In Arbutus Biopharma Corp. v. Modernatx, Inc., No. 2020-1183 (Fed. Cir. Apr. 11, 2023), the Federal Circuit affirmed a final written decision1 from the Patent Trial and Appeal Board ("the PTAB") holding the claims of U.S. Patent No. 9,404,127 ("the '127 patent") unpatentable. The Court held that the Board's finding of the '127 patent as inherently anticipated by a prior patent, U.S. Patent No. 8,058,069 ("the '069 patent"), and its incorporated references is supported by substantial evidence.
Background
The '127 patent is directed to compositions and methods of making stable nucleic acid-lipid particles ("SNALPs") to allow for efficient nucleic acid delivery into cells. Independent Claim 1 is representative:
- A composition comprising:
a plurality of nucleic acid-lipid particles, wherein each particle in the plurality of particles comprises:
(a) a nucleic acid;
(b) a cationic lipid;
(c) a non-cationic lipid; and
(d) a conjugated lipid that inhibits aggregation of particles, wherein at least about 95% of the particles in the plurality of particles have a non-lamellar morphology.
Specifically, element (d) describes the claimed composition as having a non-lamellar morphological structure (the "Morphology Limitation").
The PTAB noted that the '127 and '069 patents are directed to the same purpose and disclose the same formulations and methods. Additionally, the PTAB found that several publications incorporated by reference in the '069 patent share the same disclosures and experiments as the '127 patent.
Moderna argued that the Morphology Limitation of claim 1 is an "inherent natural property" resulting from the lipid composition of the formulations and processes disclosed in the '069 patent, despite not being expressly mentioned. While Arbutus argued against a finding of inherency, it did not dispute that the additional references were properly incorporated into the '069 patent.
PTAB Decision
The PTAB agreed with Moderna, finding that the '069 patent and its incorporated references sufficiently disclose how to make and use the claimed compositions resulting in the Morphology Limitation, a natural result of the disclosures. In its final written decision, the PTAB found all claims of the '127 patent unpatentable as inherently anticipated by the '069 patent.
Federal Circuit Decision
On appeal, the Federal Circuit held that the PTAB did not err in finding inherent anticipation of the Morphology Limitation. Arbutus Biopharma Corp. v. Modernatx, Inc., No. 2020-1183 (Fed. Cir. Apr. 11, 2023) at *9. With regard to inherent anticipation, the Federal Circuit emphasized that "[a] limitation is inherent if it is the 'natural result flowing from' the prior art's explicit disclosure." Id. at *8. "[T]he legal test requires that the embodiment(s) must necessarily yield the limitation." Id. at *9. The Federal Circuit also discussed the effect of incorporated references, such that "[w]hen a reference or material from various documents is incorporated, they are 'effectively part of the host document as if [they] were explicitly contained therein.'" Id. at *8. Additionally, each reference will be viewed as a whole so that the Court may "conclude whether or not that reference discloses all elements of the claimed invention arranged as in the claim." Id.
The Federal Circuit found that while the '069 patent does not explicitly teach the Morphology Limitation, it is nevertheless a "natural result" and "inherent property" of what is claimed in the '127 patent such that it would necessarily be produced by the skilled artisan. Id. at *9. The Federal Circuit found that disclosures of formulations and processes across the '127 patent and '069 patents are "the same or essentially the same." Id. at *10-11. Therefore, the Court agreed with the PTAB that making the disclosed formulations according to the disclosed process would "naturally result in a composition having the claimed morphological property." Id. at *11. The Federal Circuit also found that since there are only five formulations and two processes disclosed in this case, the PTAB reasonably found that a skilled artisan using this "limited number of tools" would produce a composition with the inherent property of the Morphology Limitation. Id. at *12. Additionally, the Federal Circuit held that the PTAB correctly concluded that each of the challenged dependent claims of the '127 patent were anticipated either explicitly or inherently by the '069 patent and its incorporated references. Id. at *13-15.
Take-aways
The PTAB's decision and the subsequent affirmation by the Federal Circuit highlights the potential rippling effects of incorporation by reference. At the patent prosecution stage, incorporation by reference may be a valuable tool to circumvent the need to laboriously describe each and every feature of the invention in painstaking detail and may benefit the applicant by instantly generating prior art against later filers. However, patent practitioners should be mindful of potential drawbacks as well. Although the incorporation by reference arguably worked to the benefit of the drafter in this case, there can be drawbacks to incorporating an entire document by reference if it unwittingly introduces unwanted or unhelpful disclosure. Ask yourself whether you want every single word you are incorporating. In instances where only a limited amount of prior reference disclosure is needed to supplement a patent application, it may be better to directly describe the necessary disclosures in the present application or explicitly incorporate only the specific disclosure of interest. For more discussion of incorporating an entire reference or just a specific portion, see, e.g., Harari v. Lee, 656 F.3d 1331, 1335 (Fed. Cir. 2011).
Footnote
1. See Moderna Therapeutics, Inc. v. Protiva Biotherapeutics, Inc., No. IPR2018- 00680, 2019 WL 12447121 (P.T.A.B. Sept. 10, 2019)
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