FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs / Commercial Operations

Janssen Loses Patent Dispute Over Remicade, Plans to Continue Fight

Aug. 23, 2016
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A federal judge rendered Janssen’s composition patent for Remicade invalid, marking a loss for the company engaged in ongoing efforts to block biosimilar competition.

Janssen, a Johnson & Johnson unit, plans to take the patent case to the U.S. Court of Appeals for the Federal Circuit. “Janssen will continue to defend its intellectual property rights relating to its innovative medicines,” Johnson & Johnson said in a statement Wednesday. “A commercial launch of an infliximab biosimilar prior to the outcome of the appeals would be considered an at-risk launch.”

Judge Mark Wolf of the U.S. District Court for Massachusetts rejected Janssen’s ’471 patent, which covers Remicade’s infliximab anti-TNF antibody, on the grounds that the composition was obvious due to its disclosure in a previous patent.  The decision clears a hurdle for Celltrion to sell its biosimilar Remsima and for Hospira to market its copycat Inflectra.

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