According to news reports just in, the Supreme Court has ruled against Novartis in the Glivec case and has rejected its plea for the grant of the patent for the drug molcule. Novartis had applied for a patent for the beta-crystalline version of the drug, on the basis of increased safety due to the modifications in the chemical entity. For more background see here and here.
Mr.Ranjit Shahani, CMD, Novartis India has said that, "We fought this case because we strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs. This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options."
Novartis maintained that even though 95%of patients receive Glivec through the Glivec Patient Access Program (GPAP), they still pursued the case to gain a clarity into the Indian patent system. An official statement from Novartis claimed that "The Supreme Court denial of Glivec patent clarifies limited intellectual property protection and discourages future innovation in India." Mr. Ranjit Shahani however added that the "GPAP would continue regardless of the judgement".
This has been hailed by NGOs and patient advocacy groups as a win over the notorious practice of evergreening. Section 3d of the Indian Patents Act, has special provisions against it. Leena Menghaney, India manager for MSF's Access Campaign said, "Patent offices in India should consider this a clear signal that the law should be strictly applied, and frivolous patent applications should be rejected".
According to TV reports, while reading out the judgement, the honourable judge in this case said," the claim does not mean any standards of novelty and inventiveness". Also it has been said that the new patent cannot be granted, since it is not a major modification.
NGO's have called the decison as landmark one for affordable medicines for the general public. Dr Dr Unni Karunakara, MSF International president added, "Instead of seeking to abuse the patent system by bending the rules and claiming ever longer patent protection on older medicines, the pharmaceutical industry should focus on real innovation, and governments should develop a framework that allows for medicines to be developed in a way that also allows for affordable access. This is a dialogue that needs to happen. We invite Novartis to be a part of the solution, instead of being part of the problem."