As we’ve reported previously, the parties in Amgen v. Apotex have completed the first wave of the BPCIA patent dance and are now litigating the first round of patent infringement claims. In its complaint, Amgen also alleged that Apotex provided Amgen with an “ineffective” Notice of Commercial Marketing pursuant to 42 U.S.C. § 262(l)(8)(A), because “a subsection (k) applicant may only give effective notice of commercial marketing after FDA has licensed its product” and Apotex’s product “has not yet been licensed by FDA.”
In its Answer to the complaint (covered here), Apotex claimed that notice of commercial marketing under (l)(8) is not mandatory when a biosimilar applicant has complied with the initial disclosure step of the patent dance by providing its biosimilar application and manufacturing information.
Amgen has now announced its intention to move for a preliminary injunction “to enforce [the notice] provision of the BPCIA.” In a joint motion, the parties explain that their disagreement about the notice issue is “time-sensitive: Apotex asserts that FDA’s decision regarding Apotex’s BLA application could be issued at any time.” Since Apotex has taken the position that it can begin commercial marketing immediately upon FDA approval of its biosimilar product (vs. not launching until 180 days after receiving approval and giving Amgen notice of commercial marketing), “Amgen … intends to move quickly for a preliminary injunction compelling Apotex to provide notice to Amgen, after FDA approval and at least 180 days’ notice before the first commercial marketing of Apotex’s biosimilar pegfilgrastim product.”
The joint motion requests a hearing and briefing schedule on Amgen’s forthcoming motion for a preliminary injunction. The parties agree that with regard to the expected motion, the likelihood-of-success-on-the-merits inquiry is purely a question of law involving interpretation of the BPCIA notice provision, § 262(l)(8)(A). The parties stipulate to a resolution of the other preliminary injunction inquiries in Amgen’s favor, as follows:
- (i) solely for the purposes of Amgen’s preliminary injunction motion, Apotex will not dispute that Amgen would be irreparably harmed if Apotex were to commence commercial marketing of its biosimilar pegfilgrastim product without providing notice under 42 U.S.C. § 262(l)(8)(A) after FDA approval of the product and at least 180 days prior to commencing such commercial marketing;
- (ii) if the Court finds in favor of Amgen regarding likelihood-of-success-on-the-merits, the balance of hardships favor[s] Amgen; and
- (iii) if the Court finds in favor of Amgen regarding likelihood-of-success-on-the-merits, Apotex will not dispute that the public interest favors the issuance of an injunction.
Furthermore, “in order to give the Court time to address these issues, the parties have stipulated that Apotex will not ‘commercially manufacture, use, offer to sell or sell within . . . or import into the United States its biosimilar pegfilgrastim product in the United States through’ an agreed-upon date.” (That agreed-upon date has been omitted from the public record; see the parties’ Joint Motion to File Under Seal the parties’ Joint Stipulation Regarding Commercialization and Schedule, here.)
Amgen’s preliminary injunction motion is expected October 16, 2015, according to the parties’ proposed schedule for briefing. We will continue to monitor developments in this case here on the Big Molecule Watch.