In Arbutus Biopharma Corp. v. Modernatx, Inc., No. 2020-1183 (Fed. Cir. Apr. 11, 2023), the Federal Circuit affirmed a Patent Trial and Appeal Board (PTAB) decision finding the claims of U.S. Patent No. 9,404,127 ("the '127 patent") invalid as anticipated.
The '127 patent is directed to compositions and methods of making stable nucleic acid-lipid particles (SNALPs) having a non-lamellar morphology. In 2018, Moderna filed a petition seeking inter partes review ("IPR") of claims 1-22 of the '127 patent, arguing anticipation based on an earlier Arbutus patent (the '069 patent). The PTAB found all of the claims invalid as inherently anticipated by the '069 patent.
On appeal, the Federal Circuit held that the Board did not err in finding the morphology limitation inherently anticipated. The Court found that the Board reasonably concluded that the formulations in the '127 and '069 patents "are the same or essentially the same," the references incorporated in the '069 patent disclose and describe the same method as the '127 patent, and that making the formulations according to the methods in the '069 patent would result in a composition having the claimed morphological property. The Federal Circuit also held that the Board correctly concluded that the dependent claims were anticipated by the '069 patent and its incorporated references because the incorporated references are "effectively part of the ['069 patent] as if they were explicitly contained therein."
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