A case filed by a big drug company has attracted global attention. “Doctors Without Borders” – winner of the Nobel Prize for best medical relief in 1999, has requested people all over the world to write to the company to drop the case. Over two lakh people have written to Novartis. Why is this case so important?
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, a medicine useful in the treatment of chronic myeloid leukemia (CML) - a form of blood cancer. 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 per month, whereas the Indian generic versions cost about Rs 8000 ($175)! If product patent is granted to Novartis, the Indian generic versions will be forced to go out of the market, while the treatment of the CML would cost Rupees 1.2 lakh per month and this would go out of the reach of 99 per cent of the patients of CML. There is no explanation as to why Novartis is not offering different prices depending on the circumstances in a country like India.
Objectionable
The Novartis’ claim for patent on the beta crystalline form of imatinib mesylate is objectionable 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 as specified by section 3(d) on the amended Indian Patent act – innovative step and non-obviousness to those familiar with the art. Imatinib mesylate is not a new molecule. Converting the already existing drug into crystalline form is not an innovative step nor is not non-obvious. To claim a patent on the crystalline salt form of imatinib mesylate is entirely unacceptable. Hence in January last year, the Chennai Patent office rightly rejected the Gleevec patent application on the ground that the application claimed “only a new form of an old drug”.
Novartis claims that those patients, who cannot afford to purchase Gleevec, receive the drug free of charge, through Novartis’ 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.
Constitutionality
The second case filed by Novartis challenges the constitutionality of section 3(d) of the Indian Patents Act, specifically introduced by the Indian parliament as a safeguard against the misuse of the product patent regime. Novartis is claiming that the section is not in compliance with the TRIPS agreement Each country can introduce a patent regime that is more suited to its socio-economic context. This is also in keeping with the 2001 Doha Declaration on the TRIPS Agreement and public health. Secondly, looking at the issue from a legal angle, section 3(d) can be challenged by a government and not by a company .
Novartis claims that the 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 the Chennai High Court.
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.
Hence thousands of people all over the world have signed an online “drop the case” letter to Novartis. The campaign has been launched by “Doctors Without Borders” (http://www.doctorswithoutborders.org/).
(The writer is President, Drug Action Forum, Karnataka)