Apotex ordered to provide 180 days’ biosimilar notice to Amgen

Parties are required to provide 180 days’ notice to a patent owner before marketing a biosimilar version of its drug, a US district court has ruled.

The US District Court for the Southern District of Florida ordered a preliminary injunction requiring Apotex, which is seeking to make a version of Amgen’s Neulasta (pegfilgrastim) product, to provide 180 days’ notice.

The ruling follows the US Court of Appeals for the Federal Circuit’s July decision in the dispute between Amgen and Sandoz, which said that the 180-day notice of commercial marketing may not be provided before FDA approval of the biosimilar.

Neulasta is used to treat patients undergoing chemotherapy by helping to boost their white blood cell count.

Apotex had argued that it was not required under the 2009 Biologics Price Competition and Innovation Act (BPCIA) to provide 180 days’ marketing notice to Amgen following the approval of its biosimilar product by the US Food and Drug Administration (FDA).

Section 262 of the BPCIA states that an “applicant shall provide notice to the reference product sponsor (RPS) not later than 180 days before the date of the first commercial marketing of the biological product”.

The dispute rested on the different interpretations of the term “shall” in the statute. Apotex argued that it meant “may” and therefore the notice was not mandatory, whereas Amgen argued that the 180 days’ notice was required by law.

So far, the FDA has not approved Apotex’s Neulasta biosimilar product to enter the market.

Judge James Cohn, presiding over the case, agreed with Amgen in a ruling issued on December 9.

Cohn said that the 180 days’ notice is mandated by Congress in order for an RPS to assess whether patents not identified in early exchanges (commonly referred to as the ‘patent dance’) may be infringed, and provides time to seek a preliminary injunction.

The RPS in this dispute is Amgen.

“The requested preliminary injunction will require Apotex to notify Amgen when and if it receives FDA approval and will prohibit Apotex from marketing the approved product for 180 days after the notice is provided.

“This injunction maintains the status quo and leaves the parties in the position mandated by section 262,” he concluded.