Organon, the healthcare unit of Akzo Nobel which is being acquired by Schering-Plough, has started legal proceedings in Portugal against the suppliers of two drugs that the Dutch firm claims are infringing its patents on its hormone replacement therapy Livial.
Livial (tibolone) is marketed as a treatment of menopausal symptoms and the prevention of osteoporosis in postmenopausal women and Organon’s lawsuit asserts that Tecnimede-Sociedade Técnico-Medicinal and Grünenthal, as well as the manufacturer of both the generic products in question –West Pharma – infringed a number of patents relating to tibolone which it claims are protected from dates ranging from March 2010 to May 2024.
Organon has already taken a Korean company to court in order to get an injunction to stop its generic version of Livial in a case similar to the legal action now started in Portugal. The company is also appealing decisions in Korea and Scotland and one by the European Patent Office to revoke patents covering Livial and has already chalked up a victory in a case in Mexico.
Tibolone is available in 90 countries but has never made it past the US Food and Drug Administration. It rejected Livial for the treatment of menopausal symptoms in women last June, prompting Organon to withdraw its application in the country