Janssen drops biosimilar suit against Samsung
Janssen, a subsidiary of Johnson & Johnson, has dropped a lawsuit against Samsung's biopharmaceutical arm Samsung Bioepis.
Janssen sued Bioepis in May at the US District Court for the District of New Jersey, accusing the company of infringing a patent on Janssen’s arthritis-treating biologic Remicade (infliximab).
According to the claim, Bioepis’s abbreviated Biologic License Application (aBLA) was accepted for review by the Food and Drug Administration in May last year, and was approved in April 2017.
Janssen accused Samsung’s biopharmaceutical arm of infringing three patents: US numbers 7,598,083, titled “Chemically defined media compositions; 6,900,056, called “Chemically defined medium for cultured mammalian cells”; and 6,773,600, named “Use of clathrate modifier, to promote passage of proteins during nanofiltration”.
According to the suit, Bioepis also failed to provide its aBLA and manufacturing information to Janssen as required under the BPCIA.
The suit added that Bioepis entered into an agreement with Merck in 2013 under which Merck obtained the rights to market the biosimilar infliximab in the US.
On Friday, November 10, Janssen submitted a stipulation of voluntary dismissal, explaining that it had proposed the dismissal and Bioepis had agreed.
All claims and defences pending over the three patents were dismissed.
A spokesperson for Janssen said: “Earlier this year, we filed a lawsuit against Bioepis to investigate whether their biosimilar infliximab infringes on our manufacturing process patents for Remicade.
“Upon review of Samsung’s aBLA and manufacturing information, we determined that their manufacturing processes do not infringe. We have therefore withdrawn our lawsuit.”
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