Melinta Therapeutics, LLC v. Nexus Pharms., Inc.

Minocin® (minocycline HCl)

November 5, 2021

GENERICally Speaking

Case NameMelinta Therapeutics, LLC v. Nexus Pharms., Inc., C.A. No. 2:21-cv-11198 (BRM) (AME), 2021 WL 5150157 (D.N.J Nov. 5, 2021) (Martinotti, J.) 

Drug Product and Patent(s)-in-Suit: Minocin® (minocycline HCl); U.S. Patents Nos. 9,084,802 (“the ’802 patent”) and 9,278,105 (“the ’105 patent”)

Nature of Case and Issue(s) Presented: On December 8, 2020, Nexus sent a notice letter to Melinta regarding the submission of Nexus’s ANDA to FDA for permission to market a generic version of Minocin. Nexus’s ANDA contained a Paragraph IV certification that the patents-in-suit were invalid and/or not infringed by Nexus’s ANDA product. According to Melinta, they had closed their offices at this time in response to the COVID-19 pandemic and had instituted mail acceptance and processing procedures. The notice letter from Nexus apparently did not go through this process and was lost and was only discovered by Melinta’s General Counsel on March 31, 2021. Within 45 days of discovering the notice letter, Melinta filed suit against Nexus in the District of New Jersey. Count One of the complaint sought declaratory judgment that Defendant’s attempted delivery of the notice letter on December 8, 2020 did not commence the 45-day window to file suit in order to obtain a 30-month stay of FDA approval of Nexus’s ANDA. Counts Two and Three of the complaint alleged infringement of the patents-in-suit under 35 U.S.C. § 271(e). Nexus moved to dismiss the complaint under Fed. R. Civ. P. 12(b)(3) for improper venue, or, in the alternative, to transfer venue pursuant to 28 U.S.C. § 1404(a) to the Northern District of Illinois. The court denied the former and granted the latter.

Why Nexus Prevailed: Nexus sought dismissal of counts Two and Three of the complaint under Rule 12(b)(3) arguing that it is incorporated in Illinois, not New Jersey, and that it could not be found to reside in New Jersey for patent venue purposes. Nexus further argued that Melinta did not allege that any act in preparation of submission of the ANDA took place in New Jersey. Instead, Melinta pointed to Nexus’s act of sending the Paragraph IV notice letter.

Melinta conceded that the patent counts were perhaps not properly venued in New Jersey, but that Count One, the non-patent count, was properly venued there. Melinta argued that this case presented a unique situation in which Count One was a necessary predicate to patent infringement claims. Thus, Melinta requested that the court exercise pendent venue over Counts Two and Three to keep the case in New Jersey.

The court explained that in cases where the claims “arise out of the same operative facts,” pendent venue “allows venue to be sustained over a federal claim even if venue over pendent state law claims would not be proper.” But the court further explained that courts have declined to invoke pendent venue where a plaintiff brought both patent claims and non-patent claims and where 28 U.S.C. § 1400(b) (the patent venue statute) was not satisfied. Here, the court found that while Count One was properly brought in New Jersey, the venue was not proper for Counts Two and Three under § 1400(b). The court, however, declined to dismiss Counts Two and Three and instead transferred them to the Northern District of Illinois.

Nexus further sought to transfer Count One of the complaint to the Northern District of Illinois. The court found that because Defendant and the evidence relevant to the shipment of the Paragraph IV notice letter resided in Illinois. The court further found that judicial economy weighed against proceeding on Count One in New Jersey while Counts Two and Three proceeded in Illinois. Thus, pursuant to 28 U.S.C. § 1404(a), the court transferred Count One to the Northern District of Illinois.

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