2024 Federal Circuit IP Appeals – Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., 97 F.4th 915 (Fed. Cir. 2024) (Dyk, Prost, Hughes)

Janssen sells Invega Sustenna, an extended-release intramuscular injectable of paliperidone palmitate for treating adult schizophrenia. After Teva sought FDA approval for a generic version of the drug, Janssen sued Teva for infringement of a patent on dosing regimens of paliperidone. Teva stipulated to infringement but challenged all claims as obvious and certain claims as indefinite. After trial, the district court held that Teva had not proven invalidity on either basis.

The Federal Circuit affirmed in part and vacated in part. As to obviousness, the Federal Circuit held that the district court committed several legal errors. First, the district court improperly required Teva to show that a skilled artisan would have been motivated to use the claimed dosing regimen for the general population of patients, when the claims covered a dosing regimen for a single patient. Similarly, the district court read into the claims a requirement that the drug be administered to a patient with “mild” renal impairment, when the claims did not recite such a limitation.

Second, the district court’s obviousness analysis was “erroneously rigid” because it focused on express statements of each prior-art reference individually without “fully assessing the teachings in toto.” This “siloed and inflexible approach” to obviousness, the Federal Circuit held, “left insufficient room for consideration of how background knowledge in the art would have impacted a POSA’s understanding of, or motivation to modify, the primary references at issue, thereby inflating the significance of minor variations between the prior art and the claims.” In particular, the district court erroneously found that a skilled artisan would not have been motivated to modify a prior-art clinical study protocol due to the lack of safety and efficacy data, when the claims did not recite any safety and efficacy requirements. In the same vein, the Federal Circuit held that the district court erred in requiring the protocol to “hold itself out as flawed” as a prerequisite for finding that a skilled artisan would have modified the protocol. While the protocol may not have been considered a success, a skilled artisan could still assign significance to the Phase III status of the protocol and the fact that paliperidone was already marketed for schizophrenia.

Third, the district court erroneously found that the prior art taught away from claims reciting a particular particle-size range based on the art’s statement that a different range was optimal. That statement, the Federal Circuit held, was not a criticism of all other particle sizes and thus did not teach away from the claimed range.

Fourth, the district court did not explain what significance it assigned to objective indicia of nonobviousness within its overall obviousness assessment. As to unexpected results, specifically, the district court erred by comparing the claimed invention to the patentee’s own expectations as well as prior art involving active ingredients other than paliperidone. As to industry praise, the district court failed to perform the requisite nexus analysis. Finally, as to long-felt need and commercial success, the district court improperly disregarded the impact of blocking patents. The district court found that Janssen’s other patents were not completely blocking because one could dose an unclaimed formulation of paliperidone. The Federal Circuit held that this was error, emphasizing that the relevant inquiry is whether the patents deterred others from developing the claimed dosing regimen for fear of infringement liability (rather than due to the alleged inventiveness of the invention claimed in the patent at issue). The Federal Circuit also clarified that the existence of a safe-harbor provision exempting a generic manufacturer from liability for conduct related to preparing an FDA submission does not per se negate the deterring effect of blocking patents. If it were otherwise, the court noted, blocking patents would never be relevant to the obviousness analysis.

Turning to indefiniteness, the Federal Circuit affirmed the district court’s ruling upholding the claims as not indefinite. Teva had argued that certain claims reciting a range of particle sizes were indefinite because the specification disclosed several ways to measure particle size, each yielding different results. Thus, according to Teva, a given sample of paliperidone palmitate would simultaneously fall inside and outside the claims depending on how the sample’s particle size is measured. The district court rejected this argument, finding that the discrepancy was due to an anomalous measurement taken with a defective device, not due to a discrepancy typical of the measurement techniques themselves. The Federal Circuit held that Teva failed to show that this finding was clearly erroneous.

This article appeared in the 2024 Federal Circuit IP Appeals: Summaries of Key 2024 Decisions report.