The US Supreme Court is currently investigating, following a petition from Sandoz, whether the US Court of Appeals for the Federal Circuit read too much into the word "licensed" in a provision of the BPCIA when the majority of a three-judge panel in July 2015 concluded that biosimilars makers must give innovators 180 days' notice of commercial marketing if it did not participate in a "patent dance".

The provision, known as (l)(8)(A), declares that the biosimilars applicant "shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under" the FDA's 351(k) biosimilars pathway, enacted under the BPCIA in 2010.

But Sandoz is arguing that so long as the notice is given 180 days before the 351(k) applicant brings its competing biosimilar to market, the BPCIA provision's plain language "is satisfied."

This case involves Sandoz's biosimilar Zarxio, a version of Amgen Inc.'s Neupogen. A second court case is ongoing between Amgen and Apotex Inc. regarding the latter firm's version of Amgen's long-acting human granulocyte colony-stimulating factor Neulasta (pegfilgrastim) (Also see "Court Probes Rationale Of Biosimilars' 180-Day Notice" - Scrip, 5 April, 2016.).

Sandoz's Carol Lynch Highlights Decade Of Biosimilar Dominance And Plans For Many More Winning Years

More from Business

More from Scrip