This past week, Sandoz answered Schering-Plough’s patent lawsuit titled In Re Descloratadine Patent Litigation (MDL No. 1851 Civil Action No. 07-3930), by asserting, among other matters, that both of the principal patents Schering relies upon in manufacturing and marketing the Clarinex® products (the so-called ‘463 patent, and the ‘274 patent) are invalid — and thus unenforceable, at least as to Sandoz — chiefly for procedural defects in the way Schering handled its FDA Orange Book notices, and then subsequently failed to include some of the materials listed in the Orange Book submissions — in its infringement complaint against Sandoz.
The Sandoz answer also asserts that the so-called ‘274 patent held by Schering is generally invalid, and thus presents no barrier to Sandoz’s planned generic Descloratadine [or, Clarinex®-equivalent] product.
Interesting. As ever, more to come.