India’s generic drug industry began to flourish in the 1970s when India disallowed the patenting of medicines, enabling domestic companies, which did not have to invest in research, to make copies of branded drugs at a far lower cost.
In 2005, India allowed patenting, but set the bar higher for patents than other countries.
Novartis went to court in 2006 after India turned down a patent for Gleevek - a medicine used to treat leukemia. Indian authorities argue it is not a new medicine, but a modification of an earlier one, and therefore not eligible for a patent under Indian law.
The head of the Swiss pharmaceutical company in India, Ranjit Shahani, says the legal challenge is about protecting intellectual property rights.
“Novartis is seeking clarity to see how innovation will be valued and protected in India," said Shahani. "Now Gleevek has received patent protection in 40 countries across the world including China, Taiwan and Russia. And truly you know, protecting intellectual property advances the practice of medicines and brings hope to patients.”
The case is being watched closely, because its ramifications will go far beyond a single drug.
Groups such as Doctors Without Borders argue that a ruling in favor of Novartis could severely limit the availability of low-priced versions of medicines used to treat life-threatening diseases such as HIV and tuberculosis. In the past 10 years generic drugs have slashed the annual cost of HIV treatment from $10,000 to $150.
Leena Menghaney, a lawyer with Doctors Without Borders, or MSF, in New Delhi, says these affordable drugs brought life-saving medicines within the reach of tens of thousands of people living with HIV across the developing world. That could be impacted by applying more stringent patent standards.
“We have got more than 180,000 people living with HIV on Indian made generics. Now if we are unsure about whether we can in the future continue to procure the medicine, then it basically means that AIDS treatment itself for MSF could get heavily affected. It also means that AIDS treatment run by governments in developing countries could be very seriously affected," said Menghaney. "Currently about eight million people are on treatment and you can safely say that a large number of them could get affected. Scaling up AIDS treatment will just be a dream then.”
The hearing of the landmark case is expected to last several weeks.
Critics of India’s patent law say it does not meet standards set by the World Trade Organization. Defenders say it leans in favor of public health concerns over private patent rights.