Background

The ’127 patent is directed to an invention that provides stable nucleic acid-lipid particles (“SNALP”) that have non-lamellar structure and “comprise a nucleic acid … methods of making SNALP, and methods of delivering and/or administering the SNALP.” ’127 patent, Abstract. The ’127 patent states that its purpose is to allow for more efficient methods and compositions for introducing nucleic acids into cells and methods of downregulating gene expression. ’127 patent, col. 2 ll. 54-61. The ’127 patent identifies five formulations of various compositions that can be prepared by either Stepwise Dilution Method (“SDM”) or Direct Dilution Method (“DDM”). ’127 patent, Tables 1, 3; col. 104 ll. 44-60; col. 105 ll. 53-64.

Modernatx filed a petition for inter partes review (“IPR”) challenging claims 1-22 of the ’127 patent for being anticipated by U.S. Patent No. 8,058,069 (the “’069 patent”). The Board instituted the IPR and issued a final written decision (“FWD”) finding all 22 claims of the ’127 patent anticipated by the ’069 patent.

Issue(s)

Whether claim 1(d) of the ’127 patent is inherently anticipated by the ’069 patent.

Holding(s)

The Federal Circuit affirmed the Board’s analysis that the ’127 patent is inherently anticipated by the ’069 patent.

Reasoning

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. Modernatx 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. Decision at *11. Although Arbutus (1) argued that there was no presumption of inherency, (2) argued 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 and (3) submitted experimental evidence from an expert to demonstrate that the Morphology Limitation was not met by formulations from the ’069 patent, the Board found Arbutus’s arguments and evidence submission unavailing.

The Federal Circuit states a limitation is inherent if it is the “natural result flowing from” the prior art’s explicit disclosure. Schering Corp. v. Geneva Pharms., 339 F.3d 1373, 1379 (Fed. Cir. 2003). 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, inherentanticipation requires “merely that the disclosure of theprior art is sufficient to show that the natural result flowingfrom the operation as taught in the prior art would resultin the claimed product.” SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343–44 (Fed. Cir. 2005) (internalquotation marks omitted) (modifications in the original).

The Federal Circuit further 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). Also, “[i]nsufficient 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).

The Federal Circuit 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. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000). While looking at the reference as a whole, the court will “conclude whether or not that reference discloses all elements of the claimed invention arranged as in the claim.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 n.5 (Fed. Cir. 2008).

The Federal Circuit first found that there is substantial evidence supporting the Board’s finding that the formulations in the ’069 patent and the ’127 patent “are the same or essentially the same.” Second, the Federal Circuit found that there is substantial evidence supporting the Board’s finding that the ’069 patent and the ’127 patent disclose and describe DDM the same way by referring to the ’031 publication and “the Direct Dilution Method” to provide details for carrying out the direct dilution process. Third, the Federal Circuit found there was substantial evidence to support the Board’s finding of inherent anticipation in that making the disclosed formulations according to the disclosed process, which are similarly disclosed in both the ’069 and ’127 patents with the disclosures of the incorporated references, would “naturally result in a composition having the claimed morphological property.” Decision at *21.

Therefore, the Federal Circuit held that there was substantial evidence supporting the Board’s finding that independent claim 1 and its morphological property are inherently anticipated by the disclosures of the ’069 patent and its incorporated references.