Drug Action Forum Karnataka (DAF-K) is an independent, voluntary and registered non government organisation campaigning for Rational Drugs. DAF K is part of Jan Swastya Abhiyan (JSA is People’s Health Movement India, http;//phm-india.org). Also member of AIDAN (All India Drug Action Network, www.aidanindia.org) and HAIAP (Health Action International Asia Pacific www.haiap.org).
We are writing this on a matter that can deeply affect access to medicines for your patients. The issues we highlight in this appeal are two-fold one pertaining specifically to access to treatment for thousands of patients suffering from Chronic Myeloid Leukaemia (CML) and the other to a broader issue of the cost of new medicines that may be provided Patent protection. We would urge you to read this appeal carefully and consider taking the measures suggested in it.

Background

As you might be aware, Novartis, a Swiss Multinational pharmaceutical company operating in India, has been involved in challenging the laws of our country through two petitions filed in the Chennai High Court. The facts of the two cases that Novartis has filed against the Indian Government are explained below.

In the first case, Novartis has challenged the order of the Indian Patent office in Chennai, rejecting its application for a patent on imatinib mesylate, which Novartis markets in India under the trade name: Gleevec. As you would know, Imatinib mesylate is extremely useful in the treatment of chronic myeloid leukemia (CML). In addition to Novartis, several Indian companies viz. NATCO, Cipla, Ranbaxy and Hetero — also produce and market the drug. Treatment with Gleevec (manufactured and marketed by Novartis) costs Rupees 1.2 lakh per month, whereas the same drug is marketed by Indian companies at a cost of about Rs. 8,000 per month. If a patent were to be granted to Novartis for imatinib mesylate, Indian companies would be forced to stop production of the drug. At a treatment cost of Rs.1.2 lakh per month, this would mean that over 99% of patients requiring the drug would be denied access to it. 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.

Rejection of Novartis Patent Application by Patent Office

The Indian Patent office had rejected the application for a patent on sound principles, entirely consistent with the countrys laws and the agreement on Trade Related Intellectual Property Rights (TRIPS), to which India is a signatory. Novartis had obtained a patent for the same drug in 1993, i.e. two years before the TRIPS agreement was signed. At that time the Indian law did not recognise patents on pharmaceutical products. As per the TRIPS agreement, if a drug has been patented before 1995, countries like India which did not recognise patents on medicines before the signing of the TRIPS agreement do not have to recognise such patents. Novartis tried to circumvent this by filing a fresh patent application in India for the beta crystalline form of the same drug. Novartis claimed that this form of the drug was an advance on its earlier patent on the amorphous form, because it is less hygroscopic and hence more stable. The patent office rejected this application because it felt that the application was not for a new molecule and someone who understands the chemistry of the patented molecule (imatinib mesylate) would realise that the beta crystalline form of the molecule would have these useful properties. Thus it opined that the patent application failed on two counts for the required criteria of patentability it did not demonstrate an innovative step and it was not a non-obvious invention. The Patent office further felt that the application by Novartis was not consistent with section 3(d) of the Indian Patent Act, which specifically states that a different structural form of a known substance cannot be patented. Hence in January 2006, the Patent office rejected the Gleevec patent application on the ground that the application claimed ‘only a new form of an old drug’.

Novartis claims that those patients, who cannot afford to purchase Gleevec, receive the drug free of charge, through Novartiss Gleevec International Patient Assistance Programme (GIPAP). What it does not say is that this programme was started in India because, before Novartis patent was rejected and it had an exclusive marketing right on the drug, the Chennai High Court had specifically asked that Novartis provide access to this drug to all those who need it and whose monthly income was less than 3,50,000. Further, while Novartis claims that 6,700 patients get free Gleevec, there are an estimated 20,000 new of chronic myeloid leukemia every year.

Novartis Challenges our Countrys Law

Novartis has filed a second case one which challenges the constitutional validity of Section 3(d) of the Indian Patents Act. It may be recalled that Section 3(d) was specifically introduced by the Indian parliament as a safeguard against the misuse of product patents on medicines. Novartis has claimed that this section is not in compliance with the TRIPS agreement and is in violation of the Indian constitution. These claims are patently false. Many experts have confirmed that Section 3(d) conforms to the requirements of the TRIPS agreement, as the agreement clearly allows each country to set its criteria of patentability and does not prevent countries from including safeguards against the grant of fresh patents on old drugs. Section 3(d) is also in keeping with the Doha Declaration on the TRIPS Agreement and Public Health that was adopted by the Ministerial meeting of the WTO, held in Doha in 2001.

This challenge by Novartis is of particular concern for several reasons. It is a matter of grave concern that a foreign company has chose to challenge the constitutionality of a law that has been passed by the Indian Parliament to safeguard public health. Members of the medical profession need to be particularly concerned about such cynical use of Indias legal system. The company has legally circumvented this issue by filing the case through its Indian subsidiary, but the fact remains that the challenge has been made on the directions of a foreign entity. Further, the companys contention that Section 3(d) of Indias Patent Act violates the TRIPS agreement cannot be heard by Indian courts as they do not hear appeals regarding conformity of Indian law to international treaties. Such a challenge needs to be made in the World Trade Organisations Dispute Settlement Mechanism, and that too can be made only by a member state of the WTO and not by a private corporation. No government has, till date, challenged the Indian law in the WTO. Interestingly, the companys arguments regarding the constitutional validity of the Indian law have shifting continuously, even while the case was being heard. Initially it had not made out a case on the issue of constitutionality, but later changed its line of attack to argue that the language used in section 3 (d) was vague and not used anywhere in the world and that it did not give enough guidelines to the Patent Controller.

It should be understood that if Section 3(d) of the Indian Patents Act was to be removed it would open the door for a large number of trivial patents. This Section is the principal safeguard against the misuse of the Patent system by the patenting of known medicines, by making slight modifications in their structure. Such patents do not contribute to any therapeutic benefits but do contribute to increase corporate profits by extending patent monopolies on frivolous grounds. Thus the removal of this important section would mean many new medicines would have to be granted patents on trivial grounds and multinational corporations like Novartis, who hold these patents, would charge exorbitant amounts for these medicines.

Clearly, the challenges posed by Novartis to the Indian law constitute an attempt to profiteer at the expense of tens of thousands of poor and sick patients. It is also an attempt to open the floodgates for other drug companies so that they to can apply for trivial patents. The consequences will 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 half the medicines currently used for AIDS treatment in developing countries come from India. If Indian companies are to be prevented from making generic versions of patented drugs, tens of thousands of poor patients in Africa, Asia and Latin America will be denied access to essential medicines. That is why hundreds of thousands of people all over the world have signed an online ‘drop the case’ letter to Novartis, asking it withdraw the case it has filed in the Chennai High Court. The Drop the Case campaign has been launched by the organisation, Doctors Without Borders (http://www.doctorswithoutborders.org/) winner of the Nobel Prize Award for best medical relief during the year 1999. Many reputed personalities have 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. Separately, our Health Minister, Dr.Ambumani Ramados has also appealed to Novartis to drop the legal challenges. In spite of such appeals, however, Novartis continues to pursue the court cases vigorously.

Appeal to you as a Medical Professional

It is in this background that, on behalf of Drug Action Forum – Karnataka, we are sending this appeal to you to do the following:

1. Boycott products that are manufactured and marketed by Novartis in India by refraining from prescribing drugs that are marketed by Novartis. We feel that your action will be a powerful message to the Swiss Company. Medical professionals are an important link between the people and the pharmaceutical industry as the latter depend on for the sale of their products. Drug Action Forum – Karnataka sincerely feels that your action can be decisive. The campaign for boycott is proposed to last till Novartis stops its actions that prevent patients from getting access to essential medicines. This includes dropping all legal actions related to imatinib mesylate (Gleevec) including the upcoming appeal to the patent controllers order and stopping their actions in trying to influence the Indian government to introduce laws and policies that create monopolies on drugs and that place profits before patients. The Drug Action Forum – Karnataka is compelled to call for this boycott as a last resort, and in this we seek your support because Novartis has failed to respond to all other approaches by leading global organisations and state heads. As a professional who places the welfare of her or his patients foremost, we believe that you will agree to join this Campaign. This is a campaign that is not just about one valuable medicine, but also about the broader issue of ensuring access to essential medicines and of holding pharmaceutical companies accountable to their societal duties.

For your ready reference we are providing a list of drugs marketed by the company. We are sure that you will find therapeutically equivalent or superior substitutes for virtually all these medicines from those marketed by other companies in the country. In case however you feel the need to continue prescribing a drug marketed by Novartis because of the absence of a suitable substitute, we would still urge you to sign the petition below.

2. We also appeal to you to sign the attached letter that urges Novartis to desist from jeopardizing the lives of countless poor and sick people and send it to the Drug Action Forum – Karnataka at the address mentioned.

Do feel free to edit the suggested contents of the writing to reflect your personal understanding of the issue. It would be useful if your writings were composed on your personal pad. Please do not hesitate to contact us for more details through email or correspondence.