• Dec 1 2021
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  • Category: CAFC Updates

Moderna appeals from the Board’s IPR decision holding that certain claims of U.S. Patent 9,364,435 are not unpatentable as obvious, and Arbutus cross-appeals from the Board’s decision holding that certain claims are unpatentable as anticipated. The ’435 patent is directed to stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of administering the SNALP. On the issue of standing, the CAFC notes that Moderna’s participation in the underlying IPR before the Board is insufficient by itself to confer standing to appeal to the CAFC, but rather Moderna must show that standing existed at the time it filed its appeal and has continued to exist at all times throughout the appeal. Moderna argued that royalty and milestone obligations owed for sublicenses of the ’435 patent relating to its active development program relating to a Respiratory Syncytial Virus (“RSV”) target caused harm to Moderna by increasing the financial burdens on Moderna’s RSV development program. Once that RSV program terminated, Moderna argued its ongoing development of a vaccine for COVID-19 and Arbutus’s consistent insistence that Moderna requires a license to Arbutus’s patents created a significant risk that Arbutus would sue for patent infringement. The CAFC finds 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 the CAFC’s precedent, an intervening abandonment of the controversy produces loss of jurisdiction, and Moderna’s evidence fails to show 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. Finding that Moderna failed to meet its burden on its standing to pursue this appeal, their appeal is dismissed. Regarding Arbutus’s cross appeal, the question for the Board was whether the prior art discloses at least one composition that falls within the claimed ranges, and because the CAFC finds that substantial evidence supports the Board’s decision, they affirm.

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