# \[e-drug\] Novartis in India: Patents for profit (2) **URL:** \ **Category:** e-drug\ **Created:** [June 27, 2007, 5:52pm UTC](https://talk.edrugplus.org/t/e-drug-novartis-in-india-patents-for-profit-2/28126 "2007-06-27T17:52:20Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![Dominic\_Atkins](https://avatars.discourse-cdn.com/v4/letter/d/edb3f5/32.png) [@Dominic\_Atkins](https://talk.edrugplus.org/u/Dominic_Atkins)\ **Post date:** [June 27, 2007, 5:52pm UTC](https://talk.edrugplus.org/t/e-drug-novartis-in-india-patents-for-profit-2/28126/1 "2007-06-27T17:52:20Z")
E-DRUG: Novartis in India: Patents for profit (2) ----------------------------------------------- [E-drug is restrictive in allowing companies to post messages, but due to the publicity of this case, an exception has been made. The current moderator is firmly against these patient programmes whereby some patients get the medicines for free if they fulfil the manufacturer's conditions and the doctor applies. It seems to be rather common in the USA and it is unfortunate that the companies bring them to other countries. See this e-drug message for more: [http://www.essentialdrugs.org/edrug/archive/199812/msg00041.php](http://www.essentialdrugs.org/edrug/archive/199812/msg00041.php). KM] In response to the piece "Novartis in India: Patents for profit" written by Dr Gopal Dabade of Drug Action Forum, Karnataka The legal case about which Dr Dabade writes was brought following the denial of a patent for our ground-breaking cancer treatment GlivecR/GleevecR. This case has always been about gaining clarity on how innovation is valued and protected in India. We brought the case forward because we firmly believe it was the right thing to do for patients. It is clear that there are inadequacies in Indian patent law that will have long-term consequences. Access to Glivec in India is not threatened by this case Firstly Dr Dabade states that "there is no explanation as to why Novartis is not offering different prices (for Glivec) depending on the circumstances in a country like India". Later in the same piece he makes reference to our Glivec International Patient Assistance Program (GIPAP). GIPAP is in fact one of the largest and most far-reaching patient assistance programs ever created. Recognizing the cost of such medication and the truly life saving nature of Glivec, Novartis has committed to make it available to any patient who cannot afford the treatment. This is why in India over 7,000 patients suffering from the rare cancers CML and GIST receive Glivec free of charge from Novartis through GIPAP for as long as they need it. This represents 99% of the patients in India who are prescribed the drug. Worldwide we provide free Glivec to over 20,000 patients in more than 80 countries. There is no way to say how many CML patients in India go undiagnosed, but it is clear that given India's healthcare spending and infrastructure nowhere near all the patients suffering with CML can be diagnosed and treated. That is why GIPAP goes even further than drug donation, and helps to train and support physicians to increase diagnosis and treatment of these rare diseases. There are generic versions of Glivec on the market in India currently and they will stay on the market regardless of the outcome of this case. This is because of a clause in the Indian Patent Law (the "Grandfather clause") which allows generics on the market prior to 2005 to stay there. Novartis is not challenging this clause. However, can these generics really solve the problem of access to medicines in India when they are still priced at over 4 times the average annual salary? Why a patent for Glivec? The piece states that the Novartis claim for a patent for the beta crystalline form of imatinib mesylate is objectionable. The original molecule imatinib was invented by Novartis in 1993, prior to India adopting the patent laws in place today. Imatinib can not be formulated as an oral medication and therefore we developed the beta crystalline form of its mesylate salt. This type of incremental innovation is what is at question here and exactly why we have pursued this case. Without it the many of thousands of patients who have benefited from Glivec would have been denied this medicine. In fact many Indian companies have made gains from exactly this type of work, patenting incremental innovation, and they support this cause. The beta crystalline form of imatinib mesylate has been awarded a patent in nearly 40 other countries, including China and Russia, and the same should be true in India. It is the only form of Glivec that has ever been marketed by Novartis. Section 3(d) and what it means Novartis as a company can not enter into the special international dispute redressal mechanism under WTO. This can only be taken forward by the member countries of WTO. As is our right as a company operating in India, we are asking a legal question through the proper mechanism, the Indian legal system. We are not challenging any of the flexibilities under TRIPS, specifically the Doha Declaration, allowing production of medicines for export under compulsory licenses that have been issued for public health reasons. They have been put in place to allow poor countries that do not have sufficient local production capacity to safeguard access to medicines. Acknowledging innovation by granting a patent is unrelated to the access to medicines issue. Improving access to medicines is a matter of making medicines available. Medicines can be made available through access safeguards in international agreements and, in the case of essential and life-saving medicines, special pricing arrangements in developing countries can, and must, be made. Access to medicines in the developing world is a complex problem in which medicine prices and intellectual property rights are but two pieces of the puzzle. A range of underlying or related issues such as appropriate infrastructure and distribution networks must be addressed in parallel. This can only be achieved through the collaboration of all involved stakeholders working together to ensure that patients in need receive proper care. For more information on this case, including patient testimonials and other views, please see [http://www.novartis.com/newsroom/india-glivec-patent-case/index.shtml](http://www.novartis.com/newsroom/india-glivec-patent-case/index.shtml) For more information on The MAX Foundation, the organization which runs GIPAP please see [https://www.maxaid.org/Default.aspx?trgt=home](https://www.maxaid.org/Default.aspx?trgt=home) Dominic Atkins Head of Corporate Public Affairs Novartis International AG Global Public Affairs Forum 1 CH-4002 Basel Switzerland Phone: +41 61 3244327 Cell: +41798203710 Email : dominic.atkins@novartis.com