Many composition-based inventions stem from the discovery of useful but previously unknown properties of the composition. When such a composition is patented, infringers are often tempted to dismiss the patent as merely claiming inherent characteristics of the composition or its components. Two cases demonstrate why this type of challenge commonly fails.
One case involved U.S. Patent No. 6,713,446, which covers VELCADE, an oncology prodrug developed at the U.S. Dept. of Health and Human Services (DHHS). VELCADE is the D-mannitol ester of N-(2-pyrazine) carbonyl-L-phenylalanine-L-leucine boronic acid. Upon administration to a patient, VELCADE releases the boronic acid as an active ingredient, which is a proteazome inhibitor known commonly as bortezomib. Bortezomib is known to be unstable, particularly in liquid formulations, and for this reason, it could not be transported, stored, or administered without losing its activity. The inventor of VELCADE, Shankar Lal Gupta, found that esterification of bortezomib with D-mannitol eliminates these problems. He also found that simply lyophilizing a mixture of these two components forms the ester.
Millenium Pharmaceuticals, Inc. is the exclusive licensee of the patent. When Sandoz, Inc., Apotex, Inc., Teva Pharmaceuticals, and other generics manufacturers sought to enter...
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