The war against Novartis is not yet won
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COMMENTS 
Drug activists must maintain their campaign against Novartis if they are to win the battle for the right to manufacture essential drugs
The recent Madras High Court judgement against the Swiss drug company Novartis brought joy to the hearts of Indian activists. But they must continue to fight the company's efforts to prevent generic production of essential drugs. Recently a coalition of organisations launched a boycott of the company in order to keep the struggle in the public eye.
The company suffered a setback in its efforts to win a patent in India for the anti-cancer drug imatinib (trade name Glivic), but it has many plans on how to move ahead. It is now focusing on an appeal it has pending before the Indian Patent Appellate Board (IPAB), against the rejection of its patent application by the Indian Patent Office. The company has also filed a case in the Madras High Court challenging the composition of the IPAB committee hearing its appeal. This second high court petition, scheduled to be heard on September 10, has now been adjourned till October 8.
On August 6, 2007, the Madras high court rejected Novartis' challenge of a section of the Indian Patent Act. Novartis had questioned the constitutionality of Section 3 (d) of the Act that denies patents for "minor improvements" to known drugs.
The Court ruled that it had no jurisdiction on whether Indian patent laws complied with intellectual property rules set by the World Trade Organization (WTO); the WTO was the proper forum to resolve this question.
However, only governments, not companies, can approach the WTO on matters of trade policy, and the federal councillor of department of economic affairs in the Swiss Confederation said the government did not plan to take Novartis' claim to the WTO.
"If the Swiss government approaches the WTO, it would establish the link between the corporation and the government," says K Gopakumar of the Centre for Trade and Development in Delhi.
Novartis had filed the challenge in 2006, after the Indian Patent Office rejected its patent application for the drug imatinib. Imatinib (brand name Glivic) is used to treat chronic myeloid leukaemia, of which approximately 25,000 new cases with nearly 18,000 deaths are reported in India every year. Glivec is believed to be the second largest selling drug of Novartis, with a 2005 revenue of nearly $2.5 billion.
Novartis' announcement that it was "unlikely" to appeal the decision in the Supreme Court is seen by some as a move to avoid further heat from the campaign. "Their decision not to go to the Supreme Court may be because they don't have a strong case," said Gopakumar.
However, he believes that the company will pursue the issue by other means. "Its comment that the Indian court's ruling would discourage investments in innovations is a message to policy makers that they should amend the Act if they want foreign investment."
Indeed, according to a statement from Novartis India, the ruling would "have long-term negative consequences for research and development into better medicines for patients in India and abroad".
Novartis has argued that eliminating Section 3(d) would not affect the supply of affordable medicines from India to poor countries. The company has also stated that it provided Glivic "free of charge to 99 per cent of patients in India prescribed the medicine for as long as they need it."
However, the Cancer Patients Aid Association (CPAA), a non-governmental organisation, holds that the criteria for free provision of exclude most patients who need the drug.
The fight started as far back as 2004 when the CPAA went to the Supreme Court challenging the Indian Patent Office decision to award Novartis exclusive marketing rights for Glivic in India, pending its decision on Novartis' patent application. The CPAA argued that the Patent Office's decision, which prevented Indian drug companies from manufacturing and marketing the drug, would make the treatment unaffordable to thousands of patients in India.
In 2005, India amended its Patents Act to introduce product patents. Following extensive lobbying by health activists, certain clauses were introduced in the Indian Patents (Amendment) Bill that limited what could be patented and also provided for "pre-grant" objections to patent applications. According to Section 3 (d), incremental improvements on existing products cannot be patented.
In January 2006, the Patent Office rejected Novartis's patent application, citing Section 3 (d). Novartis then filed two writ petitions in the Madras High Court, one challenging the order of the Patent Office and the second the constitutional validity of Section 3(d) of the Indian Patents Act.
The high court transferred the first petition to the Intellectual Property Appellate Board (IPAB). Novartis then went to the high court asking for the exclusion of the IPAB's technical member S Chandrasekaran from hearing its appeal; it argued that he was biased because as a government official during the patent hearings he had filed an affidavit against the company. The appeal proceedings were stayed and the case is likely to come for hearing on September 10.
If Novartis is eventually successful in its challenge it will affect the supply of affordable drugs from India, depriving millions of poor people of life saving drugs, say health activists. As one of the largest manufacturers of generic drugs worldwide, India's pharmaceutical industry is a key source of cheap generic medicines.
Section 3 (d) will apply to some of the 9,000 applications for patents, filed between 1995 and 2005, that are currently under examination by the Office of Patents, notes Gopakumar of Centad. It will also apply to the majority of the 327 new molecular entities approved between 1995 and 2005 by the United States Food and Drugs Administration.
The Indian Patent Act of 1970 was responsible for the development of the Indian pharmaceutical industry. Today it is a player in the world market, supplying generic drugs to nearly 211 countries. This is poised to change with the amended Act of 2005, unless advantage is taken of clauses that permit waiving of patent protection for essential drugs.
"The generic version of Glivic costs patients Rs 8,000 a month, compared to Rs 1,20,000 per month if Novartis is granted a patent," says Dr Amit Sengupta of the Delhi Science Forum and the People's Health Movement, commenting on the Madras High Court judgement. "Also, granting the patent would have set the wrong precedent," he notes.
"There is a global euphoria about the Madras High Court's decision," said Dr Gopal Dabade, president of the NGO Drug Action Forum, Karnataka. DAF has been active in a campaign of health organisations against Novartis. "However, if public opinion pressure is not maintained, the company's moves can have long term implications on access to medicines to people all over the world."
InfoChange News & Features, September 2007