The public health safeguard in India has successfully passed the test of judicial scrutiny. What this means is that it will be much harder for pharmaceutical companies now to gain patents for their products that are based on either just minor changes to, or combinations of, existing drugs.
At present, there are about 9,000 pharmaceutical patent applications being reviewed by the Indian patent office. Many of these patent applications are for drugs that are of critical importance for patients in developing countries. This ruling makes it less likely that many of these drugs will be patented in the future. This may help encourage generic manufacturers in India to continue developing drugs that will compete with high-priced originator products and driving down prices.
In the field of HIV/AIDS treatment alone, many generic manufacturers in the last year have held back from investing in newer drugs awaiting the verdict in this case. They will now be encouraged to advance their efforts into manufacturing and supplying newer drugs, not only for AIDS but for other disease as well.
The importance of the judgment does not only lie in keeping intact generic manufacture of affordable drugs in India but it also legally validates the right of developing countries like India to provide easy access to life saving drugs. Many other countries who are reviewing their patent laws can also adopt the Indian model of patent law which seeks a balance between recognising IPR and the need to make drugs affordable.
Following the judgment, the statement by Novartis that the court’s ruling will hinder innovation is false. Despite the fact that patent protection has increased world-wide in the last two decades, drug innovation has actually declined. Perhaps it is time for governments and pharmaceutical companies to consider a system other than patents that not only provides incentive for research and development of newer medicines but also ensures the availability and the affordability of new drugs and vaccines.
*Project Manager, India, Médecins Sans Frontières.