Source: Times of India
NEW DELHI: The health ministry has asked for a cancellation of patent to Trastuzumab – a medicine which treats a form of breast cancer – using a rarest of the rare provision in the Indian Patents Act. The move comes after the department of industrial policy and promotion (DIPP) turned down a plea for a compulsory licence, or suspension of the patent, to make the medicine more affordable.
Industry department has also opposed the move to cancel the patent of Swiss drug major Roche, arguing that it was already facing post-grant opposition in the Patents Office. The health ministry had suggested that the government use powers under section 66 of the Indian Patents Act to revoke the patent in public interest.
The government has used the provision to revoke patents only twice. In 1994, it cancelled a patent given to a US firm for developing cotton cells by tissue culture while last year it used the power for a medicine made of jamun, lavangpatti and chandan meant to treat diabetes.
Besides, the government does not want to use power available with it to meet all demands, given the international scrutiny such actions face. Already, the use of compulsory licence provisions for a renal cancer medicine, for which Bayer has a patent, to bring down the cost has put the spotlight on Indian policymakers. Similarly, developed countries, led by the US, have been critical of other provisions in the Indian Patents Act that allow the patent controller not grant exclusive rights in case of tweaking or “evergreening”.
In a landmark ruling involving Novartis’s anti-cancer drug Glivec, the Supreme Court upheld the validity of the provisions to check frivolous patents. The Indian government has argued that these flexibilities are provided under the World Trade Organisation’s Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).
Campaign for Affordable Trastuzumab, an association of breast cancer survivors and civil society groups, had written to the government seeking use of compulsory licence provisions to lower the cost of the medicine from around Rs 8 lakh for a full course of 12 injections. There have been demands that the drug should be offered free in government hospitals.
Under TRIPS, a government can issue a compulsory licence, which allows a company to manufacture or sell a patented drug to meet national health emergency.
Earlier this year, the health ministry had asked for the use of compulsory licence provisions for Trastuzumab, along with Ixabepilone and Dasatinib, which are also anti-cancer medicines. While patent suspension for Trastuzumab has been ruled out, a final decision on the other two drugs is awaited.