The revised committee report reiterates the same conclusions as the earlier report submitted at the fag end of 2006, albeit with more strong reasoning to back up its conclusions.
In short, the Committee notes, and rightly so, that any attempt to exclude an entire class of inventions i.e. incremental pharmaceutical inventions would violate the mandate under Article 27 of TRIPS to grant patents to all inventions in all fields of technology.
For those interested, please see the patent office website, where this revised report is snugged away in a quiet corner titled “Revised Report of the Technical Expert Group on Patent Law Issues”.
For those interested in this saga which captured national media attention in 2007, see these extensive posts on SpicyIP.
History of the Mashelkar Committee Report
Explaining the reasons behind the withdrawing of the earlier report and its current resubmission, the revised report states:
“The Report was submitted by the TEG (technical expert group) to the Government on 29 December 2006. It was subsequently noted that there were some ‘technical inaccuracies’ in the Report. The Chairman wrote a letter dated 19th February 2007 to seek Government’s approval to ‘’withdraw the Report, re-examine it and resubmit a Report, which meets with the requirements of the highest standards’’. The Government, vide D.O. Letter No.12/14/2005-IPR III on 7th of March 2007 accepted this request.
Subsequently, due to certain developments, the Chairman of the Committee expressed his desire to resign from the Chairmanship of the TEG vide letter dated 15th of March 2007. The Government, however, did not accept this request of resignation vide D.O. letter No.12/14/2—5-IPR II dated 1st May 2007 and requested the TEG to submit the Report incorporating the changes.
Further communications followed, and most recently, the same decision was communicated by the Government vide D.O. letter No.12/14/2005 – IPR III of 10th February 2009, and the TEG was requested to expedite and submit the Report at the earliest. Vide letter dated 9th March 2009, the Chairman, while respecting the decision by the Government, agreed to accept his responsibility as the Chairman again and to submit the Report. Accordingly, the Report, incorporating the changes, has been resubmitted.”
Key Conclusions of Revised Report
The report concludes as below:
“The Technical Expert Group (TEG) concludes that it would not be TRIPS compliant to limit granting of patents for pharmaceutical substance to New Chemical Entities only, since it prima facie amounts to a “statutory exclusion of a field of technology”. However, every effort must be made to provide drugs at affordable prices to the people of India. Further, every effort should be made to prevent the grant of frivolous patents and ‘ever-greening’. Detailed Guidelines should be formulated and rigorously used by the Indian Patent Office for examining the patent applications in the pharmaceutical sector so that the remotest possibility of granting frivolous patents is eliminated.”
Apart from the above, the main highlights of the technical expert group (TEG) are outlined right at the start of the report in a couple of paragraphs as below:
Article 27 of TRIPS
The Committee notes, and rightly so, that any attempt to exclude an entire class of inventions i.e. incremental pharmaceutical inventions would violate the mandate under Article 27 of TRIPS to grant patents to all inventions in all fields of technology. As extracted from the report:
“4.1. Article 27 of TRIPS, which deals explicitly with the issue of patentability, inter alia, states that ‘Member States may not exclude any field of technology from patentability as a whole and they may not discriminate as to the fields of technology, the place of innovation’ etc.
Reading this obligation in the light of the overall purpose of the Agreement, it appears that linking the grant of patents for pharmaceutical substances only to a new chemical entity or to a new medical entity may prima facie amount to ‘excluding a field of technology’, even when they satisfy the basic requirements of patentability’. In such a situation, TEG concludes that it is possible to hold the provision as being not TRIPS Compatible.”
Doha Declaration and Article 7/8 of TRIPS
The Committee notes that neither the Doha Declaration on Public Health nor Articles 7 and 8 can detract from the above conclusion that an outright exclusion of incremental inventions from patentability would violate TRIPS. As extracted from the report:
“4.2. The TEG carefully examined the flexibilities allowed under the TRIPS Agreement to the member states (especially Articles 7 & 8) and also as a consequence of the Doha Declaration.
The detailed analysis and reassessing provided in the Report has led TEG to conclude that it is debatable as to whether national interest or the flexibility allowed under the Agreement to Member States would be accommodated by such ‘statutory exclusion’ of an entire class of inventions.”
The report then goes on to reiterate that its point that including patents from non NCE’s does not necessarily amount to “evergreeing” and that the patent office has now enough tools to prevent this.
“4.3. Every effort must be made to prevent the practice of ‘ever greening’ often used by some of the pharma companies to unreasonably extend the life of the patent by making claims based sometimes on ‘trivial’ changes to the original patented product. The Indian patent office has the full authority under law and practice to determine what is patentable and what would constitute only a trivial change with no significant additional improvements or inventive steps involving benefits. Such authority should be used to prevent ‘evergreening’, rather than to introduce an arguable concept in the light of 4.1 and 4.2 above of “statutory exclusion” of incremental innovations from the scope of patentability.”
Encouraging Incremental Innovation
The TEG also stresses on the importance of using the patent stystem to incentivise more incremental innovation.
“4.4 The process of innovation is continuous and progressive leading to an ever extending chain of knowledge. Innovative incremental improvements based on existing knowledge and existing products is a ‘norm’ rather than an ‘exception’ in the process of innovation. Entirely new chemical structures with new mechanisms of action are a rarity rather than a rule. Therefore, “incremental innovations” involving new forms, analogs, etc. but which have significantly better safety and efficacy standards, need to be encouraged. What is important, however, is for the patent office to be vigilant about setting high standards of judging such innovations so that efforts on “evergreening” are scrupulously prevented.
Section 3(d) Examination
It was rather unfortunate that both Novartis as well as critics of the earlier report by the TEG misguided the public by stressing that the Mashelkar Committee had opined that section 3(d) violated TRIPS. I attempted to counter this false propaganda several times on this blog by noting that:
“…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. 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.”
Thankfully the committee has made clear in its revised report that its report has nothing to do with section 3(d)! It notes:
“4.5 The TEG was not mandated to examine the TRIPS compatibility of Section 3(d) of the Indian Patents Act or any other existing provision in the same Act. Therefore, the committee has not engaged itself with these issues.”
Patenting of Micro-organisms
In its earlier report, the committee concluded that excluding micro-organisms from patentability would contravene TRIPS. It reiterates the same conclusion in the revised report, albeit with better reasoning and better language this time.
IPI Report and the Alleged “Plagiarism”
In my report to the Mashelkar Committee, commissioned by the Intellectual Property Institute (IPI), I had concluded as below:
” Limiting the grant of patents to NCEs/NMEs and thereby excluding other categories of pharmaceutical inventions (the ‘proposed exclusion’) is likely to contravene the mandate under Article 27 of TRIPS to grant of patents to all ‘inventions’. Neither Articles 7 and 8 nor the Doha Declaration can be used to derogate from this specific mandate under Article 27.
2. The proposed exclusion amounts to an ‘unjustified differentially disadvantageous treatment’ of pharmaceutical inventions and is therefore likely to violate the ‘non discrimination’ mandate under Article 27.
3. If the aim of the proposed exclusion is to prevent a phenomenon loosely referred to as ‘ever-greening’, this can be done by a proper application of patentability criteria, as present in the current patent regime.
4. Lastly, it is important to distinguish the phenomenon of ‘ever-greening’ from what is commonly referred to as ‘incremental innovation’. While ‘ever-greening’ refers to an undue extension of a patent monopoly, achieved by executing trivial and insignificant changes to an already existing patented product, ‘incremental innovations’ are sequential developments that build on the original patented product and may be of tremendous value in a country like India.”
While the Mashelkar Committee agreed with my conclusions above in its initial report, it did not provide much way of reasoning. I had noted in an earlier post that :
“What worried me, however, is that while it took me about 35 pages to come to the conclusion that keeping non NCEs or incremental pharmaceutical inventions outside the scope of patentability would contravene Article 27 of TRIPS, the Committee disposed of this issue in a couple of paragraphs.”
The revised report does a lot more in terms of substantiating its conclusions.
Many critics who were keen on rubbishing the Mashelkar Committee report vehemently argued that the report plagiarised form my IPI report. Here again, I attempted to counter this false suggestion by noting that:
“I first deal with their charge of plagiarism, since I am the alleged “victim” here. They attempt to substantiate their claim of plagiarism by selectively quoting from my blog. They however omit the most critical part of my blog statement in this regard “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 my submission as an Annexure, as they did with every other submission (about 24 in all) that was made to them. It bears noting in this regard that the Committee received submissions from a variety of IP stakeholders including industry (Ranbaxy, Biocon, IPA, IDMA), civil society groups (ALF, MSF), law firms (Lex Orbis, K&S Partners), IP Associations (AIPPI) and even retired members of the judiciary (Justice Krishna Iyer). 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 to them. This being so, qualifying their borrowing of some of my conclusions as “plagiarism” is incorrect.”
The analysis of the Committee in the revised report remains similar to the old report, although there has been an attempt to strengthen the conclusions.
The revised report rightly concludes that any outright exclusion of an entire class of inventions (non NCE’s) would violate Article 27 of TRIPS.
It also rightly notes that the current version of the Indian patents act, through section 3.d and other provisons provides a robust enough mechanism to help prevent evergreening.
If one takes stock of the huge number of patent office oppositions in the recent past that denied patent rights to many pharma patent application (many of them excluded under section 3.d), one will see the force of this logic. Some of these recent rejections are listed below:
1. Pfizer’s Applications Claiming Caduet (rejected pursuant to a PreGrant Opposition filed by Torrent Pharma)
2. Novartis’ application claiming the alpha crystalline form of imatinib mesylate (oppn filed by Sun Pharma and Okasa)
3. Glaxo’s Application for Rosiglitazone Salt
4. Gilead’s application for the Tamiflu drug (Oseltamavir): Pursuant to pre-grant oppn filed by Cipla. In particular, I would recommend our readers to this extremely well reasoned decision of Dr Kardam that goes into some 50 odd pages!
Most of these decisions can be found on the website of the Indian Patent Office. We had also blogged on some earlier decisions that denied patents to weak applications. See in particular this rejection of BI’s patent over Nevirapine. For a more detailed post on the Nevirapine rejection, see here.
Anyone reading these decisions will appreciate that the standards under the Indian patent act are fairly rigorous and do not permit of frivolous patents. As to whether or not these standards are in fact being applied rigorously by the patent office is another issue altogether. Having said this, it is important to appreciate that any lapse in scrutiny by the patent office can always be offset through an effective deployment of the opposition machinery (which is perhaps the most potent machinery anywhere in the world) and/or a resort to courts and the specialised IP tribunal (IPAB) by way of appeal.