“Arbutus chose to incorporate several references to both the prior art patent and the ‘127 patent, resulting in that material being incorporated into the main document.” – CAFC
The U.S. Court of Appeals for the Federal Circuit (CAFC) today confirms in a precedent judgment the Patent Trial and Appeal Board (PTAB) holding that Moderna Therapeutics proved that certain claims in Arbutus BioPharma Corporation’s mRNA delivery patent were predictably invalid Did.
U.S. Patent No. 9,404,127, entitled “Non-Liposomal Systems for Nucleic Acid Delivery,” is directed to an invention that “has a non-lamellar structure and provides stable nucleic acid-containing lipid particles (“SNALPs”). . . . SNALPs have a three-dimensional structure that is either lamellar or non-lamellar (pictured).
The main question before the PTAB was “Claim 1(d) of the ‘127 patent—whether at least about 95% of the particles in the plurality of particles have a non-lamellar morphology (“morphology restriction”)—was Essentially, Moderna argued that it assumed all of the challenged claims of the ‘127 patent. Moderna unequivocally argued that “the morphological limitation, which is not explicitly mentioned in the prior art, is an ‘intrinsic natural property’ resulting from the lipid composition of the formulation and formation process.”
As to whether the morphological restrictions are met or inherently expected, the CAFC first found that the disclosures of the ‘127 and ‘069 patents “same formulations with “substantially identical language.” and therefore indicated the Committee’s decision that the formulations were “identical or essentially the same.” Same for both patents” was supported by substantial evidence. A direct dilution method (DDM) process is then disclosed and described identically in both patents, he said, the CAFC. And finally, because it was found that the formulation and process were similarly disclosed in both patents, the court held that using the disclosed process to make the disclosed formulation would result in a composition with morphological limitations. We considered whether the PTAB’s finding that things occur naturally is appropriate.
Turning to whether dependent claims 3 and 8-12 of the ‘127 patent are to be expected, the court found that dependent claim 3 “[t]The composition of claim 1, wherein the nucleic acid is mRNA,” and “the panel found that the ‘069 patent clearly discloses that the nucleic acid can be mRNA.” Claim 8 states:[t]The composition of claim 1 in which the nucleic acid is fully encapsulated within the particle” and “The Commission found that the nucleic acid may be fully encapsulated within the lipid portion of the particle. I found it clearly disclosed.” Thus, he said, the CAFC’s finding that claims 3 and 8 were anticipated is supported by substantial evidence. With respect to claim 9, the court agreed with the Board’s finding that “the structure described in claim 9 is an inherent property of the non-lamellar morphological limitation inherently anticipated in claim 1.”
With respect to claims 10-12, which recite a percentage range for the lipid component of claim 1, we agree with Arbutus that it is erroneous to use different references to reach the limits of the claimed range. did not do it. claim as a whole. ” The court explained: “If a patent claims chemical compositions in terms of ranges and a single prior art document discloses compositions within each range, the ranges are anticipated.”
Moderna cites, through incorporation by reference, several disclosures of prior art patents to find disclosures of cationic lipid amounts, and upon review, the PTAB found that the prior art patents and their incorporated references I have found that the document discloses each of the claimed ranges.
The CAFC said substantial evidence supports the Board’s findings, explaining:
“Arbutus elected to incorporate several references to both the prior art patent and the ‘127 patent, resulting in that material being incorporated into the main document. These disclosures, when viewed as a whole, constitute the claim We have fully disclosed and explained 10 to 12, each of which is expected.”
Moderna initiated an attempt to invalidate three of Arbutus’ LNP delivery patents at the PTAB in 2018. Inter partes review (IPR) results were mixed, with Moderna winning one case and one partial case against Moderna on the ‘127 patent (U.S. Patent No. 9,364,435). One loss (‘069 patent).
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