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# Stakeholders Ask High Court Apotex Hearing
- URL: https://www.fdaweb.com/stakeholders-ask-high-court-apotex-hearing/
- Published: 2016-10-25T12:00:00.000Z
- Updated: 2026-09-14T21:42:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137160

In separate amicus briefs, Mylan and the Generic Pharmaceutical Association’s Biosimilars Council have asked the Supreme Court to hear Apotex’ appeal of a lower court decision in its case against Amgen involving provisions of the 2009 Biologics Price Competition and Innovation Act. Apotex has asked the high court to reverse a Federal Circuit Court of Appeals July ruling that the 180-day commercial marketing notice provision is mandatory even when the parties engaged in the “patent dance.” Three Fish & Richardson attorneys write in an online blog [post](http://www.lexology.com/library/detail.aspx?g=e6e103c9-3da7-4511-9b4c-0212a1578937&ref=fdaweb.com) that both Mylan and the council ask the court to hear the case and rule in favor of Apotex that applicants who have engaged in the patent dance with a reference product sponsor should not need to provide further notice of commercial marketing.

The council says that if Congress intended for patent litigation to occur only after there was a “fully crystalized controversy” post-licensure, as laid out by the appeals court, it would not have permitted infringement suits to be filed shortly after an applicant submits an aBLA. And Mylan says that the law was structured by Congress to allow both parties to begin pre-licensure, thereby resolving all patent disputes between the earliest possible aBLA filing date and the earliest possible aBLA licensure.

The attorneys review other arguments made by both parties, including the council’s position that drug companies developing biosimilars need certainty about what the law requires and what rules govern their efforts to develop biologic therapies.