U.S. trade office hits out at Novartis ruling

‘Appears to confirm that India’s law creates a special, additional criterion for select technologies’

This week, the U.S. Trade Representative’s (USTR) office issued a strong critique of the ruling by India’s Supreme Court in the Novartis case, denying the pharmaceutical giant a patent on cancer drug Glivec.

In its 2013 Special 301 Report, the USTR said Washington was “concerned that the recent decision by India’s Supreme Court with respect to India’s prohibition on patents for certain chemical forms absent a showing of ‘enhanced efficacy’ may have the effect of limiting the patentability of potentially beneficial innovations.”

The report further said that the decision by the highest court in the land “appears to confirm that India’s law creates a special, additional criterion for select technologies, like pharmaceuticals, which could preclude issuance of a patent even if the applicant demonstrates that the invention is new, involves an inventive step, and is capable of industrial application.”

While the USTR announced its decision to retain India on its “Priority Watch List” for the present year, it noted that in 2012, “India made limited progress in improving its weak Intellectual Property Regime legal framework and enforcement system.”

However, in contrast to the U.S. view, reports quoted WTO Director Pascal Lamy saying earlier that “Recent decisions by the courts in India have led to a lot of protest by pharmaceutical companies. But decisions made by an independent judiciary have to be respected as such.”

The USTR also lashed out at decisions made by the Indian Intellectual Property Appellate Board and criticised India’s copyright protection regime.

Regarding the latter the report said that while the Copyright (Amendment) Bill 2012 provided limited improvements to India’s copyright regime, it also raised “a number of questions regarding the scope of exclusive rights under Indian law and the ability of rights holders to properly exercise those rights.”

Additional legislative changes were needed to ensure that content-based industries could effectively combat physical and online piracy and develop new models for the delivery of content, the USTR report said.