On September 9, 2016, Apotex Inc. filed a petition for writ of
certiorari in the U.S. Supreme Court seeking review of the
Federal Circuit's decision in Amgen Inc. v. Apotex
Inc., Case No. 2016-1308. This case involves
Apotex's proposed filgrastim product, which is a biosimilar
version of Amgen's Neulasta®. At issue is
whether the 180-day "Notice of Commercial Marketing"
period provided by 42 U.S.C. § 262(l)(8)(A) of the
BPCIA is always mandatory, and whether the Federal Circuit's
decision improperly extended the 12-year exclusivity period for
reference product sponsors from 12 to 12 ˝ years by holding
that a biosimilar applicant cannot give effective Notice of
Commercial Marketing for its biosimilar product until after
it receives FDA license approval.
As previously discussed on this blog, the Federal Circuit held
in Amgen Inc. v. Apotex Inc. that even
though Apotex participated in the "information exchange"
(a.k.a. the "patent dance") envisioned by §
262(l) of the BPCIA, the statute's "requirement
of 180 days' post-licensure notice before commercial marketing
... is a mandatory one enforceable by injunction."
The Federal Circuit's decision in Apotex was
consistent with its previous holding in
Amgen Inc. v. Sandoz Inc., which similarly held that the
180-day notice period was required by the language of the
statute. The facts of that case, however, differed from those
of Amgen v. Apotex in that Sandoz deliberately chose not
to participate in the information exchange intended under §
In its petition for certiorari, Apotex argues that the
Federal Circuit misread the text of BPCIA, thereby frustrating
Congress's intent to balance innovation with cost-saving
competition from approved biosimilar products. According to
Apotex, the Federal Circuit has, in effect, "functionally
extended the 12-year exclusivity period by an extra six
months," thereby disrupting Congress's carefully crafted
balance by "put[ting] a thumb on the scale in favor of the
reference product sponsors." According to Apotex, the fact
that they engaged in the disclosures set forth in §
262(l) of the BPCIA means that the Notice of Commercial
Marketing provision under § 262(l)(8)(A) effectively
"serves no purpose." Because Apotex provided Amgen
with a pre-licensure notice of commercial marketing, thereby
informing Amgen of its intentions with respect to the biosimilar
product, Apotex contends that Amgen had all in information it
needed with respect to defense of its patent rights.
Therefore, Apotex concludes that the Federal Circuit's concerns
regarding "a race to court" and "hurried motion
practice" that the 180-day period was designed to alleviate
Apotex urges the Court to grant the petition in this case as
well as the related petition for certiorari filed in Amgen Inc.
v. Sandoz Inc. With respect to the Sandoz
petition, the High Court has asked the U.S. Solicitor General to
provide comments regarding whether the petition should be
A decision on the petitions in both the Sandoz and
Apotex cases could come as early as the end of this year,
but more likely will come in early to mid-2017.
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