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AIDS patients can smile after landmark Novartis case




 

The decision made on Monday by India's Supreme Court to reject pharmaceutical multinational Novartis' plea to preserve its patent on cancer drug Glivec is a game changer, especially for HIV treatment programmes around the world.

Glivec is used to treat chronic myeloid leukaemia - a type of blood cancer - and is a life-saver for sufferers of the disease. But the relevance of the ruling on similar applications of multinational companies seeking to preserve their patents on second- and third-generation anti-retroviral drugs (ARV) for HIV can't be ignored.

Many of these applications are based on the same legal issue of patent continuation even after its expiry by slightly tweaking the existing product or process to seek a fresh lease of life for an extended period, or "evergreening".

The drug companies use this method to continue enjoying the benefits of the original invention beyond the patented period. Smart firms can enjoy unrestricted patent rights for very long periods based on original research done several years before.

Fortunately, the Indian Patent Law tried to plug this loophole by adding Section 3(d) which seeks to prevent patenting new forms of a known drug unless it exhibits enhanced efficacy. The Indian Patent Office took the view in a number of such cases that mere improvement of process without enhanced "therapeutic efficacy" cannot satisfy the requirement of patent as a new drug.

This has generated a host of litigation by pharmaceutical companies with the Novartis case reaching the Supreme Court in 2009. It then took three years for the court to examine all aspects of the patent law, and resulted in this week's historic judgement.

The landmark ruling comes at a time when more than 8 million people around the world are getting antiretroviral (ARV) treatment for HIV, with a further 6-7 million needing treatment urgently. The cost of ARV drugs is a major determining factor for providing universal access to treatment to people living with HIV.

India today supplies almost 90% of generic ARV drugs for patients in a number of countries in Africa and Asia. The Supreme Court judgement in the Novartis case raises optimism about providing drugs on a continuous basis for the 8 million people who are on antiretroviral treatment today.

But one threat still remains. India - like Thailand - is expected soon to sign a comprehensive free trade agreement with the European Union. There is overall concern that this might contain TRIPS (trade-related aspects of intellectual property rights) and other provisions that might restrict the generic drug industry in India from manufacturing new drugs that will be out of patents in coming years.

The Indian government has assured that nothing will be agreed to that affects the future of the generic drug industry in India. However, it remains to be seen whether the optimism generated by the Supreme Court ruling will be matched by a strong government stand on protecting TRIPS flexibilities for public health purposes as envisaged in the Doha declaration.

The author is the Special Envoy of UN Secretary-General on HIV/AIDS for Asia Pacific. The views of the author are personal.



 


Copyright © 2013 -Bangkok Post, Publisher. All rights reserved to The Bangkok Post. Reproduction of this article (other than one copy for personal reference) must be cleared through the Bangkok Post.

Information in this article was accurate in April 3, 2013. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.