Southern District of Florida Rules that 180-Day Notice of Commercial Marketing Is Mandatory When Parties "Patent Dance"
On December 9, 2015, United States District Court Judge James Cohn, in the Amgen v. Apotex Neulasta® litigation, granted Amgen's motion for a Preliminary Injunction barring Apotex from marketing its proposed biosimilar version of Neulasta®. The issue before the court was whether the Biologics Price Competition and Innovation Act ("BPCIA") requires a company filing an abbreviated Biologics License Application ("aBLA") to give the innovator 180-day notice of its intent to market a biosimilar product that has been licensed by the Food and Drug Administration ("FDA").
The BPCIA attempts to establish "an abbreviated pathway for regulatory approval of follow-on biological products that are highly similar" to a previously approved product. Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1351 (Fed. Cir. 2015). This process allows a biosimilar or interchangeable product to be approved using clinical data that was produced and obtained by the sponsor of the approved reference product ("reference product sponsor" or "RPS"). 42 U.S.C. § 262(k)(2)-(5). In exchange, the RPS is granted 12 years of regulatory exclusivity and "the right to file infringement suits based on a biosimilar application prior to FDA approval and prior to marketing of the biological product.'' Sandoz, 795 F.3d at 1352.
Under what has come to be known as the BPCIA's "patent dance," an aBLA filer provides the RPS with a copy of the aBLA and information about the product's manufacturing. 42 U.S.C. § 262(l)(2). The parties then exchange lists of patents they believe may be infringed by the biosimilar product. The RPS then has 30 days within which to file a patent infringement action on the listed patents. Id. § 262(l)(6). The statutory scheme provides that the biosimilar applicant "shall" provide the RPS with 180-day notice of approval before marketing the biosimilar product for sale and use in the United States. Id. § 262(l)(8)(A). This 180-day period "allows the RPS a period of time to seek a preliminary injunction based on patents that the parties initially identified during information exchange but were not selected for the immediate infringement action, as well as any newly listed or licensed patents. Id. § 262(l)(7)-(8).'' Sandoz, 794 F.3d at 1352.
The United States Court of Appeals for the Federal Circuit addressed the meaning of the 180-day notice requirement in Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015). In Sandoz, the aBLA filer did not provide the RPS with its aBLA or manufacturing process as contemplated by §262(l)(2). That is, the aBLA filer chose not to participate in the "patent dance." In such a circumstance, the court found that the use of "shall provide notice" in § 262(l)(8)(A) made the 180-day notice of commercial marketing mandatory. Id. at 1360. The court further found that, where the aBLA filer did not provide the RPS with the aBLA or manufacturing information, the 180-day notice is not effective until after the FDA has licensed the proposed biosimilar product. Id. at 1357-58. Sandoz did not specifically address whether the notice provision of § 262(l)(8)(A) applies where the aBLA filer, like Apotex, did participate in the "patent dance."
In Apotex, the court addressed questions left unanswered by Sandoz: Is the 180-day notice requirement mandatory where the aBLA filer participates in the patent dance and, if so, what is the proper timing for such notice? Judge Cohen found that § 262(l)(8)(A) requires that "Apotex give Amgen proper notice, at least 180 days before first commercial marketing but not before [the] biosimilar product is licensed by the FDA …." Slip Op. at 9 (emphasis added). The court found that a different interpretation "would result in confusion and uncertainty, as well as inconsistent results, depending on which route [an aBLA filer] chooses to travel" and that "neither the statute nor the Sandoz decision condition the 180 day notice provision of § 262(l)(8)(A) upon [an aBLA filer's] compliance with § 262(l)(2)." Id. at 5-6. This interpretation of the BPCIA, the court found, "will likely result in a more crystallized patent litigation." Id. at 7. In so ruling, the court also addressed the need for a defined statutory window for giving notice:
"[G]iving notice after FDA licensure, once the scope of the approved license is known and the marketing of the proposed biosimilar product is imminent, allows the RPS to effectively determine whether, and on which patents, to seek a preliminary injunction from the court. Requiring that a product be licensed before notice of commercial marketing ensures the existence of a fully crystallized controversy regarding the need for injunctive relief. It provides a defined statutory window during which the court and the parties can fairly assess the parties' rights prior to the launch of the biosimilar product." (quoting Sandoz at 1358). That defined statutory window exists for all biosimilar products that obtain FDA licenses, regardless of whether the [aBLA filer] complies with § 262(l)(2).
Id. at 6.
Finally, the court concluded that a mandatory post-licensure notice requirement would not unfairly grant the RPS an additional 180 days of exclusivity, because "[t]hat extra 180 days will not likely be the usual case, as aBLAs will often be filed during the 12-year exclusivity period for other products." Id. at 7.
On December 10, 2015, Apotex filed a Notice of Appeal to the Federal Circuit. Meanwhile, appeal of the Sandoz decision to the United States Supreme Court is widely anticipated, with certiorari petitions to the High Court due by mid-January 2016.
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 The court found that the use of "shall provide" in § 262(l)(2)(A) did not require the aBLA applicant to provide the aBLA and related manufacturing information to the RPS because the statute contemplated alternative procedures. Id. at 1356.