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Pharma industry   Rigorous definition of invention

Four huge markets against U.S., EU's drug requirements

Drug requirementsIndia, China, Brazil, and South Africa are attempting to counter a push by the U.S. and EU for more stringent global intellectual property rules.

The four countries have called for intensive discussions at the World Trade Organization (WTO) on a United Nations report recommending rigorous definition of invention and criteria for granting of pharmaceutical patents.

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The report also proposes punishment for those using political or commercial pressure to check use of flexibilities allowed under the WTO’s intellectual property rights (IPR) rules.

“There is a need for the UN report on access to medicines to be discussed threadbare at the WTO as it brings to light the way patents are being granted even when there are just cosmetic changes in the new form of a drug.

“Not just that, countries like India, which do not support such evergreening of patents, are facing criticism and pressure from many developed countries to make them change their laws,” a government official told BusinessLine.

India and the three other nations that initiated discussions on the report at a recent TRIPS council meeting of the WTO also insisted that the agenda item should be in the Council’s next meeting.

“The discussion is intended to facilitate an exchange of views on the recommendations of the UN Secretary General’s high-level panel, as well as to share national experiences regarding the use of TRIPS flexibilities,” the proponents said in their submission. Bangladesh, Indonesia, Nigeria and Egypt welcomed the report, calling it “a significant and bold step”.

New Delhi has been facing immense pressure from members such as the US and the EU to change its IPR regime.

The top demand is that it should drop a provision in its law, which disallows grant of patent if a new form of a known substance does not result in the enhancement of the known efficacy of that substance.

The US has been continuously putting India in its ‘priority watch’ list of countries with lax IPR rules in its unilateral annual assessment of its trading partners.

The U.S. also alleges that there is lack of clarity in India’s rules for granting compulsory licences for manufacturing of copies of patented drugs in the case of national emergencies.




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