In Re Bendamustine Consolidated Cases, C.A. No. 13-2046–GMS, April 29, 2015

Sleet, J.  Certain defendants’ motion for judgment on the pleadings is granted.

This is an ANDA case involving the generic version of Treanda®.  The two disputed patents claim compositions and preparations that include tertiary-butyl alcohol (“TBA”), which is absent in the defendants’ ANDA products.  The narrow issue presented is whether the doctrine of equivalents arguments are barred by the “disclosure-dedication rule.”  The court first finds that the patents, their file histories, and ANDA filings were all properly before the court in this motion.  The common specification for the two patents contains a list of possible organic solvents, and the specification identifies TBA as the “more preferred solvent” on that list.  The patents claim only TBA from this list.  The disclosure-dedication rule bars plaintiff from arguing infringement on a DOE theory.