Apotex cleared of Amgen patent infringement in Florida

The US District Court for the Southern District of Florida ruled yesterday that Apotex did not infringe Amgen patents centring on its biologic drug Neulasta (pegfilgrastim).

Amgen sued Apotex back in August 2015 for allegedly infringing two of its patents, US numbers 8,952,138 and 5,824,784.

Four months earlier, in April 2015, Apotex had sent Amgen a notice of commercial marketing—an intent to sell a biosimilar version of the drug.

In the notice, Apotex did not specify a date on which it intended to bring the biosimilar to market.

In order to comply with the demands for a company bringing a biosimilar to market, Apotex must provide notice to Amgen at least 180 days before the date of its first commercial marketing of the biosimilar product.

The 180 days’ notice demand was established following the Amgen v Sandoz dispute, a separate biosimilars case held in the US Court of Appeals for the Federal Circuit.

The Federal Circuit further said that an applicant may only give notice of commercial marketing after the US Food and Drug Administration has licensed its product.

In the case in Florida, Apotex had claimed that Amgen’s patents were not valid, but the court ruled that the patents were valid, despite not being infringed.