Defendant's filed a motion to dismiss pursuant to Fed.R.Civ.P. 12(b)(1) motion, contending that Plaintiffs lacked standing because no case or controversy existed at the time Plaintiffs filed the complaint. Defendant argued that the Plaintiffs had suffered an "injury in fact." The "injury in fact" element of standing requires "an invasion of a legally protected interest that is (a) concrete and particularized, and (b) actual or imminent, not conjectural or hypothetical." Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (1992) (citations and quotation marks omitted).

Defendant contended that the complaint fails to establish an "injury in fact" because it accused only one of Defendant's products of infringement (the "MoMe® Kardia System") and that product is incapable of infringement because it is still under development and not yet approved by the Food and Drug Administration ("FDA").

As the district court explained, "to the extent that Defendant challenges the sufficiency of the jurisdictional allegations in the complaint, the court accepts those allegations as true and determines that they are sufficient, at this stage, to establish that Plaintiffs have suffered 'injury in fact' and have standing. According to the complaint, Defendant has infringed Plaintiffs' patents by committing acts of infringement with 'products . . . including but not limited to the MoMe® Kardia System.' Compl. ¶¶ 25, 38, 52, 65.

The district court further explained that "Defendant acknowledges that before it began developing the MoMe® Kardia System, it developed a 'first generation' device--the 'MoMe® System'--which did obtain FDA approval. Defendant further concedes that 'the names 'MoMe® System' and 'MoMe® Kardia System' were used interchangeably, and there is no correspondence between the name and the design generation.'"

The district court also stated that "the jurisdictional allegations are not limited to Defendant's 'second generation device' as Defendant contends, and do assert that Defendant's products have infringed Plaintiffs' patents and caused Plaintiffs harm. Specifically, the complaint alleges that Defendant's products satisfy the claims of each patent, Compl. ¶¶ 26-33; 39-47; 53-60; 66-73, and that Defendant 'has committed and continues to commit acts of infringement' with those products that have harmed Plaintiffs, id. ¶¶ 36-37; 50-51; 63-64; 76-77."

Accordingly, the district court concluded that "[t]he allegations are therefore sufficient, at this stage, to establish that Plaintiffs have standing. To the extent Defendant challenges the accuracy of Plaintiffs' jurisdictional allegations, the court finds that the materials offered to controvert them either do not address the allegations regarding the 'first generation device' or are not of evidentiary quality."

As a result, the district court denied the motion to dismiss.

Cardionet, LLC v. Infobionic, Inc., Case No. 1:15-cv-11803-IT (D. Mass. Nov. 20, 2015)