IP Law Daily, PATENT—Fed. Cir.: District court erred in finding Teva Pharmaceuticals had not proven invalidity of Janssen Pharmaceuticals patent related to injectable schizophrenia drug, (Apr 1, 2024)

By Robert Margolis, J.D.

Court vacates and remands to district court to properly assess whether claims in Janssen patent should be held invalid as obvious.

Citing several errors in the district court’s assessment of whether claims in a Janssen Pharmaceuticals, Inc.’s patent related to an injectable drug for treating schizophrenia are invalid as obvious, the Federal Circuit Court of Appeals in Washington, D.C., has vacated and remanded the district court’s nonobviousness determination after a bench trial in Janssen’s infringement suit against Teva Pharmaceuticals USA, Inc. In particular, the appellate court found that the district court erred in adding unclaimed limitations when evaluating Teva’s obviousness arguments, and being improperly rigid in assessing prior art references without due consideration of how a skilled artisan’s background knowledge of the subject matter would affect the approach to, and motivation to modify, that prior art (Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., April 1, 2024, Prost, S.).

Patent and ANDA. Janssen markets and sells Invega Sustenna, which is an extended-release intramuscular injectable of paliperidone palmitate, indicated for treatment of schizophrenia. It owns U.S. Patent No. 9,439,906 (the “’906 patent”), which relates to dosing regimens of paliperidone palmitate to administer to “a psychiatric patient” needing treatment for schizophrenia and is the last remaining Orange Book patent for Invega Sustenna. Teva filed an Abbreviated new Drug Application (“ANDA”) seeking FDA approval to sell a generic version of Invega Sustenna, after which Janssen sued for infringement based on several claims in the ‘906 patent. Teva stipulated to infringement but challenged validity of the claims, asserting obviousness as to all claims, and indefiniteness as to three of the claims. After a bench trial, the district court found that Teva had not proven invalidity on either basis, leading to Teva’s appeal. The appellate court vacated and remanded the obviousness finding, while affirming the indefiniteness finding.

Prior art.As of the priority date of the ’906 patent, paliperidone’s safety, its efficacy for treating schizophrenia, and recommended dosing were all well established. And there already were long acting injectables of other drugs on the market. Teva asserted three prior-art references in support of its obviousness argument. The first was a clinical study protocol to evaluate the effectiveness and safety of three doses of Paliperidone Palmitate to treat schizophrenia patients. Due to several issues, the protocol did not lead to any results, and Janssen considered it to be a failure in that it did not provide sufficient data to obtain FDA approval.

The second prior-art reference is another patent (the “’544 patent”), which expired in 2018 and is owned by Janssen, and concerns a method of treating schizophrenia by a “pharmaceutical composition suitable as a depot formulation for administration by intramuscular or subcutaneous injection” comprising among other things, a “therapeutically effective amount” of paliperidone palmitate. The specification emphasizes the ability to space out administrations by three weeks to a month and discusses the particle size used in the formulations.

The third prior-art reference is an International Publication disclosing an invention related to “a process for preparing aseptic crystalline” paliperidone palmitate. Janssen agreed that the composition disclosed in this reference matches the composition elements of two of the claims in the ’906 patent, and the Invega Sustenna formulation.

Unclaimed limitations.Teva argued that the district court added unclaimed limitations to the claims when analyzing obviousness, in particular (1) generalized or population-wide dosing (all claims), and (2) mild renal impairment (two of the claims). The court agreed with Teva as to both arguments.

The appellate court found that the district court erred when its analysis required Teva to show that it would have been obvious to use the recited dosing regimens for the general population of patients, rather than individual patients. The district court had found that the prior art did not demonstrate population-wide safety and efficacy, and therefore did not teach a generalized dosing regimen. Since, as Teva argued, the claims themselves were not directed to a generalized dosing regimen, the district court was asking for a showing of obviousness that went beyond the asserted claims. The appellate court agreed.

Both the renal and non-renal dosing claims recite regimens for “a psychiatric patient,” and nothing in the claims requires that the regimen be used for, let alone be ideal for, the general population of patients or even a certain percentage of the patient population. Because the “objective reach of the claim” is what matters, the appellate court found error when the district court effectively defined its obviousness inquiry as concerning the “generalized” suitability of dosing regimens. The appellate court observed that the district court appeared to have conflated Janssen’s arguments related to its clinical-study design and approval process with the FDA, which emphasized general population-wide data, with the scope of the claims themselves. Because the scope of the claims was limited to “a psychiatric patient,” it was important for the court to focus its findings on single patient administration, and not get confused by other arguments and issues. The appellate court cited several instances in the district court’s opinion where this misunderstanding impacted the district court’s obviousness analysis. This error required remand as to all claims, since the record does not contain obviousness fact findings cued to the claim limitations to “a psychiatric patient,” the appellate court held.

Likewise, the appellate court agreed with Teva that the district court improperly read a “mild” limitation into claims concerning renal impairment, whereas the claims themselves do not specify a level of renal impairment. This was another basis for remand, so the district court could analyze obviousness without this “mild” limitation added to the renal-impairment claims.

Erroneously rigid. The appellate court also agreed with Teva that the district court’s obviousness analysis was overly rigid in several respects. In many instances the district court analyzed the prior art without giving the necessary consideration to the perspective of a person of ordinary skill in the art (“POSA”) capable of deducing what references fairly suggest or employing ordinary creativity. In the appellate court’s framing, the district court improperly “siloed” each prior art teaching, highlighting differences between an individual reference and the Janssen patent’s claims, without leaving room for how a POSA’s background knowledge would have impacted the understanding of prior art, or motivation to modify those references. This provided another basis to vacate and remand.

For example, the district court found that the absence of safety and efficacy data from the clinical study protocol meant that it could effectively discard it from the analysis. But the claims in the ’906 patent do not have any safety or efficacy requirement, the appellate court pointed out. Thus, the district court should have considered whether, and the extent to which, to a POSA, the absence of that data from the study protocol would impact the motivation to combine that reference with other prior art. Further, even though the protocol concluded with a lack of results, the district court still should have considered what that protocol would fairly suggest to a POSA.

Teaching away. The appellate court also found that the district court applied the wrong standard for teaching away, when it concluded that a prior art’s disclosure of an optimal or standard particle size effectively taught away from other particle sizes. Without criticism of, discrediting or otherwise discouraging other particle sizes, that prior art did not teach away from them, the appellate court held.

Indefiniteness. The appellate court affirmed the district court’s determination that Teva failed to sustain its indefiniteness argument for claim invalidity. The claims on which this argument was based do not specify what measurement should be used to determine the particle size, and Teva argued that different measurement techniques could lead to different results. But the district court found that the actual discrepancy in particle-size measurement on which Teva relied was “an outlier measurement taken with a defective device,” and the appellate court held this finding was not clearly erroneous.

The Case is No. 22-1258.

Attorneys: Barbara Mullin (Patterson Belknap Webb & Tyler LLP) for Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutica NV. John C. O'Quinn (Kirkland & Ellis LLP) for Teva Pharmaceuticals USA, Inc. Deepro Mukerjee (Katten Muchin Rosenman LLP) for Mylan Laboratories Ltd.

Companies: Janssen Pharmaceuticals, Inc.; Janssen Pharmaceutica NV; Teva Pharmaceuticals USA, Inc.; Mylan Laboratories Ltd.

Cases: Patent FedCirNews GCNNews