Sunday, August 10, 2008

Sandoz seeks Declaratory Judgment that Schering-Plough's Clarinex® Patents are Invalid. . . .


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.

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