I’ve deliberately changed the title of this “series” to enable a more constructive engagement with the debates around this theme.
I’ve received a number of emails that continue to query me on why I argue that section 3(d) is incompatible with TRIPS and why my report stated so. I do no such thing. Let me use this post to briefly dispose of this issue.
I’ve argued in an earlier post that section 3(d), according to my reading, is perfectly compatible with TRIPS. It rightly asks whether “new forms” of existing pharmaceutical substances have any increased “efficacy”. If one is unable to demonstrate such increased efficacy, then the new form is not patentable. A very sensible section to me, and perfectly compatible with TRIPS, as this is nothing more than a refined non-obviousness standard in the context of pharmaceutical inventions.
Of course, if the Indian patent office pegs the standard of efficacy so high that no new form ever gets a patent, despite having a significantly enhanced “efficacy”, the section may be subject to attack under TRIPS and/or the Constitution of India as being an “arbitrary” standard, that, in effect, grants patents only to “New Chemical Entities”. Such a reading would also have the effect of rendering section 3(d) redundan–a reading that is to be avoided under most canons of statutory interpretation that I know of.
Be that as it may, the Mashelkar Committee Report was not asked to review section 3(d) or in fact, any section under the current patents act. And in all fairness to the Committee, it did no such thing. It was asked to only review two prospective provisions that were sought to be introduced, but held back since the government apprehended that it wouldn’t comply with TRIPS. Well, not exactly, since the government thought it had already conceded too much to the Left Parties during the course of passage of the Patents Act–and this referral to the Committee was nothing more than a deft move by the government to prevent any further stalling of the Patents Amendment Act, 2005. One of these prospective provisions relates to the controversial “New Chemical Entity” debate and asks:
“Whether it would be TRIPS compatible to limit the grant of patents for pharmaceutical substances to new chemical entities?”
Those of you familiar with pharmaceutical technology will appreciate that new chemical entities are very difficult to come by and in some ways are comparable with “pioneer” inventions in other technology areas. All the other inventions that follow might in some sense be “incremental” as they attempt to build on this pioneer invention/technology. Thus for example, a new cancer drug might be based on a patented “new chemical entity”. CIPLA comes up with a new form of this old drug that is much more effective—i.e. you have less side effects whilst taking the new form by CIPLA. Should CIPLA get a patent on this improvement or this incremental innovation? This is precisely what this referral addresses. If the grant of patents is limited to new chemical entities alone, then CIPLA does not get a patent, despite the fact that it has come up with a “new” and “non obvious” invention, that also has an “increased efficacy” under section 3(d). In fact, if such a prospective section limiting the grant of patents to “new chemical entities” were to be introduced in the law, section 3(d) would be rendered redundant i.e. even if the new form by CIPLA has increased efficacy, it would still not merit protection.
In short, the two issues (the NCE query which the Committee addressed AND the TRIPS compatibility of section 3(d)) are really separate ones and ought not to be conflated.