E-DRUG: Novartis files a fresh case (3)
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Dear E-druggers and Novartis,
It is a matter of mere semantics whether the fresh appeal in the Chennai Court is to be called a second legal case. The fact remains that Novartis continues to persist in its attempt to get a patent for its drug, after being rejected by the Indian Patent office. While, legally, Novartis has the right to take recourse to such attempts, we reiterate that by doing so Novartis is attempting to put the lives of a large number of patients in jeopardy.
Novartis’ petition also displays a lack of faith in the Indian system because it presumes that someone who has given an opinion agaisnt its claim must be “partial”.
The dismissal of Novartis’ challenge of Section 3(d) and the reasons given by the court have been circulated widely. It is rather unfortunate that Novartis has taken the judgment with such bad grace and has even talked about the decision possibly affecting its decision to invest i9n India. To some this would sound like a thinly veiled threat, directed at the Indian system.
We do not differ on the fact that imatinib is a major innovation. It is precisely because we think it is a major innovation and extremely useful in treating patients suffering from Chronic Myeloid leukemia, that we are concerned that the drug should be available to all those who can benefit from it. Where we differ is in Novartis claiming that the beta crystalline form is a major innovation over the amorphous form that was patented in 1993. We would reiterate the position held by the Indian Patent office while rejecting its claim for a Patent for Glivec. The Patent office had opined that anybody “skilled in the art” would have been able to deduce that the stable form of the drug – the beta crystalline form – is the form of the drug that would be most suitable for use. So Glivec does not pass two tests required for a patent to be granted – “non obviousness” and “novelty”.
What Novartis does not mention is that the programme in India was started after the Chennai high court directed it to do so. Further, while Novartis claims that 7,500 patients get free Gleevec, there are an estimated 20,000 new cases of chronic myeloid leukemia every year in India.
This is correct. But the fact that India chose to have a clause in its Patent Act allowing generic companies to continue producing medicines that they were producing till 2004, even if the drug was granted a Patent, is no thanks to Novartis. In fact big pharmaceutical companies such as Novartis have explicitly criticised this clause in the Indian Act. Moreover, if Novartis were to be granted a Patent, generic companies would have to pay a royalty, and this would lead to an incraese in the price of the generic equivalents
There is not enough evidence to suggest that this actually happens. While innovation is necessary, the present IP regime appears to be acting to stifle innovation rather than to promote them. Many more patents are being taken out to prevent others from working than in trying to protect genuine innovation. Also, a very large portion of the innovative work is done in public funded organisations. The major contribution of companies is in commercialising innovated products, not necessarily in innovating. It would be useful to quote Dr. Brian Druker (chair of Leukemia Research and professor of medicine at the Oregon Health and Science University Cancer Institute, and recognized as the key researcher behind the discovery of STI571 or imatinib) here: “In 1993, I moved to Oregon Health Sciences University in Portland and had a single goal of finding a company that had the best inhibitor for Bcr-Abl and to bring it into clinical trials. My work in Oregon on a therapy for CML was primarily funded by public sources, particularly the National Cancer Institute. My persistence with scientists at Ciba-Geigy (now Novartis) helped to keep the development of imatinib on their agenda despite uncertainty from product managers. As imatinib progressed through early and late clinical trials and demonstrated outstanding results, scientific and media interest in our discovery increased. The approval of imatinib by the FDA in May 2001 for use in CML was the culmination of a 10-year project for me, something I had dreamed of since medical school”.
We would be happy to continue the debate. Especially, also because we think that the IP system that companies like Novartis seek to defend is bad for science, bad for medical care and bad in the long run for pharmaceutical companies as well. Already companies such as IBM in the IT secor are starting to question the sustainability of the present IP system. Perhaps companies such as Novartis would like to look at long term goals rather than concentrate on short term profits.
From
Dr Amit Sen Gupta,
Jan Swasthya Abhiyan,
New Delhi, INDIA