Biosimilars & IPR

Last year, the FDA approved the first biosimilar drug under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), and the courts have recently rendered some important statutory interpretations. This represents the dawn of a new era in the approval and marketing of biologic products. As the popularity of biosimilars grows, biosimilars manufacturers have turned to IPR proceedings to challenge patents covering biologic drugs.

Join Fish attorneys Dorothy Whelan and Brian Coggio for our third presentation in this series. This presentation will discuss recent developments, including:

• A review of biosimilars IPR filings and PTAB decisions to date
• Multiple filer/multiple petitions issues and related timing considerations
• Tips for both challengers and patent owners