Pursuant to our last post highlighting the rather trashy editorial by the Business Standard, here is an email exchange I’ve had with a friend. I am posting this here, only because it appears that that there is still some confusion about the mandate of the Committee. And some very popular “Mashelkar Myths” continue to do the rounds.My friend writes:
“Dear Shamnad
While I would agree that there is confusion about what Carlos Correa said, meant, was reported to have said, etc. I would request you to see whether the following part of the Editorial also merits a comment:
“The Mashelkar committee’s conclusion on micro-organisms — that their exclusion from patent protection would be violative of Trips — is equally contentious. The relevance of micro-organisms goes beyond the pharmaceutical sector to encompass, among others, agriculture, to improve the ability of crops and livestock to withstand pests and diseases. These microbes, billions in number, are an endowment of nature, and not the result of human endeavour. Their discovery or isolation should not, therefore, be entitled to statutory safeguards unless they have been significantly altered through human intervention.
Two arguments weigh in favour of dumping the Mashelkar report. First, its integrity is in question, on not one but two counts. And second, the pharmaceutical industry globally has been finding it increasingly difficult to come up with new molecules and breakthrough drugs; they have resorted therefore to extending the life of old patents by making minor changes to existing products. There is little or no public benefit from such activity, all that results is an increase in the price of drugs.”
(All emphases added by me)
As you can see, two separate statements are being made:
On desirability or otherwise of allowing patenting of micro-organisms, which is indeed not a settled issue on philosophical grounds (and perhaps on economic considerations as well, in a developing country, subject to being boxed out of knowledge goods)
On reasons for dumping the Mashelkar Report – Dr. Mashelkar has been a stalwart but has also committed a few rather embarrassing mistakes (The rather sordid Casablanca episode comes to mind where he almost ended up committing India to a rather insidious and devious design to dump her interests on TK and Patents). His credibility did take a beating even in the matter pertaining to two cases of plagiarism.
In addition, I do not see any sensitivity analyses being conducted on the economic ramifications associated with accepting the recommendations. In fact, I have always found absence of such analyses most surprising especially because the laws of IPRs are essentially economic in nature and thus cannot be seen to have a life of their own based solely on legal semantics. TRIPS itself is a legal document of an economic activity.
On a more practical consideration also, we may perhaps be better off being taken to the Dispute Settlement Body and fight for the continuance of our extant provisions than to acquiesce into changing our laws unilaterally (especially when we do not know if the extant provisions are damaging to our own local interests).
Perhaps our debates on such issues need to be based also on a more pragmatic ‘Where do Indian interests lie’ approach.
I REPLY TO HIM AS BELOW:
“Thanks very much for reacting to this. I think your reply really underscores an important point:
I have failed miserably in communicating the essence of the report and what it stands for. I know that vested interests conflated issues and confused the public with a view to discrediting Dr Mashelkar at any cost. I was under the impression that I did a fairly decent job of deconstructing the several issues that this controversy threw up, but your response tells me that my impression is a sadly mistaken one.
This is not to elevate myself to some grandiose position of the “clarificator” (if you will) –but only in pursuance of my commitment to run a blog that seeks to undertake some fair and relatively objective analysis of IP issues. Let me now respond specifically to each of your concerns:
You note as below:
“On a more practical consideration also, we may perhaps be better off being taken to the Dispute Settlement Body and fight for the continuance of our extant provisions than to acquiesce into changing our laws unilaterally (especially when we do not know if the extant provisions are damaging to our own local interests). Perhaps our debates on such issues need to be based also on a more pragmatic ‘ Where do Indian interests lie’ approach.”
Section 3(d) vs The Mashelkar Mandate
In several earlier blog posts, I’ve tried really hard to highlight the fact that the Mashelkar mandate was never to examine the TRIPS compatibility of section 3(d) or any current provision of Indian patent law. Rather it was to examine whether a proposed amendment to the existing 2005 Act that excluded all incremental inventions as a whole, without studying their individual merits, would have violated TRIPS.
The committee rightly concluded that such an amendment (which goes far beyond our existing section 3(d), which at least grants patents to those incremental inventions that demonstrate significant efficacy) would be likely to violate TRIPS. As you know, Article 27 of TRIPS clearly states that patents have to granted, without discrimination, to all inventions, in all fields of technology. Neither the Doha Declaration nor Section 8 nor any of the other provisions in TRIPS can derogate from this clear mandate.
TRIPS vs National Interest
More importantly, the Committee’s mandate was never really to address “national” interest issues, but only to examine the issue from a TRIPS standpoint. Of course, one may question the wisdom of having 3 eminent scientists (Dr Mashelkar, Dr Govardhan Mehta (ex Director of IISC) and Dr Asis Datta (former VC of JNU)) in a committee constituted to undertake a strictly legal “TRIPS” issue. Sadly, this issue was never raised (barring on this blog)…and I think this question ought to have been posed.
Having said this, the committee did have two legal experts (Dr Madhav Menon and Dr Moolchand Sharma) and I assume they’ve really applied their mind this time around after the current controversy.
Viewing this from a pure TRIPS standpoint, the committee was absolutely right in holding that micro-organisms and pharma incremental inventions cannot be banned outrightly as a class. I am yet to come across any convincing study that argues otherwise.
Micro-organism Patenting
Will an addition of a ‘sensitivity” analysis or an econometric study, as you recommend really alter a legal conclusion that is but evident from a plain reading of Article 27? I think not. As you will appreciate, in view of Article 27 (3) (b), it is well nigh impossible to find in favour of a law that outrightly bans patents on micro-organisms.
This does not mean that all micro-organisms can be patented. Rather countries can tailor their existing patent doctrine to limit the grant of patents to only genetically engineered micro-organisms (as Brazil and Argentina appear to do). And not to micro-organisms that are merely isolated. But this is very different from excluding micro-organisms altogether. And the Committee does echo such a sentiment by concluding that:
“The TEG has concluded that excluding micro-organisms per se from patent protection would be violative of TRIPS Agreement…. The group’s conclusion is based on the requirements of Article 27.3 of the TRIPS as articulated in 5.23 above and the provision of Indian Patent Act (Section 3 (j)). However, strict guidelines need to be formulated for examination of the patent applications involving micro-organisms from the point of view of substantial human intervention and utility.”
Ad-Hominem Attacks Against Dr Mashelkar
As for the other “personal” issues that you mention (e.g. Dr Mashelkar chairing the Casablanca meet etc), should that really determine the validity of the present conclusions? Can’t we take an issue based approach? For every Casablanca or alleged plagiarism issue, there are hundreds of other instances where this man has furthered the cause of Indian science, technology and innovation, than all of us put together.
More importantly, please remember that the Committee has other members as well who are reputed thought leaders in their domain. Are we to assume that they haven’t bothered applying their mind to this issue—particularly after the last controversy erupted.
The Plagiarism Issue
As for the plagiarism issue, I’ve always maintained that plagiarism connotes a dishonest intent to hide the source. The committee did no such thing with my work. They may have failed to attribute it in the closest footnote to their text—but they did include the entire text of my submission to their report—which makes clear that the place where they got the allegedly “plagiarised” portions was from my submission. As this wikipedia entry correctly states:
“The controversy got highlighted in the media, since some of the text in the report was reported, without attribution to the original source, especially that of Prof. Shamnaad Basheer. There was an accusation of plagiarism. This accusation was highlighted through two editorial pieces published simultaneously in the Times of India[10] and The Hindu.[11]
According to Prof. Shamnaad Basheer, this allegation was unfounded. As cited on his blog he wrote “It is unfortunate that my blog has been selectively quoted to support allegations that the Committee ‘plagiarised’ from my report. This is not correct, as amply borne out by the last sentence in the blog: “To be fair to the Committee, they did include the crux of my submission in an Annex to their Report.” In other words, the Committee did include the key points in my submission as an Annexure, as they did with every other submission (about 24 in all) that was made to them. Merriam Webster defines ‘plagiarising’ as “presenting as new and original an idea or product derived from an existing source.” Those with the patience to read the entire report including the Annexures would have gathered that some of the Committee’s observations were borrowed from my report and not ‘plagiarised’.
Plagiarism was just a convenient (and perhaps “dishonest”) tool used by some to discredit Dr Mashelkar. Note this sentiment in this “Nature Medicine” piece by one of India’s leading science journalists, TV Padma:
“In the meantime, the plagiarism charge has proven useful for activists trying to discredit the report on grounds of bias. “The public can understand plagiarism better than intricate intellectual property issues,” says Mira Shiva, board member of Health Action International-Asia Pacific, a non-profit global network working toward equitable access to medicines.”
However, blame must lie where it is due. As I’d noted earlier on this blog, the committee consisting of reputed experts simply failed to deliver a well researched report. The report was poorly reasoned and shoddy. Now that those issues have been taken care of in the revised report, why are we still taking issue? What kind of an axe are people really grinding here?
Conclusion
In any case, does any of this really affect the substantive conclusions arrived at by the Committee? Have you seen any convincing study that argues in favour of the TRIPS compatibility of India’s proposed statutory exclusions that were referred to the Committee? I haven’t.
ps: Picture from here
Dear Shamnad,
let me comment on the scope of Art.27:1 TRIPS (first and in particular second sentence). I know that the issues discussed below are not necessarily all relevant for the specific exceptions proposed in India (and addressed in the Malshelkar Report), but may still be of relevance for broader systemic issues around the non-discrimination provision in Art.27 TRIPS.
While I agree that there cannot be an exception for pharmaceutical patents covering all new chemical entities, I think the non-discrimination requirement in Art.27:1 is not absolute. One could argue that it does not prohibit any form of different treatment – but only one where there is no reasonable ground for treating distinct areas of technology differently. In part this was addressed in the Canada – Patents dispute where – as far as I recall – the fact that drugs require regulatory approval in most countries in order to be marketed (while other patented products don’t) was used to allow the pharma-specific Bolar exception which passed the test of Art.27:1 (I don’t have the report in front of me, so I relying on my memory here).
To define ‘without discrimination’, one could think of applying the rich jurisprudence of the WTO Appellate Body on similar language in the chapeau of Art.XX GATT where discrimination is interpreted narrowly. I admit however that there is a counterargument in the sense that Art.4 TRIPS mirrors the language of Art.XX GATT more closely (‘arbitrary or unjustifiable discrimination’) and that hence the mere ‘without discrimination’ requirement in Art.27:1 would e contrario have a broader application. But that still does not mean that it must cover and prohibit any form of distinct treatment: Countries arguably can accommodate specific problems which only exist in on area of technology.
Taking into account the TRIPS balancing objectives and its public interest principles in Artt.7, 8:1, such a wider interpretation of ‘discrimination’ is especially warranted if public health concerns are at stake. WTO Members confirmed this in para.5 a) of the Doha Declaration where an interpretation based on Artt.7, 8 is mentioned as a key flexibility of TRIPS. This has of course to stay within the limits of the accepted principles of treaty interpretation as laid down in Art.31-33 VCLT – which by virtue of Art.3:2 DSU govern WTO treaty interpretation as well. Here Art.31:1 confirms that the (TRIPS) treaty objective (and principles) can play a significant role whenever broad and open treaty terms are at stake and where hence the ordinary meaning may be inconclusive. And this is surely the case with an ambiguous term like ‘without discrimination’. In my opinion, operationalising Art.7 and 8 TRIPS is a crucial and so far untapped flexibility which WTO Members should utilise. Of course it has its limits where concrete and clear treaty language is at stake and ordinary meaning and context under the VCLT do not leave any real room for the TRIPS balancing objective to play out. But for open and ambiguous language – for example in key provisions of Artt.13, 17, 30 (normal, legitimate, reasonable, etc) – Art.7 and 8 can (and by virtue of the Doha Declaration should) play a major role.
(end of part one)
(comment part two)
And one further route could exist to limit the impact of Art.27:1 TRIPS. Contrary to the Panel in Canada – Patents, one could argue that especially Art.30 TRIPS (allowing for exceptions) can also limit the operation of the non-discrimination principle. A counterargument would be that Art.27 states: “Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology (…)” and further: “Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced”
Does this mean that Art.30 cannot be invoked to deviate from the non-discrimination provision? While I think that there are good arguments supporting this view, one would have to look a bit closer into the relationship between Art.27:1 and 30 (commentaries, negotiating history, etc) to confirm this. Given that TRIPS does not contain a general exception provision like Art.XX GATT or Art.XIV GATS, one should be careful before limiting the scope of the only remaining specific exception provisions such as Artt.13, 17, 26:2, 30 or 31…
Henning
Dear Henning,
Terrific points. I take it that you’re doubtful whether a blanket exclusion of all pharma derivatives would hit against the mandate to grant patents to all “inventions”.
As for the “non discrimination” point you raise, here are my quick thoughts:
As you rightly hint at, “discrimination” only means an “unjustified differentiation” and not “differentiation” per se. And Canada illustrates this. I’ve elaborated on all of this in this report for the IPI here http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1391562
But this begs the question: is the exclusion of all pharma derivatives justified? I think a panel is likely to go into the purpose behind such an exclusion. If the purpose is to keep costs down, then one can do this through compulsory licensing and price controls. But arbitrarily excluding what are legitimate inventions through a blanket provision may not pass muster. As you’ll appreciate, some derivatives may be “inventive” while others may not. And we already have section 3.d doing this job. Any additional provision that completely excludes all “derivatives” (without an independent investigation into their merits) may not pass muster under Article 27.
Correa’s opinion is also illustrative in this regard. He states:
“A key consideration is clearly the purpose for which any subject matter exclusion were to be adopted. If, for example, the same objective could be obtained by imposing permissible compulsory licenses under Article 31, an exclusion of patentability could be seen as merely an attempt to circumvent the pre- conditions of Article 31.”
Dear Shamnad,
I agree that the purpose of a measure can key to the determination of discrimination. And for an outright exclusion of all pharma derivatives, one most likely has very little chance to convice a panel of the absence of an Art.27:1 violation.
My main point was to raise more general, systemic issues of interpretation, scope and relation of Art.27:1 with other TRIPS provisions.
Henning
an interesting discussion in this thread. i missed this thread, as there were quite a few posts on the same topic n i posted my comment in another post on the same topic.
shamnad, i had suggested it to u earlier also n wud again suggest that if there is some way to cross-link or put all posts/comments on a particular topic in a single thread, then please effectuate it.
now, coming to henning’s comments: its an educative disclourse indeed, in general. but still, as far as the issue of justifiability of a blanket ban on pharma products, at the cornerstone of art.27, is concerned, it can not be justified by any form/amount/permutation-combination of argument(s).