Exelixis Sues Handa for a Declaratory Judgment That OMCAZIO Cabozantinib Capsules Will Infringe a Patent Issued the Same Day.

Exelixis, Inc. filed Exelixis, Inc. v. Handa Pharmaceuticals, Inc., No. 1:26-cv-01412 (D. Del.), on November 3, 2026, against Handa Pharmaceuticals, Inc., Handa Pharma, Inc., and Handa Oncology, LLC. The docket's November 4, 2026 assignment entry assigns the case to Judge Jennifer L. Hall. The complaint describes Handa Pharmaceuticals, on information and belief, as a Taiwan company, Handa Pharma as its Delaware subsidiary, and Handa Oncology as a California entity owned by Handa Pharma.

The product and the patent

The case concerns Handa Oncology's 505(b)(2) New Drug Application No. 220613 for cabozantinib capsules in 11.5 mg, 23 mg, and 34.5 mg strengths, which the complaint says the FDA finally approved on September 3, 2026 under the trade name OMCAZIO. Exelixis sells CABOMETYX, cabozantinib (L)-malate tablets. The complaint asserts one patent, U.S. Patent 12,778,942, "Processes for Preparing Quinoline Compounds and Pharmaceutical Compositions Containing Such Compounds," which it says issued on November 3, 2026, the filing date, and will expire on February 10, 2032. It describes the claims as covering a pharmaceutical composition comprising cabozantinib or a pharmaceutically acceptable salt and a surfactant, containing 100 ppm or less of 6,7-dimethoxy-quinoline-4-ol, with lower thresholds down to 5 ppm.

What the complaint alleges

The single count seeks a declaratory judgment under 28 U.S.C. § 2201 that Handa's manufacture, use, sale, offer for sale, or importation of the product will infringe at least claims 1 through 6 of the '942 patent under 35 U.S.C. § 271(a), (b), or (c). The complaint relies on Handa's November 25, 2025 notice letter, which it says described the product as containing cabozantinib lauryl sulfate salt and a surfactant and sought approval to market as soon as U.S. Patent 7,579,473 expired on August 14, 2026. It alleges, on information and belief, that the product contains 100 ppm or less of the quinoline impurity, and says the notice letter did not deny this when addressing related U.S. Patent 12,128,039, contesting that patent only on the ground that the product does not contain a cabozantinib malate salt. It also cites Handa press releases on the tentative and final approvals and Handa statements about its launch preparations.

Relief requested

The prayer asks for a declaratory judgment that the '942 patent claims are not invalid or unenforceable and that Handa's activities before expiration will infringe, a permanent injunction until the patent expires including any extensions or exclusivity, damages or other monetary relief if Handa launches before expiration, and costs, fees, and interest.

Where the case stands

The docket shows the complaint with its patent exhibit, the magistrate judge consent forms, the report to the USPTO on the '942 patent, a Rule 7.1 statement listing no parents or affiliates, summonses issued November 3 for all three Handa entities, a summons returned executed, and the November 4 assignment to Judge Hall. Watch for the Handa entities' answer or a motion.