The Supreme Court of India on 1 April 2013 rejected the plea of Novartis, the Swiss drug maker, to patent the updated version of cancer drug called Glivec. A bench of justices Aftab Alam and Ranjana Prakash Desai dismissed the patent plea to Novartis on the basis that there was no inventiveness or novelty in the new version of the drug.
In its ruling, the Supreme Court of India declared that because the application for patent on beta-crystalline salt did not meet any inventiveness or novelty standard, therefore the company’s plea for patent was dismissed.
The judgement implied that patents in India would only be granted to companies that were involved in genuine inventions. Litigative patenting would be dismissed.
Glivec is used for the treatment of chronic myeloid leukaemia along with certain other kinds of cancers. The cost of this drug is around 2600 US dollar per month. The generic of Glivec is equivalent to 175 US dollar in India.
Novartis had filed a patent application for the new version of this drug in 2006. Comptroller General of Patent and Design denied the patent on the grounds that only certain changes were made to its existing drugs under sections 3(d) and 3(b) of the Indian Patent Law.
Novartis then challenged this rejection of patent application for Glivec. Subsequently, the patent application was also rejected by Intellectual Property Appellate Board. In 2009, Novartis took its fight to the Supreme Court of India.
Section 3 (d) and 3 (b) of Indian Patent Law explained
• Section 3 (d) of Indian Patent Law restricts the patents for already-known drugs unless and until there is superiority in invention in terms of efficacy.
• Section 3 (b) of Indian Patent Law restricts patents for those products which are against the public interest, and also do not show advanced value over the products which already exist.
Evergreening of Patent Rights- An Issue
Evergreening of the patent rights refers to the strategy adopted by certain innovators for having renewed their patent rights on the products by incorporating only minor changes. These minor changes may include adding new formulations or mixtures. Evergreening is done by the innovators when the patent is on the verge of expiry.
A victory in this patent fight would have given monopoly of Glivec to Novartis for 20 years.