Patient groups and health activists like Cancer Patients Aid Association and Lawyers Collective are planning a public protest in Mumbai on Wednesday against the decision of Novartis to challenge the Patent Controller's decision rejecting patent application for Gleevec (Imatinib Mesylate). The protest assumes significance as the Chennai High Court is to hear the Novartis case on August 23.

According to patient groups, Novartis' constant litigation threatens the lives of cancer patients and renews fears of future availability if the patent case of Gleevec is reopened. Further it has raised concerns among other patient groups as the patent order set a good precedent for patent examination of other crucial AIDS drugs.

It was in May 2006, Novartis filed two cases in the Chennai High Court challenging the refusal of the application filed by Novartis for a patent on 'Gleevec' and the constitutionality of section 3(d) of the Indian Patents Act which was specifically introduced by the Indian parliament to protect against obtaining patents on old medicines i.e.trivial patenting, new use patents etc. While the 3 (d) case is still to come up for hearing, the challenge of the patent order rejecting the Gleevec patent is up for hearing on August 23.

The Novartis appeal came after the Chennai Patent Office rejected the patent application in January 2006 on the ground that the application claimed 'only a new form of an old drug', which does not qualify for patentability. Cancer patients point out that the order of the chennai patent office "brought relief to cancer patients as it not only prevented a patent monopoly till 2018 but also automatically withdrew the EMR". The Gleevec patent order rejecting a new form of an old drug also set an important precedent for the examination of patent applications related to essential drugs including AIDS medicines, they add.

According to the patient groups, the situation of unavailability of affordable generic versions of the drug continued till 2006. While the generic versions of the drug 'Gleevec' in the Indian market were priced at about Rs 10, 000 per patient per month, Gleevec was priced at Rs 1.2. Lakhs per patient per month. Patient groups say that after Gleevec was granted EMR, Cancer Patients Aid Association and other cancer groups who had provided the more affordable generic versions of 'Gleevec' to Myeloid Leukemia patients for their treatment had to withdraw such medical support to cancer patients. "Patients of other developing countries who were also importing generic versions of the drug were also seriously affected by the unavailability of the affordable versions of the drug." They point out While the rejection of patent application of Gleevec allowed Indian companies like Hetero, Ranbaxy, Cipla to come out with the generic versions of the drug, the case in the Chennai High Court challenging the decision of patent office has turned a matter of concern to the patients, they said.

It was in 1998, Novartis filed a patent application in India for Gleevec, the drug essential in prolonging the life of patients suffering from Myeloid Leukemia (Blood Cancer) Based on the patent application and a particular provision of the Indian Patents Act, Novartis in 2003 obtained an exclusive marketing right (EMR) for a period of five years. The EMR operated like a patent monopoly preventing Indian pharmaceutical companies from producing affordable generic versions of the drug Imatinib Mesylate (Gleevec). Companies like Hetero, Ranbaxy, and Cipla had to withdraw from producing and marketing the drug in India and other developing countries.