Schlagwort: pharma

In this episode of IP Talks, host Jan welcomes Suryansh Singh and Manya Gupta, distinguished law students from the National Law University in New Delhi, to explore intellectual property rights in India with a focus on the patent system. The discussion spans India’s historical patent practices, its journey towards TRIPS compliance, and the unique Section 3D provision that prevents evergreening, impacting international pharmaceutical companies. The guests delve into landmark cases and the patent litigation landscape while offering perspectives on the generic drug market and India’s approach to healthcare. This conversation provides a nuanced understanding of the challenges and advancements in India’s IP regime, especially concerning pharmaceutical rights and access to medication.

Overview of the Indian Patent System published by WIPO: https://www.wipo.int/patent-judicial-guide/en/full-guide/india

WIPO article „Strong IP laws prevent so-called “evergreening” of patents to enhance access to TB drugs in India“: https://www.wipo.int/web/global-health/w/news/2023/news_0023

 Disclaimer, the views, opinions, and statements expressed by the hosts and guests on this podcast are entirely their own and do not represent the views of their employers or any affiliated organizations. Additionally, the content shared on this podcast is for informational purposes only. and does not constitute legal advice.
For any legal matters, listeners should consult a qualified attorney or legal professional to receive advice tailored to their specific situation. IP Talks is a Jan-Willem Prügel production, all rights reserved.
 Welcome to IP talks, the world’s greatest private podcasts and all things. Intellectual property. In this episode, we are joined by two distinguished guests, Sodi and sing. And Manya Gupta. Distinguished law students from the national law university in new Delhi. I met them both at this year’s Oxford IP mood court, where they and their team delivered a stellar performance. So much.
So in fact that I knew they would make fantastic guests. As you will see, they proved me. Right.
In this episode, we dive deep into the fascinating world of intellectual property rights in India, discussing how the Indian patent system operates the historic backdrop of generic medicines and the nation’s Rocky history of compliance. With international agreements, like the trips agreement. Throughout the episode, we explore landmark cases and regulatory provisions, like the infamous section 3-d, which aims to prevent evergreening and has been the bane. Of many Western pharmaceutical companies.
We also delve into the generic medicines in India and touch upon the complexities and fitnessy of the Indian patent litigation system. Stay tuned for an engaging conversation filled with expert insights that shed light. On some of the most pressing issues and intellectual property law today. So without further ado. Please enjoy this episode with Syria. And Manya.
 Welcome to IP Talks, the world’s greatest private podcast on all things intellectual property, starring some of the world’s leading IP practitioners and your host, Jan Willem Prügel. You’re in for a treat. Enjoy.
Thank you both for coming today. And I’m very excited that you could make the time. Today we have many topics to discuss. So I welcome you both surgeons and manya from India.
Before we get started into the depth of the podcast, I would briefly like you both to introduce yourselves. Maybe we go ladies first and manya, if you could briefly say some words about yourself.
Sure. So hello, Jan. I’m Mania and I’m currently in my fourth year at, I’m a law student at the National Law University at New Delhi.
My connection with IP has obviously been in my tenure as a law student. where I just found it interesting because it lied at the conflicts of commercial laws and public laws. And that’s why I got interested in it and then started exploring
it. Thank you so much.
Thank you. Okay. Good afternoon. I am Suryansh.
I am also a law student. I am currently National University Delhi as well in my fourth year. And as Marnia said, the general conflux that IP has with respect to private dispute resolution and public dispute resolution is quite interesting. However, my primary interaction with IP was through the Oxford international IP mode, which both Marna and I did.
And I believe that’s how we came across as well as you were one of us. And yeah, that I believe that was the primary source of my interest and in the future as well, I believe. IP is as we discuss a huge source of civil litigation in India and irrespective of which field you’re practicing in, to some extent it manages to swoop in.
Our interest stems from that as well to the extent at which it operates in India. Yes, so essentially that.
Perfect. You guys also told me once in Oxford that the university that you go to isn’t just any university, but it’s actually quite difficult to enter. Can you shed some light on that process?
Because I was just wondering because a lot of people might not know about this.
So we went through the process four years ago. So yeah, fond memories there. But. So our university is a part of this group of institutions in India that are called National Law Universities. They’re funded by the government, they’re run by the government.
And there’s a huge entrance test, the entrance test that you hear in Asia that are a prerequisite to entering universities. So that’s supposed to be hard. And over 80, 000 people in India take it. And
80, 000?
Yes.
Wow.
And we expect the numbers to increase. Yeah.
Oh, okay. Yeah.
So and
probably there are less than 80, 000 spots available, I assume.
There are about 47 seats or spots. Wow. And it’s all on the basis of a two hour or a one and a half hour test. So essentially it requires you to put in a lot of hours that, but I’m, whether or not that system itself should stand is something that is contestable. But one thing that I believe all of us agree with is that in a country as broad as India, it is not possible to conduct a personalized, customized and entry level examination system in order to avoid which we have an objective.
test. Now whether it filters in the best way possible is up for contestation, but that’s how it works.
So is it probable that most of the judges and senior members, the legal profession come from your school then, or is it more mixed?
So it’s a group of over 13 colleges. And the first college, in fact, was started in sometime in the nineties.
I believe it’s at Bangalore right now. And a lot of people of the legal profession do come from there. But I really think that India’s legal community is very diverse. It has people from a lot of states and a lot of legal systems. And a lot of them are from different colleges as well. So you have Delhi university over here, which is a regional university.
And then you also have some government law colleges over at a lot of states, which have produced excellent legal people.
Yeah. Oh, sorry. Go ahead.
Now I was just stating that as Manya mentioned the legal fraternity itself. is way older than the concept of NLUs or any other colleges for that matter. So we have a lot of diversity and we have a lot of sources from which our lawyers, I believe, come from.
I see. Are you both in Delhi right now? Is that safe to assume? All right. Great to have you here through the magic of the internet. And so we will speak today both about the general structure of the IP space in India and the patent litigation space, which a lot of people. listening to this probably have very little idea about, certainly me, even though you gave me some great reading material that I really enjoyed.
And so I would like to start to first discuss the basic structures of the system, a patent litigation system in India, and then move on to something that I find personally very interesting, which is how the generics are treated in India and the stories around that, but we’ll get there.
So we will first now discuss a little bit about the India patent litigation system. I believe Mania, you wanted to start with this ?
Sure. I can start with, so the patent litigation system in India or the IPR system in India is being a common law country is regulated by an act. It’s called the Indian patents act.
And I think Germany has a similar one. And that encompasses the entirety of what is a patent? How can it be granted? What are the infringements to a patent? And that’s the core document. out of which patent disputes arise in India. Suryansh, if you have anything to add.
Yeah. So yeah, the Patents Act that we currently have was, I believe came in 1970 and it was, it succeeded an original act of 1911.
And between that was a very important epoch in our history, which was independence essentially. Indian patent law in that regard must be understood to some extent by our social context of colonization and other things. Our Pre Colonization Act, which was the Patents and Designs Act 1911, was quite liberal.
In fact, it was one of the most, it was the one of the most patentee friendly litigation of that time. And was introduced by the the British kingdom at that time. However, in the late 1950s, there were a number of committee reports. I won’t bore any of the listeners with the names, but the crux of those reports were the, that the society that India is.
cannot sustain a heavy patent litigation system because we need our medicines. We need our food items. We need various things where we need various consumables because of which the 1970 act was introduced as a more conservative system. So yeah, I think Mania can shed light on what exactly did for it to be called conservative by our standards today.
So the 1970 act, which came after independence, it was widely seen to be a very nationalist piece of litigation in a sense, because in India had the compound was government. We’ve had them ruling for over quite some time since 1947. And what they created was essentially a way to appease the public and guarantee rights to medicines, guarantee rights to food.
And in short, that India as a country has space to develop rather than just granting IP rights to companies and corporations. Because from the time period of independence and particularly after 1970, between 1970 and 1990, we had liberalization. Which happened in 1991. Every foreign corporation essentially turned into India and there was just a massive inflow of products that we were not ready for.
And by, by liberation, sorry what exactly does that entail? Liberalization. Oh yeah, okay.
So economic liberalization consisted of, so earlier in India, business was very difficult to do. Everything was almost controlled by the government. Everything was nationalized. And then you had Prime Minister Singh introducing in 1991, the concept of economic liberalization, which made business more in the hands of private players.
It removed barriers to business. And most importantly, it allowed foreign companies to come into India and do business. It removed a lot of it removed a lot of red tapes as India’s system is called and made business easier to do. So that was when the Indian patent act started facing a lot of criticism because it did not evolve as other patent acts in certain other countries evolved.
It still had considerations of protecting medicine, protecting India’s generic medicines regime. It did not allow product patents for medicines. It only allowed processed patents. It also had a lot of food. It also provided for agricultural protections and it provided for the safety so that India has space to develop.
So that has seen a lot of mixed reactions and a lot of countries opposed it, but India internally internalized it as a system that it was supposed to have.
Yeah, essentially. And in addition to that, it even gave a lot of power to the government to take any invention and claim it as its own, essentially creating a deemed fiction that the inventor was the government.
And they required to pay no loyalty or anything for that. For that matter, even the process patent that was granted for drugs was only valid for about six or seven years, I believe in seven years. Yes. So that’s a very short period of time. As we all know that much of time is required for the marketing of drugs itself.
And that regime essentially was. Criticize at least externally heavily, but it must be looked at in the context of in the context of the very big struggle that India was going on between that was going on across the world between socialism and capitalism and India at that time was heavily tilted towards capitalism.
towards being socialist as it was required at that time. However, in 1991, as Manya already stated, there was liberalization, introduction of liberalism, which essentially almost made it necessary that our patent act was compliant, which followed the most important incident in, I believe in this entire saga, which was the introduction of TRIPS in 1995.
And we were one of the founding signatories, if I’m not wrong, Manya, right? Yeah, we were one of the founding committees. And for developed and for developing and underdeveloped countries, there was an exemption within TRIPS, an extension of five years to be TRIPS compliant.
Can you briefly tell us what TRIPS is for anyone who might not know?
Yeah, thank you so much for pointing that out. So TRIPS or the agreement on trade and related aspects of intellectual property rights. is a subset or a sub agreement of the World Trade Organization, essentially an attempt to to universalize a standard, the standards of global trade. Now the WTO essentially brought a number of regulations and standards in order to do that, which includes the TRIPS agreement, the TRIMS agreement, TRIMS is for investments, and The TRIPS specifically introduced a number of minimum standards that the signatories must comply with.
Now, if supposedly I am a person who is a, I’m a country, which is a signatory to the TRIPS agreement, I am bound to grant patent, To certain medicines or certain goods, as long as they meet the requirement mentioned in the TRIPS agreement. And that essentially was an attempt to universalize patent laws or intellectual property laws in 1995.
Up until 1995, everything was going really well for India. because it had its own patent laws and it wasn’t really being criticized. The real problem came when India became part of the WTO in 90, when it was created in 1995. And then the TRIPS Agreement came and India did not really comply with the standards of the TRIPS Agreement.
Because of what we just discussed, it did not have product patents, it did not recognize patents which had been granted in other countries. So essentially if a patent was granted in the U. S. based on conditions laid out in the TRIPS agreement, the U. S. has now space to criticize India because it’s not following the TRIPS agreement and granting a patent to say, hypothetically say that medicine.
So then India came and then the Patents Act was amended finally after huge internal debate and discussion in our parliament for India to become TRIPS compliant. Now this was criticized internally in India, but it was appreciated universally outside and the debate become, became whether do we protect our insider, whether do we protect insiders as in domestic companies or do we protect outsiders?
And the 1999 amendment. to the Indian Patents Act came out as a balancing instrument between India following trips and India also protecting its own industry.
I wonder, but is, was India’s own industry, certainly in, in pharmaceuticals was it only generics or did there, were there also innovators that had own developments of drugs because they would have been opposed to a weak patent law as well?
So India certainly does innovate, but the kind of innovation India does is very little in terms of jobs.
I see.
India is called the global medicine supplier of the world. It’s called the pharmaceutical basket of the world. So India is still, to this date, specializes in providing generic medicines. Our innovation in national drugs or in or in our own drugs is relatively very little.
So it still continues to thrive on generics as its main exporter.
Thank you. That’s very important to know because then it makes a lot more sense why this would be so opposed because similarly, even though there are some generics in Germany as well and other countries there would also be always a lobby for the big innovators that would want a strong patent law, but that’s very important and interesting to know that there is a less of a balance in India at that time.
So thank you.
A very interesting point is still that. Even the companies that innovate medicine, medicines in India, they are themselves the producers of generic medicines. So largely the lobby was just of those companies saying that we need to protect the thing that gets us money, which is their generic exports rather than them innovating.
So in a way it can be criticized because What generic medicines do is they prevent India from innovating in medicines itself. But then again, the companies don’t really have the scope to innovate because they’re getting their money from genetics. So that’s an interesting something that we can consider.
Yeah. And So essentially it also must be looked at as the difficulty that India faces in shifting from develop from a manufacturer to a developer. And essentially that’s it’s not just India’s problem. Actually, the entire world will be significantly heard if that happens. Because if. Just to highlight one incident AstraZeneca was innovated within UK.
And it was developed as a drug within UK. However, the largest source of export of AstraZeneca, including inside UK was from India because of the fact that our manufacturing capacity is so huge that we essentially promote, we obviously created a version of it within India and promoted it. In consonance with AstraZeneca and essentially helped about, I believe 4 billion units of those vaccines were exported.
If I’m not wrong, I might be incorrect about this number, but if I’m not wrong, a number the cumulative number of vaccines manufactured, including inside and outside India, including for purposes inside and outside India was 4 billion, which is a significantly huge number. None the issue that happens is that.
Manufacturing industry requires itself to be extremely big because we need medicines for about 1. 2 billion people.
Yeah, essentially, I’ll be a bit liberal with the number. I’ll be a bit liberal with the number I use here because I don’t have the exact figure, but the number was around 4 billion.
And as I was stating that not only India itself, but also the world cannot afford India to be to be more developer friendly rather than manufacturer friendly, because everyone requires the drugs that India manufactures at this India itself requires the drugs it manufactures. At the same time, a regime can either be tilted towards the manufacturer or the developer.
While most of our, the regime itself is tilted towards the manufacturer that’s there. That’s that’s not a strange fact. However, the bigger issue that arises in India is that at the ground level, that is to say at the fundamental level of pharmaceuticals, the studies are also mostly focused in manufacturing.
That is pharmaceutical engineering. And industrial pharmaceutical manufacturing rather than research and development, and that is basically basic research into pharmaceutical sciences is very scarce in India, and it’s not a study that people usually pursue when it comes to medical.
Because of this on a fundamental level, it is very difficult for India to shift to a developing country or rather develop a friendly country and on a political level as well, it is not desirable for India itself and for countries outside India for India to shift. But as students, we all have a glimmer of hope that someday maybe.
To an extent, people will start following or people will start to get interested in how these drugs are manufactured in the first instance, and instead of creating generic versions or tilting regimes to be friendly towards that, we will be developing more of our drugs ourselves. rather than importing them or rather than manufacturing them.
That an example of that is the other drug that India manufactured. I believe a billion of those were also made, the Covaxin. So that was purely manufactured in India. We hope that more of that can happen in the future.
Just one thing I’ll add here, and it might not even be related to intellectual property rights, but the way India manufactures generic medicines, it primarily goes to either Africa or it also is exported to Europe and other countries.
But the laws relating to those exports of purely drugs are very uncertain. So we have something called the director general for the country for the control of drugs. And a recent incident happened where in Indian cough syrups were sent to Africa and they ended up poisoning half the kids that consume them.
Really?
Yeah. So in terms of, Even looking beyond IPRs, India needs to streamline its system in genetics and it has a lot more work to do.
So what was, so it was some kind of drug that poisoned Africans?
So it’s a, so it was a cough
syrup. Oh, cough syrup. Oh, isn’t that part of a drug epidemic?
Aren’t they using that to get high in some countries? Cough syrup?
Yeah, but I don’t think that was included in, I don’t think it was that particular cough syrup.
I see.
So what ended up happening is, it got the export approval, while it was not itself approved in India. So it was a really contorted process where in the manufacturer essentially could export it, even if it had not received a domestic license to be consumed.
Was that an oversight or was that, The
Indian regulator claims it was an oversight, but it’s really because India has a state law and then a central drug regulator and a state drug regulator. So they have a lot of overlapping jurisdictions and certain in spite of the overlap, certain things get left out of those laws.
It’s a lot, it’s paradise. There are way too many conflicting laws to argue on and way too many forums to go to. Yeah. Coming back to, yeah. Jan, you were mentioning something?
No, I was just exactly asking. About the next steps in the development of the patent litigation system in India.
Absolutely. Coming back. Go on.
So I was just mentioning, I believe, what Manya would have also mentioned, the, finally, there were two cases within the WTO. So just a bit more context for that. The WTO has a two tier dispute resolution structure, one at the panel level and the other at the applet body level.
Both of them in two separate cases ruled against us. One filed by the U S and the other filed by the, by European community, I believe so essentially in 1997 and 1999, we had two international judgments against us. A number of Western countries were expecting us to conform to our international obligations.
All of which led to the passage of two new amendments in 2002 and 2005, which finally made our act much more compliant to TRIPS. With a small asterisk at the top. So we had certain caveats included and we had certain exemptions. I believe I, it’s not relevant to discuss all of them, but a couple of them that can be discussed is the compulsory licensing mechanism in India, which is relatively more liberal as compared to anywhere else, especially the West in the world, and a provision called section three D, which It essentially prohibits evergreening in India.
I believe Mania can shed more light on this.
Perfect. And before, and while you explain this also maybe briefly explain what, whatever greening is, what somebody not involved in the pharma space might be familiar with.
So I think I think most of us could be familiar with something called the Doha Declaration, which came shortly after TRIPS.
And what it did was it was essentially seen as a victory for developing countries. Because what it said was that countries would interpret the TRIPS agreement to support public health for their own citizens. So that allowed India to use its patent act in such manner and justify the asterisks, which Suryansh mentioned as lying within the Doha declaration that everything we are doing to support access to public medicines for all.
So what India did then is rather than developing its patent act, it developed its jurisprudence. through cases, through the use of clauses in the app to support its own interpretations of the law. So one of the most contested cases, and I think one of the most landmark cases, I think it’s the first case we are taught when we do the IPR course, is that of Novartis, which dealt with this phenomena called evergreening.
So evergreening is a process wherein drug companies, they enhance the drugs they’ve already made, and then they get a new patent for it. So essentially you make a drug, the patent for that expires, and then you add a slight modification to the drug, that you mark it as a new drug entirely, and then you can get another patent on it.
So yeah, you were saying something.
Very good. I was just breathing in, but that’s your mood cord experience. So I was just wondering, do you have any example for such a slight modification?
So one of the modifications that came in the case of Novartis was about a There was a certain, or in another case, in fact, there was a drug called Tarsiva, which is used to cure lung cell cancer, I think.
And it was marketed and then at the time of expiry of its patent, this is not the Novartis case, this is another case, maybe the Roche case, but yeah. And then the Indian manufacturer Cipla came up with another drug similar to it, but its composition was a little different. But then what the original company did was it tried to modify the drug a little bit and state that, oh, we have created a new drug altogether.
So this was also what happened in the Novartis case where a drug called Imatinib was introduced. And what the Indian court observed was the manufacturer had increased its efficacy by changing the proportions of the base chemicals used in the drug. And then they were trying to market it as a new drug in India specifically, and trying to get a patent for it.
So the Novartis case went through four rounds of litigation, as we will discuss in India, litigation can be at several levels and in several forms. So it first went to the Delhi High Court, when there was an opposition filed to the grant of the patent by CIPLA. which is trying to make a generic medicine to sell in the Indian market of that particular drug.
The Delhi High Court rejected Novartis application for the evergreen drug. Then the case eventually went to the Indian Supreme Court, where the Supreme Court upheld the observations of the Delhi High Court and held that in order to have a new patent, it must not, it must conform to the requirements of patents in India, and that cannot have evergreening in it.
So the thing that you produce must be a substantially new product and you can’t have an argument where you say that improving the efficacy of a drug leads to the creation of a new drug, even if you have maybe added a new material in it. So that is what led to intense round of debates internationally about how India really protects developers or innovators of medicine.
Yeah. I believe something we can discuss further with regards to that. Is how does the provision section 3D operate? So as Mania mentioned evergreening is first of all something that is not very uncommon. I believe if I am to give an example, paracetamol drugs nowadays, if we, Jan, are you aware of paracetamol as a drug?
Yes. Unfortunately, because I usually take it when I’m sick. Yeah.
But if you take any paracetamol drug, it will hardly be just paracetamol. It will be some other drug mixed with that in a very small quantity, which can be either for body ache. Paracetamol is generally only for fever, but the additional drugs can be for body ache, for cold or for similar things that accompany fever.
And this was a very common strategy that was adopted initially to create a very small To add a very small quantity of some other drug to create a small mixture in order to, in order for the patent to get renewed and a new manufacturer to not be able to make the original drug and the new drug. So this essentially kept on happening.
And this was a concern that was raised by multiple committees in India because of which section 3d, as I said, was introduced. Now section 3d essentially says that something cannot be granted a patent. Until and unless it a, whether it’s a product patent or a process patent, until and unless it either significantly leads to the efficacy of an already existing product, or it creates a new product altogether.
So essentially this efficacy and new product standard is a completely new standard introduced by India. On the other hand, in the international regime, now this is where it becomes problematic content contentious we may call it whatever you want to, but the way it becomes contentious is that the TRIPS agreement says that it is required for a country to at least provide a patent application to any product that is new, includes an inventive step, Is capable of industrial application.
So there are three there are three criteria. Those three criteria are imported within our legislation as well. Now, this additional criteria of ex of a efficacy or a new product is something that we suggest is a trips plus provision. A trips plus provision is one that gives protection beyond what trips already gives.
But many Western companies suggest that it’s a TRIPS minus provision that it adds an additional requirement upon the patenting. Now there’s been, as Mania mentioned, there has been debate going on and on for a very long time, but for the purposes of our domestic application, the law is very settled for us that evergreening is not allowed in India, you cannot get a patent, which is genuine, generally not appreciated by Western companies, because their argument, to some extent, logically is that once a patent is indeed granted, and it is disclosed in the public, At least seven to eight years are required to essentially market in a market like India.
And of the 20 years that are available, if seven to eight years are gone in that, then the 20 years in fact is a very less, is a very small number. So that’s the general rationale of the Western companies. But now the debate goes on and on and I don’t think nobody, anybody has a conclusive answer to that.
Patent applications have been denied based on this provision already because, so it’s not just on paper, but it’s actually being enforced as well. Very much so the problem
with it is that what companies basically state with India having TRIPS plus and minus provisions is that the court could have said that now a patent requirement is you have to create a new product as per the TRIPS agreement and as per the patent act.
So what companies argue is what was there, why was there a need to have a separate exception in the form of a provision like Section 3D? Why couldn’t the court do it through the definition of new? And what companies state is that this essentially means that the court can slap 3D into any application for evergreening without even going into the merits.
of evergreening or examining it within conventional jurisprudence on the term new as used in patent acts across the world. So that is something that is present a lot of other provisions in Indian law, which are deemed by companies to be patent restricting in under the veil of being trips plus provisions or under the veil of simply being India protecting provisions.
That’s a very good point. Even for that matter if I am to give an example, for example a number of vaccines are said to when they’re introduced at the introductory stage, they are said to have certain difficulties, certain harms. For in my personal experience, COVID, the COVID vaccines, essentially almost mandatorily followed a day or two of fever to the person who took the vaccine and there were claims as to certain vaccines that were able to, vaccinate a person with COVID against COVID without a similar fever or body ache or similar things.
But in India, that vaccine with an additional with an additional sort of plus point. Will not be patentable because it’s just an adjustment. It’s just an improvement. Improvements in India are not patentable at all. The only thing that’s patentable is if you significantly increase the efficacy, as I stated, and that test itself is very, is a higher threshold is a very contentious threshold to meet because significantly increasing the efficacy cannot include improvements, cannot includes debugging.
It can only include almost recreating a product from scratch.
And essentially, you have a court without scientific experts or patent experts deciding what.
such an ambiguous term such a significant threshold is. So that also poses a problem for a lot of companies.
When was this introduced again? Can you remind me? 2005 2005. Okay, so it’s been around for a bit.
Yeah, so same time.
Yeah, it was a compensatory clause. Essentially, we introduced, we removed a lot of incompliant things from our legislation. And this was a breaking point of the negotiation that we cannot have evergreening in India, which is why this is a provision which must exist.
Interesting.
Very interesting.
I personally haven’t heard of any country that has a similar provision to 3D, but there are many countries that are, that lack TRIPS compliance itself.
I believe many countries, including in Africa and And some other countries in different jurisdictions have other exemptions because of being underdeveloped due to which they claim similar exemptions. But I don’t think any country has a similar provision to 3D because otherwise it would have come up at some point during the argument.
I think now that I’ve done a quick research on this, I think some countries, including surprisingly Australia, and Canada have had not exactly provisions, but jurisprudence developments in the form of cases, but it’s never been as strictly applied as it’s in India, because in India, this word significant improvement creates a lot of playground for the court to simply say no.
There’s even been cases where in Indian courts have assessed the price of a drug, the price of the original drug versus the price of a generic drug and said that in public interest, we are supposed to interpret it. as not being a significant improvement. So I think the way it’s used in India is unique.
Yeah.
Interesting. All right. So that was an interesting meandering into that area. Did you want to discuss the general patent litigation system some more? Or what would you like to talk about next?
Certainly, I believe that is something we could discuss how the litigation system itself works.
And we could delve a bit into the enforcement part of it as well, which will also bring very interesting international case laws we India has with the European community. Before that, I’ll just quickly Like for the convenience sum up the entirety of the generic, how it works is that. Initially, first of all, during the time the patent exists, we have a 107A, that is the BOLAR exemption within the Patent Act, which essentially works to allow companies to research on certain drugs while they’re still patented.
It does not go so far as to allow them to commercially use it, but just research on it so that immediately after the patent expires, they can introduce generic drugs. After that, the patent expires. After that, the provision of 3D kicks in and the patent cannot be evergreen, essentially renewed.
And after that, the generic drugs are introduced into the market. They’re exported into other countries. And after that, the enforcement issues begin, which we can discuss now.
Perfect. Just briefly. Oh, sorry. Sorry. Just very briefly before we move on from that. What is it? So is I, how does the, I don’t know if you’ve ever researched that, but the if you with the healthcare system is, are generic drugs being reimbursed by statutory health funds, sick funds, or is there like a price reimbursement and pricing list or anything of that sort?
I think generic drugs are extensively promoted in India. In fact, so that we have the medical guidelines, which actually mandate that doctors can only prescribe generic medicines.
Oh, interesting. It’s up
to the consumers which drug they actually buy. They can buy the most expensive form of the original drug, but they can also buy generic drugs.
And especially with the coming of another government in 2014, we’ve had the introduction of several clinics and several and several pharmacies that exclusively sell generic drugs. They don’t sell the original name drug, rather they sell the generic version of it. So in fact, a very interesting phenomenon, which I can tell from personal experiences, I had to get some, I had to get a drug from my grandmother and it was too expensive for us, especially to buy for one year straight.
So a lot of websites in India just tell you the base chemical of that drug and they actually tell you what the substitutes are to this drug and the price of those substitutes. So it’s pretty much forum shopping because you can go and just tell the chemist that you want this form of the drug and they’ll give it to you very easily.
I see. And is there a system where you pay a health insurance and then you can ask them to reimburse you and then they would only reimburse generic drugs and never originals?
So a little bit about that. I believe so the health insurance in India essentially is very significantly a private affair, different companies run it.
And it depends on their terms and conditions as to what they cover and what they do not. But I must add here that for the population that subsist in India, the healthcare system that we have is significantly impressive. Like Genuinely impressive because we essentially at medical at public hospitals, which are plenty in number, especially in cities, if not that much in rural areas have to pay about If I’m to, I should speak in euros.
So we have to pay essentially.
You can use dollars or rupees, whatever.
Yeah. We have to pay essentially 10 cents for consultation and the medicines are generally free until and unless you have to be admitted, in which case you have to pay about 2 a night.
And you get access to this if you are an Indian citizen, I assume.
Yes, that’s it. That’s all that you’re required to do. And essentially the system itself prevents itself from collapsing because in, and that is why generic drugs themselves are promoted to that extent. The biggest purchaser of generic drugs would, in most cases, in most states, be the government.
Yes. The government and the public hospitals. And then after that, as Manya said, the laws are also significantly in promotion of that. It’s required of the doctors that if they are not allowed to mention the name of the brand, but only the name of the salt that they want, or rather the drug that they want the patient to purchase.
So yeah, the laws are significantly tilted towards a generic friendly healthcare system.
I think we even have something similar to Germany where we have the essential commodities act, which means that in case of an emergency, one of them was COVID and other of them is local emergencies like epidemics or local diseases where the government can sanction any drug.
The manufacturer has to mandatorily license that drug. And sell it at a price that the government decides just so it’s easier for the public to access it. Now it’s not as rosy as we’ve made it sound because there are frequent problems of access in those government hospitals, sometimes you just don’t get beds.
In COVID, there was a huge problem of the lack of beds in India. We have essentially one doctor for 30 lakhs population. So that’s the proportion. And it’s quite a sad number, but yeah.
You said 30, 30 lakhs, right? Yeah. Oh, I think it’s one
doctor per 30 lakh
of the
population. That’s 3 million. A million.
Okay. Because I’ve read that before. And I’ve I know I looked it up once and then I forgot. So 30 million. Okay. Yeah. 3 million. Oh, okay. Sorry.
And that’s not quite a good number here.
It’s impressive.
Yeah.
That, that’s where we will have we will be a slightly at crossroads because I believe That that I believe that it’s very difficult to maintain healthcare for a system where in 80, like that’s 0.
8 billion people falling below poverty line and given the fact, so I’m, my awareness of how COVID was dealt with in multiple countries only comes from news and other sources, right? And I’m not sure about Europe that much, but as far as I, my awareness goes, Of the richest countries in the world, like us the situation was extremely dire and for a country like ours, where at one point we had about I’m not sure how, what will convert to, but about 200 million patients in a day.
Yeah. No, that’s not 200, 20 million people, right? Two girls between, so about 20 million people. Who were patients of COVID in a single day. There was a point at which we reached that stage. Then to the collapse was not as bad as certain other countries. So I believe that while the resources are scarce, they are still supportive of what they’re still inclined towards what the population requires.
Yeah, absolutely. I remember very vividly that India was way punching way above its weight as the, at least as people would have expected it in terms of how they dealt with the emergencies of the COVID pandemic, especially, I think they had some contract tracing. as well that was very sophisticated and they developed many methods that were quite impressive.
Absolutely. So it goes to show that there are some great ideas floating around and some very capable people, some of which I’m speaking to right now.
Yeah, we are the ones who actually block all of this because we are, we create bottlenecks by bringing in a number of laws, but the medical professional and personnel genuinely have to have a lot of respect in India because of how much they deal with almost every single day.
Sorry. So for having taken you off track. Yeah, you were talking about the patent litigation system, but go ahead. I don’t want to box you in. Before
we proceed to the litigation part, I think it’s really, I think it’d really be good for both me and Suryanshu to hear your views on what does coming from a European perspective, what we think it’s a mix of good and bad about Indian genetics and our genetics regime.
But what do you, what would you say about coming from a European perspective on it?
I’m always a fan of not having too much of an opinion if I don’t really know what I’m talking about. And one of the reasons to remove some of my ignorance was to have you guys on to actually learn more about the situation as it’s going on in India.
There is a narrative, of course, a very simplified narrative in I would say, I can only say in Germany, I’m not sure what the narrative in other countries is that there are other countries, particularly India, who do not respect the hard work and all the innovation that some of the originators put in to developing medicines.
And they’re just basically ripping them off and then copying them and then pushing them out all over the world. And especially in India, and they’re not paying for it. And so that’s terrible blow to their businesses.
But because I, and that’s why I’m so interested in getting your view and your opinion on this. And I can very much. understand the situation better now because of the historical development of the generics industries in India and the necessity for a government to actually take care of its people, because that might be, or should be its first mandate to make sure that people are not dying of diseases.
And then of course, Laws must be respected and property laws even more some might say but it’s certainly they must be dealt with. And I think the important thing is that India has shown that it’s open to to discussion and negotiations with other countries and has done, as you’ve outlined, had great strides in improving the relationship with other countries and being more TRIPS compliant.
And I believe that is a strong indication to the rest of the world that it’s to be taken very seriously as a major player in the global pharmaceutical game. And as you say it’s, I hadn’t heard put a phrase quite like that, that you said, it’s the pharmaceutical basket of the world. But that makes a lot of sense and immediately rings true.
And I think any global policy on how to deal with patents and in the pharmaceutical space, but also probably in other areas needs necessarily to include India. in the future because it’s just so important. It’s becoming ever more important. And we’ve seen in recent developments, as we just discussed during the pandemic, that it’s highly competent in certain areas.
And it’s certainly increasing its abilities ever more. So I’m very interested in the further developments and also even more interested in learning some more about the structures of patent litigation in general, which I believe we May hear from you now, even more,
but who wants to go first or does that answer your question? Even, or do you have would you, what’s your take?
I think I think we can end this part of the segment on something very important that you pointed out, which is, I think the world can look at India’s perspective, not from a point of maybe companies ripping off, original creators of drugs, but rather from a necessity perspective, which is that if India doesn’t do it, then simply more than half, maybe even me would not be able to afford medicines priced at the price that innovators of drugs are pricing them at, because it’s not disputed that even they price drugs really high, much higher than what it costs to manufacture them, which is obvious coming from a profit perspective.
But the Indian perspective simply is that it is necessary. For us to have generic medicines enabled to ensure that more than 90 percent of the Indian population have access to drugs.
Yes. And I will add some of the originators would say, of course, that there would be no medicines at all if they weren’t putting in the money and all the manpower and the time and technology to innovate and to create new solutions for pathological problems that the world is facing.
So there would be nothing to copy if they didn’t do their work. And so there should be some. in some incentive to innovate and the only way to safeguard this or one of the best ways to safeguard this would certainly be property rights and monopoly rights in the forms of patents. So there’s certainly not just greed at play because and Of course Article 3D is of a strong as we would say in German, sort, a sharp sort in terms of legislation, because, you can argue, as you pointed out earlier, there is an improvement.
You can make improvements and some people just call it evergreening. And that sort of shuts down the conversation and they say you’re just evergreening. What are you talking about? And then people have this in their mind that they’re doing some sort of evil scheme rather than maybe they are improving the drug and maybe, they’re common, Example, examples like reduced forms of injection or dosage lower dosages.
For example, where you, if you’re injecting a drug, you sometimes don’t have to inject it every day anymore. You just inject it once a week, or you sometimes inject something with a needle and then somebody finds out you can actually do it as an oral form and then you can just swallow a pill. And that’s much nicer than putting, jamming a needle in your thigh every day.
That is, objectively, probably an improvement for many people because it causes the patients to adhere to their treatments.
It’s important to have an ongoing conversations and to understand each other and to find compromises for this.
Thank you, everyone. That was our first episode with Suryansh and Manya. Since we did not want to episode that goes on too long. We’ve split it into two halves and you’ll get the next episode next week. So we’ll catch you then and stay tuned because we have a lot of interesting topics still to cover. Take care and goodbye.
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