Source: https://www.pharmapatentsblog.com/2016/02/18/sandoz-asks-supreme-court-reverse-biosimilar/
Timestamp: 2019-04-20 10:35:20+00:00

Document:
On February 16, 2016, Sandoz, Inc. filed a petition for writ of certiorari to the Supreme Court, asking the Court to overturn the Federal Circuit decision that interpreted the “patent dance” provisions of the Biologics Price Competition and Innovation Act (BPCIA) as requiring the biosimilar applicant to give 180 days’ pre-marketing notice that cannot be given until after the FDA has “licensed” (approved) the biosimilar product. The Supreme Court may be inclined to hear this case, since it involves an important provision of the BPCIA, and because the decision in effect delays the commercial availability of less expensive biosimilar products that the BPCIA was enacted to provide.
Amgen did not petition the Supreme Court to review the Federal Circuit decision regarding the patent dance, but Sandoz has sought review of its decision as to pre-marketing notice.
After receiving the notice under subparagraph (A) and before such date of the first commercial marketing of such biological product, the reference product sponsor may seek a preliminary injunction prohibiting the subsection (k) applicant from engaging in the commercial manufacture or sale of such biological product until the court decides the issue of patent validity, enforcement, and infringement with respect to any patent that is [included in either of the first lists but not included on the agreed upon list or the second lists].
We agree with Amgen that, under paragraph (l)(8)(A), a subsection (k) applicant may only give effective notice of commercial marketing after the FDA has licensed its product. The statutory language compels such an interpretation. It means that notice, to be effective under this statute, must be given only after the product is licensed by the FDA.
Judge Chen dissented from this portion of the decision, based on his view that § 262(l)(8) only comes into play if the patent dispute resolution procedures of (l)(2)-(7) have been followed. Judge Chen suggested that the majority’s position on this issue gives reference product sponsors a “windfall” by effectively extending the 12-year period of market exclusivity embodied in the BPCIA an additional 6 months.
Addressing the “licensed” term that the Federal Circuit focused on, Sandoz argues that the phrase “biological product licensed under subsection (k)” simply distinguishes a biosimilar product from a biological product licensed under subsection (a) (e.g., an original biological product). Sandoz also argues that the Federal Circuit’s interpretation “disrupts the careful balance struck by Congress,” by in effect extending the 12-year exclusivity period of § 262(k)(7)(A) by an additional 180 days.
Can 42 USC § 262(l)(8)(A) Stand Alone?
As explained in this article, the dispute between Amgen and Apotex over Apotex’s biosimilar version of Amgen’s Neulasta® (pegfilgrastim) product raises a similar but different issue regarding the pre-marketing notice requirement. In that case, Apotex agreed to litigate all the patents proposed by Amgen, and argued that it is not required to provide pre-marketing notice under § 262(l)(8)(A), since there are no other patents that Amgen could assert under § 262(l)(8)(B). The district court ruled in favor of Amgen on that issue, applying the Federal Circuit decision in Amgen v. Sandoz. The Federal Circuit is hearing Apotex’s appeal on an expedited basis.
If one of the parties to that case petitions for Supreme Court review, it is possible that the Court could review both cases, and provide important guidance on the meaning of § (l)(8)(A), and when an approved biosimilar product is permitted to enter the market.

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