Opinion ID: 4520332
Heading Depth: 1
Heading Rank: 3

Heading: Genentech’s Motion to Amend

Text: In IPR2017-00731, the petitioner challenged all fourteen claims of the ’441 patent under two alternative grounds: Ground 1 as the claims would have been obvious over Baselga ’97 2 and Baselga ’94, 3 and Ground 2 as the claims would have been obvious over Baselga ’96 4 and 2 Baselga et al., HER2 Overexpression and Paclitaxel Sensitivity in Breast Cancer: Therapeutic Implications, 11(3) (Suppl. 2) ONCOLOGY 43–48 (1997). 3 Baselga et al., Anti-HER2 Humanized Monoclonal Antibody (MAb) Alone and in Combination with Chemotherapy Against Human Breast Carcinoma Xenografts, 13 PROC. AM. SOC. CLIN. ONCOL. 63 (Abstract 53) (1994). 4 Baselga et al., Phase II Study of Weekly Intrave- nous Recombinant Humanized Anti-p185HER2 Monoclonal Antibody in Patients with HER2/neu-Overexpressing Case: 19-1263 Document: 61 Page: 9 Filed: 03/26/2020 GENENTECH, INC. v. IANCU 9 Baselga ’94. The Board originally denied institution on Ground 1 because Genentech antedated Baselga ’97, and it denied institution on Ground 2 based on its determination that petitioner had not shown a reasonable likelihood that it would prevail. Petitioner requested a rehearing on the Board’s institution decision after which the Board instituted inter partes review on Ground 2. The Board continued to decline institution on Ground 1. Genentech then filed its first contingent motion to amend its claims under 35 U.S.C. § 316(d)(1). After the Supreme Court’s decision in SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348 (2018), the Board modified its institution decision to include institution on Ground 1. Genentech then sought to amend its claims again, arguing that it had a statutory right to do so under § 316(d)(1). Meanwhile, petitioner sought an adverse judgment on Ground 1, which the Board granted. The Board rejected Genentech’s argument that it had a statutory right to amend and treated the motion as an additional motion to amend under § 316(d)(2). Pursuant to 37 C.F.R. § 42.121(c), the Board required Genentech to make a good cause showing before the Board considered the second motion to amend. No. 191263, J.A. 13211. Having found that Genentech failed to establish good cause, the Board denied the second motion to amend. The Board alternatively held that, even if good cause existed, Petitioner’s request for adverse judgment as to Ground 1 under 37 CFR § 42.73(b) mooted the issue. No. 19-1263, J.A. 21-22. The Board determined that 37 C.F.R. § 42.73(a) and (b) permit partial adverse judgment as to a single ground—in this case Ground 1. The Board referred to the “Frequently Asked Questions about SAS Implications” issued by the PTO, which states that, in order to Metastatic Breast Cancer, 14 J. CLIN. ONCOL. 737–44 (1996). Case: 19-1263 Document: 61 Page: 10 Filed: 03/26/2020 10 GENENTECH, INC. v. IANCU limit the scope of the proceeding in the event the parties cannot agree to waive additional claims, “[t]he Petitioner can request adverse judgment on claims and/or grounds at any time.” The Board went on to explain that, under 37 CFR § 42.5(b), it was permitted to waive any requirement that adverse judgment under § 42.73(b) is available only for disposition of all issues—“The Board may waive or suspend a requirement of parts 1, 41, and 42 and may place conditions on the waiver or suspension.” Genentech argues that the Board erroneously granted Petitioner’s request for partial adverse judgment because 37 CFR § 42.73(a) defines a judgment as “dispos[ing] of all issues that were, or by motion reasonably could have been, raised and decided.” We need not reach whether the Board may grant partial adverse judgment under 37 CFR § 42.73(a), however, because 37 CFR § 42.5(b) gives the Board discretion to “waive or suspend a requirement of part[] . . . 42.” The Board exercised that discretion here to waive any requirement of § 42.73(a) that could be read to preclude partial adverse judgment. The Supreme Court in SAS stated that “Congress chose to structure a process in which it’s the petitioner, not the Director, who gets to define the contours of the proceeding.” 138 S. Ct. at 1355. Here, the petitioner sought to “simplify the issues to be addressed in the final written decision” by requesting a partial adverse judgment with respect to Ground 1. No. 191263, J.A. 13406. Genentech has identified no prejudice from the partial adverse judgment aside from purportedly losing its chance at a second motion to amend. The Board did not abuse its discretion when it waived any potential requirements precluding partial adverse judgment and we see no error in the Board’s treatment thereof. The grant of partial adverse judgment on Ground 1 returned the petition to a single ground, Ground 2, for which Genentech had already filed one motion to amend. Thus, the Board properly treated Genentech’s second motion to amend as one which required a showing of good cause. See Case: 19-1263 Document: 61 Page: 11 Filed: 03/26/2020 GENENTECH, INC. v. IANCU 11 35 U.S.C. § 316(d)(2) and 37 C.F.R. § 42.121(c). We review the Board’s application of its own procedural rules, such as whether good cause exists for an additional motion to amend under 37 C.F.R. § 42.121(c), for abuse of discretion. See Ultratec, Inc. v. CaptionCall, LLC, 872 F.3d 1267, 1271 (Fed. Cir. 2017). “The Board abuses its discretion if the decision: (1) is clearly unreasonable, arbitrary, or fanciful; (2) is based on an erroneous conclusion of law; (3) rests on clearly erroneous fact findings; or (4) involves a record that contains no evidence on which the Board could rationally base its decision.” Id. at 1272. Genentech’s second motion to amend was directed to Ground 1 concerns and Ground 1 was no longer part of the inter partes review following the Board’s grant of partial adverse judgment. We see no abuse of discretion in the Board’s denial of Genentech’s second motion to amend for lack of good cause.