Janssen Biotech claims that HyClone Laboratories infringed their 083 patent for large-scale manufacture of Cellitron’s Remsima outside the US and plans to use the media for the manufacture of Remsima within the US. They believed that the infringement dates back to as early as 2010.

The lawsuit states that ‘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’.

In March 2015, Janssen Biotech, along with New York University, sued Celltrion and Hospira claiming technical infringement by not providing required manufacturer information in violation of the Biologics Price Competition and Innovation Act.

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