Indian drugmakers urged the government not to give in to mounting pressure from a section of US senators for tighter intellectual property (IP) laws in India. They said that this will hurt the domestic industry and impede consumers' access to affordable healthcare.
There is a race among the multinational companies for inclusion of two key provisions in the Indian Patents Act data exclusivity and patent linkages.
Orrin Hatch and Ron Wyden of the Senate Committee on Finance and Paul Ryan and Sandy Levin, House Committee on Ways and Means, in a letter to US secretary of state John Kerry and Penny Pritzker, US secretary of commerce expressed concerns about India's "insufficient respect for and enforcement of patents, most notably relating to biopharmaceuticals. We must make meaningful progress in addressing the significant barriers that India has erected."
While the letter had broad references to areas of business interest such as agriculture and copyrights, it pointed to issues related to intellectual property laws in India.
IPA secretary general DG Shah said that the demand for patent linkage on India exceeds the current regulations in the US itself. "The USA is pressurizing India to provide what is not in their own law," Shah wrote in his letter to Sitharaman.
The US regulator grants marketing approvals to the second and the subsequent applicants irrespective of the patent status and it is then left to the applicant to wait for the expiry of patent or to launch the product at risk.