In Jannsen Pharmaceuticals, Inc., v. Teva Pharmaceuticals USA, Inc., [2022-1258, 2022-1307] (April 1, 2024), the Federal Circuit affirmed the district court’s determination that the claims of U.S. Patent NO. 9,439,906 were not indefinite, and vacated and remanded the determination that the claims were not obvious.
The patent, which generally relates to dosing regimens of paliperidone palmitate, is the last remaining Orange Book patent for Invega Sustenna. Teva First argued that the district court’s analysis of obviousness required Teva to show that it would have been obvious to use the recited dosing regimens for the general population of patients—i.e., a generalized dosing regimen. The court found that the prior art did not demonstrate population-wide safety and efficacy and thus did not teach a generalized dosing regimen. Teva contended that the claims were not directed to a generalized dosing regimen and therefore the district court asked for a showing of obvious-ness that went beyond what was claimed, and the Federal Circuit agreed, saying nothing in the claims requires that the regimen be used for—let alone be ideal for—the patient population generally or a certain percentage of the patient population.
Teva argued that the court also read a “mild” limitation into the renal-impairment claims, whereas the claims do not specify a level of renal impairment. Janssen countered that Teva presented an obviousness theory that was pred-icated on dosing a patient with mild renal impairment. The Federal Circuit agreed that many of the district court’s statements suggest that it understood the claims themselves to require administration to a patient with mild renal impairment, yet there was no such requirement in the claims.
Teva also argue that the court’s analysis was impermissibly rigid and did not comport with KSR or otherwise reflect the Federal Circuit’s obviousness jurisprudence. The Federal CIrcuit agree, noting that Instead of considering the prior art in context or in combination, the district court’s analysis seems to tackle the ex-press statements of each reference one-by-one—identifying each difference or dissimilarity between an individual ref-erence and the claims, but not fully assessing the teachings in toto. This seemingly siloed and inflexible approach left insufficient room for consideration of how background knowledge in the art would have impacted a POSA’s un-derstanding of, or motivation to modify, the primary refer-ences at issue, thereby inflating the significance of minor variations between the prior art and the claims.
Among other things, the Federal Circuit criticized the district court for concluding that in the pharma-ceutical context, if a prior art reference does not contain safety and efficacy data, there is no reason to combine it with other prior art references. The Federal Circuit also criticized the court for looking for Teva to demonstrate an explicit problem to provide motivation, notning among other things that the motivation analysis is not limited by the problem or need recognized by the inventors. The Federal Circuit said that:
A motivation “may be found explicitly or implicitly in market forces; de-sign incentives; the interrelated teachings of multiple patents; any need or problem known in the field of endeavor at the time of invention and addressed by the patent; and the background knowledge, creativity, and common sense of the person of ordinary skill.”
Overall, the district court’s analysis ran afoul of KSR’s basic mandate in a number of ways. It failed to consider the “interrelated teachings of multiple” references, “the back-ground knowledge possessed by a person having ordinary skill in the art,” or “the inferences and creative steps that a person of ordinary skill in the art would employ.” Instead, the court sought an explicit indication in the prior art that an improvement was re-quired—at times also suggesting that it was searching for an indication that the claims captured the singular way the protocol would be modified.
Finally, Teva argued and the Federal Circuit agreed, that the district court did not apply the correct test for teaching away. A teaching that a particular value is optimal is not a criticism of all other values, nor is the fact that a reference does not disclose the claimed value a teaching away. The Federal Circuit instructed that the district court should have analyzed whether the claimed value was “criticize[d], discredit[ed], or otherwise discourage[d].”
Indefiniteness
To satisfy the definiteness requirement, a patent’s claims, viewed in light of the specification and prosecution history, must inform those skilled in the art about the scope of the invention with reasonable certainty. The Federal Circuit has held that claim scope is not reasonably certain where a claimed characteristic can be measured in multiple ways, those different measurements “would typically yield a different result” when applied to the same sample, and the intrinsic record fails to provide reasonable certainty about which measurement was intended by the claims.
The claims contain a particle-size limitation, but do not specify what measurement technique should be used to determine whether the particle-size limitation is met. The specification states that the particle size can be measured by art-known conventional techniques, such as sedimentation field flow fractionation, photon correlation spectroscopy or disk centrifugation. Teva argued that the different particle-size measure-ment techniques, which were all allowed by the claims, would yield meaningfully different results. However, the district court found that the actual discrepancy in particle-size measurement that Teva relied on was “an outlier measurement taken with a defective device,” i.e., was not based on a discrepancy typical of the measurement technique used. Teva has not shown that the court’s outlier finding was clearly erroneous. As a result, the district court correctly determined that, on this record, Teva did not meet its burden to show that the challenged claims were invalid as indefinite.