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Issue #1589      April 17, 2013

Supreme Court of India on the Novartis Patent case

The ruling by the Supreme Court of India dismissing the petition from Novartis AG is a historic decision with positive global implications. Novartis had challenged the interpretation given by the Indian Patent Office to Section 3 (d) of the Patents Act that seeks to prevent the grant of patents on non-inventive new forms of known medicines.

The Novartis AG application had claimed a patent for a new salt form (imatinib mesylate), a medicine for the treatment of chronic myeloid leukaemia. Novartis sells this medicine in several countries under the brand name Glivec (Gleevec). The Indian patent office had rejected the patent application on the ground that the claimed new form was anticipated in a US patent of 1996 for the compound imatinib and that the new form did not enhance the therapeutic efficacy of the drug. The decision was upheld by the Indian Patents Appellate Board (IPAB).

The legal challenge from Novartis had alarmed patients groups, governments of developing countries and some international organisations. This was in view of the possible negative implications for access to affordable medicines for patients in those countries if the petition of Novartis were to be allowed by the Supreme Court. Most developing countries strongly rely on Indian generic pharmaceutical companies for the supply of affordable medicines.

Any weakening of section 3 (d) would have enabled multinational pharmaceutical companies to extend their patent monopolies based on frivolous incremental improvements which – as in the case of imatinib – could delay the generic supply of essential medicines for the treatment of HIV/AIDS and other diseases.

In this context, the decision by the Indian Supreme Court is very significant. In interpreting section 3 (d), the judgment took into account the legislative history of Section 3 (d). The Supreme Court observed that this section was introduced in the Patents Act by the 2005 Amendment to ensure that while India allowed product patents on medicines in accordance with its TRIPS (Trade-Related Aspects of Intellectual Property Rights) obligations, it did not compromise public health through “evergreening” of pharmaceutical patents.

The Court, hence, took into account the concerns about the impact of TRIPS on public health and on the development of an indigenous pharmaceutical industry. Moreover, it considered the implications of the Novartis case for the availability of essential medicines at affordable prices globally. The Supreme Court decision fully reproduced two letters from Dr Jim Yong Kim, the former Director of the Department of HIV/AIDS at WHO and from UNAIDS to the Indian Minister of Health and Family Welfare expressing the concerns relating to the continuous availability of affordable drugs supplied by Indian firms in other developing countries.

Thus, the decision by the Supreme Court of India has significant positive global implications. It has effectively protected the leading role of India in supplying affordable medicines to other developing countries. The reaffirmation of the primacy of health and access to medicines as a right of citizens is particularly important for the international community when these rights are under significant threat under bilateral trade and investment agreements.

This decision is a triumph for all developing countries which will be able to continue importing affordable essential generic medicines from India. Developing countries can benefit further by emulating the Indian approach towards balancing patents and public health by discouraging evergreening. Finally, this decision also shows the importance of public health sensitivity in the judiciary in determining disputes on pharmaceutical patents.

* Martin Khor is Executive Director, South Centre   

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