Product patents a major issue at Bio Asia



Hyderabad: Intellectual property rights emerged as a major issue for most of the speakers at the ongoing Bio Asia summit being held in Hyderabad.

While several companies confirmed their plans for setting up development centres in and around Hyderabad from where a great deal of outsourcing work is being planned, speakers at the conference said that unless India became a signatory to trade related intellectual property rights (TRIPS) and recognised product patents, future progress in bio tech research and development in India would be significantly curtailed.

Vipin K Garg, CEO, Tranzyme Pharma, a chemistry-based drug discovery company, said if India didn't recognized product patents soon, the progress of the biotech and pharma industry would be affected soon. Asked about the extent of the impact, he said, "80 per cent of the new drugs developed recently and are under patent cannot be launched in India as there is no assurance of patent protection." According to him, around 187 new drugs have been introduced in the US in the recent past and approximately another 450 drugs are awaiting FDA clearance. He emphasized that these were important life saving drugs.

He said that it was important for the development of the bio tech industry in India that the country speed up on the product patents issue. Pending that, India would be relegated to being a small outsourcing destination. "For India to become a drug development centre companies must be assured of product patents," he said.

Stephen E Lawton, vice president for regulatory affairs and general counsel of the Biotechnology Industry Organization, which represents over 1000 biotechnology companies, institutions and state biotechnology centers — said Indian companies could partner with companies in the developed world especially in contract manufacturing to the benefit both the parties. He said since the cost of drug development in India was extremely low, US companies would be able to develop drugs at a fraction of the cost incurred in other countries, while India would benefit from the extensive know-how available with developed countries. However, he said India had to take immediate steps to protect intellectual property rights under the TRIPS agreement and have laws in place to protect data.

Jay Nagarkatti, president Sigma Aldrich, said, "The global pharma industry faces a number of challenges such as a huge number of drugs going off patent in this decade, which would result in lowered revenue for pharma companies and the rising cost of drug manufacture in developed countries. He said India was poised to take advantage of this situation as the cost of drug manufacture in India was 60 percent of the cost in developed markets." He added that
Indian companies were ideally suited to undertake contract manufacturing orders for global pharma companies provide India became a signatory to Trips and recognized product patents instead of process patents.

He said he felt Hyderabad offered a number of advantages such as having a bio-tech base, requisite intellectual capital and most importantly a proactive government that was serious about offering help and infrastructure. Another area of potential in bio-tech research in India was clinical trials, but that was much in the futureGarg added.