To be the world pharmacy: India !

Will India keep Novartis at bay? Wants to patent cancer drug, Glivec, in India Sushmi Dey / New Delhi Sep 06, 2012, 00:48 IST Much of the world — from patients to pharmaceutical companies to health activists and even governments — is watching an intense battle currently being fought by Swiss pharma giant Novartis in India's Supreme Court. The company wants to patent and sell its anti-cancer drug, imatinib mesylate, known as Glivec, in India but, so far, its efforts have failed. This is a high-stake contest, with serious implications for many of the above constituents.At the heart of the dispute is the Indian government's contention that Glivec, which treats myeloid leukaemia and some gastrointestinal cancers, is simply a retooled avatar of a pre-existing version patented in the US in 1993, and, therefore, doesn't deserve one here. The core issue, then, is over the degree of innovation required to obtain a patent in India. Section 3(d) of the Indian Patent Law prevents what the industry calls 'evergreening' — a process of churning out a version of the medicine with incremental modification and no innovation, simply in order to prolong the life of the patent. The case has an acrimonious history. Novartis had filed for a patent in 2006, which was denied. Then, in 2007, the Madras High Court rejected Novartis' plea. The company also lost the case at the Intellectual Property Appellate Board, which rejected the company's appeal in 2009. Novartis, then, decided to take the case to the highest court in the country.

Is Novartis 'evergreening'?  Novartis describes the case as a crucible for the future of pharma investment. "Novartis is seeking clarity on the patent law in India," says Novartis India Vice-Chairman & Managing Director Ranjit Shahani. "Knowing we can rely on patents in India benefits the government, industry and patients, because research-based organisations will know if investing in the development of better medicines for India is a viable long-term option."Besides, Novartis cannot be accused of evergreening, says Shahani. According to the company, imatinib mesylate is the salt form of an older medicine, imatinib, and the new version represents a 30 per cent increase in the bioavailability of the medicine. "Scientists at Novartis developed the mesylate salt of imatinib and then the beta crystal form of imatinib mesylate to make it suitable for patients to take in a pill form, which would deliver consistent, safe and effective levels of medicine. This process resulted in a viable drug which revolutionised cancer treatment," says Shahani.However, health activists argue that granting a patent on such incremental innovations would be violating the basic principles of inventive science. "The selection of a salt of the active ingredient with the purpose of improving bioavailability is well known in pharmaceutical art, and is an often-used form of what is known as 'evergreening'," says Leena Menghaney of Medecins Sans Frontieres, which campaigns for access to essential medicines.The drug has been granted a patent in 40 countries, including China, Russia, Mexico and Taiwan. The Supreme Court will hear final arguments in the case on September 11.

Pharmacy to the world  India provides half the world with AIDS medication, most of it in the generic form. Various developing countries, and now even developed ones, depend on India for low-cost, quality drugs, hence the country's nickname, 'pharmacy to the world.' If Novartis wins its case, this spigot of cheap drugs to those who cannot afford them could be turned off.One reason India has become such a big drugstore: Until 2005, India did not grant patents on medicines, which allowed drug makers to manufacture and sell generic versions at a much lower price. Eventually, India's stance on patents changed after it joined the World Trade Organization (WTO) and signed the trade-related aspects of intellectual property rights (TRIPs) agreement. From then on, patents would be applied in India as well. However, the Doha round gave a large degree of flexibility to governments to decide what kind of innovation was patentable, what should be the criteria included in 'novelty', what constituted an 'inventive step', and so on. There was another important clause from the Doha Declaration: "Each member has the right to grant compulsory licence and the freedom to determine the grounds upon which such licences are granted."The government was, thus, able to legitimately award Natco Pharma a compulsory licensing deal that made it possible for the company to sell Bayer's anti-cancer drug, Nexavar, used in the treatment of liver and kidney cancer, for Rs 8,880, versus Rs 2.8 lakh under Bayer.