24 Jul 2012, 17:30
let me take this opportunity to re-iterate some of my eariler observations regarding the efficacy data, specifications provided by the patent applicants. i wont jump to conclusion and would refrain from commenting on the gilead's td case, as i am not privy to gilead's version of the whole affair. but from my personal experience in handling such matters, i can say that (1)on the one hand, interpretation and implementation of section 3(d) requires impartiality/objectivity and even section 3(d) itself needs to be tweaked (may b, somewhat like what shamnad has proposed) to bring about that impartiality, (2)but on the other hand, the pharma mncs, too, need to realise two things, (i)evergreening shall no longer be permitted and (ii)one can no more take the indian patent system for granted (esp. as far as disclosure of data on efficacy and wordings of specifications and claims are cponcerned). regarding the sub-point no.(ii), i have observed from my practical experience that many a times the pharma biggies have taken things lightly and not provided sufficient data on efficacy (despite having them in their possession). mncs need to be careful, esp. in the light of the stricter (or slightly over-zealous/skewed?) interpretation/implementation of section 3(d). the indian patent regime may b right in attempting to prevent evergreening/incremental improvements thru section 3(d), but the limited interpretation of efficacy ("therapeutic efficay", per novartis judgment) is unfortunate. so, beware pharma mncs, as u ve to bear the brunt of the maturing (e.g. section 3(d)) new indian patent regime, which has some inevitable side-effects (e.g. "therapeutic efficacy"), too.