Celltrion, Inc. v. Genentech, Inc.

IPR2017-01122 (Final Written Decision)
October 3, 2018

Brief summary: Genentech’s claims 1-11 and 14-17 of US 7,892,549 B2 related to Herceptin® (the humanized anti-ErbB2 antibody trastuzumab) shown obvious by a preponderance of the evidence.

Summary: Celltrion challenged claims 1-11 and 14-17 of US 7,892,549 B2 related to Herceptin® (the humanized anti-ErbB2 antibody trastuzumab). Seven other IPRs regarding Herceptin® patents, both related and unrelated to the ‘549 patent, and final decisions were also issued concurrently with this FWD. Litigation regarding the ‘549 patent is also pending (18-cv-00274 (NJ) and 18-cv-00095 (Del.)). ‘549 claims 1, 5 and 16 are independent. Claim 1 claims a method for treating ErbB2 receptor-overexpressing human breast cancer by “administering a combination of an antibody that binds” “to epitope 4D5” of “ErbB2, a taxoid, and a further growth inhibitory agent”. “Claim 16 is similar to claim 1” and includes the negative limitation “in the absence of an anthracycline derivative”. Claim 5 “recites ‘administering an effective amount of a combination’ of three agents similar to those of claims 1 and 16” (“the taxoid is paclitaxel, and the third element is broadly described as a ‘therapeutic agent’”). Regarding the level of skill in the art, the FWD adopted Genentech’s definition as “a clinical or medical oncologist specializing in breast cancer with several years of experience with breast cancer research or clinical trials” and notes “that the prior art itself demonstrates the level of skill in the art at the time of the invention” (Okajima, FC 2001). “[A]dministering a combination” was construed “to mean that the drugs are administered as part of the same treatment regimen” (as in IPR2017-00737 FWD). The terms “amount effective to extend the time of disease progression” and “an effective amount” were construed to mean “relative to an untreated patient”, which “reflects Applicant’s choice” during prosecution (“Applicants overcame the § 112 rejection by providing an express definition”). Celltrion argued for obviousness in view of Baselga 1996 (stable disease after anti-ErbB2 administration), Seidman 1996 (HER2 overexpression…seems to confer sensitivity…to taxanes”), Pegram 1995 (positive response after treatment with cisplatin and rhuMAb HER-2), 1995 TAXOL PDR, and the knowledge of one of ordinary skill in the art, evidenced, in part by Baselga Abstracts 53 and 2262 (xenograft studies showing combination of hu-4D5 antibody and paclitaxel showed 93% inhibition of tumor growth), and Seidman 1995 (paclitaxel review article describing “strong synergy” shown by Baselga Abstract 2262) (see FN14 explaining that “to establish the knowledge of one of ordinary skill in the art, ‘it is permissible, and sometimes even necessary, to establish such background knowledge by pointing to other prior art’” (Rovalma, FC 2017)). Celltrion (and its experts) argued a motivation to combine because it “particularly made sense because the combination satisfied the four principles of combination therapy” and a “reasonable expectation of success that the three-drug combination would have been safe and effective.” Regarding claim 16, the PTAB found the record to show “that while anthracyclines were widely employed,” the skilled artisan would have selected a taxoid such as paclitaxel rather than an anthracycline” due to, e.g., known “drug resistance or cumulative cardiotoxicity” (Bayer, FC 2017; In re Fulton, FC 2004 (“combination claimed” need not be “the preferred, or most desirable”)). The PTAB also found “the ordinary artisan would have had a reasonable expectation of success in achieving the claimed clinical efficacy.” It therefore found Celltrion had demonstrated obviousness by a preponderance of the evidence. Genentech’s motion to amend the claims was denied as failing “to satisfy the no new matter requirement of 35 U.S.C. § 316(d) and 37 C.F.R. § 42.12(a)(2)(ii)” and the amendments would not overcome the obviousness findings. The PTAB also denied Genentech’s motions to include evidence of secondary considerations and other articles and declarations.

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