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Federal Circuit Affirms the Board's Finding of Anticipation Because Prior Art Patent and References Incorporated Therein Inherently Meet the Disputed Claim Limitations
On April 11, 2023, a Federal Circuit panel consisting of Judges Reyna, Schall, and Chen issued a unanimous opinion, authored by Judge Reyna, in Arbutus Biopharma Corp. v. ModernaTx, Inc., Case No. 2020-1183. Patent Owner Arbutus appealed from the Patent Trial and Appeal Board's final written decision in an inter partes review (IPR) proceeding that found all claims invalid as anticipated. Because a prior art patent, including references incorporated therein, inherently discloses the disputed claim limitations, the panel affirmed the decision.
The patent at issue is directed to compositions comprising stable nucleic acid-lipid particles ("SNALP") that have a non-lamellar morphology. Slip Op. at 2-3. Whether SNALP particles adopt a lamellar or non-lamellar morphology depends on both the lipids used for making the formulations, and the process used for forming SNALP particles. Id. The patent identifies five formulations (i.e., formulations using conjugated lipid and cationic lipid in molar ratios of 1:62, 1:57, 2:40, 2:30, and 10:15) that can be prepared by either Stepwise Dilution Method ("SDM") or Direct Dilution Method ("DDM"). Id. at 3-4. The patent further incorporates by reference each of two published patent applications (the '031 and '025 publications) "in its entirety for all purposes," including for disclosing the SDM and DDM methods. Id. at 4.
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