On 1st April patients in India celebrated a victory in the battle for affordable medicines. The Indian Supreme Court rejected a patent on B crystalline form of Imatinib Mesylate (Glivec®/Gleevec®), a cancer treatment developed by the pharmaceutical company Novartis. This decision enables patients suffering chronic myeloid leukaemia to access generic versions of Glivec at $175 per month – nearly fifteen times less than the $2,600 charged by Novartis. As the court handed down their verdict, it became clear that India chose to prioritise protecting the health of citizens above the commercial interest of pharmaceutical companies.
Novartis has been trying to challenge the Indian Intellectual Property law since 2006 when its patent application for Glivec was first rejected. Novartis claimed that Indian Patent Law did not conform to the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). It is worth noting that no other company or country has ever sought to make this claim against India to the World Trade Organisation – the body responsible for settling such disputes. After much debate, the court turned down the Novartis case.
The case rests on the way the India intellectual property law makes use of many of the flexibilities of the TRIPS agreement, including how the patentability criterion defines innovation. Section 3D of the Indian law, which is condemned by Novartis and other pharmaceutical companies, prevents patents on new forms, uses, doses, formulations and combinations of known medicines or substances. Instead, to be granted a patent, the revised medicine must show significantly enhanced therapeutic efficacy.
In the Novartis case, although the company provided evidence of improved physical features of the medicine, it did not demonstrate improved therapeutic efficacy. Novartis presented some late evidence of increased bio-availability of the revised medicine but even that was based on comparison with the original molecule of imatinib which is actually no longer marketed as treatment. Moreover, increased bio-availability does not automatically mean enhanced therapeutic efficacy.
The claim by pharmaceutical companies that Indian patent law will stop innovation is without foundation. On the contrary, Section 3D encourages innovation (incremental or otherwise) by preventing companies like Novartis securing patent extensions for making trivial changes to their products – a practice known as ‘Evergreening’. Allowing companies to secure patents, and therefore profits, by making trivial changes to existing products acts as a disincentive for much needed R&D investment in new products to treat and prevent diseases.
Novartis, along with other companies are also claiming the court ruling will put an end to R&D investment by companies in India. They argue that the unlikelihood of securing patents removes any incentive for R&D investment. The reality is that other scientific and economic factors have proven much more important for R&D investment including the availability of a strong science base in a country, appropriate infrastructure and an industry-friendly tax system.
In short the court resolution means that more people suffering chronic myeloid leukaemia can be treated now. Novartis says that its patent on Glivec is protected in 40 countries. That means the rest of the world can now use generic versions of Glivec without worrying about patent issues. Developing countries need to learn from India in promoting the use of high-quality generic medicines so that patients can access treatment at affordable prices.
The story highlights the urgent need to review the dysfunctional intellectual property system and find new ways of stimulating R&D to produce new medicines that have real therapeutic value. In the interim, pharmaceutical companies should stop spending millions of dollars on litigation in their effort to secure patents for evergreening their products. Instead they should invest in R&D for new products that could make a real difference to people’s lives.
Mohga Kamal-Yanni is a Senior Health and HIV Policy Adviser at Oxfam GB