Isis Pharmaceuticals, Gilead, Merck infectious news
Gilead filed suit against Merck and Isis in the U.S. District Court for the Northern District of California seeking declaratory judgment that Gilead's sofosbuvir does not infringe U.S. Patent Nos. 7,105,499 and 8,481,712. Merck and Isis are both listed as assignees on the two patents, which cover nucleoside analogs inhibitors of RNA viral polymerase. Sofosbuvir, a single isomer form of a nucleotide analog HCV NS5B polymerase inhibitor, is under review in the U.S. to treat chronic HCV infection.
According to Gilead's complaint, Merck sent a letter on Aug. 5 stating that Gilead would need to license rights to the '499 and '712 patent to commercialize sofosbuvir and pay Merck 10% royalty on net sofosbuvir sales until the patents expire. Gilead said it believes Merck's license demand is prohibitive and is meant to threaten Gilead with the prospect of a patent infringement suit "on the eve" of sofosbuvir's Dec. 8 PDUFA date. Gilead noted that if approved, sofosbuvir will directly compete with Merck's HCV drug Victrelis boceprevir. Merck recorded $226 million in 1H13 sales of Victrelis, a small molecule HCV NS3/4A protease inhibitor. ...