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Thursday 4 April 2013

Patent truth: no research funds - Backlash scope limited as Novartis has made little R&D investments

Patent truth: no research funds 
- Backlash scope limited as Novartis has made little R&D investments

New Delhi, April 3: Novartis cannot inflict new innovation pain on India even if it wants to because the Swiss pharmaceutical giant has not invested in basic research and development in the country.
"There is no basic research and development in India," a company spokesperson said in response to a question from The Telegraph, seeking details of research efforts that the company has supported in the country over the past five years.
After the Supreme Court denied Novartis a patent on its anti-cancer drug Glivec on Monday, the company had said India's lack of respect for intellectual property has discouraged innovation and that the country had lost potential research investment.
But the company's reply to the question makes it clear that few such investments had been made even before the verdict. According to CMIE data, Novartis India's investment in research and development in one plant in Maharashtra's Mahad in 2011-2012 was Rs 29 lakh. But it has not been specified if this amount covered basic research or not. In the same year, the company clocked a turnover of Rs 933.27 crore and a net profit of Rs 147.60 crore.
Novartis India vice-chairman and managing director Ranjit Shahani had been quoted as saying on Monday that the company would shift R&D investment to "favourable destinations". But the company clarified yesterday that he did not say this.
Video footage of a statement on Monday has Shahani saying: "We will continue with our investments in India, even though cautiously. We will ask for patents on the new products that we launch.… We hope the ecosystem for intellectual property in the country improves."
Novartis has research hubs in China, Singapore, Switzerland and the US. It had invested in an institute for tropical diseases, a research centre focused on dengue, malaria, and tuberculosis, in Singapore in 2002.
"These are diseases of concern in India — ideally such a research centre should have been located in India," a company official said.
Since 2005, several global companies, including Novartis, have set up research centres in China. "India has already lost out (on research investments)," the company official said.
But sections of public health experts and industry analysts say the benefits to patients from India's unique patent law outweigh the losses from foreign drug companies declining to establish research centres in India.
Several pharmaceutical industry analysts said India has emerged as a major hub for "upstream" research and development efforts, activities aimed at seeking out new candidate therapeutic molecules.
"The idea that there is some loss from the absence of a research and development centre is misleading," said Chandra Gulhati, editor of the Monthly Index of Medical Specialities, India, an independent journal on drugs.
"Even if there is minor research work on the development of a drug in the pre-patent stage, it is automatically and invariably forwarded to the home base for further work," Gulhati told The Telegraph.
Whether basic research is done in India or outside, the product is patented in North America or Europe and then introduced in other countries, he said.
Gulhati said some companies may be classifying quality control, mandatory phase III trials required for approval of drugs in India, and even phase II trials of new candidate drugs under research and development activities.
"I don't see how the locations of research centres have any bearing on access to medicines," said Leena Menghaney, a lawyer with Medicins Sans Frontieres, the international humanitarian agency that procures generic medicines from India for patients in developing countries.
While some foreign life sciences corporations have established research centres in India, analysts say they are likely to be primarily using local human resources — PhD-qualified research scientists — to pursue specific research problems whose solutions will be transferred to a hub research site outside India for downstream work towards developing a product.
A Novartis official said the company's parent organisation — Ciba Geigy — had set up India's first foreign research centre in Goregaon, Mumbai, in 1964, but shut it down in 1982 and sold the land.
Gulhati said companies like Novartis had grown used to receiving patents on new forms of known therapeutic molecules. Now they find it hard to accept that India has a unique patent law that demands that new forms of known molecules should also have significantly higher efficacy than the known molecules to become eligible for a patent, he said.
But other industry analysts said such provisions in the patent law were unfair to companies pursuing genuine innovation. "What generic companies are doing is copying, reverse-engineering," said Ajaykumar Sharma, associate director for pharmaceuticals and biotechnology with Frost & Sullivan, a private consultancy.
Glivec has been granted patents in 40 countries, including China. "The government should grant patents and then subsidise medicines for the poor," Sharma said. "Why is the government shying away from this duty to the poor?"

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