Varun Chhonkar has this great post at Patent Circle, where he highlights two critical Indian patents that Cipla received for a Fosamax derivative (alendronate) and a Nexium derivative (esomeprazole). He questions as to whether the section 3(d) hurdle was as rigorously applied to Cipla, as it is to the various MNC's, who have, in the recent past, been at the receiving end of this potent section. The Economic Times seems to have picked up in Varun's post here.
Reading the ET piece, Nathan Evans of Finnegan Henderson, who's a very astute commentator on the Indian patent scene and has written a couple of articles in this regard posed this question to me:
"This makes me wonder if the patent office in India will apply the laws less strictly to Indian pharmas than MNCs (kind of like they apply the patent laws more strictly for essential medicines)"
We might get to some kind of a reasonable answer to Nathan's query, only after we've looked at a decent bunch of patent applications here (of MNC's and domestic majors) and figured out what the ratio of acceptances vs rejections were. And also after we've read the decisions on section 3(d) and figured out if there was a subtle lowering of standard for our home grown generics. Even in respect of the cases cited above, I'm not entirely sure if Cipla got away with a lower standard, as none of us know what their claims in India were and what kind of "efficacy" information was submitted. Any of our readers undertaking such a study? Please let us know.
In any case, SpicyIP congratulates Varun for digging out this valuable information out and helping us frame the debate through another lens. How ought section 3(d) to be interpreted when our very own generic manufacturers are applying for supposedly "incremental" inventions?
Reading the ET piece, Nathan Evans of Finnegan Henderson, who's a very astute commentator on the Indian patent scene and has written a couple of articles in this regard posed this question to me:
"This makes me wonder if the patent office in India will apply the laws less strictly to Indian pharmas than MNCs (kind of like they apply the patent laws more strictly for essential medicines)"
We might get to some kind of a reasonable answer to Nathan's query, only after we've looked at a decent bunch of patent applications here (of MNC's and domestic majors) and figured out what the ratio of acceptances vs rejections were. And also after we've read the decisions on section 3(d) and figured out if there was a subtle lowering of standard for our home grown generics. Even in respect of the cases cited above, I'm not entirely sure if Cipla got away with a lower standard, as none of us know what their claims in India were and what kind of "efficacy" information was submitted. Any of our readers undertaking such a study? Please let us know.
In any case, SpicyIP congratulates Varun for digging out this valuable information out and helping us frame the debate through another lens. How ought section 3(d) to be interpreted when our very own generic manufacturers are applying for supposedly "incremental" inventions?
Thanks Shamnad. Indeed it is important to know exactly what is claimed under claims but anyhow our job is to keep things transparent.
ReplyDeleteSeriously, you should see the claims! I have seen the claims and the description of IN 219034. Well, not surprisingly, claims with "more mettle" have been rejected under Section 3(d). I am reproducing the main claim as granted:"A stable inclusion complex comprising substantially pure S-omeprazole and a cyclodextrin"
ReplyDeleteThe process claims are more horrendous.
I won't comment on how this patent would have been obtained. free your mind!!