Janssen Sues HyClone Laboratories Over Cell Cultures Used to Grow Celltrion’s Remicade Biosimilar

In the ongoing litigation over infliximab biosimilars, Janssen has filed two new complaints alleging infringement of claims in U.S. Patent No. 7,598,083: one against Celltrion and Hospira, and a second against HyClone Laboratories, Celltrion’s Utah-based supplier of cell culture media.  These complaints follow Judge Wolf’s recent order in Janssen’s original case against Celltrion and Hospira allowing Janssen to amend the protective order in that case to allow Janssen to use information produced pursuant to the protective order to institute new proceedings against Celltrion, Hospira and/or HyClone (previously reported here).

In the new complaint against Celltrion and Hospira, filed in the United States District Court for the District of Massachusetts in parallel to the pending litigation there, Janssen is alleging infringement of the ’083 patent through technical acts of infringement under the BPCIA.  According to Janssen, the claims of the ’083 patent cover “particular compositions of cell culture media, the important material that is used to grow the living cells that produce biologic medicines such as infliximab.”

Janssen also sued Hyclone in federal district court in Utah. According to Janssen, HyClone, a subsidiary of GE Healthcare, makes and supplies cell culture media used to manufacture the infliximab biosimilar sold by Celltrion and Hospira. In the complaint, Janssen alleges that:

Celltrion has caused HyClone, Celltrion’s agent and supplier, to develop and manufacture in the United States (Logan, Utah) cell culture media… that infringe claims of Janssen’s [‘]083 patent.  Celltrion has already used these infringing media in the manufacture of large quantities of infliximab biosimilar that have been sold, and are currently being sold, outside the United States and intends to use the infringing media in the manufacture of infliximab product for sale in the United States.  Celltrion’s and Hospira’s infliximab product, as manufactured using the infringing media made by HyClone, was recently approved by the FDA as a biosimilar of Janssen’s Remicade®.  Celltrion controlled the development of the infringing media, directing details of its composition and instructing HyClone to use the combinations of ingredients that together infringe the claims of the [‘]083 patent.”

Janssen is seeking damages and injunctive relief.  Stay tuned to the Big Molecule Watch for further developments.