Teva invalidate patent covering method of use and Kit on Alendronate sodium in Netherlands and France

Teva Pharma announced (Feb 25, 2008) the following decisions by two European courts: On February 13, 2008, the Hague District Court in the Netherlands, decided to revoke the Dutch part of Merck 's European Patent no. EP1175904 which covers methods for inhibiting bone resorption in mammals while minimizing the occurrence of or potential for adverse gastrointestinal effects. Also disclosed are pharmaceutical compositions and kits for carrying out the therapeutic methods disclosed herein. The compounds are bisphosphonates selected from the group consisting of alendronate, cimadronate, clodronate, tiludronate, etridronate, ibandronate, risedronate, piridronate, pamidronate, zolendronate, optionally in combination with a histamine H2 antagonist. due to lack of inventive step, which relates to Fosamax(R) Once Weekly (Alendronate 70mg Once Weekly). This decision is the first European court decision on the merits of this patent, which is currently being litigated by Teva in Belgium, France, Italy, Sweden and Spain as well as in the European Patent Office. On February 15, the Tribunal de Grande Instance de Paris, decided that Merck's supplementary protection certificate SPC 96C0032 covering the use of Alendronate for the treatment of Urolithiase and Bone Resorption was invalid for lack of inventive step. Both decisions may be appealed. Teva's Alendronate products are a subject to multiple European litigations between MSD, Teva and other parties, relating to both Alendronate 10mg and Alendronate 70mg. Teva is already marketing Alendronate 10mg and 70mg in various European countries.