 Hello and welcome to NewsClick. Today we have with us Dr. Amit Sengupta from Delhi Science Forum who has also been associated with Jan Swasti Abhyan. Welcome to our show, Amit. So Novartis, the Swiss pharmaceutical multinational, has challenged Indian patents law in the Supreme Court. What are the grounds for this challenge? Actually, Novartis has been pursuing this case for the last more than five years and it started with their having applied for a patent for their anti-leukemia drug, that's a drug for blood cancer, which they sell as Gleevec. The drug is called imatinib mesolate. And their patent was rejected by the patent office first and then again by the patent appellate board and then again by the Chennai High Court. So there has been a long sequence of legal battle that Novartis has been fighting. And the Indian patent office as well as the court has given an opinion that the Novartis' drug Gleevec should not be given a patent because under the Indian Patent Act, there is a provision that if you make minor modifications to an existing molecule, then that does not mean that it is a true innovation, that it is a true patent that can be granted. And the section of the Indian Patent Act, which says this is the section 3D. So what Novartis is now doing in the Supreme Court of India is challenging the Indian Patent Act and specifically section 3D of the Indian Patent Act, saying that that provision was not properly applied in the case of its drug Gleevec by the patent office as well as by the High Court and that that decision should be overturned and they should be given a patent for Gleevec. Novartis claims that through its Gleevec International Patients Assistance Program, it provides drugs for free to poor people. So what is the harm if they get this patent? Actually there are several issues. The first issue if you specifically look at Gleevec itself, it is true that Novartis is providing to Indian patients who cannot afford it free of cost the medicine. But this is part of an international program called GPAP and the whole program actually has been criticized for example the New York Times first carried a story on this in 2003 where they analyze the GPAP program and see this as an attempt by Novartis to create a demand for the drug and subsequently to mobilize patients to ask the government that they should reimburse the patients for the drug that they get from Novartis. Now there are clear examples in the New York Times story for example talked about this in Argentina, in Korea and many other places where Novartis is playing is doing this. Now you have to also understand that Gleevec, the global turnover of Gleevec is about 4.3 billion dollars which is about 20,000 crores in Indian rupees which is something like half of the Indian market. So that is the kind of revenue that Novartis gets globally. So they can play a waiting role in India in anticipation that they will be able to drum up a situation where the government actually reimburses them. The second point is that again global experience has shown that the charity model with the GPAP basically is not the best way to ensure access because the control is always with the company and Novartis for example in a few years back had threatened and actually had stopped the free supply of Gleevec in India saying that their patent application was being rejected. Second point is that Novartis is fighting this case not only for its drug Gleevec. It is a larger case which involves the whole issue of section 3D which has been instrumental in denying patents to a whole range of medicines which the Indian law believes are not true innovations. So the problem is not only about Gleevec and the third issue is that if Novartis gets a patent for this drug then there is we do not have any evidence that they will continue the patient's assistance program. You said that it is a section 3D which is being actually challenged by Novartis. How big do you think will be the implication if Novartis's challenge is being upheld by the Supreme Court? Section 3D is a key provision in the Indian Patent Act that prevents the patenting of trivial innovations. Now the whole understanding of a patent system is that you should provide patents, you should give a monopoly for a limited period of time. In case the inventor is able to show that he has made an effort to create something new that is called the novelty criteria. Now section 3D lays down clearly what we mean by the novelty criteria in India and what it says is that you cannot patent a combination of two existing drugs. You cannot patent an existing drug for a new use. You cannot patent an existing drug which is made into a different form for example a tablet into a syrup and you cannot patent different salt forms of the same molecule. So there are these various definitions that are provided in section 3D. Now this section has been used by the patent office not only to deny patent to GLEVAC but for a whole range of anti-retroviral medicines used for HIV AIDS. Many companies actually have not filed patents for this kind of innovations because of section 3D. Now if section 3D gets overturned then the situation changes entirely and a whole new sort of situation would arise where a number of patent claims would be made which were earlier rejected or which were earlier withdrawn or which were not even made in the first place. So you have drugs for TB, you have drugs for HIV AIDS in addition to GLEVAC that again would be opened up for scrutiny by the patent office. An interesting turn of events just as Dalveer Bandari was hearing the case, he has recused himself from this case. What has caused this thing to happen? Actually it came about because there were concerns in different quarters especially among health activists who have been following this case that Justice Bandari as part of a much larger program that drug companies have been now conducting across the world has attended conferences which are supported by the IP Owners Association and he has had occasion to also present a paper on patent law which takes a very clear position that the patent system is something that needs to be strengthened. Now the apprehension that was raised is that perhaps because of the clear views that Justice Bandari has expressed, he may not be an appropriate person to hear the case and this was this position was actually communicated to the minister to the law ministry and Justice Bandari himself decided to recuse himself on the case. Now we have Justice Markandey actually five years back in a similar situation on a patent dispute also had recused himself from a case but for an opposite reason where he had said that he had written in a journal saying that drugs should be made more affordable and the patent system actually prevents affordable drugs from getting to patients. So that was also a kind of a precedence that existed based on that. So the judgment in this case how will it impact the medicine access in other countries as well? You see India has been called the pharmacy of the south which means that Indian medicines are going not just to Indian patients but to a whole range of African, Latin American, the nation countries especially poor patients in poor countries. For example if you look at HIV medicines about 80 percent of people residing in developing countries who get HIV medicines get it from Indian companies. Now 3D is a key what is called a health safeguard in the Indian Patents Act which allows the continuing manufacture of a large number of new medicines. So if 3D is overturned it compromises the ability of Indian companies to be able to supply not just Indian patients but patients across the world and you have to understand that the challenge that Novartis has now placed on the Indian Patents Act is not just about getting into the Indian market. It is about preventing Indian manufacturers from manufacturing not just for the Indian market but for a whole range of countries across the world. So that is the kind of impact that we are talking about not just in the case of cancer medicine like GLIVAC but whole range of HIV AIDS medicines and a large number of other medicines that Indian generic manufacturers are making. So this is a case that is actually being watched by health activists, by patients associations across the world in many different countries because it has implications not just for India but a much larger global implication. Thank you Amit. Hopefully we get a judgment which takes care of access of health care not just to people of India but elsewhere as well. Thank you. Thank you. Pleasure.