Janssen Pharms., Inc. v. Teva Pharms. USA, Inc.

Case Name: Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., No. 2022-1258, 2022-1307, 2024 WL 1355733 (Fed. Cir. Apr. 1, 2024) (Circuit Judges Dyk, Prost, and Hughes presiding; Opinion by Prost, J.) (Appeal from D.N.J., Cecchi, J.)

Drug Product and Patent(s)-in-Suit: Invega Sustenna® (paliperidone palmitate); U.S. Patent No. 9,439,906 (“the ’906 patent”)

Nature of the Case and Issue(s) Presented: Invega Sustenna is an extended-release intramuscular injectable of paliperidone palmitate, which is indicated for the treatment of schizophrenia in adults. After Teva filed an ANDA seeking FDA approval to sell a generic version of Invega Sustenna, Janssen sued for patent infringement. The ’906 patent claims dosing regimens of paliperidone palmitate and is the last remaining Orange Book patent for Invega Sustenna. Claim 2 (non-renal-impairment claim), which depends from claim 1, relates to a normal or non-renal-impairment dosing regimen. Representative claims 10 and 13 (renal-impairment claims) claim dosing regimens for renally impaired patients. Claims 20 and 21 are particle size claims. The ’906 patent discloses that skilled artisans “could easily determine the effective amount of paliperidone to administer,” and that for purposes of the ’906 patent’s invention, “[t]he amount of paliperidone palmitate is provided in sufficient amount to provide the equivalent dose of paliperidone after the palmitic acid moiety is removed from the ester.” Additionally, a tablet formulation of paliperidone was already on the market and indicated for the treatment of schizophrenia. The safety of paliperidone, its efficacy for treating schizophrenia, and its recommended dosing were all well established as of the ’906 patent’s priority date.

At the district court, Teva stipulated to infringement and challenged validity. Teva argued that all representative claims were invalid as obvious and that claims 19-21 were indefinite. The district court found Teva has not proven either and Teva appealed. The Federal Circuit vacated and remanded the district court’s finding of obviousness and affirmed the district court’s finding of no claim indefiniteness.

Why Teva Prevailed: To demonstrate obviousness of the paliperidone palmitate dosing regimen claims, Teva relied on three primary prior-art references: (i) the ’548 clinical study protocol, which hypothesized that three fixed doses of paliperidone are each more efficacious than placebo in treating subjects with schizophrenia; (ii) the ’544 patent, which claims a pharmaceutical composition suitable for administration by intramuscular or subcutaneous injection comprising a therapeutically effective amount of paliperidone palmitate and a method for treating schizophrenia using paliperidone palmitate; and (iii) WO ’384, which relates to a process for preparing aseptic crystalline paliperidone palmitate.

The district court found that the prior art did not demonstrate population-wide safety and efficacy and thus did not teach a generalized dosing regimen. But Teva argued—and the Federal Circuit agreed—that the claims were not directed to a generalized dosing regimen and therefore the district court asked for a showing of obviousness that went beyond what was claimed. The non-renal impairment and renal impairment claims recite a dosing regimen for “a” psychiatric patient. 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. “Given the scope of the claims here, it was important for the court to recognize the distinction and focus its findings on single patient administration. The district court did not do so.”

The Federal Circuit also found that the district court’s obviousness analysis was flawed because it was erroneously rigid in several respects. The district court analyzed the prior art without giving the needed weight to the perspective of a skilled artisan capable of deducing what references fairly suggest or employing ordinary creativity. “Instead of considering the prior art in context or in combination, the court’s analysis seems to tackle the express statements of each reference one-by-one—identifying each difference or dissimilarity between an individual reference and the claims, but not fully assessing the teachings in toto.” For example, the district court discounted the ’548 protocol because of a lack of results, but failed to consider what the ’548 protocol would fairly suggest to a skilled artisan; namely, the significance of the Phase III status of the protocol, or that paliperidone was already on the market and prescribed to patients in need of treatment for schizophrenia. “Overall, the 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 background 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 ’548 protocol that an improvement was required—at times also suggesting that it was searching for an indication that the claims captured the singular way the protocol would be modified.”

The Federal Circuit further found that the district court did not apply the correct test for teaching away and that its determinations related to secondary considerations did not disturb the Federal Circuit’s conclusion that vacatur was required.

Regarding the issue of indefiniteness, Teva argued that different particle-size measurement techniques, which were all allowed by the claims, would yield meaningfully different results, creating a situation where the same physical samples of paliperidone palmitate would simultaneously fall inside and outside the claim depending only on how its particle-size measurement is taken. But the district court found that the actual discrepancy in particle-size measurement of paliperidone palmitate that Teva relied on was “an outlier measurement taken with a defective device,” and not based on a discrepancy typical of the measurement technique used. This finding was not clearly erroneous. As a result, the district court correctly determined that, on the record below, Teva did not meet its burden to show that the particle size claims were invalid as indefinite.