Plexxikon Inc. v. Novartis Pharmaceuticals Corporation

Background

Novartis Pharmaceuticals Corporation asked for permission to file a second motion for summary judgment. Summary judgment is a request for judgment without a trial when the moving party contends that the undisputed facts and law require that result. The court’s standing order allowed each party to file only one summary-judgment motion and required a showing of “good cause” to exceed that limit. The deadline for dispositive motions had passed, pretrial filings had been submitted, and trial was scheduled for June 2020.

Novartis relied on the Federal Circuit’s decision in Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., arguing that the decision was an intervening change in law and showed that all asserted claims were invalid for lack of enablement. Enablement is the patent-law requirement that the patent’s specification explain how to make and use the claimed invention without undue experimentation.

Court’s Analysis

The court held that Novartis had not shown good cause. First, the court concluded that Idenix did not represent a change in law that justified Novartis’s delay. According to the court, Idenix applied a rule established in an earlier Federal Circuit decision, Wyeth, and involved facts that were strikingly similar. Novartis did not explain why it could not have raised its proposed argument earlier under Wyeth. The court therefore found that Novartis had not acted diligently.

Second, the court found that Idenix did not apply to the claims in this case. Idenix concerned whether the full scope of claims directed to compounds effective for treating hepatitis C would require excessive experimentation. Novartis argued here that the patent specifications did not identify the compounds effective at inhibiting kinase. But the court stated that kinase inhibition was not a limitation of the asserted claims. The court noted that claims 11 and 12 of the ’640 Patent included functional limitations involving treatment of melanoma, thyroid cancer, or colorectal cancer, not kinase inhibition. The court therefore concluded that the specifications did not need to enable compounds that inhibit kinase in order for a person skilled in the field to practice the full scope of the claims.

Novartis also argued in its reply that the motion could proceed under the patent-law requirement of utility. Utility concerns whether a claimed invention has a significant and presently available benefit to the public. The court explained that utility and enablement involve different analyses, and that Idenix did not address utility or its relationship to enablement. Novartis also did not explain why it could not have raised lack of utility in its first summary-judgment motion.

Disposition

The court DENIED Novartis’s motion for leave to file a second summary-judgment motion. The order decided only whether Novartis could file another motion after the deadline; it did not decide the ultimate validity of the asserted patent claims. Judge Haywood S. Gilliam, Jr. issued the order without oral argument.