It’s been over two decades since India adopted an evolved patent system under the TRIPS Agreement. However, there is no consistent patent and public health policy framework even when there are obvious social and market problems in India. Numerous cases involving issue of compulsory licensing have been litigated in India. At present there is no long-term policy framework to deal with social and market problems, which scuttles innovation and economic growth in India. The patent and public health policy issues are complicated because of the public health challenges that India is facing with its large population.
A. Issues.
(i) Compulsory license
The issue of compulsory license is the most controversial issue in India and is still unresolved even after the ruling of Supreme Court of India on 13 December 2014. The Supreme Court of India ruled against Bayer, which in a last ditch attempt tried to block the sale of a cheap generic version of its cancer drug Nexavar in India. The Supreme Court dismissed Bayer’s claim that no compulsory license should be issued, however the court did not rule on any questions of law and have left all questions of law open. Compulsory license has been used regularly in India to meet public health
demands of cheap medicines. However, excessive licensing hampers growth and development. It impacts not only the foreign direct investment (FDI) but provides little incentive to Indian pharmaceutical companies to spend considerable energy in drug discovery research.
(ii) Section 3 (d) of the Indian Patent Act.
India has incorporated Section 3 (d) in the Indian Patent Act, which prevents firms from extending patents on their products by making slight changes to a compound, a practice known as “evergreening”. In 2013 the Supreme Court of India upheld the rejection of patent application for Glivec (Novartis) on the grounds that it is not a new medicine, but an amended version of a known compound. Indian courts have in recent years also revoked patents granted to other international drug makers, including Pfizer, Roche and Merck. Experts are concerned that this provision prevents pharmaceutical companies from supporting continued research and development of new medicines.
(iii) Access to Medicine.
Access to medicines is one of the biggest challenge and by far the most important issue in India. In
last few months the government of India has put hundreds of medicines under price control to make medicines more affordable for its citizens. A long-term patent policy framework has to take into account the public health interest of India and balance it with the interest of patent owners.
(iv) Patent Litigation.
Continuous patent litigation on the issues of life saving drugs is a result of absence of any policy framework to deal with the issue of life saving drugs. In absence of any clear policy framework, patent disputes are used as a tool to provide solution to the public health challenges because there is no consistent policy to address the issue of life saving drugs.
B. Challenge
Since the time an evolved patent system was superimposed on the Indian legal system the policy issues have perplexed policy experts in India. Most of the policy issues have being litigated in Indian courts. The unresolved policy issues have long-term implications on the market economy, the deadweight loss to the society and economic growth & innovation. It is imperative that India should address these policy issues with an objective framework based on an empirical socio-economic analysis.