India has finally rejected patent for a cancer drug Gleevac by Novartis after a prolonged legal battle of seven years. The Indian patent office disagreed in 2006, saying that this was merely a reformulation of an existing compound (which had been approved in the US back in 2001), and rejected the application.
Indian patent law has a section 3(d) which sets a higher threshold for patentability of inventions in India. Although, Indian patent system is nacent and patent practice is evolving, section 3(d) incorporates newer ideas which are basic to the world wide patent reforms. Most of the advance patent systems, including EU, and US, are moving towards adopting higher inventive step thresholds for issuing patents for newer inventions.
Gleevec, used in treating chronic myeloid leukaemia and other cancers, costs about $2,600 (£1,700) a month. Its generic version was available in India for around $175 per month. Although, the cost considerations were one of the reasons for stronger opposition to grant a patent to Novartis, Indian Supreme court did not consider this factor.
Many experts, even those who are sympathetic to Novartis, agree that Gleevac was not a strong case. Indian patent office was not considered as capable of taking such an independent bold stance when Glivec has been awarded patents in nearly 40 other countries, including China, Russia and Taiwan.
Indian decision helps not only cancer patients in India but also patients from other parts of the world. Indian patent system is moulded on the recommendations of EPO and USPTO experts. Indian patent examiners use search reports generated by other patent offices and the examination of patent applications is influenced by the outcome of related patent applications in US and EU.
Indian universities and industries are lagging behind in patent filings compared to many similar organizations in other countries. English language has become official language of Indian patent office. Increased number of filings, processing and publishing patent literature in Indian languages have long term strategic implication for the technological capability of India. Such simple but tactical measures have the capability to protect crucial interests of key industries of India and could bring deserved economic prosperity to many Indians.
India has demonstrated its ability to pursue an independent patent strategy with the verdict of Gleevac. It should continue to pursue this path more vigorously in a professional way. There is no need to violate any international treaty including TRIPS of WTO.