Lack of coordination between the offices of Drug Controller General of India (DCGI) and the Patent Controller of India is triggering a series of fierce legal battles in various courts in the country between the Indian pharmaceutical companies and the multinationals.
The dispute arises when the office of DCGI grants marketing approval to one or more companies for a new drug when the original discover of the drug is a different company and it has already obtained a product patent from the Patent Controller's office.
When a pharma company obtains a product patent from the Patent Controller's office, it has got an exclusive marketing right for the product in the country for a specified number of years. No other pharma company is expected to get manufacturing or marketing right within the country.
The ongoing legal fight between Cipla and Swiss drug major Roche is a case in point. Both companies are fighting in Delhi high court over the Roche's lung cancer drug Tarceva for which the Swiss major had received patent from the Indian patent office. But Cipla went on to manufacture Tarceva's generic version and launched the product in the country under the brand name of Erlotinib, forcing the Swiss company to approach court. While Tarceva costs Rs 4800, the generic version costs jut Rs 1600 per tablet.
Unlike in the highly regulated markets like US, India has not yet decided on Data Exclusivity. That is the root cause of all these issues. "As per the existing laws, the DCGI is not governed by the patent laws and he is free to grant permission to any new drugs", said Dr Gopakumar Nair, a well known patent expert in the country.
"The product patent regime set in motion in India from 2005 only we are in a transition period. We have not come to a stage where such issues are well settled. Some element of confusion is bound to be there", Dr Nair said.
Apart from the price issue, another issue on which heated argument is going on in the court is whether the patent receiver can import the patented product and market it in the country. Roche is not manufacturing the product in India, but is importing it from outside the country and is marketing in India under the brand name of Tarceva. "Under Article 27 (1) of the TRIPS agreement, import is also allowed. As per the TRIPS, a product has to be worked in the country. Working a product can also be interpreted as importing under the TRIPS", Dr Nair said.
Meanwhile, Hyderabad-based Natco Pharma has sought a compulsory licence as per provisions under the TRIPS to manufacture cheaper versions of the patented cancer drugs Sutent and Tarceva. It is likely that more Indian companies will be approaching the government for compulsory licences to produce costly patented drugs in the country.