Posts Tagged: "intent to market"

The Supreme Court is currently considering whether to review Amgen Inc. v. Sandoz Inc., the Federal Circuit’s first decision regarding the Biologics Price Competition and Innovation Act (BPCIA). Although the Federal Circuit does not technically have any input into the Supreme Court’s grant or denial of certiorari, it nonetheless took the opportunity last week to bolster one of the challenged holdings: that a biosimilar applicant cannot provide its biologic competitor with 180 days’ notice of intent to commercially market a biosimilar product until that product is licensed. Specifically, in the course of ruling in Amgen Inc. v. Apotex Inc. that a biosimilar applicant must provide such notice even if it participated in the BPCIA’s so-called “patent dance,” the Federal Circuit addressed a primary criticism of its earlier decision, namely, that permitting only post-licensure notice effectively extends by 180 days the twelve-year exclusivity term of the biologic product. The solution suggested by the panel, however, is far from a legal certainty.