Indian drugmakers and IT representatives will be in Washington tomorrow, making submissions before the US International Trade Commission to explain India’s trade policies.

The hearings are part of the US trade agency’s investigations into the impact India’s trade policies have on American companies and jobs. And the final report from the USITC is scheduled for November.

The investigation follows a flood of complaints from US companies and Government representatives against India’s trade policies, particularly the implementation of the amended Indian Patents Act (2005).

The implementation of the Act (amended to honour product patents) has been dotted with litigation, with a couple of key judgements going against multinationals. In the high-profile case on Novartis’ blood cancer drug Glivec, the Supreme Court dismissed the company’s application for patent protection. And in another case involving Bayer’s advanced kidney cancer drug Nexavar, the Patent Office issued a compulsory licence allowing Natco to make the same drug on a revised seven per cent royalty.

These cases are oft cited in representations made by US companies to illustrate India’s “deteriorating” IP environment.

Explaining the implementation of the Patents Act, the Indian Pharmaceutical Alliance’s (IPA) submission points out, “Since 2005 when India fully implemented the TRIPS Agreement, over 1,500 patents have been granted to the top nine global pharmaceutical companies alone, for products and compositions, apart from patents for manufacturing processes. When the innovator pharmaceutical industry talks of ‘denial’ of patents, it is not talking of patents for medicinal products in general, but really of second or third patents for the same product.”

Indian representatives making submissions before the USITC include the Confederation of Indian Industry, Nasscom (representing the IT players) and the IPA (a platform for large Indian drugmakers).

Giving its side of the story are the US Chamber of Commerce, the National Manufacturers’ Association and the Pharmaceutical Research and Manufacturers of America, to name a few. Civil society is also represented by Knowledge Ecology International and Doctors Without Borders.

Super 301 report

Parallel to the USITC hearings, another process is also underway in the run-up to the US’ Special 301 report. This annual exercise evaluates US trading partners on their IP protection record.

In its submission on 301, the US Chamber of Commerce’s Global Intellectual Property Centre suggested that India be designated a ‘Priority Foreign Country, given the rapid deterioration of the nation’s IP environment.’

Indian industry representatives and IP lawyers are concerned that a negative US report from the USITC, and the 301 report (slated for this April) could increase the pressure on Indian policymakers on IP-protection, clinical trials and drug pricing, to name just a few.