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.

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  1. Dear Shamnad, I am yet to come to grips with the Mashelkar Report controversy and its various nuances. I find your posts on this extremely useful. Meanwhile, I just used the other blog, to bring to your notice today’s TOI report on Mashelkar’s previous alleged plagiarism. Your response on that blog would be useful.

  2. Dear Venkatesan,

    Thanks for pointing this out to me. I know Dr Dutfield— he is a very respected academic in the UK and writes some fabulous stuff. Its unfortunate that his paper has been plagiarised. Certainly a far more serious charge than the earlier one –which I didn’t think was “plagiarism” anyway, not least because I had made a submission to the Committee for the very purpose of hoping that the Committee would rely on it. Secondly, the committee had included all that they “borrowed” from me in an Annexure to the Report, indicating indirectly that I was the source. Thirdly, what the Committee borrowed were mere conclusions. Given these circumstances, I’m not sure if you could call it “plagiarism”, which somehow connotes a calculated move to hide your source and pass stuff as your own. And given the allegation that the Committee sold out to Western multinational firms, I think a “plagiarism” charge would indicate that they cleverly hid their source since they were trying to further the interests of these firms. Which is why I think some people are very keen on labelling this as “plagiarism”. I would put it down to “sloppy” drafting–not expected of a Committee with so many reputed members.

  3. Mr. basheer,

    It was interesting to read your article as well as the comments about 3(d).
    Now i would like to submit the following observations for your scruitny.
    You are correct in saying that the mashelkar commettie has desisted from getting into the TRIPS compatibility of 3(d)[atlest explicitly].
    but i believe they do make veiled reference to 3(d) in para 5.8
    quoted below:

    “….Thus, a chemical to be patentable must be new, non-obvious and have utility. However, Section 3 excludes certain inventions from being patented. ……….
    Thus, the new form of a known substance would not be patentable unless it differs significantly in properties with regard to efficacy.”

    It appears that the commettie has taken efficacy as a fourth pillar of patentability. If that is the case then i believe 3(d) will nt be TRIPS compliant.

    but as you have brought out if effiacy is merely taken as a measure of inventive step then 3(d)is perfectly TRIPS compatible. is’nt it?

    and i believe some of the subsections on section 3 has outlived its relevace.
    for eg: 3 (e): a mere admixture will not be patentable anywhere in the world even if their act do not have an express provision of 3(e).

    some subsections under 3 were relevant , in the pre 2003 era when examiners at the indian patent office were not legally allowed to raise questions on inventive step. at that time inventive step was a ground only during oppositon (much like some provisions of TM).

    bt now inventive step has been brought into the definition of invention we may well do away with redundant provisions of the
    section 3.

  4. basheer
    in reply to my previous posting(28-1-07 ,comments) on raising of inventive step bar ,you were saying that 3(d) indeed raises the bar.if so, will such heightened inventive step bar only in respect of pharma/drug cases be TRIPS compatible?

  5. Dear “Information is Wealth”

    As I’ve urged in an earlier post (, the sensible approach is to delink the Novartis issue from the broader issue of whether the proposed amendments reviewed by the Mashelkar Committee contravene TRIPS.

    I’m not sure that its a good idea to remove section 3(e) which calls for “synergy” of some sort. As you will appreciate, under the US standard of non obviousness (at least as interpreted till recently by the Court of Appeals for the Federal Circuit), “synergy” is not a requirement, and therefore, unless there is a “teaching, suggestion or motivation” to combine, a non synergistic combination is “non obvious” and therefore patentable. We can’t therefore merely rely on our non obviousness standard to weed away “non synergistic” combinations. Further, section 3(e) and other provisions in section 3 are clear rules that would help an examiner right at the outset, without having to wade through the difficult waters of “non obviousness”. What other provisions in section 3 are defunct according to you?

  6. hi mr.basheer,

    thanks fr replying fr my comment.
    I feel even 3 (e) is a bit outdated..

    however i will be happy if you could comment on o my observations abt the possible inferences frm mashelkar report abt “efficacy” bieng construed as the fourth step of ptentability.

  7. Dear “Information is Wealth”

    Its an interesting point you raise about 3(d) being construed as an additional patentabiulity standard. I’m not sure I agree with this. As I’ve written in several posts, 3(d) can be likened to a refined non obviousness (or even a utility standard). Both the EPO and now the US (see Pfizer vs Apotex) call for an “unexpected property” standard before any new salt form can be granted patent protection. this is done under the normal obviousness standard. India has only made this standard more clear in its legislation–without having our judges trying to do it through case law.

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