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.
Fish attorneys Dorothy Whelan and Brian Coggio presented for our third presentation in this series. (Replays of the first and second webinars are available here.) This presentation discussed 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