Photo: Brandon Bourdages /
1 May 2014Asia

US hits out at Indian pharma patent protection

Patent protection in the pharmaceutical sector in India has raised “serious” concerns, the US government said yesterday, April 30, in its annual Special 301 Report.

The US has “growing concerns” about the environment and enforcement of IP in India, it said, although it decided against imposing the strongest possible sanction on the Asian nation.

In the report, which assesses US trading partners’ efforts to protect and enforce IP, the US Trade Representative said it has kept India on its Priority Watch List (PWL) but decided against listing it as the Priority Foreign Country.

The Indian pharma sector was highlighted as one of the most problematic areas in the report, which each year contains a PWL and a Watch List, identifying the countries that are of concern, as well as occasionally listing a Priority Foreign Country (PFC)—a country about which it has particularly serious concerns.

“In the pharmaceutical sector and increasingly in other sectors, such as the agro-chemicals and green technology sectors, some innovators face serious challenges in securing and enforcing patents in India,” it said.

Ukraine was listed as a PFC last year, the first time a country had been put in that category in seven years and prior to the report’s publication there were calls for India to go the same way.

“Many of the submissions made by a wide array of stakeholders in this year’s Special 301 reporting process underscored increasing challenges right holders face, and a number of those submissions sought the strongest censure of India’s IP environment available under Special 301,” the report said.

However, despite those calls, the government opted to continue “constructive” engagement and keep it on the PWL.

The USTR said India had made “some limited progress” in improving its weak IP rights legal framework but added that in “many areas” challenges are growing.

“The US encourages India to adopt policies that support both cutting-edge innovation to address important health challenges and a robust generic market. For example, a patent system should encourage the development of inventions that meet the well-established international criteria of being new, involving an inventive step.

“The US urges India to take specific actions to address the concerns raised, including by means of constructive bilateral engagement,” the report added.

The other countries on the PWL are Algeria, Argentina, Chile, China, Indonesia, Pakistan, Russia, Thailand and Venezuela.

“These countries will be the subject of particularly intense bilateral engagement during the coming year,” the report said.

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at