On 1st January 2005, the transitional period for India to start granting patents on medicines as required by the TRIPS Agreement came to an end, and the country had to change its law to make pharmaceutical products patentable.
As India’s thriving generic industry is one of the world’s biggest sources of affordable medicines, playing a crucial role in bringing the price of essential medicines down, the consequences of the new patent law threatened to be devastating for access to medicines, not just for India, but for the entire developing world.
What happened was a mixed blessing.
Public health safeguards
On one hand, India fully used its right to shape a patent law according to its national sovereign interests. Indeed, the new India Patents Act takes a pro-public health stance on many issues, for example by making it possible for Indian generic companies to continue to produce drugs they had already marketed when the new law came in, even if a patent were subsequently awarded to another company for that drug; by allowing anyone to challenge a patent application before it is granted, in a step known as a pre-grant opposition; and by restricting what can be patented to avoid patent holders continuously extending monopolies by filing for new patents once an initial patent expires (known as ‘ever-greening’).
This last point was first tested in a landmark lawsuit brought by the Swiss pharmaceutical company Novartis against the Indian Patents Act in 2006.
All these are great steps that mean that supply of generic drugs currently produced in India may not dry up overnight. For this was indeed the potential outcome, and would have been devastating for the millions of patients that rely on Indian generics for their survival. If the Indian law is correctly applied, more affordable generics will continue to be made in India – for all but entirely new compounds or substances. Supporting the Indian law is therefore essential, and other developing countries should learn from India’s experience and approach their patent laws with public health needs in mind.
On the other hand, patents will be granted for entirely new medicines and Indian generic manufacturers will not be free to develop more affordable versions of these drugs. These are likely to be sold by the patent-holding pharmaceutical companies only, and priced out of reach of most in the developing world. This will have a major impact, in particular on the supply of AIDS medicines across the developing world, as people become resistant to their drug combinations and need to be switched to newer drugs.
In the post 2005 world, therefore, access to medicines in the developing world will depend on the use of compulsory licences by governments, in order to allow for generic production and price competition.
Last update January 2009