Federal Circuit Review December 2021
In Modernatx, Inc. v. Arbutus Biopharma Corporation, Appeal No. 20-2329, the Federal Circuit held that a presumption of obviousness based on overlapping ranges requires showing that the overlapping range is actually taught by the prior art.
Moderna petitioned for IPR against an Arbutus patent directed to stable nucleic acid-lipid particles comprising a nucleic acid. Moderna contended that all of the ranges for the components in the claimed nucleic acid-lipid particle were disclosed or taught by the prior art, and that a presumption of obviousness should therefore apply. The PTAB disagreed that the presumption applied because the prior art expressly disclosed the ranges for only three out of the four sub-components of the claimed composition. Moderna derived the overlapping range for the sub-component with no specific disclosure in the prior art by making certain assumptions about the other three sub-components. The PTAB rejected Moderna’s argument, noting that the claimed range for the fourth sub-component was not necessarily disclosed based on broader ranges for the other three components. The PTAB found the claims were not unpatentable as obvious. Moderna appealed.
The Federal Circuit first addressed standing, noting that a party’s participation in the underlying IPR before the PTAB is insufficient by itself to confer standing on that party to appeal. The Federal Circuit explained that a specific threat of infringement is not required, but it is sufficient for the appellant to show that it has engaged in, is engaging in, or will likely engage in activity that would give rise to a possible infringement suit. The Federal Circuit found Moderna had demonstrated a risk of suit by Arbutus based on the combination of its own activities in developing the COVID-19 vaccine, Arbutus’s broad public statements about its extensive patent coverage in the area, and Arbutus’s refusal to grant a covenant not to sue.
The Federal Circuit then affirmed the PTAB’s decision that the asserted claims were nonobvious. In particular, the Federal Circuit agreed that a presumption of obviousness did not apply because Moderna failed to show that an overlapping range was actually taught by the prior art.
In Astrazeneca Ab v. Mylan Pharmaceuticals Inc., Appeal No. 21-1729, the Federal Circuit held that for purposes of claim construction, intrinsic evidence can trump the plain and ordinary meaning of scientific conventions such as significant figures.
AstraZeneca AB and AstraZeneca Pharmaceuticals LP (collectively, “AstraZeneca”) sued Mylan Pharmaceuticals Inc. and Kindeva Drug Delivery L.P. (collectively, “Mylan”) for infringement of patents directed to a pressurized metered-dose inhaler that administers a stable formoterol/budesonide pharmaceutical. The district court construed the term “0.001%” in the limitation “PVP K25 is present at a concentration of 0.001% w/w” according to its “plain and ordinary meaning, that is, expressed with one significant digit” (i.e., encompassing a concentration of PVP K25 in the range of 0.0005% to 0.0014%). Mylan then stipulated to infringement and the district court entered final judgment of infringement.
The Federal Circuit held the district court erred in its claim construction and vacated and remanded the infringement holding. The Federal Circuit stated that while the plain and ordinary meaning was based on scientific convention, the intrinsic evidence (i.e., written description and prosecution history) placed considerable emphasis on formulation stability and thus supported the narrower construction of “‘0.001%’ as [a] precise number, with only minor variations, i.e., 0.00095% to 0.00104%.” For example, the written description showed the inventors understood that a formulation comprising 0.001% w/w PVP K25 is more stable than a formulation with even a slight difference in the concentration (e.g., 0.0005% w/w PVP K25). Furthermore, over the course of the prosecution history, the patentees narrowed the concentration of PVP K25 to 0.001% w/w from a broader range without using the qualifier “about” in order to “emphasiz[e] to the Examiner that 0.001% w/w PVP K25—not concentrations slightly more or less than 0.001% w/w—was critical to stability of the formulation.”
Judge Taranto dissented in part, arguing that, “0.001%” should be construed to have its significant figure meaning with one “possible interval-shrinking change” that ultimately would not disturb the previous finding of infringement.
In Intel Corporation v. Qualcomm Incorporated, Appeal No. 20-1664, the Federal Circuit held that a “generic” motivation to combine that has broad appeal or applicability is not deficient so long as it is supported by more than conclusory expert testimony.
Intel requested inter partes review of a patent owned by Qualcomm. Intel successfully argued several claims were obvious in light of a combination of references, and Qualcomm substituted new claims. Intel then argued that the substituted claims were obvious in light of a different combination of references. The PTAB rejected Intel’s motivation to combine the references as “nothing more than a generic reason to make something better” and therefore disagreed the substitute claims were obvious.
The Federal Circuit vacated the Board’s decision with respect to the substituted claims. The Federal Circuit explained that “a rationale is not inherently suspect merely because it’s generic in the sense of having broad applicability or appeal.” Rather, generic improvements may give rise to “a motivation to combine prior art references even absent any hint of suggestion in the references themselves.” The Federal Circuit found that Intel’s motivation to combine was sufficiently supported by expert testimony explaining specifically how and why a practitioner would combine the cited references to achieve the claimed improvements. Thus, the Federal Circuit remanded.
In Intel Corporation v. Qualcomm Incorporated, Appeal No. 20-1828, the Federal Circuit held that indefinite claims do not preclude a patentability analysis at the PTAB.
Intel Corp. requested inter partes review of a patent owned by Qualcomm Inc. The PTAB found several claims non-obvious over the prior art but declined to rule on other claims, finding that Intel had failed to meet the threshold burden to demonstrate unpatentability.
In reviewing the decision, the Federal Circuit reasoned that the Board failed to fully assess claims 16 and 17 for patentability. The Board had ruled that since there were issues of indefiniteness, a full patentability analysis for those claims could not be carried out. The Federal Circuit, however, stated that the “Board did not itself conclude that the prior-art analysis task was impossible” and concluded that the Board should nevertheless address whether the underlying patentability of the claims could be analyzed despite any indefiniteness issues. Accordingly, the Federal Circuit vacated and remanded the Board’s decision.