On October 22, 2019, the Patent Trial and Appeal Board ("the Board") issued a final written decision on remand from the Federal Circuit in the inter partes review of U.S. Patent No. 8,927,592 ("the '592 patent") in favor of Venable Fitzpatrick's client, Sanofi Mature IP ("Sanofi"). The '592 patent is directed to methods of using the active ingredient in Sanofi's JEVTANA® product for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing regimen.
In February 2019, the Federal Circuit vacated the Board's original decision on Sanofi's motion to amend because the burden of proof had been improperly placed on Sanofi, and the Board incorrectly found the "increasing survival" language in the preamble of the proposed amended claims to be non-limiting. On remand, the Board granted Sanofi's motion to amend because Mylan had failed to show by a preponderance of the evidence that a person of ordinary skill in the art would have reasonably expected the treatment regimen recited in the proposed amended claims to increase patient survival. The Board also rejected Mylan's arguments related to anticipation by public use and patent-eligible subject matter.