Docket No. 2017-1694 (IPR2015-01537)
NEWMAN, DYK, CHEN
February 7, 2019
Brief summary: Momenta’s appeal of PTAB FWD finding BMS’s claims relating to its Orencia CTLA4Ig product patentable dismissed as moot because evidence showed Momenta had abandoned its Orencia biosimilar project since, e.g., “an actual controversy must be extant at all stages of review.”
Summary: Momenta appealed PTAB IPR final written decision (FWD) finding claims 1-15 of BMS’s US 8,476,239 relating to CTLA4Ig formulations marketed as Orencia, for which Momenta was pursuing a biosimilar when the IPR was filed in 2015. BMS moved to dismiss Momenta’ appeal, arguing Momenta did not have standing under 35 USC § 319 because its “proposed product had failed its Phase 1 clinical trials and had been withdrawn.” Momenta argued it had not abandoned the proposed product, “that the ‘239 Patent is an obstacle to these activities, …that it is injured by the estoppel provision, 35 U.S.C. § 315(e)”, and “that this appeal meets the criteria of Article III, citing the ‘relaxed’ standard for Article III compliance when the right of appeal is established by statute.” In October 2018, Momenta submitted a press release to the court indicating that it had “initiated discussions with its collaborative partner, Mylan, to exit” the Orencia biosimilar program, and the FC “issued an Order to Show Cause why the appeal should not be dismissed as moot”, and Momenta replied with a letter from its Chief Business Officer that the program was not actually terminated. BMS argued “that a third party’s possible future development of this abandoned product does not provide constitutional standing to Momenta” and “possible future royalty…is too speculative to support standing” (“hypothetic injury”). BMS also submitted an excerpt from Momenta’s December 2018 Form 8-K including Momenta’s statement that “[o]n November 19, 2018, we delivered a formal notice of…termination” of its “collaboration agreement with Mylan with respect to the development of…M834, a proposed biosimilar to Orencia”, to which Momenta did not respond. The FC panel found that “now upon Momenta’s termination of all potentially infringing activity, Momenta has not shown ‘an invasion of a legally protected interest’ that is ‘actual or imminent, not conjuctural or hypothetical’” (Lujan, US 1992; “[T]he appellant must always have a ‘concrete and particularized’ interest in an outcome-an interest, to the extent one existed, that has now been eliminated by Momenta.”) The FC panel also explained that “[e]stoppel cannot constitute an injury-in-fact when Momenta ‘is not engaged in any activity that would give rise to a possible infringement suit’” (Consumer Watchdog, FC 2014; Hollingsworth, FC 2013; Gill, US 2018). The FC panel also found the future royalty argument to have “no support in precedent” (Clapper, US 2013; Phigenix, FC 2017 (no standing based on “assertion of a possible future economic interest”); RPX, FC 2018; E.I. DuPont, FC 2018 (Article III standing based on “significant risk of patent infringement in their demonstration plant that was entering into operation… ‘concrete plans…that create a substantial risk of future infringement or likely cause the patentee to assert a claim of infringement’”); Arizonans, US 1997 (“an actual controversy must be extant at all stages of review, not merely at the time the complaint is filed”)). The FC panel therefore dismissed Momenta’s appeal.