Fresh From the Bench: Latest Precedential Patent Cases
CASE OF THE WEEK
Janssen Pharms., Inc. et al. v. Teva Pharm. USA, Inc. et al., Appeal Nos. 2022-1258, -1307 (Fed. Cir. April 1, 2024)
In this week’s Case of the Week, the Federal Circuit vacated-in-part a district court’s bench trial decision that Teva had not shown claims of Janssen’s U.S. Patent No. 9,439,906 to be invalid, and remanded for further proceedings. The ’906 patent is the last remaining Orange Book patent that covers Johnson & Johnson’s successful schizophrenia drug Invega Sustenna, and the Court’s decision will provide Teva with another opportunity to clear the way for generic formulations. The opinion focused predominantly on several erroneous aspects of the lower court’s obviousness analysis, and provided a clear reminder that challenges to obtaining regulatory approval will typically have limited relevance to the question of whether a pharmaceutical patent is obvious over the prior art.
The claims at issue were directed to a dosing regimen of intramuscular administration of paliperidone palmitate to a patient suffering from schizophrenia or certain similar disorders, including unequal initial loading doses of 150 mg-eq. and 100 mg-eq. prior to the administration of smaller monthly maintenance doses; a reduced dosing regimen for renally impaired patients; a formulation with specific average particle sizes; and a deltoid injection site. The use of paliperidone for the treatment of schizophreniform disorders was well-known in the prior art, as well as the use of long-acting injectable (LAI) formulations of antipsychotics to improve treatment adherence over daily regimens.
ALSO THIS WEEK
AI Visualize, Inc. v. Nuance Communications, Inc., Appeal No. 2022-2109 (Fed. Cir. Apr. 4, 2024)
Also this week, the Federal Circuit summarily affirmed the District of Delaware’s dismissal of AI Visualize’s patent infringement suit against appellants Nuance and Mach7, finding that the asserted claims were patent-ineligible under 35 U.S.C. § 101.
AI Visualize’s asserted patents were intended to overcome limitations in existing medical scan viewing technology, and claimed a method and system for receiving, storing, processing, and viewing large medical scans via a low-bandwidth web portal. In response to an earlier motion to dismiss, AI Visualize had filed the amended complaint at issue before the Federal Circuit. At Alice step one, the Federal Circuit agreed with the district court that the asserted claims were directed to abstract ideas—namely, converting data and using computers to collect, manipulate, and display the data. At Alice step two, because the Federal Circuit was reviewing a 12(b)(6) dismissal, all AI Visualize had to show was that its amended complaint adequately alleged that its claims contained inventive concepts. However, the Federal Circuit agreed with the district court that AI Visualize had made no arguments that the amended complaint presented any additional allegations, and no assertions that the construction of certain claim terms were relevant to the Alice inquiry. As a result, AI Visualize’s amended complaint did not contain sufficient factual allegations to support a finding that the asserted claims involved unconventional technology or a concrete application of an abstract idea, such that AI Visualize had also failed Alice step two.
The district court’s order of dismissal was affirmed.
The opinion can be found here.
Editors:
Nika Aldrich, IP Litigation Group Leader, Schwabe, Williamson & Wyatt, P.C.
Jason A. Wrubleski, Shareholder
Contributors:
Tyler Hall, Shareholder