Janssen Pharms., Inc. v. Tolmar, Inc.

Case Name: Janssen Pharms., Inc. v. Tolmar, Inc., Civ. No. 21-1784-WCB, 2024 WL 2972832 (D. Del. June 13, 2024) (Bryson, J.)

Drug Product and Patent(s)-in-Suit: Invega Sustenna® (paliperidone palmitate); U.S. Patent No. 9,439,906 (“the ’906 patent”)

Nature of the Case and Issue(s) Presented: Janssen sued Tolmar for patent infringement and after a four-day bench trial, the court found all the asserted claims of the ’906 patent not obvious in view of the referenced prior art. Three weeks later, the Federal Circuit issued an appellate decision, the Teva decision, vacating another district court’s non-obviousness determination of the same patent. Tolmar argued that the Federal Circuit’s determination in the Teva appeal reveals errors in this court’s reasoning that require this court to amend its judgment under Fed. R. Civ. P. 59(e). Tolmar also argued that the court erred by enjoining all five dosage amounts of Tolmar’s ANDA product in its final judgment, and that the court should amend its judgment to affect only the highest of the five dosage amounts. The court denied both grounds of Tolmar’s motion for reconsideration.

Why Janssen Prevailed: Tolmar raised three arguments in its motion concerning the court’s non-obviousness finding.

First, the court improperly determined that a skilled artisan would have had little reason to modify the NCT 548 prior art reference, and that this finding is contrary to the Federal Circuit’s Teva decision. “The Federal Circuit held that the absence of safety and efficacy data in a reference cannot justify simply discarding that prior art. Instead, the Federal Circuit instructed that the district court in that case should have looked to what the ’548 protocol would fairly suggest to a POSA. That is precisely what this court did.” While the court acknowledged that there could be several reasons to modify NCT 548 to achieve the desired invention, it was Tolmar’s burden to show there was a reason to do so and it failed to meet that burden.

Second, the court erred in finding that a skilled artisan would not have arrived at the claimed dosing regimen based on NCT 548 and the overall prior art on dosing. The court noted that Janssen arrived at the claimed dosing regimen using proprietary knowledge and data, knowledge and data that a skilled artisan would not have had. That is not the same thing as suggesting that Tolmar was foreclosed from attempting to show that such a person could have arrived at the claimed dosing regimen without such knowledge. Tolmar just failed to do so at trial.

Third, the court misapprehending the law relating to unexpected results and by failing to consider the impact of Janssen’s blocking patents on commercial success. To begin with, “the analysis of the secondary considerations was not critical to the court’s ultimate conclusion regarding obviousness.” After considering Tolmar’s unexpected results argument, the court concluded that there was no basis in the prior art to expect the dramatic difference in results between NCT 548’s fixed-dose, gluteal regimen and the claimed dosing regimens in terms of achieving rapid onset of the therapeutic effects of the drug without creating proportionally higher increases in peak concentration in the patient’s body. The Federal Circuit in Teva held that the correct inquiry regarding unexpected results was to compare the expectations based on information available to a skilled artisan with the claimed regimens’ results. “The Federal Circuit’s decision in Teva is not at odds with this court’s ruling on that issue; in fact, the Federal Circuit expressly agreed that the safe harbor provision is a relevant factor to be considered in determining the role of blocking patents in ANDA cases.”

Finally, Tolmar’s efforts to modify the final judgment were also unpersuasive. The parties stipulated that if any of claims 1–7, claim 15, and claims 17–21 of the ’906 patent were not found to be invalid, Tolmar would agree to entry of a judgment of infringement and order pursuant to 35 U.S.C. § 271(e)(4)(A) with respect to such claim. “Although it does not say so expressly, the stipulation unambiguously encompasses all five dosage sizes in Tolmar’s ANDA within the scope of what the judgment of infringement would cover.” Thus, Tolmar’s argument for reconsideration is contrary to the stipulation. The language in the stipulation governing Janssen’s concession of non-infringement applies to the exact same subject matter as Tolmar’s concession of infringement.