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« Court Report | Main | Takeda Chem. Indus., Ltd. v. Mylan Labs., Inc. (Fed. Cir. 2008) »

December 15, 2008


"A more intriguing argument by Apotex was that recognition in the art that enantiomers existed provided sufficient motivation to separate them, using known methods, and that routine methods could be used to identify the properties of the separated enantiomers."


You should see the blathering about this case on the Patently-O blog, mainly using the above argument (or something similar) as to why Newman's panel got this wrong. The sort of reasoning proffered by Apotex and others was rejected by the CCPA way back in 1979 in the case of In re Kratz on the "essence of strawberry", better known as 2-methyl-3-pentenoic acid. The Examiner (one who I had many difficult dealings with) argued that discovering what "essence of strawberry" was required merely using standard analytical techniques. What the CCPA said was that's the problem, the PHOSITA didn't know what the "essence of strawberry" was until they carried out those analyses which weren't part of the prior art.

Another thing that's been ignored by many on this thread on the Patently-O blog is "enablement" by the prior art. As Newman's panel carefully noted, the prior art didn't "enable" the claimed stereoisomer in that there was no teaching of how to even separate the stereoisomers. In fact, the panel opinion also noted very carefully how quite a bit of experimentation was required by the inventor(s) before a separation of the stereoisomers could be achieved

Another factor being ignored here is that what was claimed was a particular salt (the hydrogen sulfate/bisulfate salt) because of its tabletting ability (versus the hydrochloride salt which is far more common in the drug field). Let's face it, Judge Newman and the rest of this panel got it quite right this time.

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