CAFC Sends Janssen Schizophrenia Treatment Claims Back to District Court for New Obviousness Analysis

The U.S. Court of Appeals for the Federal Circuit (CAFC) ruled in a precedential decision authored by Judge Prost on Monday that certain claims of Janssen Pharmaceuticals Inc.’s patent for a schizophrenia drug are not indefinite but vacated and remanded the district court’s finding that Teva Pharmaceuticals had not proven all of the claims obvious.

U.S. Patent No. 9,439,906 covers an extended-release intramuscular injectable schizophrenia treatment marketed by Janssen as Invega Sustenna. Janssen sued Teva for patent infringement in the U.S District Court for the District of New Jersey after Teva filed an Abbreviated New Drug Application (ANDA). Teva stipulated to infringement but challenged validity, arguing that all claims of the patent were obvious and claims 19-21 were also invalid as indefinite. The district court found Teva failed to prove invalidity on either ground.

On appeal, Teva said the district court’s obviousness analysis was legally flawed, including with respect to its analysis of secondary considerations. In particular, Teva said the district court improperly required Teva to show that the prior art recited dosing regimens for the general population of patients, or a generalized dosing regimen, when the claims were not directed to a generalized dosing regimen. The CAFC agreed and said the relevant claims reference “a” patient, rather than the patient population generally or a certain percentage of the patient population.

“Because ‘[w]hat matters is the objective reach of the claim,’…the district court erred to the extent it effectively defined its obviousness inquiry as one concerning the ‘generalized’ suitability of the dosing regimens,” wrote the CAFC, quoting from KSR v. Teleflex.

The CAFC said the district court “misunderstood” the claims in part because it conflated arguments Janssen made related to the Food and Drug Administration (FDA)-approval process that referred to population-wide data. The opinion explained: “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 CAFC also agreed with Teva that the district court’s obviousness analysis did not adhere to the flexible approach taught by KSR and was “impermissibly rigid.” The court failed to give the necessary weight to the perspective of a person of ordinary skill in the art (POSA); did not apply the correct test for teaching away; made incorrect comparisons in its treatment of unexpected results; did not properly address a nexus in its industry praise analysis between the praise and the claims; and relied on faulty premises in its “blocking patent” analysis, said the CAFC. The court therefore remanded the case for the district court to reassess obviousness in light of the opinion and to conduct a new secondary considerations analysis.

Turning to indefiniteness, however, the CAFC said Teva had not shown the factual findings leading to the district court’s determination that the claims were not indefinite to be clearly erroneous. Specifically, the district court found that the discrepancy in particle-size measurement that Teva relied on to prove indefiniteness was “an outlier measurement taken with a defective device,” and “not based on a discrepancy typical of the measurement technique used.” The CAFC said Teva had not shown this conclusion to be clearly erroneous and the district court’s decision was thus affirmed on that point.

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