Arbutus Biopharma Corp., et al. v. Modenatx, Inc. FKA Moderna Therapeutics, Inc.

Docket No. 2020-1183 (IPR2018-00680) (https://cafc.uscourts.gov/opinions-orders/20-1183.OPINION.4-11-2023_2108936.pdf)

REYNA, SCHALL, CHEN

April 11, 2023

Brief Summary:   Board IPR finding that Arbutus’ claims are invalid for inherent anticipation affirmed. Summary:  Arbutus appealed the USPTO’s IPR final written decision (FWD) finding claims 1-22 of US 9,404,127 directed to “stable nucleic acid lipid particles (‘SNALP’) that have a non-lamellar structure and “comprise a nucleic acid . . . methods of making the SNALP, and methods of delivering and/or administering the SNALP” invalid as anticipated by US 8,058,069.  The ‘069 patent claims priority to a 2008 provisional application (“PA”) and found to be prior art to the ‘127 patent that claims priority to a 2010 PA, and to share “several of the same components between the two patents…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 [US 2007/0042031] for details on using” the “direct dilution method” (“DDM”) “and the apparatuses for carrying out DDC” by incorporation by reference “in its entirety for all purposes.”  The ‘127 patent also incorporates US 2004/0142025 to describe the “Stepwise Dilution Method” (“SDM”) “and the apparatuses for carrying out SDM”.  The ‘069 patent also incorporates the ‘780 and ‘025 US patent publications as well as US 5,885,613, and was found to include those disclosures therein (Adv. Display, FC 2000; Harari, FC 2011).  “Together,” the FC panel opinion stated, “the ’069 patent and its incorporated references detail several of the same disclosures and experiments as the ’127 patent.”  The FC panel explains that the ‘069 patent, “its child patent” (US 9,364,435), and the ‘127 patent are commonly owned by Arbutus.  The ‘127 patent does not claim priority to the ‘069 patent.  The FC panel opinion explains that “[t]he 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.”  “Moderna argued that the Morphology Limitation [ML], while not expressly mentioned in the prior art, is an “inherent natural property” resulting from the lipid composition of the formulation and formation process”, and Arbutus submitted experimental evidence to support its contrary argument that the Board found “unavailing.”  “The Board noted—and relied upon—Arbutus’s expert’s apparent concession that the ’435 patent, a continuation of the prior art patent, would also disclose the Morphology Limitation”, and found “the ’069 patent and its incorporated references sufficiently demonstrate to a person skilled in the art how to make and use the claimed compositions, processed by DDM, that results in the” ML (i.e., “inherently anticipated”).  The FC panel agreed with the Board that ML is  “the “natural result flowing from” the prior art’s explicit disclosure” (Schering, FC 2003; Hospira, FC 2020; Bristol Myers, FC 2001 (“[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent”); Atlas Powder, FC 1999 (““Insufficient prior understanding of the inherent properties of a known composition does not defeat a finding of anticipation.”).  It agreed with Moderna’s argument with which the Board agreed that “the ’127 and ’069 patents disclose the same formulations with ‘almost identical wording’” (King, FC 2010), as well as “DDM the same way”, and that together these “would naturally result in a composition having the” ML (Toro, FC 2004; not “only a probability” (Continental Can, FC 1991; Hansgirg, CCPA 1939; Blue Calypso, FC 2016 (“limited number of tools”); Titanium Metals (FC 1985), Perricon (FC 2005) and Ineos (FC 2015) (ranges)).  The Board anticipation finding was therefore affirmed.

Patrick Halloran

Pat has a Ph.D. in Microbiology and Immunology from The University of Health Sciences / The Chicago Medical School (now the Rosalind Franklin Institute (North Chicago, IL) (1994)). He also completed post-doctoral studies at The National Cancer Institute (1994-1996) where he developed novel…

Pat has a Ph.D. in Microbiology and Immunology from The University of Health Sciences / The Chicago Medical School (now the Rosalind Franklin Institute (North Chicago, IL) (1994)). He also completed post-doctoral studies at The National Cancer Institute (1994-1996) where he developed novel approaches for gene therapy of melanoma. Pat has been an attorney (IL) since 1999 after graduating from Chicago-Kent College of Law, which was recently ranked as one of the top five law schools for Intellectual Property in the U.S. (U.S. News and World Report link). Pat also has a B.A. in Biology from Augustana College (Rock Island, IL; 1989) where he was on two NCAA Division III National Championship football teams (1985, 1986). He currently resides in Center Valley, PA.