Here is what she writes in the five year review piece:
“It was on the eve of January 2005 that an Ordinance was issued to amend the Patent Act 1970 and bring in a regime that would honour product patents.
Five years on, if there is an agreement among stake-holders of the pharmaceutical industry – a sector covered by the Act – it is their unhappiness with the implementation of the Patents (Amendment) Act, 2005.
But the agreement ends there, as criticism of the Act goes along the expected divide of the domestic drug industry’s outlook, as opposed to that of the multinationals.
Though the amended law has been implemented on the ground, it has not used flexibilities provided by world trade norms to the optimum level, says an IP expert. While Section 3 (d) of the Act has been used to block frivolous patent applications, there still is room for interpretation, he observes. Besides, there are too few patent examiners to clear the manifold increase in patent applications, he adds.
Over 35,000 patent applications were filed in 2007-08, of which over 15,000 were granted, says the Indian Patent Office. This is an increase from 12,000-odd patent applications in 2003-04, of which about 2,400 were granted. And by its own admission, there are only about 160 patent examiners – and even this is dwindling, says a patent expert familiar with the development.
Bringing in the product patent law is one thing, but there still is no domestic eco-system available to implement it on the ground, observes Mr Ranjit Shahani, President, Organisation of Pharmaceutical Producers of India, and head of Novartis in India.
Glivec case
Novartis’ patent application on its blood cancer drug Glivec has become a bench-mark case under the amended regime. Glivec was the first pharmaceutical product to get a green signal from the Indian Patent Office in the run-up to the amended regime in 2005. Subsequently, the Patent Office rejected Glivec’s patent application in 2006, and ever since it has seen a long and litigious journey. The case awaits legal proceedings, now in the Supreme Court.
IP expert Dr Prabuddha Ganguli says five years is too long to set right anomalies in the amended law, on compulsory licensing and disclosures on geographical origin of biological material, to mention a few.
“We are losing time,” he says, with the debate taking an emotive tone, rather than a rational one.
But IP expert Mr Shamnad Basheer feels it is too early to judge the Act. However, the mechanism to oppose patent applications seems to have worked, he observes. Of 9,719 pharma applications filed between 2005 and 2008, he says, only 34 were challenged. And 25 of these resulted in rejections, with the patent applicant winning in only 9 cases, he adds. Why the oppositions were few remains unclear, he says, despite India’s vibrant generic sector and active non-government organisation community that oppose frivolous pharma patents.
But what is clear, say industry stakeholders, that the there is the need for a better equipped patent and judicial infrastructure to handle the increasing number of patent applications and possible challenges.
