Astellas sues Spanish generics companies over patent infringements

Astellas Pharma Europe, the European affiliate of Japanese drug major Astellas, has instituted legal proceedings at the Juzgados de los Mercantil of Madrid, Spain, against the generic pharmaceutical companies Ratiopharm Espana SA, Laboratorio Stada SL, Laboratorios Edigen SA, Merck Genericos SL, Bexal Farmaceutica SA, Sandoz Farmaceutica SA and Teva Genericos Espana SL, which have launched or are expected to launch modified-release hard capsules with the active ingredient tamsulosin HCl on the Spanish market.

Astellas says it is the holder of a Spanish patent protecting a galenic process for manufacturing pharmaceuticals with the active ingredient tamsulosin HCl. Two products manufactured in accordance with this patent are legally marketed by Astellas and its licensee, Boehringer Ingelheim, on the Spanish market under the brand names Omnic and Urolosin. Before instituting the legal proceedings, Astellas says it has been confirmed that the capsules of the generic tamsulosin products that thus far have been launched on the Spanish market have the same relevant characteristics as the original capsules. The firm has, therefore, alleged before the Spanish court that the modified-release hard capsules of the above-mentioned generic companies fall in the scope of Astellas' patent.

Others have agreed to respect patent