New BPCIA Complaint: Amgen Sues Apotex, Again, over Proposed Pegfilgrastim and Filgrastim Biosimilars

Amgen filed a complaint against Apotex today in the Middle District of Florida, alleging infringement of U.S. Patent No. 9,856,287 based on Apotex’s aBLAs for filgrastim and pegfilgrastim biosimilars.

The ’287 patent issued on January 2, 2018 and is directed to methods of protein refolding in non-mammalian expression systems.  According to the complaint, the ‘287 patent issued after Amgen provided Apotex with lists of potentially infringed patents for both aBLAs during the patent dance pursuant to subsection (l)(3)(A), and pursuant to subsection (l)(7), Amgen supplemented its (l)(3)(A) lists with the ‘287 patent on January 31, 2018. The complaint further alleges that on March 2, 2018, Apotex in turn provided its statement pursuant to (l)(3)(B) of reasons why the ‘287 patent is invalid, unenforceable, and/or would not be infringed by its biosimilar product.

Amgen previously sued Apotex for infringement under the BPCIA of another protein folding patent based on these same aBLAs, but Amgen lost those suits last year when the Federal Circuit affirmed the district court’s judgments of non-infringement in favor of Apotex, as covered here.

The ‘287 patent is also being asserted by Amgen in its BPCIA litigation against Adello regarding its filgrastim aBLA.