and the BPCIA’s provisions governing these activities can be quite complex. As these activities become more common, pharmaceutical companies and their counsel should understand the key features of the BPCIA, including:
- The pathway for biosimilar approval, and related FDA guidance for biosimilar applications.
- The available exclusivity periods for reference products and interchangeable biologic products.
- The “patent dance” procedures for determining which patents will be the subject of patent litigation.
- The differences between the BPCIA and the Hatch-Waxman Act.
- How the courts have handled the first patent litigations related to the BPCIA.
- Ethical issues that may arise under the BPCIA.
- Best practices for preparing for eventual litigation under the BPCIA.
To learn more from the experts on the BPCIA, see Expert Q&A on Biosimilar Patent Litigation under the BPCIA