Sam Chun Dang Pharm(000250) said on the 18th that it signed a global settlement agreement with U.S.-based Regeneron Pharmaceuticals and Bayer Consumer Care regarding "SCD411," a biosimilar of the macular degeneration treatment "Eylea."
The company said, "Under this settlement, ongoing patent lawsuits and opposition proceedings before the Korean Intellectual Property Office and the European Patent Office (EPO) in Europe, Japan, Korea and elsewhere will be concluded."
Sam Chun Dang Pharm has been engaged in legal disputes over patents with Regeneron ahead of the commercialization of SCD411.
In particular, in the United States, it said in Feb. that it had ended the patent dispute through a settlement via its local partner, but uncertainty remained over whether the dispute had fully ended as Regeneron continued discovery procedures against Sam Chun Dang Pharm's U.S. subsidiary.
In Apr., Regeneron asked the U.S. District Court for the District of Delaware to order Sam Chun Dang Pharm's U.S. subsidiary to produce an Eylea-related biologics license application (BLA) and manufacturing process records. Sam Chun Dang Pharm sought to vacate the discovery order and quash the subpoena, and in Jul. the court separated this request into a separate case for hearing.
Eylea, developed by Regeneron and Bayer, is an ophthalmic treatment used for wet macular degeneration and diabetic macular edema. As patents have expired in key countries, competition among biosimilar companies has intensified.