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Apotex to Supreme Court: Review BPCIA 180-Day Notice Requirement

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 ½ 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 § 262(l).

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 are misplaced.

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 granted.

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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Thomas H. Wintner is an intellectual property and commercial litigator at Mintz. Tom handles cases in trial and appellate courts, counseling clients in life sciences, health care, education, real estate, and other sectors. He has extensive experience with patent litigation and other IP matters.