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[KM GOPAKUMAR ने लिखी · 2013 · 4 में हवाला दिया गया — of the Indian Patents Act. Section 3(d) is a legislative ... Late B K Keyla, Convener of National. Working Groups on Patent Laws (1989-2010) disclosed this to the ...

आप इस पेज पर 15/6/21 को गए थे.Print]

Centre may face stiff opposition for amending D&C Act to introduce data exclusivity Joe C. Mathew, New Delhi, Thursday, June 8, 2006, 08:00 Hrs  [IST] The non-governmental-organisations and public interest groups of the country have decided to protest against the chemicals and fertilizers ministry's move to push amendments in the Drugs and Cosmetics Act to introduce data exclusivity for drugs. The activists accused the government of succumbing to US pressures and thereby attempting to introduce TRIPS Plus provisions. The activists have found allies in the Left parties and hope that any amendment to the Act that can jeopardize the capabilities of Indian generic industry to supply low cost medicines to poor will be questioned in the Parliament. The turn of events which led to the dilution of the original proposals in the Patent Amendment Act early last year can happen again, they feel. Speaking to Pharmabiz, B K Keyla, convener, National Working Group on Patent Laws said that the whole talk about data exclusivity is unnecessary as it is not required under the TRIPS agreement. "If you are planning to give data exclusivity, it only means that you are introducing a TRIPS plus provision. Succumbing to external pressures to recommend such a piece of legislation is very dangerous, as it can extend towards other areas as well. Once you grant data exclusivity, compulsory licensing will also suffer," Keyla warns. According to him, the actual intention behind seeking data exclusivity is market exclusivity. Once market approval is denied for a particular drug, no company would be in a position to manufacture it even if the country issues a compulsory license. He felt that government should not talk about data exclusivity but should just provide "data protection". He also wanted a provision to offer fair compensation to the innovator if the data generated by that company is used for marketing approval purposes by another generic company. "If you are preventing the generic manufacturer from using the data generated by the innovator, the company would not be able to manufacture the drug even if you issue compulsory license. Further, it is just wastage of funds to duplicate the data that has already been generated," he opined. Sharing similar views, Dr Amit Sen Gupta, Drugs Action Forum, said that the government should have taken a clear stand to avoid the situation. "The TRIPS agreement does not seek data exclusivity. We have no valid reason to offer data exclusivity or amendment Drugs and Cosmetics Act," he said. Medecins Sans Frontieres (MSF), a leading international aid agency, has also expressed its protest against the government move. In a plea to the Prime Minister, MSF (India) has said that if India provides exclusive rights over test data, generic competition from Indian pharmaceutical companies will be delayed even in cases where there is no patent protection for medicines. MSF also pointed to the recent recommendation of the World Health Organisation's Commission of Intellectual Property Rights, Innovation and Public Health which had specifically ruled out the necessity of data exclusivity in medicines. MSF wanted the generic competition to be kept alive for continuing the supply of low cost drugs to the entire developing world.

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21. Keyla BK. Review of national patent legislations of India, Indonesia, Sri Lanka and Thailand. New Delhi: National Working Group on Patent Laws; 2003.Keyla

Patent scrutiny stuck in a groove
August 16, 2007 12:59 IST

Even after two and a half years of the new patent regime, Indian patent offices continue to function without the patent examiners' Bible -- the key operational manual essential to guide patent examiners carry out uniform scrutiny of patent applications.

While non-government organisations (NGOs) like National Working Group on the Patent Laws term this as a grave mistake that is leading to granting of frivolous patents, government officials say the issue will soon be resolved as the draft manual is close to finalisation.

"It is the most important document that needs to be prepared. We have gone into every aspect of the patent law and the patent rules to prepare the manual. We have incorporated the suggestions of the parliamentary committee in this regard. The draft should be ready by September 15. It will be finalised after we have got suggestions from all stakeholders," said NN Prasad, joint secretary, Department of Industrial Policy and Promotion.

What has made matters worse is the sudden increase in the work load of the patent offices in Delhi, Chennai, Kolkata, and Mumbai.

The offices have been flooded with 53, 297 patent applications after India introduced product patents across all categories in 2005.

The 140 patent examiners on the rolls have managed to examine only 25 per cent of the 28,882 applications filed in 2006-07 and only 17 per cent of the 24,415 applications filed in 2005-06.

"The absence of proper scrutiny to provide faster clearances for real innovations and a chronic shortage in the number of quality patent examiners have turned the patent system a tool for shopkeepers and vendors rather than researchers," B K Keyla, the convenor of NWGPL, said, adding: "All kinds of applications are cleared and patents are being given for brooms, tooth brushes and toilet seat covers while thousands of applications on pharmaceuticals and other novel processes are pending."

"We have earmarked Rs 320 crore for the second phase of modernisation of patent system. In phase II, 600 more patent examiners will be recruited to augment the current strength of around 140," Prasad said.

On the question of trained patent examiners opting for highly-paid jobs in private sector, Prasad said that all patent examiners who were given overseas training were on a three-year bond.

"Beyond that one can do nothing. If our patent examiners are offered excellent salaries outside, it is a compliment to us. It shows that our training is world class. With so many freshers around, we will have no problem in getting sufficient patent examiners," he explained.

However, Amit Sen Gupta, secretary, All India Peoples Science Network, said the results from the first phase of modernisation were yet to be seen.

"The first phase itself had seen the government spending Rs 153 crore on modernising the entire system. However, the quality of data available in the public domain remains poor. Even abstracts of patent applications are not always given," he said.

According to him, Indian patent office should make patent applications, patent grants and full text of patents granted available online.

"The transparency that we see in the US and Europe is nowhere to be seen here.Our request for a list of pre-grant opposition to patents were not entertained by the patent offices. The weekly patent journal does not give clear details about the patent application. A person is compelled to go for paid information (cost of getting full text of one application is Rs 1,500) even when patent officials are supposed to give the abstract free," he said.

Joe C Mathew in New Delhi