On Jun 13, 2024, Delaware district court denied Tolmar’s motion for reconsideration.

Janssen Pharmaceuticals sued Tolmar, Inc. for patent infringement under the Hatch-Waxman Act. The case revolved around U.S. Patent No. 9,439,906 (“the ’906 patent”), which Janssen held. This patent is listed in OB for product, Invega Sustenna. Following a four-day bench trial, the court ruled in favor of Janssen, declaring the asserted claims of the ‘906 patent nonobvious over the prior art. The final judgment was entered on March 13, 2024.

Tolmar sought reconsideration of the court’s judgment, arguing that the Federal Circuit’s decision in the Teva case revealed errors in the court’s reasoning. Tolmar also contended that the court should amend the judgment to enjoin only the highest dosage amount of its ANDA product, not all five dosage amounts.

Court’s Analysis and Rulings:

1. Nonobviousness Arguments:
   • Modification of NCT 548: Tolmar argued the court improperly determined that a person of ordinary skill in the art would not have had reason to modify the NCT 548 prior art reference due to lack of safety and efficacy data. The court maintained that its analysis was consistent with the Federal Circuit’s guidance in Teva, concluding that there was no persuasive reason to modify NCT 548 in a manner that would result in the claimed invention.
   • Arrival at the Claimed Dosing Regimen: Tolmar asserted the court erred in finding that a person of ordinary skill in the art would not have derived the claimed dosing regimen from NCT 548 and other prior art. The court held that Tolmar failed to meet its burden of proof, noting that proprietary knowledge and data not available to the public were used by Janssen to arrive at the claimed regimen.
   • Secondary Considerations: Tolmar challenged the court’s assessment of unexpected results and the impact of Janssen’s blocking patents on commercial success. The court found these arguments unpersuasive, stating that its analysis aligned with the legal standards and that secondary considerations were not crucial to its final conclusion on obviousness.
2. Modification of the Final Judgment: Tolmar argued for relief from the final judgment to exclude four of the five dosages listed in its ANDA from the injunction. The court rejected this argument, stating that the parties’ stipulation covered all five dosage amounts. The court concluded that the stipulated judgment applied to the entire ANDA product and that amending the judgment was unwarranted.

Tolmar’s motion for reconsideration was denied, affirming the initial ruling that the asserted claims of the ’906 patent were nonobvious.