This week the Indian Supreme Court denied the patent application of Novartis for its breakthrough medicines Glivec even though it was rewarded a patent in 40 other countriesincluding China, Russia and Taiwan. We as an industry believe that this decision will undermine incentives for innovation in the long term in India but also in other emerging countries and is detrimental for patients. It also confirms the deteriorating standards in India regarding intellectual property protection and that these are not well-adapted to the realities of pharmaceutical R&D while being in variance to those of many other countries, including its main trading partners.
Regarding the details of the case itself, the Court denied the patent claiming that the request for the patent was for a modified form, when in fact Glivec had never received any patent in India before. The verdict also stated that the purpose of a patent law is to support local industry, which is clearly protectionist and not to the benefit of innovation and patients. The industry recognises that the granting of the exclusivities provided by intellectual property comes with a responsibility to promote access. Recognising that Glivec represents a unique, life saving treatment possibility, Novartis has put in place an generous donation programme (GIPAP). This programme provides free drug to 95% of patients with a prescription for Glivec. Currently more than 16,000 patients get Glivec free through this programme. It must also be noted that multiple generic versions of Glivec have been on the Indian market for close to ten years and are widely available in India.
A much greater number of patients do not have access to diagnosis or treatment due to the deficiencies of the healthcare system in India. The issue of access to medicines is not caused by patents- most essential medicines are not patented and are still not available to patients in India. Without a basic health system and adequate financing, patients are still unable to reach the basic medicines that are already available. The industry is strongly-committed to playing its part in improving access in partnership with governments and other stakeholders
Finding a way to fund innovation and access in economically-diverse countries, such as India, is a challenge. India is the 10th largest economy in the world, but still only spends 2$ per person on Healthcare. Whatever approach is taken, it will likely be for the richer population to contribute more and the poor relatively-less. .. Incentives must also be put in place to support the industry when taking the risk associated with the development of new medicines for unmet medical need. For example the European Union legislation incentivizing orphan drugs has led to an increase in innovation with 107 new medicines in 2011, 148 last year, and more than 150 expected in 2013. Whatever happens stakeholders must come together to find common solutions that will, be beneficial to innovation and to patients.
The pharmaceutical industry has in the last decades proudly provided treatments that have significantly contributed to a 49% decrease in cancer mortality for children, a 40% decrease of overall mortality for cardiovascular diseases, and a 70% reduction of HIV based death rate. The many innovative products also significantly improve the quality of lives of patients and enable them to be active participants in the work force and society.