Janssen’s brief emphasizes two points. First, Janssen asserts that the express statutory purpose of the 180-day notice of commercial marketing is to trigger the innovator’s right to seek a preliminary injunction. According to Janssen, to satisfy this purpose, the requisite notice must be given after the FDA licenses the product for commercial marketing. “A notice that is prior to FDA approval of the biosimilar product is not a ‘notice of commercial marketing’ in any meaningful sense. This kind of premature notice fails to serve the purpose of a ‘notice of commercial marketing’ because it does not provide the innovator notice that commercial marketing is imminent, a prerequisite to a motion for a preliminary injunction under 42 U.S.C. § 262(l)(8)(B).” Second, Janssen emphasizes that Section 262(l)(2)(A) states that a biosimilar applicant “shall” make the information disclosures at issue in this case. Janssen asserts that the mandatory nature of this obligation is underscored by Congress’s use of the permissive “may” in other statutory provisions, when an optional meaning was intended. Accordingly, says Janssen, the BPCIA does not offer the biosimilar applicant the choice between participating in or declining to participate in the statutory patent dispute resolution procedures.
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