INDIA: Novartis Patents Case Far From Dead

Cancer patients in India have reason to be relieved at a high court ruling this week which dismissed a petition by Swiss pharmaceuticals multinational corporation (MNC) Novartis challenging an Indian law which denies patents for minor or trivial improvements to known drugs.



At immediate stake is the cost of a leukaemia drug, imatinib mesylate. Novartis prices its brand of the medicine, Gleevec/Glivec, at Rs 120,000 (3,000 US dollars) per dose. Indian generic drug manufacturers sell it at Rs 8,000 (200 dollars).



India's average per capita annual income is equivalent to only a fifth of the price of a single dose of Gleevec/Glivec. Had Novartis been granted a patent on its version of the drug, tens of thousands of Indians would have been deprived of life-saving treatment.



The Novartis judgment will have far-reaching implications for generic drugs used in many countries of the world for the treatment of countless diseases and disorders, including vaccines for HIV-AIDS, as well as medicines for cancer, asthma, heart disease and mental illness.



Health activists the world over, including Medicins Sans Frontieres (MSF), the Berne Declaration group, as well as the All-India Drug Action Network (AIDAN) based in this country, have welcomed the verdict in the Novartis case for its "positive impact on public health" and the cause of promoting patients' access to affordable medicines.



They see the judgment as a vindication of India's Patents Act, in particular its Section 3(d), which disallows frivolous patents for "the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance". They have also appealed to Novartis not to contest the judgment.



However, the Indian government is itself reportedly planning to amend that very Section to allow the "evergreening" of patents on the original molecule of a new drug through its marginal modification which does not constitute an original invention.



This will in effect achieve more than Novartis can by appealing the Madras (Chennai) High Court verdict in India's Supreme Court.



"That would make a travesty of the very rationale of one of the few measures in the Patents Act of 1970, amended in 2005, which protects the public from the abuse of a monopoly patent right granted to corporations," says Mira Shiva, a long-standing health activist with AIDAN.



Adds Shiva: "The sour irony is that by changing Section 3(d), the government would be sanctifying the discredited report of an official committee on patent laws, headed by the former director general of the Council of Scientific and Industrial Research (CSIR), R.A. Mashelkar, which had recommended just such an amendment."



The Mashelkar report created a scandal six months ago because it plagiarised text pertaining to "incremental innovations" (or marginal modifications to patented drugs) from a document prepared for a pro-Big Pharma think-tank based in Europe, funded by drug multinationals, including Novartis.



Disgraced and embarrassed, Mashelkar himself withdrew the report, although he unconvincingly denied the plagiarism.



But India's commerce ministry is now trying to smuggle his recommendation into law though the backdoor. "The Economic Times" reported Thursday, quoting a senior bureaucrat, that the government is planning to allow "incremental innovation" by redefining "efficacy" enhancement.



That would entirely negate the effect of the Madras High Court judgment, dismissing Novartis' contention that section 3(d) is "vague, arbitrary and violative of Article 14" of the Indian Constitution, which guarantees the right to equality and non-discrimination.



Novartis also claimed that the Section does not comply with the Trade-Related Intellectual Property Rights (TRIPS) agreement of the World Trade Organisation, mandating a strict patent regime, which India has signed.



The Court ruled that it had no jurisdiction to decide whether Indian patent laws comply with TRIPS; and that Section 3(d) does not suffer from "vagueness, ambiguity and arbitrariness" and contains reasonable "in-built protection" for patent applicants.



Novartis can appeal against the judgement in the Supreme Court, or get the Swiss government to move the WTO's Disputes Settlement Body against it. The company has not announced what it intends to do.



The fate of Section 3(d) of the Indian Patents Act will have a huge impact on the health situation in the countries of the Global South.



India, called "the medicine factory of the Third World", is a leading manufacturer of generic drugs and has successfully developed cheap but high-quality medicines across a wide spectrum. Indian-made generics cost only a fraction of the same chemical entities manufactured in the West, which enjoy monopolistic privilege through strict product patents.



More than half the medicines currently used for AIDS treatment in the developing countries come from India. Indian-made products are also used to treat over 80 percent of the 80,000 AIDS patients in (MSF) projects.



Currently, nearly 10,000 drug patent applications await examination in India. If India grants "evergreening" patents, that would spell the end of affordable medicines in the developing countries.



That is why the Novartis case triggered widespread protest in global civil society. Over 420,000 people worldwide signed a petition asking Novartis to drop the case.



Among them were Archbishop Desmond Tutu, the former Switzerland president and health minister Ruth Dreifuss (currently chair of the World Health Organisation board on intellectual property and TRIPS), and several members of the European Parliament and the U.S. Congress.



"Given this context, it would be utterly treacherous for the Indian government to amend or drop Section 3(d)," says Dinesh Abrol, a specialist in intellectual property issues at the National Institute of Science, Technology and Development Studies in New Delhi. "The arguments commerce ministry bureaucrats advance for doing so are largely specious and wrongly hold that India will lose foreign direct investment in the drugs industry and offshoring opportunities in pharmaceuticals research and development (R&D)."



Many researchers argue that R&D offshoring is largely a function of low costs and the state of the pharmaceutical sciences in India, and not of the degree of patent protection. "There is no evidence that India has lost contracts because of poor intellectual property protection or lack of confidentiality in pharmaceuticals research," says Abrol.



He adds: "What the government needs to do after the Madras judgment is to systematically set out in a Patents Office manual the criteria for judging the enhanced efficacy of a drug, including reduced side-effects, contraindications and hard data on assessing greater bio-availability. That's the best way of defending and preventing the abuse of Section 3(d)."



However, it is far from clear if the Indian government, in particular its commerce ministry, itself deeply compromised with the WTO, can summon up the will to defend the public interest against predatory multinational corporations. 

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• 116 Human Rights
• 122 Pharmaceuticals
• 208 Regulation