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
1360.1 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.
Footnote
1 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.
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