Last week, Intellectual Property Appellate Board ruled that Novartis' cancer drug Glivec (Imatinib Mesylate) cannot be granted a patent in the beta crystalline form. The Board sent the two process patent claims, 13 and 17, back to the Patent Controller's Office for reassessment. IPAB denied patent to Glivec by upholding objections under Section 3(d) of the amended Patent Act. Section 3(d) of the amended Act does not recognize incremental innovation of known substances unless it significantly improves the efficacy of the substance. IPAB ruling said that while the drug has novelty and inventiveness, it failed to demonstrate 'significant enhanced efficacy'. Another reason cited by IPAB for rejection of the patent application is the excessive pricing of the drug the company is charging. Glivec costs Rs 1.2 lakh for an year's treatment for a patient whereas generic version of the same drug marketed by the Indian companies such as Natco, Cipla, Hetero and Ranbaxy just costs Rs 10,000. Novartis, on the other hand, maintains that it has, as part of its GIPAP (Glivec International Patient Assistance Programme), given patients the drug at no cost. It also says that more than 11,000 patients currently receive their medicine through GIPAP in India. Since late 2002, Novartis claims to have freely distributed Glivec valued at Rs 3,000 crore to patients enrolled under GIPAP.
Novartis' product patent on Glivec, the beta crystalline version of Imatinib Mesylate, had been rejected by the Patent Controller's office in January 2006.The company had then moved Madras High Court challenging rejection of its application by the Patent controller's office. And in August 2007, Madras High Court rejected Novartis' petition challenging the constitutional validity of the section 3(d) of the Patent (amendment) Act. The Madras HC thus upheld the Patent Controller's decision in January 2006 of not granting patent protection to Glivec. Madras High Court then directed Novartis to appeal against Chennai Patent Office decision in IPAB. Now with IPAB's ruling the company's options are limited. It can approach TRIPS forum of the World Trade Organization or even the higher courts in India. But it is quite unlikely that the company will get a favourable verdict considering its weak claims and the humanitarian angle to the whole issue. The company can, of course, argue that it has obtained patent for the product in 30 countries and therefore denial of patent right in India is not justified. The patent law for pharmaceutical products cannot be made applicable uniformly in all the countries as the socio economic conditions of the people vary quite vastly. In most of the developed countries, cancer patients are relatively well placed and can afford to buy such expensive treatments but that is not the case in India.