Celltrion, Hospira, J&J, New York University autoimmune, biosimilars news

Johnson & Johnson’s Janssen Biotech Inc. unit and New York University filed a suit in the U.S. District Court for the District of Massachusetts seeking to delay or block the U.S. launch of CT-P13, a biosimilar of J&J’s autoimmune drug Remicade infliximab. The suit alleges Celltrion and Hospira tried to bypass the patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA) by filing two declaratory judgment suits in 2014 seeking protection from patent infringement allegations. The court dismissed one suit, and Celltrion withdrew the other. Janssen and NYU also argue that the defendants refused to provide manufacturing information as required by BPCIA.

Additionally, Janssen and NYU allege that CT-P13 infringes six patents covering Remicade. Two of the patents are co-owned by the plaintiffs, including U.S. Patent No. 6,284,471, which the U.S. Patent and Trademark Office rejected in February, and U.S. Patent No. 7,223,396, which expires June 29, 2016. Janssen owns the other patents, U.S. Patent Nos. 5,807,715; 6,773,600; 7,598,083; and 6,900,056. The ‘396 patent covers methods of producing antibodies and expires Sept. 15, 2015, while the ‘600 patent covers methods of purification and expires June 4, 2023. The ‘083 and ‘056 patents cover cell growth media and expire Feb. 7, 2027, and Oct. 5, 2022, respectively. On Feb. 12, J&J said it had 60 days to respond to the ‘471 rejection. ...