Amgen Files New BPCIA Lawsuit Over Mylan's Pegfilgrastim

Amgen has filed a news Biologics Price Competition and Innovation Act (BPCIA) suit against rival drug maker Mylan. Amgen claims that Mylan has infringed on 2 US patents: 8,273,707 and 9,643,997, which cover processes and methods of purifying proteins.

The complaint indicates that Mylan submitted its Abbreviated Biologics License Application (aBLA) to the FDA prior to the expiration dates of the 2 patents in question, and that Amgen had included both patents in its disclosures under the BPCIA’s so-called “patent dance.” According to Amgen’s complaint, Mylan committed an act of infringement by submitting its aBLA prior to the expiration of the patents that Amgen identified in its disclosures.

In its complaint, Amgen states that Mylan, in developing a biosimilar product, is “piggybacking on the fruits of [its] trailblazing efforts,” and that the manufacture, use, or sale of a biosimilar pegfilgrastim within the United States while Amgen’s patents remain valid will “cause injury to Amgen, entitling it to damages or other monetary relief.” Amgen asked the court for an order enjoining Mylan from infringing on either patent.

Mylan is not the only biosimilar pegfilgrastim developer currently engaged in litigation with Amgen; last month, Coherus sought a stay in its own BPCIA litigation over CHS-1701. However, while Amgen has fought against alleged patent infringement from biosimilar challengers, it has yet to face a US competitor for the drug; the FDA rejected Coherus’ pegfilgrastim biosimilar and issued a complete response letter (CRL) in June of 2017. The FDA asked Coherus to perform a reanalysis of a subset of samples with a revised immunogenicity assay, and to provide additional details concerning manufacturing processes. It is not yet clear whether Coherus will resubmit its drug to the agency.

Also rejected by the FDA was Sandoz’s proposed pegfilgrastim biosimilar, Zioxtenzo. Sandoz did not disclose the content of its July 2016 CRL, but said that it was “working with the agency to address remaining questions.”

The fact that Mylan and Biocon withdrew their application to the European Medicines Agency (EMA) for the pegfilgrastim biosimilar candidate at issue in the patent infringement lawsuit has raised questions as to whether Mylan’s drug will succeed at being the first FDA-approved biosimilar to Neulasta. In August, Mylan and Biocon said that the EMA would require a re-inspection of its manufacturing plant after a French regulatory inspection identified 11 “major deficiencies” at the facility. Mylan and partner Biocon announced in February of 2017 that the FDA had accepted the companies’ aBLA for the pegfilgrastim biosimilar under the 351(k) pathway, and that a regulatory decision was expected by October 9, 2017.