Invega Sustenna® (paliperidone palmitate)
Case Name: Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., Civ. Nos. 18-734, 19-16484, 2024 WL 5135666 (D.N.J. Dec. 17, 2024) (Cecchi, J.)
Drug Product and Patent(s)-in-Suit: Invega Sustenna® (paliperidone palmitate); U.S. Patents No. 9,439,906 (“the ’906 patent”)
Nature of the Case and Issue(s) Presented: Invega Sustenna is an injectable paliperidone palmitate medication used to treat schizophrenia in adults. Individuals diagnosed with schizophrenia often struggle to adhere to treatment regimens, particularly those that require daily intake of oral medication. “In order to help solve this adherence problem, long-acting injectables (‘LAIs’)—otherwise known as ‘depots’—were developed.” Teva filed an ANDA in 2017 seeking FDA approval to make and sell a generic version. In response, Janssen sued Teva alleging infringement of the ’906 patent. The ’906 patent claims dosing regimens of paliperidone palmitate, including in psychiatric patients with renal impairment. The asserted claims do not include any safety and efficacy requirement.
Teva stipulated to infringement and after a bench trial, the court concluded that Teva had not proven invalidity on the basis of obviousness or indefiniteness. Teva appealed and the Federal Circuit affirmed the court’s holding on indefiniteness but vacated and remanded the obviousness determination. While Teva’s appeal was pending, the D. Del. district court presided over a case involving an obviousness challenge to the ’906 patent. Relying on the prior art reference NCT00210548 (“NCT 548”), a protocol for one of Janssen’s Phase III clinical trials, which is also the closest prior art in the pending action, the Del. court found the ’906 patent was not invalid. On remand, the court found that the ’906 patent was not invalid as obvious.
Why Janssen Prevailed: NCT 548 discussed three regimens of four equal doses of 50, 100 or 150 mg-eq. A skilled artisan would not have known merely from NCT 548 itself which, if any, of the many aspects of the protocol should be altered. Teva relied on various other pieces of prior art to prove a skilled artisan’s motivation to modify NCT 548. But the court ultimately held that “Teva’s argument that a POSA would be motivated to modify the initial loading dose of [NCT 548] is unpersuasive; it is not sufficiently supported by Teva’s own expert testimony and is contradicted by the prior art.”
The court also examined secondary considerations of non-obviousness. It found that there was a persistent need for a second-generation LAI antipsychotic that did not require oral supplementation and the novel dosing features of the ’906 patent solved this need. Invega Sustenna® was an undisputed commercial success. Since its launch, the size and annual growth of its sales, revenue, and market share had contributed to its “blockbuster” status and that success was closely tied to its unique dosing features. The court also found that a skilled artisan would have understood from the prior art that the use of higher LAI loading doses may have led to increased risk of side effects, and that a skilled artisan would have been surprised to discover that the ’906 patent’s dosing regimens achieved “rapid onset of the therapeutic effects of the drug” without thereby producing adverse side effects in a patient. Janssen also pointed to industry praise in the form of an article published in the journal Neuropsychiatric Disease, which reviewed Invega Sustenna® and concluded that paliperidone palmitate is an “important treatment option.” The court also credited the existence of skepticism and discounted blocking patents that prevented market entry from entering the market.
