Arbutus case affirmed. Inherent anticipation found.

The outcome:


Appellant Arbutus Biopharma Corporation appeals a final written decision in an inter partes proceeding of the Patent Trial and Appeal Board that found claims 1–22 of U.S. Patent No. 9,404,127 invalid as anticipated. On appeal, Arbutus Biopharma Corporation challenges the Board’s anticipation finding. We affirm.


Previous


The Patent Trial and Appeal Board (“Board”) instituted the IPR and issued a final written decision (“FWD”) finding all 22 claims anticipated by the ’069 patent (“’069 patent” or “prior art patent”). Id. at *1. In doing so, it found the ’069 patent to be prior art to the ’127 patent.1 Id. at *9, 12. The Board then found several of the same components between the two patents. Both patents: are directed to the same purpose (providing SNALP, methods of making and delivering SNALP); disclose at least the 1:57 and 1:62 formulations; explain that SNALP can be formed by any method in the art including direct dilution, and direct the reader to rely on the ’031 publication for details on using DDM. Id. at *7–8; ’069 patent, col. 57 ll. 50–55.

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The main issue before the Board was whether claim 1(d) of the ’127 patent—wherein at least about 95% of the particles in the plurality of particles have a non-lamellar morphology (the “Morphology Limitation”)—is inherently disclosed in the ’069 patent. Id. at *9. Moderna argued that the Morphology Limitation, while not expressly mentioned in the prior art, is an “inherent natural property” resulting from the lipid composition of the formulation and formation process. Id. at *11. Arbutus disagreed, arguing that there was no presumption of inherency and that there was no evidence (such as testing or reasoning) showing that the ’069 patent and its formulations would necessarily have the same morphology as disclosed by the ’127 patent. Id. at *12. Arbutus also submitted experimental evidence from its expert, who prepared two 2:30 lipid formulations from the ’069 patent, to demonstrate that the Morphology Limitation was not met. Id. at *17. After weighing the evidence, the Board found Arbutus’s arguments unavailing.



Inherency


A limitation is inherent if it is the “natural result flowing from” the prior art’s explicit disclosure. Id. at 1379. A patent “can be invalid based on inherency when the patent itself makes clear that a limitation is ‘not an additional requirement imposed by the claims . . . but rather a property necessarily present’.” Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322, 1332 (Fed. Cir. 2020) (quoting In re Kubin, 561 F.3d 1351, 1357 (Fed. Cir. 2009)). Thus, inherent anticipation requires “merely that the disclosure of the prior art is sufficient to show that the natural result flowing from the operation as taught in the prior art would result in the claimed product.” SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343–44 (Fed. Cir. 2005) (internal quotation marks omitted) (modifications in the original). We have also explained that “[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.” Bristol–Myers Squibb Co. v. Ben Venue Labs, Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001). “Insufficient prior understanding of the inherent properties of a known composition does not defeat a finding of anticipation.” Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342, 1349 (Fed. Cir. 1999).


Incorporation by reference


This court has also discussed the effect of incorporated references. When a reference or material from various documents is incorporated, they are “effectively part of the host document as if [they] were explicitly contained therein.” Advanced Display Sys., Inc., 212 F.3d at 1282.





We have explained that the “critical question” for inherent anticipation is “whether the [prior art] patent sufficiently describes and enables one or more embodiments— whatever the settings of their operational features—that necessarily include or result in the subject matter of [the] limitation. . . .” See Toro Co. v. Deere & Co., 355 F.3d 1313, 1321 (Fed. Cir. 2004). Here, because there is no error in the Board’s determinations that the prior art teaches the We have explained that the “critical question” for inherent anticipation is “whether the [prior art] patent sufficiently describes and enables one or more embodiments— whatever the settings of their operational features—that necessarily include or result in the subject matter of [the] limitation. . . .” See Toro Co. v. Deere & Co., 355 F.3d 1313, 1321 (Fed. Cir. 2004). Here, because there is no error in the Board’s determinations that the prior art teaches the