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Comments
Zureis 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.
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