At the May 2018 Managing IP PTAB Forum in New York, Corinne Atton presented statistics relating to Bio/Pharma IPRs Filed To Date, focusing on IPRs filed identifying patents that read on CDER-listed biologic drugs, and IPRs concerning Orange Book listed patents.
Of note, as of February 28, 2018:
- More than 6700 IPRs have been filed across all technologies;
- 410 of these IPRs (6% of the total filed) concern Orange Book listed patents;
- A further 106 IPRs (1% of the total filed) concern patents identified as reading on CDER-listed biologic drugs.
Biologic Drug IPR Petitions include IPR petitions relating to CDER-listed biologic products and drugs for which follow-on products are approved under the 505(b)(2) pathway, such as insulin. IPR petitions relating to manufacturing patents that may be relevant to multiple products (for example, U.S. Patent No. 6,331,415 (a “Cabilly” patent)) are not included.
Orange Book Drug IPR Petitions include IPR petitions relating to patents that have been listed in the FDA’s Orange Book.
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