At the May 2018 Managing IP PTAB Forum in New York, Corinne Atton presented statistics relating to the Interplay Between IPR Proceedings & District Court Litigation in the context of CDER-listed biologic drugs and Orange Book listed drugs.
- IPR challenges to patents identified as reading on CDER-listed biologic drugs that have also been litigated in district court are on the rise: from 11% in September 2017 to 46% in March 2018;
- Meanwhile, 93% of Orange Book listed patents have been challenged in both IPR and in district court litigation.
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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