Remicade Patent Fight: Janssen Loses Big, But Pfizer Not Out Of Woods
Pfizer would still be at risk for damages from biosimilar launch if Janssen's manufacturing process patent is upheld even as US Federal Circuit affirms that patent covering Remicade's active ingredient is invalid.
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In several firsts last year, US Supreme Court ruled on BPCIA, Amgen won a damages award in infringement litigation, and Amgen and Mylan inked deals clearing way for future launch of Humira and Herceptin biosimilars. Chart includes status of 15 cases and questions teed up for courts to tackle in 2018.
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.
Oral arguments suggest Janssen may have difficulty getting reversal of district court and patent office rulings that its composition patent is invalid.