Source: https://www.pharmapatentsblog.com/2016/04/07/amgen-hedges-its-bets-with-biosimilar-cross-petition-for-certiorari/
Timestamp: 2019-04-24 09:57:26+00:00

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Although Amgen originally did not petition the Supreme Court for certiorari to review the first Federal Circuit decision interpreting the BPCIA framework for resolving biosimilar patent disputes, Amgen now has filed a “Conditional Cross-Petition” for certiorari. Amgen urges the Court to deny Sandoz’s petition for certiorari, but asks the Court to grant its Conditional Cross-Petition if the Court decides to grant Sandoz’s petition. The gist of Amgen’s position seems to be that the 180-day pre-marketing notice issue raised by Sandoz is not ripe for review, but if the Court decides to review that aspect of the Federal Circuit decision, it should consider it in the context of the statutory framework as a whole, including the “requirement” that the biosimilar applicant provide a copy of its application to the reference product sponsor, and review the Federal Circuit’s decision that that “requirement” is optional.
(B) may provide to the reference product sponsor additional information requested by or on behalf of the reference product sponsor.
The Federal Circuit held that the “shall provide” in § 262(l)(2) is optional, while the “shall provide” in § 262(l)(8)(A) is mandatory. You can read more about the Federal Circuit decision in this article.
You can read more about Sandoz’s petition for certiorari in this article.
Other biosimilar cases that may be making their way to the Supreme Court include Amgen v. Apotex, relating to Apotex’s proposed biosimilar of Amgen’s Neulasta® (pegfilgrastim) product. Apotex has appealed the district court’s application of § 262(l)(8)(A), arguing that that requirement to give 180-day pre-marketing notice does not apply if the biosimilar applicant has provided a copy of its application in accordance with § 262(l)(2). The Federal Circuit heard oral arguments in that case on April 4, 2016.
Janssen Biotech, Inc. v. Celltrion Healthcare Co., relating to Celltrion’s biosimilar of Janssen’s Remicade® (infliximab) product, which was approved by the FDA on April 5, 2016, may raise similar and/or different questions under § 262(l), such as whether § 262(l)(2)(A) permits a biosimilar applicant to provide a copy of its application but not information regarding its manufacturing process; whether a biosimilar applicant can circumvent the negotiation procedures of § 262(l)(4) and (5) by consenting to the reference product sponsor’s patent list, and whether providing notice of commercial marketing before a product is approved accelerates the time in which the reference product sponsor must bring suit.
Other biosimilar disputes are bound to raise other issues, as parties try to operate under (or around) the complex provisions of § 262(l). The question is how long the Supreme Court will wait to weigh in, and how parties will adapt to evolving understandings of the statute in the meantime.

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