The Indian Pharmaceutical Alliance, seeking an amendment to the Patent Bill, today urged the government to introduce two changes to the Bill.
One, exclusion of patentability of new forms of previously patented compounds and, second, allowing provision for pre-grant opposition to patent application.
"The Patent (Amendment) Bill, if passed in its present form, could lead to almost 15 per cent of medicines now marketed in India, coming under product patent," Habil Khorakiwala, president of IPA said in a press conference in Mumbai on Thursday.
The absence of the proposed provisions could lead to grant of frivolous patents and endless litigation, Khorakiwala added.
The current Bill does not restrict patentability of new forms of previously patented compounds. This essentially means that current Bill leaves it open to the drug originator or the original patent holder to file an application for patenting salts or polimorphs of the original molecules, which are going off-patent.
This leads to an extension of the patent life beyond the stipulated period, which in pharmaceutical parlance known as 'evergreening of patents'.
Also, while the current bill allows a pre-grant opposition, the newly drafted bill does not have this provision. 'Pre-grant opposition' refers to the 120-day provision given to generic companies before they are asked to withdraw their copied versions of a patented drug and during this period they can raise objections on the grant of patentability.
"The absence of such a provision could lead to grant of frivolous patents and endless litigation. Also, the idea is to avoid a chaotic situation as several companies will be forced to withdraw their brands from the market and the innovator company will be able to jack up the prices, hurting patients," Khorakiwala said.
IPA also highlighted the need for steps to support pharmaceutical research in India. The government has in principle agreed to the suggestion and has asked IPA to come up with detailed proposals.