The Johnson & Johnson (J&J) unit made the accusation against HyClone in a lawsuit (16-cv-00071-BCW) filed in the Utah District Court.
Janssen also filed a suit against Celltrion (1:16-cv-11117), accusing the biosimilar manufacturer of causing HyClone to infringe its patent.
“Celltrion has caused HyClone, Celltrion’s agent and supplier, to develop and manufacture in the United States (Logan, Utah) cell culture media (“Celltrion media” or “Celltrion custom-made media”) that infringe claims of Janssen’s 083 patent.”
The suits were prompted by information Janssen obtained during a separate, ongoing lawsuit it brought against Celltrion and partner Hospira (1:15-cv-10698) in light of their efforts to launch a Remicade biosimilar in the US.
The medium covered by US patent 7,598,083 is used to culture the cells that produce Remicade. It was developed by Centocor, Janssen’s predecessor.
HyClone was hired to make test batches of the Remicade medium in 2003 in a deal that saw Centocor provide formulation information under a confidentiality agreement.
Centocor filed for US patent protection for the medium in October 2004.
Despite being pleased with the results of the development work Centocor decided not to use HyClone as a supplier.
According to Janssen, Celltrion and HyClone started developing culture media in 2003 “a number of months after Centocor had retained HyClone, and less than one month before Centocor provided HyClone the formulation of the 083 media.”
The firm also says “At least four of the same HyClone employees that worked on the cell culture media project for Centocor also worked on the development of Celltrion’s cell culture media.
“HyClone did not disclose to Centocor that it was collaborating with Celltrion or that its employees who worked on Centocor’s media were helping to develop media for Celltrion.”
A GE spokesman told us "GE Healthcare is cooperating fully in this case. Respect for intellectual property rights and ethical business practices are an integral part of how GE Healthcare does business. It would be inappropriate to comment further on pending litigation at this time."