The parties and the court

The case is Novartis Pharmaceuticals Corporation v. Apotex Inc., No. 1:26-cv-01281 (D. Del.), filed October 5, 2026. Novartis is a Delaware corporation that holds NDA No. 204114 for Mekinist (trametinib dimethyl sulfoxide) tablets, 1 mg, which the complaint says the FDA first approved on May 29, 2013. The complaint alleges, on information and belief, that Apotex Inc. is a Canadian company and that Apotex Corp. is a Delaware corporation and its U.S. subsidiary.

The notice letter

The complaint says Apotex notified Novartis by letter dated August 31, 2026 that it had submitted ANDA No. 220471 seeking approval to sell trametinib tablets, 1 mg, before the patents expire, with Paragraph IV certifications on the '304, '706, '941, '021, and '781 patents. The docket's supplemental ANDA information lists September 1, 2026 as the date Novartis received notice and gives a thirty-month stay deadline of no earlier than March 1, 2029.

The patents

The complaint asserts U.S. Patents 8,580,304 (issued November 12, 2013), 9,155,706 (October 13, 2015), 9,271,941 (March 1, 2016), and 9,399,021 (July 26, 2016), each titled Pharmaceutical Composition; 8,703,781, titled Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors (April 22, 2014); and 10,869,869, titled Method of Adjuvant Cancer Treatment (December 22, 2020). The complaint says Novartis owns all six. It describes the '304 patent as claiming pharmaceutical tablets of trametinib dimethyl sulfoxide solvate with specified excipient content, limits on unsolvated drug, and particle size; the '781 patent as claiming combinations of trametinib and dabrafenib and methods of treating melanoma with them; and the '869 patent as claiming adjuvant treatment of resected melanoma with dabrafenib at 150 mg twice a day and trametinib at 2 mg once daily.

The counts

The twelve counts alternate, for each patent, between infringement and a declaratory judgment under 28 U.S.C. 2201 and 2202 that commercial sales would infringe. The infringement counts on the '304, '706, '941, '021, and '781 patents are pleaded under 35 U.S.C. 271(e)(2), and the infringement count on the '869 patent is pleaded under 35 U.S.C. 271(a) and (b). For the '781 patent the complaint alleges, on information and belief, that Apotex intends to market its trametinib product alongside a generic dabrafenib for use in combination, citing the parties' separate dabrafenib case, C.A. No. 26-cv-141 (D. Del.).

Relief sought

Novartis asks for judgments of infringement, an order that the effective date of any approval of the ANDA be no earlier than the latest expiration of the patents, a permanent injunction against commercial activity before then, a declaration that commercial sales would infringe or induce infringement, a finding that the case is exceptional under 35 U.S.C. 285 with attorneys' fees, and costs.

What to watch next

The docket shows an answer to the complaint and a Rule 7.1 disclosure statement filed October 27, 2026. Watch for a scheduling order and for the defendants' invalidity and noninfringement contentions.