TWN Info Service on Health Issues (January 07/01)

9 January 2007

Novartis targets India’s Patents Act

India could dry up as a source of newer and future affordable medicines if Novartis succeeds in its challenge against India’s Patent act. Medecins sans Frontiers has launched an international petition to urge Novartis to immediately drop the case (for further information visit

India is one of the most vital sources of generic drugs and Novartis’ attack on India’s patent law could have disastrous consequences on access to affordable medicines for millions of people in the developing world.

Thailand and Philippines push generic drugs

Meanwhile Thailand and the Philippines are pushing ahead with plans to provide cheaper generic drugs despite threats from Big Pharma. The following articles provide the background to the stories. It is reproduced with the permission of South-North Development Monitor (SUNS) # 6167, 21 December 2006 and # 6165, 19 December 2006.

With best wishes
Evelyne Hong

Health: Novartis urged to drop patent case against India

By Kanaga Raja, Geneva, 20 December 2006

A legal challenge by the Swiss pharmaceutical company Novartis against India's patent law could have disastrous consequences on access to affordable essential medicines for millions of people across the developing world, the international medical humanitarian agency Medecins Sans Frontieres (MSF) warned on Wednesday.

In launching an international petition to put pressure on the company, MSF urged Novartis to immediately drop the case.

At a media briefing on Wednesday, Christian Captier, General Director of MSF Switzerland, said that what was at issue is the legal steps being taken by Novartis in challenging the government of India in its ability and capacity to develop, produce and export affordable generic drugs to developing countries.

India is one of the most vital sources of generic drugs, he added, pointing to the fact that generic antiretroviral medicines produced in India are being used to treat over 80% of the 80,000 people that receive treatment today in MSF's AIDS projects in more than 30 countries.

This is a battle for principle, he said, recalling what had happened in South Africa in 2001 when 39 pharmaceutical companies - Novartis among them - took the South African government to court in an effort to prevent the government from importing cheaper AIDS medicines.

The campaign launched at that time by MSF and other organizations ultimately persuaded the pharmaceutical companies to drop their legal proceedings against the South African government.

What is at stake, Captier warned, is the undermining of the ability of millions of people to have access to efficient and affordable drugs.

He also said that since the legal case started a few months ago and the first hearing took place in September, MSF has been trying to discuss the issue with Novartis. It has written to the CEO of Novartis asking the company to drop the case and to meet with MSF. The company however replied that it was going to continue with its action.

Captier said that this was the reason why MSF decided to launch the petition to raise public awareness and mobilize various actors around this issue. He added that similar public events will be taking place in India and Brussels.

Dr Christophe Fournier, President of the MSF International Council, said that the court case could have a disastrous consequence on the patients that MSF is treating as well as the millions of patients all over the world that need access to generic drugs.

In citing the reduction in AIDS treatment costs of over $10,000 per patient per year in 2000 to about $130 per patient per year today, Fournier highlighted the impact that generic drugs have on the ability to scale up the offer of good and affordable treatment that MSF can provide to patients.

AIDS is a lifetime disease that requires lifetime treatment, and since patients will one day become resistant to the drug combinations they take, newer drugs will be needed. To illustrate, Fournier cited one of MSF's AIDS treatment programs in South Africa where MSF in five years' of treatment has seen 17% of patients becoming resistant to the AIDS drugs. Thus, there is an urgent need to have access to newer drugs, said Fournier.

He also pointed out that where only about 240,000-280,000 patients were able to receive treatment for AIDS from 2001, there now are 1.3 million patients receiving treatment. While there has been a real improvement in access to treatment for AIDS patients, there are still some 3.7 million who remain in urgent need of treatment.

If there is no longer any access to newer generic AIDS drugs, ''we will be back to square one with all these patients not having access to proper treatment and that will have a disastrous consequence,'' he said.

Dr Tido von Schoen-Angerer, Director of MSF's Campaign for Access to Essential Medicines, said that there is already a situation where people in the developing countries are cornered due to WTO rules.

In 2005, India had to change its patent law due to WTO rules, which Von Schoen-Angerer said MSF foresees as having a severe impact on access to newer generic medicines.

Von Schoen-Angerer added that India however has put a safeguard in the law that means that patenting is relatively strict and patents should only be granted for real new innovations and not for simple improvements of existing medicines. The Indian law has also put in place another safeguard called 'pre-grant opposition' that allows any interested group to oppose a patent before it is granted.

He pointed out that this happened with respect to Novartis' patent on the cancer drug Gleevec where Indian patient groups opposed this patent and it was not granted on the grounds that it was only an improved version of a previous compound.

This was the reason why Novartis was taking the Indian government to court, and to have the particular safeguard (Article 3d) reversed, he said.

According to an MSF briefing note, Section 3(d) of the Indian Patents Act stipulates that patents should only be granted on medicines that are truly new and innovative. This means that companies should not be able to obtain patents in India for medicines that are not actual inventions, such as drug combinations or slightly improved formulations of existing medicines.

Section 3(d) was specifically targeted at preventing a common practice among drug companies of trying to get additional patents on the basis of insignificant improvements of drugs already patented, said MSF, adding that it is this part of the law that Novartis is challenging.

According to the MSF briefing note, if Novartis succeeds in its challenge against Section 3(d) of India's Patents Act, patents could end up being granted in India just as broadly as they are in wealthier countries. This would mean that virtually no generic versions of newer drugs could be produced by Indian manufacturers during patent terms lasting at least 20 years. And that would mean that much of the developing world would no longer be able to rely on Indian manufacturers for their supply of cheap essential medicines, in particular newer medicines.

Von Schoen-Angerer said that if Novartis wins the case, it would have disastrous consequences on access to medicines. He feared that patents would then be granted on a much easier scale similar to what is being seen in rich countries, in a practice called 'ever-greening' - where companies try at the end of a product's patent term to make a small improvement in order to prolong the patent.

He stressed that there are not many alternatives to India as a key supplier. ''There is no place today that can replace India as a key supplier especially of new quality generic medicines for the developing world,'' he said.

Today, he added, other developing countries have also had to change their patent laws and recognize patents. This has been the result of efforts by pharmaceutical companies with the support of rich countries over many years to change the rules of the game. India had fulfilled its obligation last year by changing its patent law but it has also made an effort to balance the need to protect public health and to recognize intellectual property.

Von Shoen-Angerer said: The question is how far do pharmaceutical companies want to go with this. Have they not already won the battle? Where does public health and the rights of patients come into the equation?

The impact of this case is enormous for access to medicines across the developing world and this is the reason why MSF takes this case very seriously, he said.

He expressed hope that India will stand firm in its position as well as stand by the important steps that it has taken. This is very much about Novartis challenging a law that tries to balance the rights of patent holders and patients, he said.

Health: Asian governments push generic drugs

By Marwaan Macan-Markar, IPS, Bangkok, 18 December 2006

In moves that are winning them praise, two South-east Asian governments - in Thailand and the Philippines - appear determined to push ahead with plans to provide cheaper generic drugs even if they incur the wrath of pharmaceutical giants.

In both cases, India finds itself roped into these groundbreaking efforts as a major producer of affordable generic medicines. Thailand recently issued a compulsory licence to break the patent of the drug Efavirenz, a vital anti-AIDS drug produced by the multinational Merck, to import the generic version of the medicine from India.

The Philippines, on the other hand, appears keen to fight a legal battle with the pharmaceutical giant Pfizer in its drive to import a generic version of Norvasc, a drug needed by heart patients, from Indian manufacturers. Manila's case was strengthened in mid-November when Filipino patients who need the cheaper drug joined the court case to defend their rights for affordable medicines, making it a three-way tussle.

Such measures in the interest of a country's health over private sector wealth come at a time when ''pharmaceutical companies are on the offensive in developing countries, trying to undermine existing world trade rules to prevent developing countries from getting affordable medicines,'' Oxfam, the international development agency, said this week.

Pressure from developed countries where the pharmaceutical companies are based has also dissuaded developing countries in South-east Asia from exerting their rights to secure affordable medicines to deal with major public health emergencies that they face at home.

These rights were guaranteed at the 2001 ministerial meeting of the World Trade Organisation (WTO) in the Middle Eastern city of Doha. At that meeting, governments from both the developing and developed world endorsed the trade-related aspects of intellectual property rights (TRIPS), including the safeguards enabling governments in the South to access or produce cheaper generic drugs in the face of a public health crisis.

Issuing a compulsory license was one option, enabling a country to locally produce a generic version of a brand name drug to meet domestic demand. The other was parallel importing, where a country can import a generic drug into its local market despite an expensive brand-name medicine being guaranteed exclusive patent rights.

Thailand's decision to issue a compulsory license to import the generic version of Efavirenz till it starts producing the version locally in six months was a first since it passed the Drug Patent Act nearly three decades ago.

''Thailand is completely within the law under TRIPS to seek an alternative to the drug Merck's produces,'' says Paul Cawthorne, Thai country coordinator for Medicins Sans Frontieres (MSF - or Doctors Without Borders), the international relief agency that has been leading a campaign for cheaper drugs in the developing world.

''Thailand was faced with a supply problem of this drug due to a massive global demand. The high price was also an issue.''

The measure taken by Bangkok should strengthen its case when it negotiates the price of drugs with other pharmaceutical companies in the future, he added in an interview. ''The pharmaceutical companies will know that the Thai government will now not hesitate to get a better deal, cheaper drugs. Since it said that this is the first time to break a patent but not the last.''

''It is important for developing countries in the region to make similar moves to ensure that they use their rights under TRIPS,'' Jacques-chai Chomthongde, research associate at Focus on the Global South, a Bangkok-based think tank, told IPS. ''I hope what is happening in Thailand will encourage other developing countries to pursue a similar line.''

The Merk's product, which is used as a first- and second-line of medication needed by people living with HIV to prolong their lives, cost patients $41 a month. The generic version slashes that price in half, being available at $22 a month.

Thailand's quest to offer cheaper drugs for its citizens infected with the killer disease AIDS is in keeping with a pattern established four years ago, when the state-owned pharmaceutical agency started producing a local line of generic anti-AIDS drugs that cost $37.50 for a month's course.

Cheaper medicines together with a universal health care package have seen Thailand emerge as a leader among developing countries offering anti-retroviral (ARV) drugs for HIV/AIDS patients. Currently, some 85,000 people are covered by this medical care initiative out of over 600,000 people living with HIV. Yet public health experts warn that the country should be ready to supply the second-line therapy of ARVs as the first-line drugs lose their potency.

In the Philippines, the pharmaceutical giant Pfizer has turned the heat on Manila after it filed charges earlier in the year against two government agencies for importing the hypertension drug Norvasc, over which Pfizer enjoys a monopoly in the Philippines.

''Pfizer earns $60 million a year in the Philippines selling Norvasc at more than twice the price it charges in other countries - even though heart disease is the country's number one killer and more than 40% of Filipinos do not have access to medicines,'' states Oxfam.

''This case is setting a precedent and the government's ability to secure cheaper generic drugs will depend on its outcome,'' Shalimar Vitan, trade campaign coordinator for Oxfam in the Philippines, told IPS during a telephone interview from Manila. ''It is also a first for consumers to fight for their rights against Pfizer. There has been no other opportunity for them.''

Filipino public health and fair trade activists fear that a Pfizer victory could undermine further the promises held up at the Doha WTO meeting, since it could strengthen the drug company's patent protection clauses and bolster other pharmaceutical giants in the Philippines to follow. That flies in the face of the decision by the state-owned Philippine International Trading Corporation and the Bureau of Food and Drugs being ''legal under Filipino law,'' they say.

''If Pfizer is successful, it will severely limit the government's ability to access cheaper medicines and assert its right to enforce TRIPS safeguards,'' states Oxfam.