Janssen hits Celltrion and Hospira with biosimilar suit

Pharmaceutical company Janssen has sued drugs businesses Celltrion and Hospira in one of the first patent infringement actions brought under the Biologics Price Competition and Innovation Act (BPCIA).

The suit was filed last Friday (March 6), on the same day the US Food and Drug Administration (FDA) approved the first biosimilar for use in the country.

The BPCIA was enacted in 2009 and provides a shorter regulatory pathway for the approval of biosimilars, which are versions of biologic drugs.

Janssen’s suit concerned Remicade (infliximab), an antibody-based therapy that can be used to treat Crohn’s disease, rheumatoid arthritis and ulcerative colitis, among other conditions.

Celltrion had earlier sought to make and sell a biosimilar version of Remicade, which it plans to market as Remsima through its partner company Hospira.

In its complaint, filed at the US District Court for the District of Massachusetts, Janssen accused Celltrion of infringing six patents related to Remicade, as well as refusing to follow the dispute resolution provisions of the BPCIA.

Celltrion last year brought two—now dismissed—actions for declaratory judgment of non-infringement or invalidity of the Remicade patents, in what Janssen described as an effort to “short-circuit” the BPCIA process.

In August 2014 the biosimilar makers sent an abbreviated biologic licence application (ABLA) to the FDA for permission to make and sell its biosimilar version of Remicade. The FDA accepted the application for review in October.

However, they did not notify Janssen that their application had been accepted for review or provide Janssen with a copy of the ABLA. They also failed to negotiate with Janssen over which patents should be subject to any possible litigation Janssen might bring, as is required under the BPCIA.

Janssen has now asked the court for a declaration that Celltrion and Hospira did not comply with the BPCIA’s patent dispute resolution process, and for a preliminary or permanent injunction stopping them from marketing a biosimilar version of Remicade until 180 days after they provide Janssen with a notice that they have received a licence to do so.

It has also sought a judgment that Celltrion and Hospira infringed the six patents and asked for any damages incurred by the companies’ actions.

“Janssen will continue to defend its intellectual property rights relating to its medicines,” a spokesperson for Janssen told LSIPR. He added that one of the patents at suit remains valid and enforceable as it undergoes a reexamination proceeding at the US Patent and Trademark Office.

Celltrion did not respond to LSIPR’s request for comment.