A medical worker prepares a dose of the Pfizer-BioNTech COVID-19 vaccine at a vaccination center in Paris, July 23, 2021. Photo: Reuters/Sarah Meyssonnier/File Photo
- The Indian government has consistently discouraged compulsory licenses on generic drugs.
- One of the big questions the India government has not answered is why it isn’t using pharma PSUs to produce drugs and vaccines.
- Not one member of Indian industry is willing to stand up and fight for compulsory licenses, and for patients, says lawyer Murali Neelakantan.
India has played a crucial role in supporting South Africa, as a lead co-sponsor in bringing the TRIPS waiver proposal to the World Trade Organisation (WTO) in October 2020. In the months since, more than 60 other WTO members have formally supported the proposal – a bold initiative that seeks to temporarily suspend a range of intellectual property protections in order to decisively respond to the pandemic by seeking to unblock production shortages for critical COVID-19 medical products.
As these discussions reach a critical juncture ahead of the WTO ministerial in November this year, concerns have been expressed on India’s commitment to the waiver proposal. Perplexing as it may sound, it is easy to see why. Look no further than Indian government’s stated policy announcements on these matters at home in the context of the pandemic, notwithstanding its leadership on the waiver proposal in Geneva.
To understand this complex, discordant position, Priti Patnaik of Geneva Health Files spoke with Murali Neelakantan, principal lawyer, amicus, and former global general counsel, Cipla, who has been familiar with the terrain of IP policy and politics in India. The questions are in bold.
At the WTO, led by South Africa, India is a co-sponsor of the TRIPS Waiver proposal. And yet, domestically, the Indian government has made statements that are contrary to the spirit of the waiver proposal including a reluctance to issue compulsory licenses. How do we understand this?
I think the Indian government has had a consistent position on the issue of compulsory licensing. The aberration was issuing a compulsory license for Bayer’s Nexavar. But, other than that, the government has consistently discouraged compulsory licenses and dissuaded everybody from applying for compulsory licenses. So even if you went and spoke to somebody in the Department for Promotion of Industry and Internal Trade (DPIIT) or with the Patent Controllers Office, they would dissuade you from even applying for it.
In 2014, there was a move to seek a compulsory license for Daclatasvir, but they were dissuaded by the government. They were quietly told by the government, “don’t bother, you will not get it”. But this attempt to seek a compulsory license led to Daclatasvir being included in the medicines patent pool in November 2015.
Another one was Cipla’s move to get a compulsory license for Indacaterol, a product for chronic obstructive pulmonary disease (COPD) – the same thing happened.
It is therefore very clear that the government doesn’t intend to issue any compulsory licenses. More recently, an affidavit was filed by the Indian government in the Supreme Court in the suo moto matter, where they said the same thing – if we exercise the statutory power of compulsory licensing, it will come in the way of what we are doing, in terms of diplomacy. It does not make any sense at all. (See below for excerpt from affidavit)
Even where the Indian Supreme Court specifically told the Indian government in April 2021: why don’t you implement Section 100 of the Patents Act 1970, they have simply responded stating that they are processing it. It shouldn’t take more than an hour to draft and issue a notification under Section 100, but more than three months later, we don’t see any outcome from that process.
So I think there’s been a consistency – whether this government or the previous one, they have been consistent in discouraging generics from apply for compulsory licensing.
What the Indian government said in an affidavit in May 2021:
“Any exercise of statutory powers either under the patents act 1970 read with TRIPS agreement and Doha declaration or in any other way can only prove to be counter-productive at this stage, the central government is very actively engaging itself with global organisations at a diplomatic level to find out a solution in the best possible interest of India. It is earnestly urged that any discussion or a mention of exercise of statutory powers either for essential drugs or vaccines having patent issues would have serious, severe and unintended adverse consequences in the countries efforts being made on global platform using all its resources, good-will and good-offices though diplomatic and other channels.”
Over the last few years, the Indian government has ostensibly moved towards a pro-IP position. But the pandemic muddies the water in the context of shortages of medical products, isn’t it? Do you think there has been an apparent change in the government’s position?
Whether there is been a change in position or not, we can only gather from what government is saying and doing. We have the National IPR Policy 2016 that didn’t say anything encouraging about compulsory licenses. It only spoke about encouraging more IP, and more patenting and Geographical Indicators, trademarks in traditional knowledge etc. They did not deal with compulsory licenses in any particular detail.
Then we have the report of the Parliamentary Standing Committee on IP rights, released in July 2021. And again, look at whom they have consulted. When they invite experts to give evidence to them, they didn’t ask anybody from the pharma industry even though there are industry groups like Indian Pharmaceutical Association (IPA), Indian Drug Manufacturers Association (IDMA); they didn’t invite any of the lawyers representing pharma clients; they did not consult civil society nor any of the patient rights groups. How can that report be a credible account of the state of IP rights in India?
So, whether it’s the Parliament or the government, they have been consistent in that they do not want to address this issue at all. Yes, they make the usual noises that this is a pandemic and we should do something about compulsory licenses.
Parliamentarians should have said: this is a pandemic, here is a chance to address it, and the government did nothing. They should have said: here is what you should have done and this is our evidence to say if you had issued licenses, this is what would have happened. They could have done that, but even the Parliamentary standing committee did a wishy-washy job of producing the long report without actually addressing the issue.
So, we do not see anybody whether in government or in the Parliament, anybody holding the government to account and saying – you should have done it, you didn’t do it. Or explain to us, why you did not. None of that has happened. There is a consistency and it doesn’t matter which party is in power or in opposition. Nobody has actually forced it upon the government to answer this question for us. Why didn’t you do it? And what’s stopping you from doing it? Isn’t that the point of parliamentary standing committees?
It is understood that Indian diplomats in Geneva have not had enough support from New Delhi on the waiver proposal. At the same time, we also note that the waiver proposal has been taken up with other world leaders at the highest levels in the Indian government. It appears as if there isn’t enough fleshed-out thinking about these issues even during COVID-19. With this kind of dissonance within the Indian government, it is hard to understand how India can play an effective role in pushing the waiver. The waiver aside, the Indian government does not seem to support compulsory licensing.
Absolutely right. I said it once before when this issue came up before the Supreme Court that this just makes us look terrible in Geneva. We are not really sure where the Indian government stands. We say something once to the Supreme Court, and then a few weeks later, the government’s official stand is, we don’t know and then a few weeks later it is reluctant to exercise statutory powers. Then you have a stand in Geneva which is – we need the IP waiver, Doha [Declaration] is important and all of that.
The Supreme Court itself writes in an order on April 30, 2021, where Justice Bhat has effectively written the book on compulsory licenses, everything from Doha, TRIPS, 31bis, etc. No one asked Justice [Ravindra] Bhat to write it, but he still wrote it. All the government should have done is follow that and start issuing compulsory licenses.
And yet the government’s response to that is very brief. It does not even address the issue. Sadly, the response of the Supreme Court is to let it go. When the second affidavit was filed on June 26, the Supreme Court should have said, “This affidavit is inadequate. You have to answer these questions.” Instead, a judge feels pleased with himself that the court nudged the government into action.
That case before the Supreme Court has now gone to sleep. There are a number of different and contradictory positions – by the health ministry, the home ministry, then the position at the WTO. Inevitably, the question that gets asked is: why doesn’t the Indian government implement the TRIPS flexibilities and the Doha Declaration?
Also see Supreme Court’s May 31 order questioning Government of India’s basis of pricing of vaccines.
Indeed, these questions are being asked by the opponents to the waiver, and others. The discussions as you know, are at a pretty critical juncture.
We also noticed that senior Indian officials from other ministries [science and technology, for example] have made a statement saying that IP is not a problem for vaccines. This is not in line with the Indian government’s position at the WTO. But we also understand that in many countries there is a huge gap between the trade and the health ministries, since interests are different. It is nevertheless difficult to reconcile this, given India’s leadership on the TRIPS waiver talks.
The government’s Press Information Bureau issued a press release on May 27 and it was fronted by V.K. Paul1, and was written as a “myth buster”. He says that IP is of no relevance at all for vaccines, the problem is with raw materials supplies. The problem is tech transfer. So, this is their position.
This is VK Paul talking for, I don’t know which ministry now, but he speaks for the Indian government. He’s talking across ministries here and this is the official position. If you then look at India’s stand at the WTO, it’s exactly the opposite. Paul is saying everything that Germany, Britain and others are saying which is that even if the IP waiver is approved, it’s not going to be very useful. So why are you asking for it?
So, it’s very difficult, I think, for those of us who are watching this to make sense of it. What is the game? None of us has been able to figure it out. I think we are all struggling to understand what India really wants. Do you want the waiver or not? Are you just there to hijack this South Africa proposal from the inside? What are you trying to do here?
The PIB statement:
Myth 4: Centre should invoke compulsory licensing
Fact: Compulsory Licensing is not a very attractive option since it is not a ‘formula’ that matters, but active partnership, training of human resources, sourcing of raw materials and highest levels of bio-safety labs which is required. Tech transfer is the key and that remains in the hands of the company that has carried out R&D. In fact, we have gone one step ahead of Compulsory Licensing and are ensuring active partnership between Bharat Biotech & 3 other entities to enhance production of Covaxin. Similar mechanism is being followed for Sputnik. Think about this: Moderna had said in October 2020 that it will not sue any company which makes its vaccines, but still not one company has done it, which shows licensing is the least of the issues. If vaccine-making was so easy, why would even the developed world be so short of vaccine doses?
At this point, India is not even speaking forcefully in favour of compulsory licensing. In contrast, the EU, the prime opponent to the waiver is actually discussing compulsory licensing in its internal policies in the context of COVID-19, and some individual EU member states have actually gone ahead made changes to their rules. This is striking. It may not be too far-fetched to say that as a co-sponsor of the TRIPS Waiver proposal, India is undecided on its position, or worse is probably against the waiver in so far as its actions at home are concerned. We believe it is important to highlight this incoherence.
I hear you. But you should not punish the world because of the Indian government. I think there is a way to reconcile these two positions. So, when I criticise the way the Indian government has behaved and yet support the waiver, I’m not undermining the waiver by criticising the government. I have argued before that countries have to be criticised for their response to the pandemic, but that does not undermine the merits of the waiver.
What is difficult to understand is that India was seen as a vaccine manufacturing powerhouse till a few months ago, and a pharmacy for the developing world, but the actions by the government and the industry do not meet these expectations. It shows a lack of leadership and a disservice to the developing world dependent on India.
Yes. But also, a disservice to India’s own pharma Public Sector Undertakings (PSUs). One of the big questions that the government has not answered is – why are you not using your pharma PSUs to produce drugs and vaccines? You own the rights to Covaxin, so why don’t you use your own facilities to manufacture it. You can make a billion doses with the facilities you have, so why don’t you use those facilities? You knew all of this last year. Even to this day you have not produced one vaccine out of those PSUs.
The government has spoken in very general terms that they are exploring the possibility, increasing capabilities, upgrading technology, etc but there is no specific plan that has been disclosed that says here is a vaccine that will be produced by this particular facility by this date in 2021.
The only institution which could have made the government answer was the Supreme Court. And now they don’t seem to be keen anymore. The question was asked in the Supreme Court order and by many high courts, but the government seems to have successfully sidestepped it. So, even when the question was asked, in Parliament, there was not a clear answer to it. The Madras high court of Madras has asked why the vaccine production was limited to private manufacturers and why vaccine manufacturing facilities owned by the government were not utilized. The government has refused to answer that question.
When the Supreme Court told them to do it, the Indian government could have licensed the IP widely and got many manufacturers involved in the production of Covaxin. The government would have had a very good excuse if questioned by the west: we were pushed by the Supreme Court! But the government did nothing.
What according to you is the Indian government’s position on trade secrets, and other aspects of the waiver proposal? There are number of countries who are raising this in the context of the waiver discussions. The US, and the EU have more evolved legislation to protect Trade Secrets, but many countries do not.
The Patents Act 1970 requires the transmission of knowledge to be the basis for the grant of a patent. So, one of the conditions for a grant of a patent is that they will be a transfer of knowledge. You could argue… the developed world will argue that it is only transfer to the extent of what is disclosed in the patent. But to me, that limitation is not logical. When a patent has to disclose the invention, it does not need to be said that it must be full disclosure. When it specifically mentions that there must be a transfer of knowledge in technology, clearly the Patents Act expected that with the patent will come all of that knowledge necessary to work the invention. There is no place for trade secrets within patented inventions. That’s cheating the patent system.
I have a slightly different view to say we need a trade secrets act – maybe we do, but what we have is sufficient for what we need to do now. One of the ways in which we can force tech transfer is by saying that if a compulsory license is issued, and it requires a tech transfer and you don’t provide a tech transfer, then the patent will be revoked. This is what Brazil has threatened to do. So, within our existing system, we can do it too. Whether we need a trade secret act for everything else, we will see. But we have enough in the patent legislation to make sure that if the government wanted, it could get companies to transfer trade secrets with the license.
The government’s position should be: if you do not cooperate with the licensing, either voluntary or compulsory, by transferring technology to make the patent work then we revoke it because you have not disclosed the invention completely. If you want to look at it differently, you will only be granted a patent if what you have disclosed in the patent is sufficient to work it. If you are saying that the disclosure in the patent is not sufficient, because you need know-how, or tech transfer, then you are admitting that your patent application is defective for incompleteness. In which case, there is a threat of revocation. Perhaps you can be given a chance to fix by actually adding the “secret sauce” to that patent to avoid revocation.
This doesn’t require any change in the legislation. I don’t think enough people write about it in this way. We don’t need new legislation. We have legislation that is adequate, but we just don’t read it, don’t use it.
Section 83, Patents Act 1970:
General principles applicable to working of patented inventions.
- Without prejudice to the other provisions contained in this Act, in exercising the powers conferred by this Chapter, regard shall be had to the following general considerations, namely:(a) that patents are granted to encourage inventions and to secure that the inventions are worked in India on a commercial scale and to the fullest extent that is reasonably practicable without undue delay;(b) that they are not granted merely to enable patentees to enjoy a monopoly for the importation of the patented article;(c) that the protection and enforcement of patent rights contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations;(d) that patents granted do not impede protection of public health and nutrition and should act as instrument to promote public interest specially in sectors of vital importance for socio-economic and technological development of India;(e) that patents granted do not in any way prohibit Central Government in taking measures to protect public health;(f) that the patent right is not abused by the patentee or person deriving title or interest on patent from the patentee, and the patentee or a person deriving title or interest on patent from the patentee does not resort to practices which unreasonably restrain trade or adversely affect the international transfer of THE PATENTS ACT, 1970 Page 65 technology; and(g) that patents are granted to make the benefit of the patented invention available at reasonably affordable prices to the public.
What do you think is driving the motivations of the Indian government in these discussions?
The narrative 20 years ago, during the AIDS crisis, was that we are the pharmacy of the world. In the 20 years since, all of those Indian pharmaceutical companies have cosied up to Big Pharma. We have nobody now who is able to lead the fight for a compulsory license, or those who led the fight against Big Pharma in the past. You are left with perhaps NATCO and BDR Pharma, who are not comparable in size to Cipla.
And this is also by design.
It also appears there is some amount of self-censoring among developing country manufacturers. While they want tech transfer, they don’t want to be too loud in asking for it. In some sense, they have been co-opted.
Completely by design. You may have read the recent remarks by Dr Yusuf Hamied, the chairman of Cipla. He is now saying the opposite of what he has been saying for 50 years. He says that, in the context of biologics, there are trade secrets and issues of tech transfer and, therefore, compulsory licensing is not really an effective instrument any more. However, in the past, while speaking about Erlotinib, he said that Cipla will make biologics on its own terms and will fight this battle against Big Pharma monopolists.
But today, he is saying the exact opposite, and exactly what big pharma is saying. It is shocking that somebody who led the fight against Big Pharma monopolies has moved over to the other side. The narrative sounds different because the players have all moved over to the other side. They have all benefited from voluntary licensing of products from Big Pharma. They are very scared that they will lose the oligopoly if compulsory licenses are issued and the voluntary licensing deals they have done will not be as profitable for them anymore.
So almost everybody who could have potentially sought a compulsory license has now been given little sops by Big Pharma, by offering licensing, production or export deals.
But the pandemic could have been a game-changer for Indian pharma servicing not only the Indian market but much of the developing world.
Yes, but it is not really a game changer. It has just accelerated the process of co-opting Indian generics into the Big Pharma world because now big pharma is saying we will “work with you” and Indian generics are happy with those crumbs.
Take tuberculosis (TB) drugs for example. Why can’t we get Indian manufacturers to make any of the key TB drugs like bedaquiline and delamanid? Why can’t you get one of them to apply for a compulsory license? We can’t say there is no market for TB drugs: thousands die of TB every year in India.
But we can’t get a single generic manufacturer to apply for a compulsory license. Why is that? If a compulsory license was granted and Indian pharma companies manufactured large quantities of these two drugs, we could have the same impact on TB around the world like we did for HIV/AIDS.
Do you think this can change if a Bangladeshi or a Thai company stepped in?
I think the Indian companies feel secure that they have a closed market. I sense that they think that “nobody is going to enter it, and so let’s do deals that will help us in this market.” So even if manufacturers from other countries get rights to export vaccines to India, Indian companies will be happy to just distribute.
Cipla had signed up with Moderna, others like Dr Reddy’s too. Who amongst the leading Indian pharma companies is left? Who is left to fight any of these big deals?
Everybody has been co-opted. COVID-19 would have been a great opportunity, but unfortunately, Indian pharma has decided to take the easy way to profits.
Even as Indian companies do not take the lead, the population continues to be under-served.
Yes, but Indian pharma companies are not expecting significant quantities to be imported. It’s not as if Bangladesh is going to be making vaccines or drugs at such scale that it will be able to sell it in India. Even if Bangladesh manufactures, it will come to the Indian pharma companies for distribution and they are very happy to do that. They would think that they have got the market covered by distribution, not necessarily, because of production. So even if we do not have production, we are going to distribute it and make profits.
If you look at tocilizumab, Cipla has been distributing it for years now, without bothering to manufacture it. We have several of these examples – take raltegravir by MSD. Cipla has been distributing from MSD for years, but did not manufacture it initially.
So I’m just trying to understand – where is the leadership in all of this? Either from the Indian industry or the government? You were at this cusp of a challenging moment in time where you have been asked to step up but it has not quite happened that way.
Yes, and that I think all the activists have been just been feeling so let down. I have heard many say – “When the AIDS crisis happened, you guys stepped up but those who stepped up then have been unwilling to step up now. What is happening? They are just so keen to do private deals.” And that’s the shocking part of it: not one of them is willing to stand up and fight for patients. And obviously, if they are not willing to stand up and fight, who’s going to tell the government that compulsory licensing is a good idea? Just the activists or the judges saying that the government should do it seems insufficient to get the government to act.
Until there is enough pressure from industry to tell the government: we are here, we are going to do it if you support us. If only a few Indian drug manufacturers held a press conference and said, “We have been chasing the Indian government down for compulsory licenses. We can produce the vaccines, we can produce these drugs and we have been stonewalled.” But I am not optimistic that anybody is going to do it.
Finally, in terms of the climate in India for activists and lawyers fighting for these issues, the fact that, committed access to medicine advocates have been targeted, how does one reconcile India’s push for the TRIPS waiver in the context of all this.
I think we have a crisis now in very, very different ways. I think the previous dispensation sometimes saw activists as a nuisance but it engaged with them. Now we are all “anti-nationals”. So, we don’t even get any engagement with the government.
Earlier, we used to also be able to have our day in court. Now we don’t even get that. All the cases that have been filed in the last eight years have had no progress at all. We really have nowhere to turn to. No one will publish activists’ opinions or policy briefings in the mainstream media.
The government won’t listen to us. They don’t invite us to standing committee meetings, consultations, none of that stuff. Even if there is a pretense of public consultation, they won’t publish all the responses and be transparent about what the consultation resulted in. So all of what we have said goes into a bin somewhere and they declare that public consultation has been done. Then the policy comes out to be exactly as it was before. So you don’t see any outcome from the consultation.
We can’t do anything with the executive, legislature or the judiciary, and the press is ignoring us – it’s just a state of muted helplessness.
We can have round tables and discuss amongst ourselves but that’s probably not going to make much of a difference. We are really locked out.
A member of NITI Aayog and head of India’s COVID vaccine response↩