There has been a mixed response to the decision by an Indian court to reject Novartis’ challenge to the patent laws in the country and the drugs major says that the ruling will discourage “investments in innovation”.

Novartis had challenged the constitutionality of Section 3 (d) of India's patent laws, a move brought on by the country's patent office’s decision to decline coverage for a new version of the leukaemia drug Glivec/Gleevec (imatinib). The law, which came into effect in 2005, allow patents for products that represent new inventions after 1995 but India argues that Glivec is merely a new form of an old drug and should not be protected.

A specific appeal against the ruling on Glivec has not been decided yet but the High Court in Chennai has dismissed the petition challenging Section 3(d). Ranjit Shahani, managing director at Novartis India, noted that the firm disagrees with the ruling but “we likely will not appeal to the Supreme Court,” he said, adding that “our actions advanced this essential debate in India; now local and international leaders in both industry and academia recognise the inadequacies of Section 3(d) and are raising serious concerns about the deficiencies of the Indian patent system."

Negative consequences of Indian patent law

His view was echoed by Paul Herrling, head of corporate research at Novartis, who said that “it is clear there are inadequacies in Indian patent law that will have negative consequences for patients and public health in India". He claimed that “medical progress occurs through incremental innovation. If Indian patent law does not recognise these important advances, patients will be denied new and better medicines."

Novartis received the backing from the International Federation of International Pharmaceutical Manufacturers and Associations and its director-general, Harvey Bale, who said that “there is a mismatch between India’s huge innovative potential, especially in the field of pharmaceutical and biotechnology R&D, and the wording of the 2005 Patent Law”. He added that the latter “explicitly defines pharmaceutical innovation so narrowly as to render potentially unpatentable many breakthroughs”, arguing that the country “has a strong incentive to remove this restriction and thereby give its scientists full scope to impress the world with a growing stream of innovative new medicines, researched, developed and made in India.”

However other groups were delighted with the Chennai High Court’s decision. Medecins Sans Frontieres described it as “a major victory for patients’ access to affordable medicines in developing countries”, and Tido von Schoen-Angerer, director of the MSF Campaign for Access to Essential Medicines, said that the move “now makes Indian patents on the medicines that we desperately need less likely”. He went on to call upon “multinational drug companies and wealthy countries to leave the Indian Patents Act alone and stop pushing for ever stricter patent regimes in developing countries.

MSF noted that India only began giving patents on medicines to comply with World Trade Organisation rules, “but it designed its law with safeguards so that patents can only be granted for real innovations. This means that companies seeking a patent for modifications to a molecule already invented, in order to extend ever further their monopolies on existing drugs, would be unsuccessful”.

Status as ‘pharmacy of developing world’ safe for now

A ruling in favour of Novartis would have drastically restricted the production of affordable medicines in India that are crucial for the treatment of diseases throughout the developing world, said MSF which noted that 84% of the antiretrovirals that MSF prescribes to its patients worldwide come from Indian generic companies. “India must be allowed to remain the ‘pharmacy of the developing world’,” the organisation concluded.

However Novartis is not convinced by this claim and Mr Herrling said that “eliminating Section 3(d) will not hinder the supply of medicines from India to poor countries given the safeguards in international agreements". In addition, he noted that medicines are made available through “tiered pricing solutions, public-private partnerships, shared contribution models and donation programmes" and stressed that Novartis provides Glivec free of charge to 99% of patients in India “for as long as they need it”.

By Kevin Grogan