Final Amendments to the Patents Act and Our Critics

IN an earlier PD article, we had noted that some of the International NGOs such as Oxfam and MSF had made uninformed criticism of the Left intervention in the Amended Patents Act and painted an alarmist picture of the threat the final version of the Act poses to the export of cheap anti-AIDS drugs from India. Though they have now revised their initial assessment somewhat, they have not clarified publicly that their earlier assessment was faulty. Worse, while they are campaigning internationally for India to tighten its compulsory licensing provisions and provide royalty caps, they do not seem to be interested in such a campaign in countries where they are located. We have yet to see statements from either MSF or Oxfam in which they have asked France or England, their parent
countries, to change the patents laws to reduce drug prices there or for export to Africa. The activists in India do believe that India has an international obligation to continue with export of low cost drugs. But it is hypocritical of
agencies such as Oxfam to criticise India and Indian groups for not fulfilling such international obligations when they are not willing to take up this struggle in Europe and in other developed countries as well.







We have already clarified in an earlier article that the Left does not believe in an either or approach to TRIPS/WTO – either live within the confines of TRIPS forever or walk out of TRIPS/WTO. We need to take advantage of whatever flexibilities TRIPS provides while simultaneously continuing the campaign to take TRIPS out of WTO. In this, we need global and local movements to pressurise the governments of all countries: be it the developing world or the developed one. Also, in the developing world, we need movements to force their governments to use the TRIPS review process and put back on the TRIPS/WTO agenda the issue of process patents. The Left, Indian groups and activists need to come together to continue this battle. One-upmanship and levelling charges against each other as is currently happening is destructive of this unity.


We also need to dialogue with the International NGOs on the issue of TRIPS. They seem to believe the problems of TRIPS can be solved without addressing the core issue, whether such “intellectual property rights” should be subject to an international trade body such as WTO or be in the domain of national laws. From a reading of their literature, it appears all that they are arguing for is better compulsory licensing features with royalty caps. While we do agree on the need to have such provisions and will continue our campaign for the same, we do not believe that this is the entire issue. At best it can mitigate the worst features of the product patent and TRIPS regime. The experience of the pre-TRIPS period shows that even when very strong compulsory licensing and even license of
right has existed in national laws, they have rarely been exercised. It can be used for a few specific drugs and when there is a major health crisis, but cannot be used routinely. Therefore the only long-term goal is to get intellectual property rights out of WTO and not restrict it to a sanitised TRIPS.


If the key issue is only compulsory licensing, as these international NGOs seem to hold, then one can understand the need to campaign with the Indian government to keep the flow of cheap drugs intact. This leads to a rather anomalous situation in which the US and EU governments mount pressure on the Indian government to change its patent laws while their NGOs mount pressure on the other side. However, if the long-term goal is to attack TRIPS itself, while using provisions such as compulsory licensing for only mitigating the worst affects of TRIPS, the focus shifts elsewhere. The focus then becomes forcing all governments to take a stand against TRIPS. The asymmetry between what is to be done at home and what is done elsewhere then disappears. Unless this asymmetry is resolved, it will leave MSF and Oxfam’s positions under a question mark.


There are certain criticisms that have been made regarding the Patents Act Amendments and the role of the Left by others. It is easier for us to understand criticismof groups such as CPI(ML) Liberation, whose arguments are largely
political. They would have dubbed anything short of voting against the bill as a betrayal in any case — the merits of what has been done would be a moot point to them. Some other groups believe that India should walk out of WTO and saw in the patents amendment an avenue for the same. There is little one can answer on this count except to restate what we have already written earlier.


We will examine some of the criticisms that has emanated from other quarters and address some of the concrete issues raised about the amendments. We will also discuss Vandana Shiva’s argument that the Left missed a major opportunity to defeat TRIPS and the amended patent act will build a Monsanto seed monopoly.





One criticism levelled against the final Act, is regarding the possibility of ever-greening of patents due to the “weak” definition of the “inventive step” in the Amended Act. This criticism has been levelled, amongst others by Lawyers Collective/Access to Medicine and Treatment Campaign (AMTC). The amended Act defines the inventive step as “a feature of an invention that involves technical advance as compared to the existing knowledge or having
economic significance or both and that makes the invention not obvious to a person skilled in the art.” While it is true that the definition of an inventive step could be defined better (and certainly we could argue for its further tightening), what the AMTC completely misses is that the inventive step that was given in the 2002 Act was met solely by the invention not being obvious to a person skilled in the art! AMTC’s statement, “Furthermore, the
inventive step requirement has been severely diluted” is completely at variance with the facts. Diluted from what, the 2002 Act? If we compare what the Left was able to force the government to accept, it is clear that the definition
of an inventive step has been considerably strengthened from the 2002 Act and not diluted as AMTC claims.


The second criticism relates to what is a new entity as a pharmaceutical substance. In the Amended Act, a pharmaceutical substance is defined as any new entity involving one or more inventive step. AMTC has argued that this definition allows for loopholes for ever-greening of patents by patentees. AMTC had criticised the initial version of the Patents Amendments of allowing patents for new use and new dosage; both these are now not possible in the final version. The key difference remains on the issue of what constitutes a new pharmaceutical
entity. In AMTC’s view, it is only a new chemical entity. In the final version of the Act, while a number of riders have been put on what is not a new entity, it does not define that a new entity is only a new chemical entity.


What again is missed in the AMTC critique is that the Left’s introduction of the definition of a pharmaceutical substance is a major advance from the 2002 Act where this clause did not even exist and reduces considerably the chances of ever-greening by claiming either a new use or creating a minor variant of the chemical substance. Further, to strengthen the provision of denial of patents on frivolous claims, the amendments clarify that the mere discovery of a new form of a know substance which does not result in the enhancement of the known efficacy” is not patentable. It also adds that: “Salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substances shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.


One of the fears that were expressed on the AIDS issue was the continued availability of combination drugs, e.g., the 3-in-1 anti-retroviral combinations that has simplified drug regimen considerably. The final version protects this,
as it does not allow for patenting of substances just because they are in a combination.


The question of whether only a new chemical substance should qualify as an innovation is not only a legal issue but also a technical one. It can be argued, for example, that nano-particles display properties that are quite different
from that of conventional macro particles that we normally deal with (we have earlier carried an article on nano-technology in the PD) and therefore producing such nano-particles with new properties qualifies as an innovation. It still remains open to us not to issue patents for the same, and arguments can be advanced for this. But we cannot argue today that only new chemicals show new properties. It is because this issue is not merely a legal one that the Left agreed to refer this to a technical committee.


Before we decide that there are too many loopholes in the final amended version, let us also subject the Act to some hypothetical test cases. Let us take the example of AZT that AMTC had raised earlier. If a drug such as AZT, which was known as a cancer drug earlier, can be patented under the current Act for its new anti-AIDS property, then we would have to accept that the new Act is faulty. Even a cursory glance of the Act will show that under this Act, AZT could not have been patented again, a possibility that certainly existed under the 2002 Act. The second test case is that of aspirin, which was patented again when it was found to have anti-blood clotting properties in smaller doses. Again, the current patent Act would prevent such patenting. Of course, one can argue that any language that is adopted in an Act has loopholes, otherwise how would the legal profession survive? But on this basis, let us not quibble in the abstract against the language of the law. Instead, we would like to ask AMTC to provide one concrete example of a drug where they feel that the amended Act allows for its ever-greening through such loopholes. One has to look at the patents Act of various countries to realise the strengthening that has been provided against such spurious patenting in the Indian Act.


The third criticism of AMTC is with respect to the compulsory licensing provision. It is true that the original Left Amendment wanted the compulsory licensing procedure to be considerably simplified from that in the 2002 Act and reduce the possibility of bureaucratic delays. Some of this has not been accepted even though a definite time period has now been accepted for the patent holder’s denial to constitute grounds for granting of a compulsory license. AMTC has also argued that the three-year period that is permitted under the Compulsory licensing provision is much too long. Here, there is a misconception about the way the patents and production of drugs
take place. Patents are taken out long before large clinical trials, production and marketing of drugs take place – it is this gap that the three-year period is supposed to cover. One cannot ask for compulsory license to be issued even
before the drug has been brought to the market. For rhetorical purposes, it is good to hear that people cannot wait for three years or even three days as AMTC is arguing. The fact remains we have to wait till large-scale drug trials are
undertaken, production facilities set-up and the drug brought to the market before asking for compulsory licenses to be issued as the drug companies are not working their patents in the country or are charging exorbitant prices.




(To be continued)