J&J autoimmune news
A federal judge in the U.S. District Court for the District of Massachusetts ruled that Johnson & Johnson’s U.S. Patent No. 6,284,471, which covers immune drug Remicade infliximab, is invalid. The decision, which J&J plans to appeal to the U.S. Court of Appeals for the Federal Circuit, removes an obstacle to biosimilar competition for Remicade in the U.S. The judge ruled on a suit filed last year by the pharma’s Janssen Biotech Inc. unit and New York University (New York, N.Y.) against Celltrion Inc. (KOSDAQ:068270, Incheon, South Korea) and Hospira Inc., now part of Pfizer Inc. (NYSE:PFE, New York, N.Y.), seeking to prevent the companies from marketing the biosimilar Inflectra infliximab-dyyb. FDA approved Inflectra in April in all of Remicade’s indications except pediatric ulcerative colitis, for which Remicade has Orphan Drug status. Celltrion and Hospira have agreed to not launch the biosimilar in the U.S. before Oct. 3. The companies already market the biosimilar in Europe as Remsima. J&J’s suit alleged that Inflectra infringes six patents covering Remicade. Among them is the ‘471 patent, which is co-owned by the plaintiffs and expires in September 2018. J&J said the other patents have been dismissed from the suit. ...