Venable LLP
Biosimilar litigation includes litigations relating biosimilar/follow-on product of CDER listed reference products. 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 relating to manufacturing patents which may be relevant to several products (for instance, U.S. Patent Nos. 6,331,415, 7,923,221, and 4,816,567 (“Cabilly Patents”)) also are not included.
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