Invega Sustenna® (paliperidone palmitate)
Case Name: Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., Nos. 2025-1228, -1252, 2025 WL 1874090 (Fed. Cir. July 8, 2025) (Circuit Judges Prost, Reyna, and Taranto presiding; Opinion by Taranto, J.) (Appeal from D.N.J., Cecchi, J.)
Drug Product and Patent(s)-in-Suit: Invega Sustenna® (paliperidone palmitate); U.S. Pat. No. 9,439,906 (“the ’906 patent”)
Nature of the Case and Issue(s) Presented: Invega Sustenna® is a long-acting injectable antipsychotic medication indicated for the treatment of schizophrenia in adults. The ’906 patent addresses the problem of noncompliance with antipsychotic medication by claiming a treatment regimen which uses a long-acting, injectable formulation of paliperidone palmitate that requires less-frequent administration than oral medication. Specifically, the claims cover a series of “loading doses” of paliperidone palmitate followed by monthly maintenance doses, with additional claims concerning reduced dosage in patients with renal impairment and certain mean particle sizes for the paliperidone suspension to control the rate of uptake.
In December 2017, Teva filed an ANDA seeking approval to market a generic version of Invega Sustenna®. Janssen filed suit, alleging infringement under 35 USC § 271(e)(2). Teva stipulated to infringement but alleged obviousness, lack of adequate written description, and indefiniteness defenses. In support of its obviousness argument, Teva relied on Janssen’s own references as prior art: (i) a testing protocol for a phase III study, which described administering set doses of paliperidone palmitate in the ranges disclosed in the ’906 patent at specified time intervals; (ii) a patent that described administering a “therapeutical effective amount” of paliperidone palmitate via intramuscular or subcutaneous injection; and (iii) an international publication that described a process for preparing aseptic crystalline paliperidone palmitate in the range of dosages described in the ’906 patent.
The district court found that Teva did not meet its burden in establishing invalidity. Teva appealed that ruling, but only as to obviousness and indefiniteness. The Federal Circuit affirmed the district court’s ruling with respect to indefiniteness, and vacated the ruling with respect to obviousness after finding that the district court’s analysis was flawed for failing to adequately differentiate between Teva’s general challenges to all claims and individual challenges to specific claims, as well as failing to adequately analyze secondary considerations.
On remand, the district court again held that Teva could not meet its burden to prove the asserted claims obvious, finding no motivation to combine or a reasonable expectation of success with respect to the claimed dosing regimen. The district court also rejected Teva’s argument that it should be entitled to a presumption of obviousness based on the fact that the dosage ranges claimed in the ’906 patent overlapped with ranges disclosed in the prior art. On appeal for the second time, Teva argued that the district court erred in: (i) failing to apply a presumption of obviousness; and (ii) otherwise finding that there was no motivation to combine or reasonable expectation of success. The Federal Circuit rejected both arguments and affirmed.
Why Janssen Prevailed: With respect to the claimed dosing regimen, the Federal Circuit found that (i) Teva was not entitled to a presumption of obviousness and (ii) Teva had not otherwise demonstrated a motivation to combine or reasonable expectation of success. On the presumption of obviousness, the Federal Circuit noted that the cases cited by Teva largely involved what it called “overlapping-range cases,” in which a challenged claim “requires a numerical amount . . . and a prior art reference teaches that feature in amounts that overlap with the claimed numerical amount.” The Federal Circuit acknowledged that such situations are often entitled to a presumption of obviousness and that the presumption may still apply even where there are some differences between the claimed value and the prior art, but emphasized that there is not a blanket rule and that courts must look to the “inventive context” when considering whether a presumption of obviousness should apply. The Federal Circuit then distinguished the present case from other “overlapping range” cases based on the fact that the claimed dosing regimen involved not just a dosage amount, but a combination of doses in a particular sequence so as to achieve the desired loading effect. This “combination of loading doses is addressed to the relation between two dosage figures in a way that does not clearly fit within the presumption’s focus on simply selecting a number or range overlapping a prior-art range of a variable” (emphasis in original).
Next, the Federal Circuit held that the district court did not commit clear error in finding that Teva had failed to establish a motivation to combine and a reasonable expectation of success. Teva’s argument on appeal was that the district court had “placed too much emphasis on the ‘unequal’ and ‘decreasing’ characteristics of the claimed dosing regimen” in its obviousness analysis. After a fact intensive review of the district court’s analysis and the prior art, the Federal Circuit rejected Teva’s arguments, agreeing with the district court that the claimed regimen was more than merely “com[ing] up with an optimal dosage regimen,” and that a POSA would not have the motivation to combine or a reasonable expectation of success in combining the prior art to arrive at the claimed regimen, particularly its requirement for progressively declining loading doses in a treatment regimen for psychosis.
Finally, with respect to Teva’s obviousness arguments regarding claims for the treatment of renally-impaired patients, the Federal Circuit similarly upheld the district court’s analysis, holding that the claimed regimen was, contrary to Teva’s argument, more than merely lowering the dose for renally-impaired patients. Specifically, the Federal Circuit credited the district court’s analysis that there was no motivation to combine the prior art to arrive at the claimed regimen for the treatment of mildly-impaired patients in particular.
