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.
Biosimilar-Related Litigations include litigations relating to biosimilar/follow-on products and include insulin. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as litigations between two biosimilar applicants/manufacturers are included. Litigations relating to disputes between two reference product sponsors, or non-practicing entities/universities and reference product sponsors are not included. Litigations related solely to manufacturing patents that may be relevant to multiple products (for example, U.S. Patent Nos. 6,331,415, 7,923,221, and 4,816,567 (“Cabilly Patents”)) also are not included.
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