Amgen has sued Apotex in connection with Apotex’s efforts to market biosimilar versions of Amgen’s cancer drugs Neupogen (filgrastim) and Neulasta (pegfilgrastim). In a complaint filed on August 7 in the Southern District of Florida, Amgen alleges infringement of U.S. Patent No. 9,856,287.

The lawsuit over the ‘287 patent, a manufacturing patent relating to refolding proteins, is the third time Amgen has sued Apotex in connection with its proposed filgrastim and pegfilgrastim biosimilars. The FDA accepted for review Apotex’s abbreviated Biologics License Applications (aBLAs) for the two products in late 2014 and early 2015. For both products, Amgen and Apotex completed the patent dance, the intricate back-and-forth information exchange provided for in the Biologics Price Competition and Innovation Act of 2009 (BPCIA) that the Supreme Court ruled last year was not mandatory. Amgen then sued Apotex for infringement, bringing one action for each aBLA. Amgen lost a consolidated bench trial.  The court found no infringement by Apotex, and the Federal Circuit affirmed.

Amgen is able to now file a further BPCIA lawsuit because the ‘287 patent issued this year (on January 2, 2018), after completion of the Federal Circuit appeal for the prior actions.  Because the ‘287 patent only issued recently, Amgen did not identify that patent as potentially infringed during its initial patent dance period with Apotex in 2015. The BPCIA provides, however, that a reference product sponsor may supplement its list of potentially-infringed patents if a new patent issues. According to the complaint, Amgen supplemented its lists on January 31, 2018 for both the proposed biosimilar versions of Neupogen and Neulasta, and Apotex provided a response on March 2.  Although Apotex submitted both of its aBLAs years ago, FDA has not approved either proposed biosimilar.  Amgen seeks to enjoin the launch of both products until the expiration of the ‘287 patent.