ISSN (Print) - 0012-9976 | ISSN (Online) - 2349-8846

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No to 'Ever-Greening'

Pharmaceutical R&D merely meant to keep off generic competitors will not be rewarded.

The Pharmaceutical Research and Manufacturers of America and the United States India Business Council are miffed over the recent Novartis judgment of the Supreme Court (SC) of India. For us, however, this ruling on the question of the patentability of the beta crystalline form of Imatinib Mesylate (IM) is one of the most significant verdicts on patent law in independent India. That it has come at a time when the pharmaceutical industry is once again tending towards tight “oligopolisation” and high prices, which was the case before 1972 when the country had pharmaceutical product patent protection, is all the more welcome.

With the coming into force, once more, of pharmaceutical product patent protection in January 2005 following the third amendment of the Indian Patents Act (IPA) of 1970, it seemed that the positive aspects of that law were on the road to being negated. Transnational pharmaceutical companies have been marketing patented medicines at exorbitant prices, particularly in the case of life-threatening diseases such as cancer, of which Novartis’ Glivec for the treatment of chronic myeloid leukaemia (a form of blood cancer) has been a prime example. The company had applied for a patent for the beta crystalline form of IM on 17 July 1998, which went into the “post-box for filing” under Article 70(8) of the World Trade Organisation’s Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement), but it was granted an exclusive marketing right under Section 70(9) in 2003. Novartis was charging an unaffordable Rs 1.2 lakh per month for the required dose. Fortunately, Indian drug manufacturers such as Natco, Cipla and Ranbaxy (the latter, before its takeover by the Japanese transnational Daiichi Sankyo) entered the market with generic variants at one-tenth of that price.

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