Though the signing of the WTO agreement makes it obligatory for India to usher in the product patent regime by 2005 for pharmaceuticals and agrochemicals, the new government should ensure that domestic industry is well-supported to get its act together on the R&D front in the interim. Besides, India could take more than a leaf out of the US' books to actually assert her "national interests robustly". Industry experts say that the "trick lies in playing by the rules and beating them at it".The country's rich scientific base, strong links between industry and academia, enhanced efforts to maintain confidentiality of joint research efforts and high research-based incentives could go a long way in nurturing domestic challenge on the product patents front. India's successes in the case of the first indigenously developed anti-leprosy vaccine and a hepatitis-B vaccine at half the innovator's cost are examples of the rich scientific talent available. Such a strategy may also be accompanied by a gradual reductionin the number of drugs under price control (but followed up with strict price monitoring) which will also indirectly help spruce up domestic R&D effort.
The country must withstand any pressure to usher in product patents before time, as the fact remains that India, like all other developing countries, can use the transition period upto January 1, 2005, to amend national laws to include product patents for pharmaceuticals and agrochemicals. However, in terms of Article 70.8 and 70.9 of TRIPS, developing nations must provide for a mail box to receive applications for product patents and grant exclusive marketing rights on these, subject to certain conditions. So while India must support domestic industry, it cannot dishonour these international commitments.
On legitimate protection for domestic industry, the way out is shown by the US, the principle votary of free trade. In a recent speech made at an Indian Drug Manufacturers' Association (IDMA) function, former RBI governor S Venkitaramanan, points out howthe superpower merely pays only lip service to the concept of free trade.
The US has its own legislation which legally allows it to deviate from its much touted concept of free trade. "Wherever, the WTO is in conflict with US interests, the USA can refer to Section 301. Section 301 enables the US government to punish countries for alleged deviation from free trade, even though the deviation may be in keeping with the principles of the WTO. Besides, the US congress has also called on its trade representatives to give a specific report on various matters arising out of the implementation of the WTO agreement, every six months. The Congress has even reserved to itself the powers to review and take decisions about continuing in WTO," Venkitaramanan said.
Research Foundation for Science, Technology and Ecology's director Vandana Shiva in a recent article said that a significant distortion in the US Patent Law is the interpretation of the term "prior art", which currently permits patents to be filed ondiscoveries in the US, despite the fact that identical ones may be already existing and in use in other parts of the world. Unless Section 102 of the US Patent Law is changed, new examples of bio-piracy will continue, she says.
While several such examples could be cited, a provision in the Canadian laws (though now being contested by the European Union) is a worthy example of government initiative to spur generic R&D effort.
The Canadian government is reportedly defending certain sections of Canada's patent law which allows manufacturers to stockpile for upto six months, so that generic drugs are ready to hit the market as soon as the patent expires. Put simply, the deletion of this provision would delay a generic company from beginning the regulatory approval process until after the date of patent expiry of a product, thus effectively extending the actual period of patent protection for another 3 to 5 years. The Canadian Drug Manufacturers Association (CDMA) says that these provisions allow its membersto conduct important research prior to patent expiration in Canada and if this is stopped it would result in billions of additional costs, besides enhancing the effective period of protection. The EU on the other hand alleges that the research and stockpiling provisions are not compatible with Canada's obligations under the WTO.
Here, it would also be worth mentioning how several companies use new drug delivery systems to get an extension of a patent life. Cipla chairman YK Hamied in a recent speech points out several such cases. For 20 years, cyclosporin was marketed as a normal product and then close to the expiry of the patent, a microemulsion form of cyclosporin was introduced. The originator withdrew the older product from the market, thereby extending their monopoly for another 20 years, he says. Clearly, if the domestic drug industry is crying itself hoarse on the patents issue, it has strong reasons for doing so.
Copyright © 1998 Indian Express Newspapers (Bombay) Ltd.
