Novartis, the Swiss Multinational pharmaceutical company, has filed a case in the Chennai High Court against the order of the Chennai Patent office rejecting the patent application filed by them for getting a patent on imatinib mesylate, the trade name being Gleevec. Imatinib mesylate is extremely useful in the treatment of chronic myeloid leukemia (CML). Currently it is being produced in its generic form by NATCO, Cipla, Ranbaxy and Hetero as well as by Novartis under the brand name Gleevec. Treatment with Gleevec, the Novartis’ brand costs Rs. 1.2 lakh (2500 US dollars) per month, whereas the Indian generic versions cost about Rs. 8000 (175 US dollars)! If product patent is granted to Novartis for imatinib mesylate, the Indian generic versions will be forced to go out of the market, while the treatment of the CML would cost Rs. 1.2 lakh per month and this would go out of the reach of 99% of the patients of CML. Novartis price is a clear example of excessive pricing which it has enforced across the world. There is no explanation as to why Novartis is not offering different prices depending on the circumstances in a country like India. It is clear that they are only interested in placing profits before patients lives.
The Novartis claim for patent on the beta crystalline form of imatinib mesylate is objectionable. This is because though this beta crystalline form is less hygroscopic is easier to process, stores better, it doesn’t satisfy the two essential criteria of patentability innovative step and non-obviousness to those familiar with the art. Imatinib mesylate is not a new molecule. Converting the already existing drug in to crystalline form is not an innovative step or is not non-obvious. To claim a patent on the crystalline salt form of imatinib mesylate is entirely unacceptable.
Novartis claims that those patients, who cannot afford to purchase Gleevec, receive the drug free of charge, through Novartis’s Glivec International Patient Assistance Programme (GIPAP). Novartis says that 6,700 patients get free Gleevec, whereas in India 20,000 patients suffer from chronic myeloid leukemia every year. Dr. Purvish Parikh, professor and chief of medical oncology, Tata Memorial Hospital, has filed an affidavit based on his experience, debunking the claim of the Company about GIPAP.
Novartis claims that Chennai Patent Office’s rejection of Novartis patent for Gleevec violates TRIPS. If so then this claim should be taken to the special international dispute redressal mechanism under WTO, which deals with such matters. However, instead, Novartis has decided to approach Chennai High Court in India. It has dragged the Indian Government and cancer patients to court and challenged the constitutional validity of an extremely important public health safeguard in Indias patent law. This is highly questionable. Put all these facts together we sincerely feel that the act of the company to get patent for Gleevec is motivated by desire to get huge profits at the cost of the patients suffering from Chronic Myeloid Leukemia. If Novartis wins this case, other MNCs would also claim patents for similar, already well-known medicines and there will be the danger of making a series of medicines out of the reach of ordinary Indians. Since India also supplies cheaper, generic drugs to the tune of thousands of crores to many developing countries, this will also be adversely affected. Patents in India threaten a key source of affordable medicines. India produces affordable medicines that are vital to many people living in developing countries. For example, over half the medicines currently used for AIDS treatment in developing countries come from India.
Hence hundreds of thousands of people all over the world have signed an online ‘drop the case’ letter to Novartis, asking to drop the case that it has filed in the Chennai High Court. Drop the Case campaign has been launched by Doctors Without Borders (http://www.doctorswithoutborders.org/) winner of Nobel Prize Award for best medical relief during the year 1999. Many reputed personalities including heads of nations have publicly appealed to Novartis to withdraw the court case. Few among leading personalities that have appealed are Mr. Erik Solheim, Minister of International Development, Norway (for details Deccan Herald date 2nd May 2007), Mr Henry A Waxman, Chairman, Congress of United States (for details click on the URL mentioned above), Dr. Anbumani Ramdoss, Health Minister, India and several others. But in spite of all these appeals Novartis hasnt complied. Moreover Novartis is continuously trying to influence the Indian government to bring in laws and policies that create monopolies on drugs that keep them out of the hands of our patients. Novartis played a role in trying to influence an important government report to recommend patents on small improvements in drugs and is now trying to push for monopolies like data exclusivity. Therefore we feel time has now come for all of us to put more pressure on Novartis, by boycotting its products hence, this appeal.
The Community of Practising Medical Doctors play an important link between the people and the pharmaceutical industry as the latter depend on the prescribing Medical Doctors for the sale of their products. We in DAF-K sincerely feel that you have an important role to play in bringing pressure on the industry by boycotting the drugs produced by Novartis company till they stop their actions that prevent patients from getting medicines. This includes dropping all their legal actions relating to imatinib mesylate including the upcoming appeal to the patent controllers order and stopping their actions in trying to influence the Indian government to introduce laws and policies that create monopolies on drugs and that place profits before patients. DAF-K feels strongly that you should take up Boycott Novartis Products Campaign as the Company has not responded positively to earlier appeals from various people all over the world to withdraw its wholly unjustified and anti-people stand about the imatinib mesylate patent. In fact DAF-K is compelled to call for this boycott as last resort and seek your support because Novartis has failed to respond to all other approaches by leading global organisations and state heads. We are sure you are interested in the welfare of the human society and will certainly join this Campaign to make the drug available and affordable to poor patients. This will not only help with respect to Gleevec but will send shock signals to other pharmaceutical companies who would indulge in similar acts.