Novartis’ Supreme Court case threatens access to medicines in India and across the world
Drug Action Forum – Karnataka objects to Novartis’ five year long legal attack on health safeguards in India’s patent law
The Drug Action Forum – Karnataka (DAF-K), an organisation engaged in promoting issues related to public health in India, announces a call to boycott all products manufactured by Swiss MNC, Novartis, till Novartis withdraws its Supreme Court case (SC 20539 – 20549/2009) for seeking a patent on Glivec/Gleevec and abandon all its attempts and plans to misuse Indian decision making and redressal systems for its narrow ends. This is a renewal of the boycott call as the Supreme Court case hearing starts on 29th November 2011.
DAF-K has decided to renew the boycott call after prolonged deliberation, given the intransigent attitude shown by Novartis in obstructing access to a vital medicine for blood cancer. Imatinib mesylate is useful in the treatment of chronic myeloid leukemia (CML) a type of blood cancer. In addition to Novartis, several Indian companies – viz. NATCO, Cipla, Ranbaxy and Hetero -- also produce and market this drug. Treatment with imatinib mesylate manufactured and marketed by Novartis costs Rs. 1,20,000 per patient per month, whereas Indian companies market the same drug at about Rs. 8,000 per patient per month.
The huge difference in the price of the same drug is an illustration of how a patent monopoly can be used by drug companies to generate super-profits while endangering the lives of thousands, or even millions. Health safeguards in India’s patent law – most notably Section 3(d) have prevented Novartis from getting a patent on this medicine in India. In a bid to get its patent, Novartis’ earlier attempt at the removal of Section 3(d) failed at the Madras High Court. It is now in the Supreme Court hoping instead to dilute the provision. But this case will not only impact patients dependent on the affordable, generic versions of this cancer medicine. It will also impact people living with HIV, heart disease, mental illness. In fact, the impact will be felt across the health spectrum as generic production of medicines for all diseases will be under threat if the health safeguard – Section 3(d) of India’s patent law is weakened in any way.
Novartis’ continuing legal attacks on Indian law
The legal saga of the Novartis case currently in the Supreme Court dates back to 2005 when India’s patent law was amended to comply with the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Keenly aware of the importance of generic production of medicines in India, the Indian Parliament included important provisions in the amended patent law that if properly implemented could ensure that patents are granted only for truly innovative and new medicines and that companies would not be able to use tactics like evergreening (making new forms or combinations of existing medicines) to get patents on old medicines. This provision is Section 3(d) of India’s Patents Act.
The Indian Patent Office examined oppositions filed against Novartis patent application for the beta chrystalline form imatinib mesylate including by cancer groups and in 2006 rejected Novartis’patent application on several grounds including Section 3(d). When Novartis did not get the patent, it challenged the constitutional validity of Section 3(d) of the Indian Patents Act before the Madras High Court. Section 3(d) was specifically introduced by the Indian parliament as a safeguard against the misuse of product patents on medicines and has been used by health groups to ensure that key medicines are not patented including AIDS medicines.
It is a matter of grave concern that a foreign company chose to challenge the constitutionality of a law that has been passed by the Indian Parliament to safeguard public health. The consequences of a change in the safeguards in the Indian Patent Act would not be limited just to India. Today India is known globally as the “Pharmacy of the Third World”, because Indian companies export cheaper versions of patented drugs to over 150 countries. For example, over 80% of medicines currently used for AIDS treatment in developing countries come from India. Many reputed personalities publicly appealed to Novartis to withdraw the court case. They include Erik Solheim, Minister of International Development, Norway and Henry Waxman, Chairman, Congress of United States.
The Madras High Court’s decision on 6th August, 2007 to dismiss Novartis’s plea has vindicated our stand. The Chennai High Court stated clearly that Section 3(d) was introduced by Parliament keeping in mind the obligation of the government to fulfil the right to life and health under Article 21 of the Indian Constitution.
Instead of accepting the Madras High Court’s decision, Novartis has now decided to try and weaken the interpretation of Section 3(d) by once again challenging the denial of a patent on Imatinib mesylate before the Supreme Court. Novartis has also held out a veiled threat in its response to the dismissal of its petition by the Madras High Court. Chief Executive, Daniel Vasella, has been quoted by the Financial Times as saying: "This [ruling] is not an invitation to invest in Indian research and development, which we would have done. We will invest more in countries where we have protection. It's not a punishment. It's just a question of the culture for investment."
This is the background of DAF-K’s boycott appeal. We once again appeal to Novartis to desist in persisting to challenge the Indian legal system and in attempting to jeopardise the lives of millions. We appeal to the Medical community and consumers in India to unite in a show of opposition to the methods used by Novartis that compromise access to vital medicines, by signing the boycott by signing the online petition at http://novartisboycott.org/. The two best selling products marketed by Novartis in India are Voveran (a pain killer and anti-inflammatory drug) and Calcium Sandoz (a calcium supplement). Further information is available on the website. We are sure that patients would not suffer because of this boycott, because good substitutes are available in India for all Novartis products. When and if a substitute is not available in a city/village for a Novartis product, we would urge doctors to boycott other Novartis products.
(Dr. Gopal Dabade)
President, Drug Action Forum – Karnataka