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Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.
In a lawsuit against Celltrion, Janssen alleges the GE subsidiary infringed one of Janssen’s patents covering the method of making the cell-culture media that HyClone later supplied to Celltrion.
In a lawsuit meant to block Celltrion’s Remsima, a biosimilar to Janssen’s Remicade (infliximab), Janssen names the GE subsidiary HyClone Laboratories as unlawfully making a cell-culture media for Celltrion that is protected by Janssen’s 083 patent. The lawsuit claims Celltrion used this infringing media for the large-scale manufacture of Celltrion’s version of infliximab outside of the United States and plans to use the same media for the manufacture of Celltrion’s infliximab biosimilar within the US. Celltrion’s infliximab biosimilar was recently approved by FDA.
Specifically, the lawsuit says, "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." Although Janssen claims it asked HyClone to share the details of composition of the media in question, HyClone refused to disclose composition details, saying that it was “custom-made for Celltrion.” Janssen, however, claims that with the information it obtained about the culture media used by HyClone, it had a valid claim of infringement against HyClone. The suit says at least four HyClone employees that worked with Centocor also worked with Celltrion on its cell-culture media, and HyClone has been infringing Janssen’s patent since as early as 2010.
Janssen lawyers wrote that Hospira may also be liable for infringement “at least as an inducer,” as Hospira was unable or unwilling to provide documentation of its knowledge of the use of the media in question for the manufacture of its biosimilar version of infliximab, Inflectra. The suit alleges that “Hospira knows that ordering infliximab from Celltrion causes the infringement by Celltrion and HyClone of the claims of the 083 patent,” and that ordering infliximab from Celltrion after having this knowledge is grounds for legal action.
The media formulation, which was produced by Janssen predecessor Centocor, is capable of sustaining a high level of cell growth, according to court documents. It calls for 52 required ingredients and 9 optimal ingredients. Centocor shared the confidential formulation information covered by the 083 patent with HyClone in 2003. HyClone acknowledged the media formulation was a job well done, the lawsuit claims: "HyClone congratulated Centocor on Centocor’s successful design of the 083 media." Nevertheless, Centocor decided not to use HyClone's services for the mass production of Remicade.