A very curious article popped up in the Business Standard (BS) yesterday. Apparently, Prof Carlos Correa is miffed that the Technical Expert Group (TEG, headed by Dr Mashelkar) has misquoted him. I’ve combed through Correa’s article and the revised report by the Masehelkar Committee and can’t exactly fathom as to how Correa claims to have been misquoted. The record would suggest that the expert committee rightly (and contextually) cited Prof Correa.This is what the BS stated:
“Patent expert says his views were ‘misinterpreted’ to support conclusion that India’s patent laws could not be tightened.
The Mashelkar Committee report on patent laws, which was re-drafted recently to rectify certain controversial “technical errors”, has run into trouble again.
Carlos M Correa of Brazil, a patent expert of international repute whose views have been widely quoted by the Mashelkar committee to support its conclusions, has complained of “misinterpretation” of some quotes from a published article titled “Integrating Public Health Concerns into Patent Legislation in Developing Countries”.
Two years ago, R A Mashelkar, former chief of Council of Scientific and Industrial Research (CSIR) who headed the panel, withdrew the report after some portions of it were found to be copied from one of the submissions made by a UK-based researcher. The “technical errors” were later rectified and the government had recently approved the report.
The current allegation turns serious because the Mashelkar panel had included Correa’s quotes to establish that under World Trade Organisation (WTO)’s TRIPS agreement, India will not have the right to limit the granting of patents for pharmaceutical substances to strictly new medicines.
Correa, in an email response to Business Standard. said the the Mashelkar committee had misinterpreted the text quoted from his study to convey a meaning that he had not suggested.
In other words, while Mashelkar committee says India is obliged under WTO rules to extend patent protection to incremental changes made to known medicines (that have significant therapeutic benefits),
Correa feels that a WTO member-country has the flexibility to prevent patent protection to incremental innovations in pharmaceuticals that are non-inventive but the result of routine experimentation and known techniques.”“Inventive Step”
Let’s begin with the last sentence in the quoted text above (marked in bold). This is but an obvious proposition well known to most folks with even an elementary understanding of patent law. And most countries do include “inventive step” as one of the pre-requisites for patentability.
Nowhere does the Mashelkar Committee Report suggest that “non inventive” inventions that are merely routine or that deploy well known techniques should be granted patents. In fact, the Committee clearly states that
while “incremental innovations” involving new forms with significantly enhanced efficacy need to be encouraged, it is “important for the patent office to be vigilant about setting high standards of judging such innovations so that efforts on ‘evergreening’ are scrupulously prevented”. In other words, “non inventive” incremental inventions that are merely routine ought not to be patentable.Section 3(d) vs. The Mashelkar Mandate
At this juncture, it may be relevant to once again reiterate and clarify that the mandate of the Mashelkar Commmitee was never to examine the TRIPS compatibility of section 3(d).
The difference between section 3(d) and the proposed amendment that the Left Parties wanted to bring in is this: Under section 3(d), a derivative of an existing pharmaceutical substance would merit a patent, if it demonstrated a significant enhancement in “efficacy” over and above the earlier known pharmaceutical substance. Under the proposed amendment, no “derivative” would gain patent protection, whether
or not it demonstrated significantly increased therapeutic benefits.Correa Paper
If one were to go only by the Business Standard report above and the apparently similar sentiments echoed by both Prof Correa and the Mashelkar Committee, one is at a loss to understand as to what Correa’s quibble really is. Perhaps he will clarify in the days to come. Digging deeper, one finds that Correa’s classic report titled “Integrating Public Health Concerns into Patent Legislation into Developing Countries” states the following:
“The TRIPs Agreement obliges all WTO Members to recognize patents in all fields of technology (Article 27.1)24. When fully in force, this obligation will have eliminated the varying patent policy approaches that previously existed.
Literally interpreted, Article 27.1 does not permit the exclusion from patentability of medicines in general or, arguably, of specific groups thereof. Under this interpretation, WTO Members could not exclude from patentability even the “essential medicines” listed by the World Health Organization (WHO).
There are two exceptions in the TRIPs Agreement under which pharmaceuticals might conceivably be excluded from patentability, but neither appear sufficient to justify an exclusion, except in limited circumstances.”
The two exceptions that Prof Correa mentions, but is very skeptical of, is the “morality” exclusion under Article 27.2 and a proposed exclusion under “Article 8” of TRIPS.
Let’s take the proposed exclusion under Article 8 of TRIPS first. This article stipulates that a member states is free to customise its patent law to cater to public health concerns. However, the article also makes clear that such customisation cannot violate any of the other express provisions of the TRIPS agreement including, presumably, Article 27 which clearly mandates that patents shall be granted, without discrimination to all inventions in all fields of technology.
Immoral Drug Patents?
As for the morality exclusion, Article 27.2 of TRIPS provides that member states may exclude from patentability those inventions that violate “public ordre” or morality”. The key limitation in excluding pharmaceutical patents from patentability on this ground is that a member state would also then have to ban the sales or commercialisation of any products based on such patents. In other words, unless India bans the sales of patented pharmaceutical products, it may not be able to deny patents to such products on the ground that such patents are “immoral”. In any case, given the recent ruling by the Delhi High Court in the Naz Foundation case, where the court read down Article 377 of the Indian Penal Code to permit consensual non penile sex between adults, and in the process drew a distinction between constitutional and public morality, it may be very difficult to label a pharmaceutical drug as an “immoral” invention!
Correa goes on to note that the only kind of patent exclusion under Article 8 that might be justifiable is a case where patents on a certain class of pharma inventions are excluded in order to address an “emergency” situation. However, even here such exclusions can be maintained only till such time as the “emergency” subsists.
Prof Correa then summarises his key conclusions by noting:
“In sum, under the current TRIPs Agreement, a straightforward exclusion from patentability of pharmaceuticals — even the category of essential medicines — does not seem to be a viable option. The admissibility of exceptions based on ordre public will depend on the interpretation of both Article 27.2 and Articles 7 and 8, but does not seem a promising basis for exclusion from patentability.
Exclusions to meet specific public health emergencies, especially if limited in time, might be justifiable if they are a necessary part of an overall strategy for addressing the emergency. ”
Conclusion: Quote, Misquote or a Faulty Understanding of English?
Reading all of the above, I am at a loss to understand as to how Prof Correa claims that he has been misquoted by the Mashelkar Committee, which reproduced one of his key paragraphs above to support its conclusion. We’ll have to wait for the actual text of the letter that Prof Correa wrote to Business Standard to verify what he really meant.
In any case, even assuming that there was a “misquote”, would this really impact the conclusions laid down by the Technical Expert Group (popularly known as the “Mashelkar Committee”), which also included noted legal experts such as Prof (Dr) Madhav Menon, the founder director of the National law school and Prof (Dr) Moolchand Sharma, the Vice Chairman of the UGC.Would Professor Correa suggest that India could exclude incremental pharmaceutical innovations as a class without violating TRIPS? And this is where it is important to appreciate that despite the passage of two years from the date that this first controversy broke out, with several groups levelling plagiarism charges against the Committee and even going to the extent of labelling Dr Mashelkar as an “anti national”, none of them have come forward with a substantive critique of the conclusions put forward by the Committee.
In other words, till date, there is no convincing paper explaining as to how India’s proposed move to deny patents to the entire gamut of incremental pharmaceutical drugs, irrespective of whether or not such drugs were actually inventive and yielded significant therapeutic benefits, would be compatible with TRIPS. We could argue about whether or not such an exclusion might be in India’s national interest. However, the Committee’s mandate was not to examine the issue from a “national interest’ perspective, but solely from the vantage point of TRIPS, to which India is signatory. And from a TRIPS standpoint, I fail to see how such an amendment might have passed muster.
I reproduce the key paragraph of Prof Correa’s paper that was quoted by the Mashelkar committee and resulted in the present controversy: “Literally interpreted, Article 27.1 does not permit the exclusion from patentability of medicines in general or, arguably, of specific groups thereof. Under this interpretation, WTO members could not exclude from patentability even the ‘essential medicines’ listed by the World Health Organisation (WHO).”After quoting the above from Prof Correa’s paper, the Committee goes on to note that “The statement that `Article 27.1 does not permit the exclusion from patentability of …… specific groups thereof’ is directly pertinent to the TOR of TEG.”
The Mashelkar Committee’s key conclusion is that a blanket exclusion of the entire “class” of incremental pharmaceutical innovations, without an independent enquiry into the merits or otherwise of the invention in question is likely to violate TRIPS. If the statement by Prof Correa above (that was in fact quoted by the Committee) is not supportive of that conclusion, I really need to go back and relearn my English!
ps: Contrary to what the BS report states, Prof Correa is an Argentine and not a Brazilian national. Though I’m sure that the Brazilians would love to claim him.
dear shamnad,
while dealing with the roche/osi (tarceva) case before m/s anand, i had extensively studied correa’s article (as i wanted to take up the selection invention argument with full force, which however, was overruled by the 2:1 majority of the v 3 who comprised the team handling that case) and i would certainly side with correa, as far as his claim of being mis-interpreted / mis-quoted in the mashelkar committee report is concerned. the overall tenor of the correa article is tilted towards imparting validity (vis-a-vis trips/wto) to the provisions based on the allowed ‘flexibilities’ granted under the article 27(1)&(3) of trips. in particular, it tacitly acknowledges the justification of having section-3(d) in the indian patent act. however, correa never justifies it ‘absolutely’. the curtailment of ‘incremental developments’, under certain circumstances (for which he provided ‘guidelines’), is justifiable, per correa who does not advocate a blanket exclusion of all “…incremental pharmaceutical drugs, irrespective of whether or not such drugs were actually inventive and yielded significant therapeutic benefits…” (i am quoting you here, shamnad), without violating trips. correa has not touched upon the aspect of the extent of such exclusions/ curtailments – he has provided comparison of various patent jurisdictions, as to how this issue has been dealt with by various jurisdictions. apart from tacitly accepting the rationale of the flexibilities, correa himself has been non-committal to any extreme view and has left the issue undecided, despite being tilted towards justifying the flexibilities. this is about the real general nature of correa’s contentions/thinking.
now lets come to the passage from correa which has been cited by the mashelkar report. you have quoted the following, “Literally interpreted, Article 27.1 does not permit the exclusion from patentability of medicines in general or, arguably, of specific groups thereof. Under this interpretation, WTO members could not exclude from patentability even the ‘essential medicines’ listed by the World Health Organisation (WHO).” i have not gone thru the mashelkar report, but if this is the quotation that has elicited the mark of protest, then i must say that correa is perfectly right in his protest. this passage has been taken/quoted totally -out-of-context. in fact, this particular passage does not correctly reflect correa’s views on the subject-matter. on the contrary, in the out-of-context quoted form, it tends to give just the opposite picture about what correa’s line of thinking is.
i am ready to debate on this issue further.
however, despite citing correa wrongly and out-of-context, it appears that the mashelkar report has come to the right key conclusion [just like the novartis case in which madras high court did a defective analysis and yet arrived at the right conclusion about the constitutionality of section-3(d)] that “a blanket exclusion of the entire “class” of incremental pharmaceutical innovations, without an independent enquiry into the merits or otherwise of the invention in question is likely to violate TRIPS.” (i am again quoting you here, shamnad). as a proposition/recommendation, this is the right recommendation that the mashelkar report could/should have made.
i would love to hear from u on this, shamnad.
(……contd. from last comment)
i forgot to mention in my last comment/post that correa’s real position/viewpoint can be best gauged from his (WHO/ICTSD/UNCTAD sponsored) working paper, titled “Guidelines for the examination of pharmaceutical patents: developing a public health perspective”.
i am sorry for this 2nd addenda. i ve to add one more relevant thing. the correa article that was cited by the mashelkar committee is of 2000, while the one i am relying on (to buttress my contention that correa is right in his protest) is of 2007. this also, may partly explain why/how correa is complaining. he has evolved over time.
Dear Mnbvc…
I’m afraid I don’t really understand your argument. Correa seems to suggest that exclusion of a “class” as a whole (such as essential drugs) may not be TRIPS compatible. The Mashelkar Committee suggests that excluding an entire class of pharma inventions would not be TRIPS compatible. The underlying sentiment in both these statements seems pretty similar to me. And in what respect has Correa changed this position? Can you quote some para’s from his later papers suggesting such change? In any case, the BS article does not talk of his being miffed since an old article was cited and his position had changed (or evolved as you call it). It talks of him being miffed at the very statement from the old article itself being misinterpreted.
“Correa seems to suggest that exclusion of a “class” as a whole (such as essential drugs) may not be TRIPS compatible. The Mashelkar Committee suggests that excluding an entire class of pharma inventions would not be TRIPS compatible. The underlying sentiment in both these statements seems pretty similar to me.”: u may b only partially right. both r suggesting the same conclusion, albeit couched in different expressions. however, mashelkar report’s cited quotation is not truly representative/reflective of the correa’s main line of thinking. i guess, this seems to be the reason why correa has protested, probably. (however, just like u, i, too, am guessing as to the exact nature of correa’s protest. but when i read both of his aforementioned articles specifically (and many others, generally, e.g. “AN AGENDA FOR PATENT REFORM AND HARMONIZATION FOR DEVELOPING COUNTRIES, By Carlos M. Correa, University of Buenos Aires, October 26, 2005”, delivered at UNCTAD-ICTSD Dialogue on IPRs and Sustainable Development:
Intellectual Property and Sustainable Development: Revising the Agenda in a New Context
24 – 28 October 2005, Bellagio, Italy) conjointly, i get the unmistakable feeling that although he does not support the exclusion of a “class” as a whole, yet he supports various ‘flexibilities/exclusions’. here is a passage from his 2005 article (mentioned in brackets above):
“In this scenario, however, developing countries should resist any attempt to limit their capacity to prevent the patenting of developments that do not constitute a real technical contribution to the state of the art. If such countries wished to promote ‘minor’ innovations, the appropriate policy would not be to lower the patentability requirements, as it is often argued, but to establish utility models (or ‘petty patents’) that confer less extensive rights than patents or to explore other options, such as the
recognition of a remuneration right rather than exclusionary rights. In brief, developing countries should endeavour to keep the existing policy space to determine the level of the ‘inventive step’.”
in the conclusion of the same article, he again opines as follows:
“Developing countries…………………… The ability to determine the required level of inventive step should not be negotiable; in particular, no proposals should be admitted that allow for a low inventive step standard for the granting of patents. Developing countries should consider means alternative to patents to promote minor innovations, if suitable to their developments needs.”
there r numerous such averments that leave me in no doubt that he tacitly supports flexibilities/exclusions. however, he has just fallen short of making categorical statement that he supports full exclusion or not. the 2007 article is even more illustrative of his line of thinking. in fact, the 2007 article has the advantage of having our section 3(d) been taken into account, before advancing his proposition. the 2007 article, despite providing instances of how different jurisdictions have dealt with the issue of incremental improvements, leaves the question open whether the flexibilities r right or wrong or what shud be the extent of such flexibilities. correa merely provides ‘guidelines’, thereby ceratinly recognizing the legitimacy of flexibilities/exclusion. but the extent thereof is left undecided.
to summarize: although mashelkar and correa recommend similar ideas on the extent of exclusion/flexibilities, yet the passages that mashelkar has quoted (of correa) are not representative of correa and that may be one of the reasons why correa has probably protested. this is my guess.
Love the picture you’ve put up. Its so very apt
Dear mnbvc,
I’m sorry I still don’t follow you. Yes, Correa has certainly written extensively about TRIPS flexibilities. But he no doubt acknowledges that TRIPS cannot be stretched endlessly. For if that were the case, a member state could exclude pharma patents altogether and claim that it was doing so since TRIPS was “flexible”. Correa’s flexibilities approach is a carefully nuanced one, if you read him carefully. He supports a flexibility such as section 3(d)–but that is only because Art 27 has not clearly defined what it means by inventive step–and countries are free to peg them where they wish. And India has therefore legitimately used such flexibility in coming up with 3.d. However, you willl appreciate that in section 3(d), there is an examination on individual merits i.e. does the new form demonstrate increased efficacy or not? Contrast this with the proposed exclusion that would not undertake such an individual examination of merits but would deny patents to an entire class. It is this class based approach that Correa felt would likely violate TRIPS. So did the Mashelkar Committee. All the passages you cite from Correa’s later works do not support the stand you take i.e that Correa would defend a class based exclusion under Art 27. Rather it only reiterates his earlier approach, that countries are free to peg their patentability criteria (novelty, non obviousness etc). By supporting 3.d and in fact recommending guidelines to help clarify it, the Mashelkar Committee follows the same sort of framework for TRIPS interpretation as Correa.
dear shamnad,
u r again getting me wrong; may be i have not been able to articulate myself clearly.
1. many times i ve said that correa n mashelkar arrive (correa suggests it while mashelkar recommends it) at the same conclusion.
2. “All the passages you cite from Correa’s later works do not support the stand you take i.e that Correa would defend a class based exclusion under Art 27.” :- in this regard again, u ve gotten me wrong. i am not interpreting correa to suggest that correa would defend a class-based exclusion under article 27. correa has never taken categorical stand. he has merely provided guidelines. n his guidelines r heavily tilted towards legitimising the flexibilities. i guess that even for a layman (in the field of patent), it should be clear that absolute/blanket exclusion of a particular class can not be sustained, legally. there ought to be some ‘intelligent differentia’ (if i may borrow the term from administrative law) for such a ban. and in the absence of such an intelligent differentia, such blanket exclusions are bound to violate the governing laws (in this case, trips). so, it would be akin to stating the obvious (with due respect to mashelkar report’s authors) that ‘Article 27.1 does not permit the exclusion from patentability of medicines in general or, arguably, of specific groups thereof.’
3. what i am saying is that probably correa has objected to the cited quotation because it is not representative of his main view on incremental improvements.
While Mr. Carlos Correa of academia is Argentine, Mr. Carlos Correa of futbol is Brazilian.