India must document and legally protect the farmers' varieties (FVs) and use them globally as a trade strategy.

The Union government is likely to enact a law to create uniform legal framework for government-funded research and give universities and research institutions ownership and patent rights for their inn

If the number of patent applications filed under the World Intellectual Property Organisation's (WIPO) Patent Cooperation Treaty (PCT) is any indication, India appears to be a laggard among the knowledge- and innovation-driven economies. That the country is way behind developed nations like the US and Japan in seeking patent safeguards for inventions, is understandable. What is more noteworthy is that it compares poorly even with a much smaller economy like South Korea, as also the much bigger China. The data put out by WIPO show that only 686 patent applications were filed from India in 2007, against 7,061 from Korea and 5,456 from China. And while the rate of patent filings is growing steadily elsewhere, it is on the slide in India. The number of applications in 2007, as a result, was the second-smallest in the last five years. However, single-number comparisons of complex processes can be deceptive. So it is worth pointing out that any comparison based merely on the number of patent applications could be misleading, and other relevant factors also need to be taken into the reckoning. A comparison of India with China must be weighted for the fact that the sectors that drive economic growth are different in the two countries. While software and services predominate as Indian growth engines, Chinese growth is coming in substantial measure from new, mass-scale manufacturing activities. In the Indian software sector, research and development (R&D) activity is controlled largely by the big global companies, with headquarters elsewhere, and they treat India as an offshore R&D hub to make use of its low-cost, scientific and engineering talent pool. The patents filed on the basis of such work will mostly be done in the company's country of origin, so it will not show up in India's number. Also, there is little scope for patenting when it comes to software services. And where the life-science and pharmaceutical industry is concerned, investments in in-house R&D are a recent phenomenon. As this trend picks up, one should expect patent filings to increase. That said, the importance of patenting has come slowly to Indian companies. This could be because of a slow awakening to globalisation, and because India is a signatory to a large number of global pacts and protocols that provide automatic intellectual property protection to innovations in different fields in all the member countries. China, on the other hand, has not been as open to embracing knowledge protection obligations through such treaties. In any case, the Chinese track record in respecting intellectual property has been dismal and many global companies have suffered on this account. Though India's record in this respect may also not be perfect, it has taken two key steps through the amendment of the Patent Act in 2005 to align it with the international agreement on trade-related intellectual property rights (Trips), and the enactment of a law on sui generis plant variety and farmers' rights protection. Nevertheless, even after considering these factors, the truth is that India does not score very well on the R&D front. The positive change is that, even in manufacturing industries like automobiles, Indian companies now show signs of doing serious R&D work.

Mumbai-based Sun Pharmaceuticals has filed a post-grant opposition with the Mumbai patent office against a product patent granted to the extended release version of Johnson and Johnson's (J&J) blockbuster drug Risperdal, used in the treatment of psychological disorders and schizophrenia. Risperdal, with the molecular name risperidone, is the second-largest selling drug of Johnson and Johnson with over $4.5 billion worldwide sales in tablet, injection, syrup and orally dispensable forms. It is also one among the largest selling psychiatric drugs, according to sources. Sun Pharma has been marketing a generic version of this drug for the last few years in India under the brand name Sizodone, according to company sources. The patent on Risperdal, granted in February 1986, will expire in the US on June 29, 2008. The Indian patent was for an extended release version and this had not been patented in the US, said patent experts having knowledge of the development. Patent wars Swiss drug maker Roche's anti-cancer drug, Pegasys, was given a patent in India in 2006 and this was challenged by Wockhardt and a Mumbai-based non-governmental organisation, Sankalp. Generic drugmaker Cipla is battling in the Supreme Court to revoke a patent granted in February 2007 to Roche's cancer drug Tarceva. Another patent granted to Roche's anti-HIV drug, Valganciclovir, is also being challenged in the court by Lawyers Collective, a Mumbai-based NGO, and Cipla. According to the Indian Patent Act, which was amended in 2005, a product patent that bars other companies from copying the drug for generics, can be challenged within one year. The Mumbai patent office granted a patent to Janssen Pharmaceutica, a group company of Johnson and Johnson, on July 20, 2007, with patent number 208191, against its mail box application number 188AL/1995. The patent related to sustained-release particles of risperidone, said sources. Company sources declined to reveal the sales figures for the drug in India. "We don't comment on litigations and patent-related issues as a matter of policy,' said a Sun Pharma spokesperson. Interestingly, Dr Reddy's Laboratories and US-based Mylan Laboratories were among the first to challenge the patent on Risperdal in the US, where the drug has sales of over $2 billion, said sources. "Since the product patent regime was introduced in India in 2005, we estimate that more than 150 product patents have been granted and over 90 per cent of this is for multinational pharmaceutical companies. So far, very few products have been opposed by Indian companies, according to our knowledge,' said Varun Chonkar, a patent expert. He said the Indian patent office was yet to officially announce data on the number of patents granted and challenged in India.

Even as India is fast turning into the diabetes capital of the world, multinational drug companies are busy patenting new-generation diabetes medicines for exclusive marketing rights in the country. The Indian Patent Office has already awarded patents to at least three such products, say patent experts. Though the immediate impact of the patent protection to such drugs is not known, experts say prices of diabetes medicine has a long-term economic significance due to the fast-growing diabetic population of the country. Official estimates predict the number of diabetics in India to be 3.77 crore by 2010 and 4.58 crore by 2015. "Considering the World Health Organisation (WHO) estimates for Indian diabetic population, patenting of these drugs are sure to have significant impact on the diabetic population,' Varun Chhonkar, a Mumbai-based intellectual property consultant said. In February, a patent was granted (the most recent grant of such patent) to Swiss drug major Novartis for Vildagliptin, an anti-diabetic compound. Vildagliptin is the second drug in the class of dipeptidyl peptidase IV (DPP IV) inhibitors to reach the market. The first one was Merck's Sitagliptin which also received an Indian patent in December. Globally marketed as Januvia, Merck's Sitagliptin recorded $668 million in worldwide sales in 2007 and is projected to reach $2 billion by 2011. In June, Bristol-Myer had received an Indian patent for its Saxagliptin, a likely global blockbuster diabetes drug. "The drug companies will have to make medicines affordable to Indian patients. I have suggested Merck to have an India specific pricing for Januvia as the prices they charge in the US, $5 for a pill, may not be affordable for majority of our patients. Diabetic patients often have multiple medical complications and will have to take other medicines also, thereby making treatment very costly,' A K Jhingan, chairman, Delhi Diabetes Research Centre, said. According to World Health Organisation estimates, the projected number of diabetic patients in the next decade globally will exceed 20 crore. India had 3.2 crore diabetics in 2000 and might touch 8 crore by 2030, it has pointed out. The International Diabetes Federation (IDF) has also reported that the total number of diabetic subjects in India was 4.1 crore in 2006 and would rise to 7 crore by 2025. It should be noted that the chemicals ministry, the administrative ministry for the pharma sector, has constituted a committee to recommend a scheme for price negotiation of patented medicines to make such new generation drugs cheaper in the country.

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