On December 26, 2004, India issued the Patents (Amendment) Ordinance, paving the way for an ecosystem that would eventually recognise product patents from January 1, 2005.
The ordinance had introduced the third amendment to the Patents Act 1970.
Twenty years on, the amended product patent regime has had its moments. And intellectual property experts say it’s time to take stock of the impact of the product patent regime on access to medicines, among other issues.
Patents give innovative medicines (in this case) 20 years’ exclusivity. Price comes into this discussion, as patents allow monopolies, leading to high prices that push up the cost of healthcare for individuals and the State, say experts.
Drugmakers say these prices help recoup investments in researching the innovative product. But public health advocates counter this by saying universities and governments also contribute to research and investments in some cases. They also allege that the “cost of production” remains opaque. Some experts even call for “access planning” — where the State negotiates access to innovative and breakthrough medicines in early discussions with companies.
Dr Biswajit Dhar, Distinguished Professor, Council for Social Development, calls the last 20 years a “mixed” performance. “India led discussions in the developing world,” says Dhar, pointing to flexibilities ensured in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, in the interest of public health. He points to Section 3 (d) of the Patents Act 2005 (which did not recognise minor tweaks in a drug molecule as patentable, unless it showed therapeutic efficacy); and pre-grant oppositions (on patent applications) as among the major achievements. This was achieved despite international pressure, he says, adding that there are few instances where the views of people get reflected in policy.
Two critical cases under the amended patent regime involved Novartis’ blood cancer drug Glivec, with the Supreme Court dismissing its plea for patent protection; and the compulsory licence issued to Natco to make Bayer’s kidney cancer drug Nexavar, with a royalty payment.
Dhar alleges that India is losing its initial headway, as patents are being granted without attention to quality in “a reversal of what was intended”.
India had set high standards by granting a 20-year protection only to quality patents. It is “unfair” to put breakthrough products and those achieved from minor tweaks in the same league, Dhar points out.
Krishna Sarma, Managing Partner, Corporate Law Group, says that “providing product patents for bio-pharmaceuticals, after a gap of 35 years, was indeed a big step forward for the research-based bio-pharmaceutical industry.”
But there are challenges. Section 3 (d) was “initially included to prevent a phenomenon loosely referred to as ‘evergreening’ of patents”, she explains. But its interpretation by the Indian Patent Office and the SC “in effect discouraged incremental innovation”, she says. While ‘evergreening’ refers to an undue extension of a patent through insignificant changes to an existing product, ‘incremental innovations’ are sequential developments, building on the original patented product, she explains.
“Without market exclusivity, no one will invest in R&D, which is expensive, risky and takes a long time to get a drug from the lab to market,” adds Sarma. Patents were, and are being challenged on “specious grounds”, she says, pointing to cases involving Roche’s erlotinib and MSD’s sitagliptin. Successive courts “not only upheld the validity of the patents but also found infringement of the respective patents”, she adds.
“For far too long, India’s approach to patents and IP have been defensive... India needs to leapfrog the innovation ladder, and transition from being the ‘pharmacy of the world’ to ‘pharma powerhouse of the world’. To foster innovation and strengthen India’s position in the international value chain, a robust patent regime providing RDP (regulatory data protection) and its meaningful enforcement can be a very important enabler,” she adds.
KM Gopakumar, an associate with Third World Network, says 20 years is a perfect milestone “to take stock” of the impact of patents on medicine access, patented drugs and their prices in developed countries, and those registered and launched in India.
The implementation of the product patent regime has been “patchy”, he says, pointing to consistency and quality concerns in some granted patents.
Calling for greater political will, he recalls a time when there was bi-partisan consensus to use the flexibilities available under TRIPS, in the best interest of public health.
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