Yondelis® (trabectedin)
Case Name: Janssen Prods., L.P. v. EVER Valinject GmbH, Civ. No. 24-7319, 2025 WL 639380 (N.D. Ill. Feb. 27, 2025) (Harjani, J.)
Drug Product and Patent(s)-in-Suit: Yondelis® (trabectedin); U.S. Patent Nos. 8,895,557 (“the ’557 patent”) and 7,420,051 (“the ’051 patent”)
Nature of the Case and Issue(s) Presented: Yondelis® is indicated for the treatment of rare forms of soft tissue cancer. The patents-in-suit claim a formulation containing trabectedin and a disaccharide selected from sucrose, lactose, or a combination thereof (’557 patent), and a method of making trabectedin (’051 patent). Plaintiffs sued defendants EVER Valinject, GMBH (“EVER”) (headquartered in Austria), Nexus Pharmaceuticals, LLC (Illinois), Shanghai Haoyuan Chemexpress Co., Ltd. (“SHC”) (China), Medchemexpress LLC (“MCE”) (New Jersey), and Ruyuan HEC Pharm Co., Ltd. (China) based on EVER’s submission of an NDA for approval to sell a version of Yondelis® in the US (the “EVER NDA Product”). Defendants SHC, MCE, and Ruyuan moved to dismiss under Rule 12(b)(2) for lack of personal jurisdiction, defendant MCE moved to dismiss under Rule 12(b)(3) for lack of venue, and all defendants moved to dismiss plaintiffs’ declaratory judgment claim with respect to the ’051 patent for lack of subject matter jurisdiction under Rule 12(b)(1) due to non-ripeness. All defendants also moved to dismiss for failure to state a claim under Rule 12(b)(6). The court ultimately denied the motions to dismiss based on lack of personal jurisdiction, transferred the case against MCE to District of New Jersey for improper venue, and granted defendants’ 12(b)(1) motions to dismiss for lack of jurisdiction with respect to the plaintiffs’ declaratory judgment claim on the ’051 patent. The court also granted in part and denied in part the defendants’ motions to dismiss pursuant to Rule 12(b)(6).
Why Defendants (Largely) Prevailed: While the court denied certain of the defendants’ motions and permitted the plaintiffs’ § 271(e)(2) claim to proceed in one form or another against all defendants, one defendant achieved a transfer of the case to another jurisdiction, while all defendants achieved a dismissal of both declaratory judgment claims brought by the plaintiffs.
Personal Jurisdiction. The court denied the motions of SHC and Ruyuan, both Chinese companies, regarding personal jurisdiction, finding personal jurisdiction to be present because the submission of an NDA created “a substantial connection with the forum state where the defendant plans to market its proposed drug[] in the forum state and the lawsuit is about patent constraints on such in-State marketing.” The court did not find SHC’s and Ruyuan’s arguments that they were not “submitters” of the EVER NDA convincing, holding that SHC’s and Ruyuan’s involvement in the manufacturing, testing, and R&D for the EVER NDA Product, assistance in the preparation and submission of the EVER NDA, and the benefits they would receive were the EVER NDA to be approved all rendered SHC and Ruyuan “submitters” of the NDA. The court also held that personal jurisdiction over SHC and Ruyuan would be reasonable in this case, including because of the state’s strong interest and the “slight” burden that SHC and Ruyuan would undergo in travelling from China. Finally, the court denied MCE’s motion to dismiss for lack of personal jurisdiction as moot in light of its ruling on MCE’s motion to dismiss for improper venue.
Venue. The court next found that venue was improper with respect to MCE, denying MCE’s motion to outright dismiss for lack of venue but still severing MCE from the case and transferring the suit to the District of New Jersey, where it found venue to be proper. The court’s ruling was based on the fact that MCE, a New Jersey-based biochemical supplier, did not have a “regular and established place of business” in Illinois such that venue would be proper. As the court noted, while MCE’s involvement in the manufacture of the EVER NDA Product may have been sufficient to establish personal jurisdiction, MCE’s complete lack of a physical presence in Illinois meant that venue was still improper.
Subject Matter Jurisdiction. Next, the court granted the defendants’ motion to dismiss for lack of subject matter jurisdiction with respect to plaintiffs’ declaratory judgment claim on the ’051 patent. The defendants argued that no justiciable controversy existed because the EVER NDA Product had not been approved and approval was not imminent, meaning that the defendants could neither import for use nor take active steps to market the trabectedin-containing product in the US. In response, plaintiffs argued that an actual controversy existed because the defendants would, upon FDA approval, import, offer to sell, sell, or use in the US the EVER NDA Product, thereby infringing the ’501 patent under § 271(g). The court started its analysis by noting that § 271(e)(2) provides courts with jurisdiction over claims directed to “drugs or to methods of using drugs, but [] does not provide jurisdiction to consider infringement claims directed to methods of making drugs.” Because the ’501 patent claims a method for making a drug, the court found that plaintiffs were only able to seek relief under the Declaratory Judgment Act, which provides that a party may only seek declaratory judgment “[i]n a case of actual controversy[.]” After canvasing the case law on what constitutes an “actual controversy,” the court ultimately held that plaintiffs’ reliance on “EVER’s NDA filing coupled with Defendants’ failure to state that FDA approval or their future product is speculative” was “insufficient to state an actual controversy as required by 28 U.S.C. § 2201.” The court also found that, because the “filing of the § 271(e)(2) claim triggered the automatic 30-month stay of FDA approval of EVER’s NDA” and this 30-month stay would not expire until after the trial date in the present case, there was “no sufficient immediacy to the controversy Plaintiffs allege[d]” with respect the plaintiffs’ ’051 Patent claim as required by the Declaratory Judgment Act.
Failure to State a Claim. First, the court rejected SHC and Ruyuan’s argument that they were not “submitters” of the EVER NDA (on the same grounds discussed above), but granted SHC’s and Ruyan’s motion to dismiss the plaintiffs claims for indirect infringement given that the “Complaint ha[d] only one conclusory sentence about these claims.” The court next granted the defendant’s motion to dismiss the plaintiffs’ other declaratory judgment claim with respect to the ’557 patent. While there was not the same issue regarding jurisdiction, the court still dismissed plaintiffs’ claim without prejudice after finding that there was “not sufficient immediacy as to the alleged future infringement of the ’557 patent under section 271(a), (b), and/or (c)[.]” The court also noted that “courts routinely dismiss § 271(a), (b), and (c) claims for future infringement because there is simply no sufficient immediacy to the controversy and the claims appear inconsistent with Congressional intent, as plaintiffs have an express statutory remedy designed to provide full relief” in 35 U.S.C. § 271(e)(2). Finally, the court rejected defendants’ arguments that their asserted defenses of prosecution history estoppel and disclosure-dedication barred the plaintiffs’ claims of infringement under the doctrine of equivalents. The EVER NDA Product contained L-arginine in place of sucrose and/or lactose, and the defendants’ arguments on this issue boiled down to a claim that plaintiffs were barred from asserting the doctrine of equivalents with respect to L-arginine either because plaintiffs allegedly disclaimed L-arginine in prosecution or disclosed but failed to claim L-arginine, thereby dedicating that subject matter to the public. While not outright rejecting the defendants’ defenses, the court did note the weakness of the arguments based on the available evidence and denied the defendants’ motion on the ground that the defendants’ arguments were “premature at the motion to dismiss stage of the proceedings.”
