No changes in Indian patent law for now

NEW DELHI: The prime minister’s office ( PMO) does not plan to seek any changes in two out of four key controversial provisions of the Indian patent law, which can compromise local drugmakers’ ability to sell lowcost medicines.

The PMO will not ask for any modifications in section 3(d) of the Indian Patents Act that rejects grant of patent to foreign drugmakers for incremental innovations , unless it provides significant thereupatic advantages to existing drugs. It has also decided not to push for patent term extension that would have allowed global pharma companies to increase existing patent period of 20 years for the time taken for examination and grant of a patent.

But the PMO is yet to clarify its stand on global drugmakers’ request to provide data exclusivity and link marketing approval with patent status, Indian Pharmaceutical Alliance secretary general D G Shah said.

As first reported by ET last year, the PMO had sought a review of several key sections of the country’s patent laws following a meeting with chiefs of global MNCs such as Novartis , BMS, Eli Lilly and Pfizer in August. Data exclusivity restricts local generic players from relying on clinical data submitted by original drugmakers for their own drug.

“This could increase cost of developing low-cost medicines, which will be passed on to consumers besides delaying entry of generic drugs by 5-7 years,” Delhi-based patent attorney Pratibha Singh said.

Although all the ministries related to healthcare sector have unequivocally objected to any tweaking of the existing law, the PMO sought their views on sections of the patent law.