Officials of the US International Trade Commission (USITC) wanted to visit India to examine New Delhi's IPR policies in respect of pharmaceuticals on February 24.
On the 19th, they sought a meeting with at least 10 secretaries of various departments and ministries along with joint secretaries and one ministry level person. This includes representatives from commerce, industry, external affairs, agriculture, animal husbandry and human resource development, among others. They had a long list of officials they wanted to meet to discuss the issue of violations of trade and investment rules, said an official.
However, the Indian government did not yield to the request as the USITC has no jurisdiction over Indian laws and IPR laws are compliant with the Trade Related Aspects of Intellectual Property Rights (TRIPS) under the WTO. India does not grant patents on incremental pharmaceutical inventions if they don' bring in significant improvement in efficacy over the existing products but has given several patents for many incremental inventions that have solid therapeutic rationale.
Another senior official in the know told FE: A strategy is being made but we are not writing to the US in this regard. They can't scrutinise our IPR regime. Besides, a lot of NGOs and private parties from both sides have made presentations in this regard.
India already figures on the US government's special 301 priority watch list and there is also a proposal to include India in the list of America's Priority Foreign Country.
Under the US Trade Act, a Priority Foreign Country is the worst classification given to foreign countries that deny adequate and effective protection of IPR or fair and equitable market access to US persons relying upon IPR protection. This means that they could impose trade sanctions on India in the long term but we are not afraid and will take up the issue to WTO. TRIPS is an issue of national treatment, the official added.
The USITC has raised the matter of rejection of patent to Bristol-Myers Squibb's Sprycel and Novartis' Gleevec saying that these were not TRIPS compliant. Besides, it pointed out that Swiss pharma major Novartis AG had lost a legal battle for getting its blood cancer drug Glivec patented in India and to restrain Indian companies from manufacturing generic drugs.
The US is also concerned that India might issue more compulsory licences, sidestepping patents. Washington feels that other countries like Brazil, China and Africa might follow India's model of compulsory licensing. In fact, last year, the US and the EU had raised strong objections to Indias decision to allow compulsory licensing in the green technology sector. Compulsory licensing allows domestic producers to manufacture copied versions of patented environment-friendly products.
Till now, close to 50 compulsory licenses have been granted world wide and these are not restricted to pharmaceuticals only.
They also want to review the data protection and exclusivity laws and patent revocation here, the official explained.
India has revoked 10 patents including Roche's for its breast cancer drug Herceptin, Pfizer's cancer drug Sutent and Merck & Co's asthma treatment aerosol suspension formulation on grounds that included lack of innovation.