Cancer Patients Aid Association Challenges EMR on Gleevec

Affordable Medicines and Treatment Campaign
August 7, 2004


Cancer Patient Aid Association challenged the grant of exclusive marketing rights (EMR) through a writ petition in the Supreme Court of India. The Petitioners filed this petition in public interest under Article 32 of the Constitution of India on account of the violation of the right to health and equality of cancer patients suffering from Chronic Myeloid Leukemia (CML). The Patent Controller of India granted EMR to Novartis AG, for the drug called Gleevec, containing b-crystalline form of the compound Imatinib Meyslate, used for the treatment of patients suffering from CML, a life threatening form of cancer. According to the petitioners the grant of EMR to the life saving drug containing the b-crystalline form of the compound Imatinib Meyslate, resulted in the denial of access to the drug. Gleevec is sold by Novartis AG at Rs. 1,20,000 (Rupees one lakh twenty thousand) per month. There were nine generic manufactures producing the drug that treats CML, at rates lower than that of Gleevec. The generic version of the drug was otherwise available to CML patients at a Rs 9000-12,000. Consequently the overwhelming majority of patients that suffer from CML every year in India will die. The Madras High Court issued an interim injunction against 6 generic manufactures preventing them from producing the drug. Another petition filed by Novartis seeking a similar injunction is pending against a major generic manufacturer in the Bombay High Court. Even the prices of the generic manufacturers the drugs were beyond the reach of majority of the 24,000 new CML patients per year and the 18,000 CML patients that die each year, due to the un-affordability of the life saving drugs. According to the petitioners, this would result in the denial of right to health and life as enshrined in the Article 21 of the Constitution. The right to health is also guaranteed under Article 12 of the International Covenant on Economic Social Cultural Rights (ICESCR), which is ratified by India.

The Petitioners, in particular, challenged the grant of EMR to Novartis for the drug Gleevec. Generally, for the grant of patents three major steps are required, viz. (a) inquiry under sections 2, 3 and 4 of the Patents Act, 1970; (b) report under section 12 resulting in acceptance of complete specification, after which the Applicant for patent has the same rights as that of a patent holder, except the right to sue for infringement; and (c) consideration of opposition to grant of patent under Chapter V of the Act. Only thereafter the does Applicant for patents have the right to sue for infringement. However, an EMR can be granted after a simple consideration vis--vis sections 3 and 4 and compliance with grounds under section 24-B (grant of patent and marketing approval in respect of the same article or substance in a convention country to be the same). An EMR entitles the holder of EMR the right to sue for infringement under section 24-E.

Section 24-A postpones the examination and report under section 12 of the Act till 31.12.2004. By virtue of sections 24-B, EMRs can be granted without examination and report under section 12 or without following the procedure prescribed for opposition to grant of a patent under Chapter V. As a result, a person who is granted an EMR is entitled to sue for infringement under section 24-E. This is permitted despite the fact that on following the procedure for the report under section 12 and/ or the opposition to grant patent application may ultimately be rejected. Hence, the petition seeks to declare the provisions of sections 24-A, 24-B and 24-E of the Patents Act to the extent it postpones the procedure under sections12 and 13 of the Patents Act before granting EMRs, and does not provide for opposition or revocation of EMR and the EMR holder to sue for infringement are violative of Articles 14 and 21 of the Constitution of India

The Petition also challenges Patent Rule 53 which restricts the interpretation of public interest in the EMR context it is violative of Articles 14 and 21 of the Constitution of India.

Further, the petition seeks an order or direction from the Court directing the National Pharmaceutical Pricing Authority to exercise its power under the DPCO (Drug Price Control Order) and fix the prices of the drugs containing the b-crystalline form of compound Imatinib Mesylate at affordable prices;

The petition also seeks a relief from the Court to direct Novartis to deposit an amount as a security to compensate patients illegally deprived of the drugs containing the b-crystalline form of Imatinib Meyslate equivalent to the sales of the drug Gleevec in India for a period of 5 years for which they have been given the EMR in case the patent is not granted to them.

As an interim relief, the petition seeks an interim stay on the operation of EMR granted to Novartis.

The petition also raises the following interesting legal questions.

Whether, the provisions of ICESCR and in particular Article 15(1)(b), which provides everyone the right to enjoy the benefits of scientific progress and its applications, have to be read into Article 21 of the Constitution of India?

Whether the intellectual property rights (IPRs) can override the right to life and health, particularly in view of the Articles 7 and 8 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (hereinafter TRIPS) and the Doha Declaration that interpreted it. This has been recognized in Section 83 of the Patents Act, 1970.

Petitioners

Cancer Patients Aid Association, 5, Malhotra House Opp. G.P.O. Mumbai - 400 001 and Mr. Y.K. Sapru, Founder Chairman of the Cancer Patients Aid Association.

Respondents

Union of India, (a) Through the Secretary,Ministry of Commerce and Industry Udyog Bhavan, New Delhi and (b) Through the Secretary, Ministry of Health and Family Welfare, irman Bhavan, New Delhi - 110 011

The Controller General of Patents, Designs and Trade Marks, the Patent Office, Nizam Place, 2nd MSO Building, 5th to 7th Floor, 234/4, Acharya Jagdish Bose Road, Kolkatta - 700 020.

Drug Controller General of India, Directorate General Health and Services, Room No. 342, A- wing, Nirman Bhavan, Maulana Azad Road, New Delhi - 110 011.

Novartis AG, Schwarzwaldallee 215, 4058 Basel, Switzerland.

Novartis India Limited, Sandoz House, Shivsagar Estate, Dr. Annie Besant Road, Worli, Mumbai - 400 018.

National Pharmaceutical Pricing Authority, 5th/ 3rd Floor, YMCA Cultural Centre, Building, 1 Jaisingh Rd, New Delhi 110001


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