Pfizer’s appeal of IPR decision dismissed for lack of Article III standing

Pfizer Inc. v. Chugai Pharmaceutical Co., Ltd.

Docket No. 2019-1513, -1514 (IPR2017=01357, -01358)
April 27, 2020 (Non-precedential)

Brief Summary: Pfizer’s appeal of IPR decision finding it did not show invalidity of Chugai’s protein purification claims dismissed for lack of Article III standing.

Summary: Pfizer appealed Board IPR decision finding it did prove the challenged claims of Chugai’s US 7,332,289 and 7,927,815 regarding “methods for purifying proteins by ‘removing contaminant DNA from a sample containing a physiologically active protein’” (e.g., “the surprising finding that contaminant DNA can be efficiently removed…without using complicated chromatographic processes”) unpatentable. The FC panel explained that while “[a]ny person or entity may petition” for institution of an IPR proceeding (JTEKT, FC 2018; Fisher & Paykel, FC 2019), “[a] party that appeals” and IPR decision “to this court…must have Article III standing” (Consumer Watchdog, FC 2014 (“a personal stake in the outcome”); Spokeo, US 2016 (“(1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision”)). “To qualify”, the FC panel wrote, “actual controversy must be extant at all stages of review” (Arizonans, US 1997; Momenta, FC 2019) and “where the appellant is not currently engaging in infringing activity, the appellant typically must show that it has concrete plans for future activity that creates a substantial risk of future infringement or would likely cause the patentee to assert a claim of infringement” (JTEKT; DuPont, FC 2018). Citing Phigenix (FC 2017), the FC panel explained that “[a]s the party seeking judicial review, Pfizer bears the burden of establishing standing”. Pfizer argued “that its purported injury in fact stems from Pfizer’s launch of its produce Ruxience® in January 2020” and that the settlement agreement with Genentech authorizing it to begin selling Ruxience® (an authorized biosimilar) did not protect it from Chugai (owned by Roche which also owns Genentech), which was not a party to the settlement agreement and did not provide Pfizer a license to the ‘289 and ‘815 patents. Pfizer filed its notice of appeal on January 30, 2019, but the FC panel noted that “the only evidence of standing…relates to events that occurred much later in 2019” (e.g., FDA approval in July 2019; October 2019 announcement that its biosimilar would start selling in January 2020). Pfizer argued “it was self-evident to the parties’ that there was ‘a product at issue’ when the appeal began”, but the FC panel wrote that that “is not self-evident to the court”. The FC panel also disagreed with Pfizer “that the statutory estoppel effect of 35 U.S.C. 315(e) ‘enhances Pfizer’s stake’” since “there is no evidence that the appellant was or is engaged in any activity that would give rise to a possible infringement suit” (AVX, FC 2019; Gen. Elec., FC 2019; Argentum, FC 2020). The appeal was therefore dismissed.

This entry was posted in Article III disputes, Inter Parties Review (IPR), IPR. Bookmark the permalink.

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