Docket No. 2016-1544
DYK, WALLACH, HUGHES
January 9, 2017
Brief Summary: Phigenix found not to have Article III standing for its appeal of PTAB final written decision after IPR.
Summary: Phigenix appealed PTAB final written decision after IPR that claims 1-8 of ImmunoGen’s US 8,337,856 for “huMab4D5 ANTI-ErbB2 antibody-maytansinoid conjugates” (Genentech’s Kadcyla®TM) are nonobvious. The question was whether Phigenix “offered sufficient proof establishing that it has suffered an injury in fact” and had “standing to bring suit in federal court.” The FC panel opinion explains that the “dispute involves three principal parties, each of whom allege to have some relation to the ‘856 patent” (ImmunoGen and it licensee Genentech, and Phigenix). Phigenix is explained to have “describe[d] itself as a for-profit discovery stage biotechnology, pharmaceutical, and biomedical research company’ that focuses ‘on the use of novel molecular therapeutics’ designed to fight cancer”, not to manufacture any products but to have “developed, and [to be] developing, an extensive intellectual property portfolio’ that includes U.S. Patent Not. 8,080,534” covering “Genentech’s ‘activities relating to Kadycla” (the subject matter claimed in the ’856 patent). Phigenix argued “it ‘was forced’ to bring litigation in various fora when Genentech refused its offer to license the ‘534 patent” and sought IPR “[t]o further its commercialization efforts with respect to its patent portfolio.” ImmunoGen argued Phigenix lack standing to appeal and it was Phigenix’s burden to establish standing (“[a]n appellant ‘must have (1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the [appellee], (3) that is likely to be redressed by a favorable judicial decision” (Spokeo, US 2016; Hollingsworth, US 2013; Lujan, US 1992)). Footnote 2 explains that “[a]n appellant’s obligation to establish an injury in fact remains firm even though it need not ‘meet all the normal standards for redressability and immediacy’ when, as here, a statute provides the appellant with a right to appeal” (35 U.S.C. § 141(c), “dissatisfied” party “may appeal the [PTAB]’s decision only to the…Federal Circuit”). And the Cuozzo (US 2016) decision recognized “that not every party will have Article III standing in an appeal from a PTAB final written decision” if, e.g., it does “not have a concrete stake in the outcome” even if it initiated the IPR. Phigenix relied on ImmunoGen’s declaration “to argue that ‘[t]he existence of ImmunoGen’s ‘856 patent has…encumber[ed] Phigenix’s licensing efforts” and its attorney’s letter to ImmunoGen that it “‘believes that it has a strong patent portfolio’ and ‘believes’ that the ‘856 patent is invalid.” The FC panel found these to be “insufficient to demonstrate injury in fact” (e.g., “the hypothetical licensing injury [does not] satisfy the requirements of Rule 56(c)(4)”). The FC panel also disagreed Phigenix “suffered an injury in fact because  § 141(c) provides a statutory basis for appeal” (see Spokeo and Raines, US 1997 (“the exercise of its right to appeal does not necessarily establish that it possesses Article III standing”)). And its argument under § 315(e) that “the estoppel effect of the [PTAB]’s decision adversely impacts Phigenix’s ability to provide a contractual warranty” was also found insufficient. Thus, the appeal was dismissed.