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”).
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