Janssen further argues that the notice of commercial marketing must be considered mandatory in order to achieve the "statutory purpose" of "ensuring a 'fully crystallized controversy regarding the need for injunctive relief'" by providing a "pre-launch notice period to allow [the reference product sponsor] to assess the need for and seek such relief." The declaratory judgment remedy provided for in the statute, which Celltrion has argued is Janssen's sole remedy to redress Celltrion's alleged violation of the notice provision, is not an adequate remedy, Janssen argues, because it "does not address the irreparable injury of launch."