Inevitable Does Not Equal ObviousJuly 21, 2017

Earlier this week, the Unites States Court of Appeals for the Federal Circuit (“CAFC”) held that the United States District Court for the District of Delaware clearly erred in its obviousness analysis in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc, reversing the lower court’s decision and entering judgment in favor of Millennium.

Millennium Pharmaceuticals, Inc. (“Millennium”) sued the defendants under the Hatch-Waxman Act for patent infringement regarding the cancer treatment drug Valcade. The defendants admitted infringement and raised the defense of obviousness to invalidate various claims of the patent. The district court held those claims to be invalid, and Millennium appealed.

Valcade is a drug product formed during the lyophilization of bortezomib in the presence of bulking agent mannitol. Valcade does not have the solubility or stability issues that inhibited the FDA approval of bortezomib.

The district court held that the patent claims were obvious because they were the result of an allegedly obvious process: lyophilizing bortezomib in the presence of mannitol. Further, the district court found that the prior art did not ‘teach away’ this process, but instead ‘pointed to’ it without specific mention. Moreover, the district court reasoned that the natural result of a chemical procedure is inherent in the procedure, and thus the product thereof would be inevitable and therefore obvious.

However, the CAFC found that no prior art, or any other reference, taught or suggested this new product. Valcade is a new compound with distinct properties. While lyophiliztion and bulking agents such as mannitol were all generally known to those skilled in the art, the specific lyophilization of bortezomib in the presence of mannitol was not. Further, the CAFC found that there was no reference that supports the district court’s conclusion that skilled formulators would be motivated to create this compound.

In addition, the CAFC concluded that the district court clearly erred in it consideration of inherency. The CAFC held that foresight or expectation is required, and that non-obviousness may be established when an invention ‘yields more than predictable results.’ The CAFC notes that the existence of a long-unsolved need met by the claimed invention is further evidence of non-obviousness.

For more information or if you have questions, please contact one of our MVS IP attorneys or call us at (515) 288-3667.

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