Samsung's Biosimilar Manufacturing Documents Lead Janssen To Drop Infringement Suit
Janssen concludes the manufacturing processes for Renflexis do not infringe its Remicade patents, clearing Samsung and partner Merck from potential damages resulting from their at-risk launch of the biosimilar; innovator's legal action remains against Inflectra partners Pfizer and Celltrion.
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Oral arguments suggest Janssen may have difficulty getting reversal of district court and patent office rulings that its composition patent is invalid.
Merck & Co. launched Renflexis in the US, marking the first time two biosimilars will compete for share against a brand, in this case J&J's Remicade.
Hoping to hold off a biosimilar to Remicade, Janssen challenges Samsung's decision not to participate in patent dance as it claims infringement of three manufacturing patents.