Janssen and Pharma Mar Sue Somerset and Chongqing Sintaho Over a Generic Yondelis ANDA.

The case

The case is Janssen Products, L.P. v. Somerset Therapeutics, LLC, No. 2:26-cv-13830 (D.N.J.), assigned to Judge Madeline Cox Arleo, with Magistrate Judge Jessica S. Allen. The complaint is signed by William C. Baton and also lists Alexander L. Callo of Saul Ewing LLP in Princeton, New Jersey, and Irena Royzman, Alyssa Caridis, Neal Vinaixa and Jonathan Liu of Orrick, Herrington & Sutcliffe LLP.

The complaint describes Janssen Products as a New Jersey partnership based in Horsham, Pennsylvania, and Pharma Mar as a Spanish corporation based in Colmenar Viejo, Spain. On information and belief, it describes Somerset Therapeutics, Somerset Pharma and Odin Pharmaceuticals as Delaware limited liability companies based in Somerset, New Jersey, and Chongqing Sintaho Pharmaceutical as a Chinese limited liability company based in Chongqing. It says Somerset Therapeutics holds the ANDA and Chongqing Sintaho holds Drug Master File No. 044134 for the trabectedin in the proposed product, and it alleges, on information and belief, that the four defendants collaborated in preparing and submitting the ANDA.

The drug and the patent

Janssen holds NDA No. 207953 for Yondelis (trabectedin) for injection, 1 mg per vial, which the complaint describes as a second-line treatment for patients with unresectable and metastatic liposarcoma or leiomyosarcoma after conventional therapy fails. U.S. Patent No. 8,895,557, titled Pharmaceutical Formulations of Ecteinascidin Compounds, issued November 25, 2014. The complaint says Pharma Mar owns it, Janssen holds an exclusive license, the patent is listed in the Orange Book for Yondelis, and it expires January 7, 2028, with pediatric exclusivity running to July 7, 2028.

Claim 1 covers a lyophilised composition containing ET-743 as the single active anti-tumor compound and a disaccharide selected from sucrose, lactose or both, present in an amount sufficient to inhibit conversion of ET-743 into ET-701, so that after storage at 5 degrees C for 3 months the composition contains less than 2 percent ET-701.

The ANDA and the notice letter

The complaint says the plaintiffs received a paragraph IV notice letter from Somerset Therapeutics dated September 17, 2026, on or around September 18, explaining that the defendants had submitted ANDA No. 221774 seeking approval before the '557 patent expires. It says the letter does not dispute that the commercial manufacture, use, importation, offer for sale and sale of the proposed product, if approved, would infringe claims 1, 3 to 8, 11, 14 to 20 and 22 to 26.

According to the complaint, the plaintiffs' outside counsel began negotiating confidential access to the ANDA with Somerset's counsel on September 25, 2026, and on October 7 the defendants provided selected portions of the ANDA for review by outside counsel only. It says the parties did not agree on an offer of confidential access and that the plaintiffs filed within 45 days of receiving the notice.

The counts

Count I alleges infringement under 35 U.S.C. 271(e)(2)(A) by submitting the ANDA. Count II seeks a declaratory judgment that commercial manufacture, use, offer, sale or importation of the proposed product would infringe under 35 U.S.C. 271(a), (b), (c) or (g). The complaint also alleges, on information and belief, that the proposed product is made using processes claimed in the patent and then imported into the United States without material change.

The relief sought

The plaintiffs ask for a judgment of infringement under section 271(e)(2)(A); an order under section 271(e)(4)(A) that the ANDA's effective approval date be no earlier than the day after the patent expires, including any additional exclusivity period; a declaratory judgment of infringement; a permanent injunction against commercial manufacture, use, offer, sale or importation of the proposed product until then; a finding that the case is exceptional; and costs and attorney fees under 35 U.S.C. 271(e)(4) and 285.

The complaint's certification of related cases lists two earlier suits by the same plaintiffs in the same court over the '557 patent, Janssen Products, L.P. v. Medchemexpress LLC, No. 25-1867, also before Judge Arleo, and Janssen Products, L.P. v. eVenus Pharmaceuticals Laboratories Inc., No. 20-9369.