In the interest of patients

Ranjit Sahani, Vice Chairman and Managing Director, Novartis India Limited, Mumbai.

THIS has reference to the articles by Sarah Hiddleston ("Patent trouble", February 23), Dinesh Abrol ("Batting for MNCs", March 23) and Praful Bidwai ("Cleaning up after Mashelkar", March 23).

The Hindu Group is known for its ethical practices and for upholding the right to present a balanced viewpoint. I, therefore, find it difficult to understand why Novartis India was not contacted for its point of view on any of these stories and instead references have been taken from its web site in one instance.

The story by Sarah Hiddleston has a box item titled "A case of luck" which particularly disturbed me. The caption is grossly misleading - Novartis has in place a very generous patient assistance programme, the Glivec International Patient Assistance Program (GIPAP) for those patients suffering from Philadelphia chromosome positive chronic myeloid leukaemia (CML) or C-KIT positive gastrointestinal stromal tumours (GIST) who were prescribed Glivec but could not afford it or were not insured or were non-reimbursable.

GIPAP is one of the most generous and far-reaching patient assistance programmes ever developed for a cancer therapy. As of date there are more than 6,700 patients who receive Glivec absolutely free of any charge while a minuscule 45 patients pay for Glivec and these are people who are reimbursed. In fact, more than 99 per cent of the patients who are on Glivec receive the product absolutely free of charge while hardly 1 per cent of the patients who are on the drug pay for it, and these are patients who are reimbursed.

In fact, please take a look at the criteria spelt out by the journalist in the report. With such criteria in place, it is very easy for a patient who needs Glivec to actually get on to the programme and luck really plays no role.

India is a democratic country and we are proud to have a free press but it is important to remember that along with freedom comes a great deal of responsibility. The report by Dinesh Abrol has this to say: "If Novartis is granted the patent for it, the price of the medicine would increase. The same drug sold by Indian companies is about 10 times cheaper than Novartis' Gleevec in the Indian market."

This statement seems to have been made through lack of information. The price of Glivec, as it is known in India, has remained unchanged since its launch in India and will continue to remain the same irrespective of whether or not Novartis receives a patent for the drug. Further, irrespective of whether or not Novartis gets its patent for Glivec the generic versions will continue to be on the market. Without going into the details of each article, I have put here a few points that I hope will help put things into perspective.

The base compound for Imatinib was invented in 1993, at a time when India did not allow for patents for pharmaceutical products. When India joined the World Trade Organisation (WTO) in 1995, a system was enacted to effect the transition to the global standards for patent laws. Under this interim system, Novartis submitted a so-called black box application to register the beta crystal form of imatinib mesylate. In 2003, Novartis was granted exclusive marketing rights (EMR) for Glivec by the Indian Patent Office. This marked the first time a pharmaceutical company was granted an EMR in India.

When the Indian patent law came into effect in 2005, the Indian Patent Office examined the black box application for the beta crystal form of imatinib mesylate and rejected it in early 2006 under Section 39(d).

It is important to understand that imatinib was not suitable to be taken by patients in the form of pills and it was necessary to develop first the mesylate salt of imatinib and the beta crystal form of imatinib mesylate is the active ingredient of Glivec, which is the only medicine that has ever been marketed worldwide as Glivec. Novartis has patent protection for both the molecule and its crystal form in more than 40 countries.

Novartis decided to pursue legal action following the rejection of the patent for Glivec, a breakthrough cancer treatment for CML and GIST. Novartis has filed two writ petitions. The first writ petition, which has since been converted into an appeal, seeks to set aside the Indian Patent Office's denial of the Glivec beta crystalline formulation patent application on the grounds that the ruling has no factual or legal justification. The second writ petition takes the unprecedented action of requesting the Court to declare Section 3(d) of the Patent Amendment Act of 2005 unconstitutional and in breach of India's obligations under the TRIPS Agreement.

Novartis believes that the Indian patent law creates new hurdles for pharmaceutical innovation, narrowing what is patentable. Additional requirements for patentability beyond novelty, commercial applicability and non-obviousness are inconsistent with the TRIPS Agreement.

Glivec is one of the medical breakthroughs of the 20th century, widely recognised with patents in over 40 countries as true innovation. That Glivec purportedly failed the Indian test for patentability indicates deficiencies in India's patent system.

We are seeking clarity about India's patent laws. Knowing if we can rely on patents in India is good for the government, the industry and patients because research-based organisations will know if investing in better medicines for India is a viable long-term option.

I would appreciate it if this letter is carried as prominently as these various articles to make amends for the damage done to our reputation and to reaffirm our belief in the values of a balanced media. Most importantly, patients who need Glivec and cannot afford it must not be misled into believing that this is an expensive drug or that they have to depend on luck to get on to the programme and they have no hope - when they can actually get it totally free of charge from Novartis' GIPAP programme.