Wednesday, December 01, 2021

Moderna loses at CAFC on standing issue

The outcome

ModernaTx, Inc. (“Moderna”) appeals from the decision of the U.S. Patent and Trademark Office Patent Trial and Appeal Board (“Board”) holding that claims 7–8, 10–11, 13, and 16–20 of U.S. Patent 9,364,435 are not unpatentable as obvious. See Moderna Therapeutics, Inc. v. Protiva Biotherapeutics, Inc., IPR2018-00739, 2019 Pat. App. LEXIS 13612 (Sept. 11, 2019) (“Board Decision”). Arbutus Biopharma Corporation (“Arbutus”)1 cross-appeals from the Board’s decision holding that claims 1–6, 9, 12, and 14–15 are unpatentable as anticipated. Id. For the reasons provided below, we dismiss Moderna’s appeal for lack of standing. Regarding Arbutus’s cross appeal, we affirm.

Of note

We also agree with Arbutus that, even if Moderna had standing at the time it filed this appeal, Moderna has failed to demonstrate that it continuously had standing throughout the pendency of the appeal. Under our precedent, an “intervening abandonment of the controversy produces loss of jurisdiction.” Momenta, 915 F.3d at 770. Moderna’s evidence fails to show an approximate date when the RSV development program was terminated. Thus, on the record before us, it is impossible to determine whether, by the time the RSV development program was terminated, Moderna was already sufficiently underway with its development of a COVID-19 vaccine to “create[] a substantial risk of future infringement or likely cause the patentee to assert a claim of infringement.” E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1004–05 (Fed. Cir. 2018). As the appellant, Moderna bears the burden on the issue of standing, JTEKT, 898 F.3d at 1220, including the burden to demonstrate that there has been no gap in its standing while this appeal has been pending, Momenta, 915 F.3d at 770. In view of Moderna’s concession that the basis for its standing shifted during the pendency of this appeal—i.e., from the financial burdens of the Acuitas sublicenses to a potential infringement suit for the COVID-19 vaccine—Moderna had to come forth with evidence to demonstrate the necessary continuity of jurisdiction. Moderna failed to do so. For the reasons explained above, we find that Moderna has failed to meet its burden on its standing to pursue this appeal. Therefore, Moderna’s appeal must be dismissed.


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