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Preliminary Thoughts on the Implications of Prometheus v. Mayo for Biotechnology

1 Readers' Comments

Posted by: Michal Svoboda

07/08/2012

Amidst the general outcry on the Prometheus ruling and sofisticated law finesses the main reason why the patent should never have been granted - obviousness - has never been mentioned.

"Those skilled in the art" know well the therapeutic drug monitoring is widely used for at least half a century (see e.g. a review by S.L.Cohan at http://www.ncbi.nlm.nih.gov/pubmed/6809398). Those skilled in the art also know all too well that if the drug level itself is not a meaningful measure of efficacy or toxicity a suitable metabolite should be sought for.

The takehome lesson for the industry is that we should concentrate on improvement in the method of to determine the drug level, where there is ample field for radical innovation rather than trying to patent the obvious principle.

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MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.

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