At the May 2018 Managing IP PTAB Forum in New York, Corinne Atton presented statistics relating to the fate of formulation claim challenges in IPRs filed against patents that have been identified as reading on CDER-listed biologic drugs, versus IPRs filed against Orange Book listed patents.
Of note, as of March 31, 2018:
- The institution rate of formulation claim challenges in the Orange Book context is higher than in the Biologic drug context: 61% (Orange Book) to 37% (Biologic drug);
- In final written decisions, method of treatment claims have been found unpatentable in 51% of IPRs concerning Orange Book listed patents.
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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