Dupilumab - USA

Decision on IPR: Feb 14, 2019

AIA Review	Filing Date	Institution Date	Petitioner	US Patent	Respondent	Final Written Decision
IPR2017-01879	07/28/2017	02/15/2018	Sanofi-Aventis U.S. LLC	8,679,487	Immunex Corp	Claims 1–14, 16, and 17 are patentable
IPR2017-01884	07/28/2017	02/15/2018	Sanofi-Aventis U.S. LLC	8,679,487	Immunex Corp	Claims 1–17 are unpatentable

Previously Sanofi also filed another IPR (IPR2017-01129) on 03/23/2017 which was denied by PTAB.

US 8,679,487 (Immunex Corp) :

1. An isolated human antibody that competes with a reference antibody for binding to human IL-4 interleukin-4 (IL-4) receptor, wherein the light chain of said reference antibody comprises the amino acid sequence of SEQ ID NO:10 and the heavy chain of said reference antibody comprises the amino acid sequence of SEQ ID NO:12.

In IPR2017-01884, PTAB was persuaded by Petitioner arguments that a person of ordinary skill in the art would have had a reason to humanize Hart’s MAb230 using Schering-Plough’s humanization technique to create a potential therapeutic for allergic diseases with a reasonable expectation of success. Petitioner’s expert, Dr. Zurawski, explains that a person of ordinary skill in the art would have had a reason to graft the CDRs and other binding-determinant amino acid residues from MAb230 into a human framework according to the teachings of Schering-Plough to “derive a less immunogenic version of MAb230 that could be used as a potential therapeutic.” Thus PTAB concluded that Petitioner has established by a preponderance of the evidence that claims 1–17 of the ’487 patent are unpatentable as obvious over Hart and Schering-Plough.

In IPR2017-01879, PTAB concluded that Petitioner has not established by a preponderance of the evidence that claims 1–14, 16, and 17 of the ’487 patent are unpatentable as anticipated by the ’132 Publication. Specifically, Petitioner has not satisfied its burden to prove the portions of the ’132 Publication relied upon for anticipation (i.e., mAb 6-2) represent the work of another to qualify as prior art under § 102(e).

Simultaneously, EPO on Feb 14, 2019 revoked Immunex's corresponding European patent No. 2,990,420 for insufficiency of disclosure.