In 2005, cancer patient groups in India used Indian intellectual property law to stop a patent application by Swiss company Novartis for its anti-cancer drug, Glivec. This allowed Indian companies to continue making generic versions at about $2,700 a year, as opposed to Novartis having a monopoly priced version for sale at about $27,000 a year.
Novartis recently appealed the decision in a direct challenge to India's right to use safeguards contained in trade rules agreed by the WTO in 2001 in the interests of public health.
What is Glivec?
Glivec (Gleevec in the US) is an important drug that means the difference between life and death for cancer patients suffering from leukemia (CML), stomach tumors, and other conditions. Glivec is a significant improvement over other forms of treatment and should be as widely available as possible, at affordable prices.
Why is Novartis enforcing its patent on Glivec in India and in other in developing countries?
Glivec is a key drug for Novartis worldwide. It's the company's second best selling drug with sales reaching $2.8 billion in 2005 and accounts for 9.6 per cent of Novartis's estimated share value. Research indicates that there are multiple diseases that respond to the drug. In only five years, Glivec is now approved in the US for seven different diseases. There is a danger that the company could apply for a new patent based on these "new uses" elsewhere, which would extend its monopoly and delay availability of affordable generic versions of Glivec for people who need it.
Novartis says that there is virtually no commercial market for Glivec in India and that it is taking the case in part to "align Indian IP laws with TRIPS", The World Trade Organization's agreement on intellectual property. This action is one that will affect India's right to produce not only generic versions of Glivec but also for other new medicines in the future.
What would happen if Novartis were successful in its appeal?
Not only would it increase the price of the drug it would also jeopardize India's generic export industry. India is the world's leading supplier of inexpensive generic medicines to developing countries with approximately 67 percent of its exports going to developing countries. As a result people needing cheaper versions of medicines in many developing countries would lose out.
Oxfam believes that generic competition reduces the price of many patented medicines and makes them much more affordable to poor people in developing countries. Lower prices via generic competition could ensure free or subsidized medicines for millions of poor people through increased public sector funding for health, through health insurance and because many poor people are willing to pay out of pocket for medicines because the health and well being of themselves and their family a top priority.
]]>Intellectual property is knowledge which societies have decided can be assigned specific property rights to either individuals, companies or organizations. It allows people, companies and organizations to own their creativity or innovation in the same way they can own physical property.
Intellectual property includes inventions, literary and artistic works, symbols, names, images, and designs used in commerce.
The owner or creator has the right to prevent others to use his property during a limited period of time.
A patent is a legal creation describing "ownership" of an invention. Patents are issued by individual governments and are meant to benefit both the inventor and the society at large. Patents provide the inventor with a temporary right to produce and sell their invention without the threat of competition. This monopoly results in higher prices which provide incentives for inventors.
A Trademark is ownership over product names or brand identity e.g. NIKE and PUMA. This allows for a distiction to be made between different traders of goods and services
Copyright is ownership over creative materials such as literature, art, music and films, sound recordings, software and multimedia. Copyrights usually provide the author or creator with lifetime ownership over their own materials.
These give ownership protection over designs for a product's appearance and can last up to 25 years.
Developing countries, taken as a whole, are net importers of technology and new inventions, most of which are supplied by the developed countries. Companies and organisations in developed countries own the overwhelming proportion of patent rights worldwide.
It is widely recognized that knowledge is essential for development, and that developing countries have much to gain if they are to fully exploit the many opportunities opened up by new technologies. However, increasingly restrictive intellectual property rights are limiting the benefits that new technologies can bring to developing countries.
Fact: Between 1991 and 2001, the net US surplus of royalties and fees (which mainly relate to IP transactions) increased from $14 billion to over $22 billion. In 1999, figures from the World Bank indicate a deficit for developing countries for which figures are available of $7.5 billion on royalties and license fees.
The challenge is for developing countries to use Intellectual property to their own benefit. Only under 2 percent of patent applications in the US in year 1999-2001 came from developing countries.
A reason for that is the lack of capacity for most developing countries to generate their own inventions. To build their capacity, they need to be able first to use other people's inventions, hence their need to have access to cheap technology to kick start their own development. The current IP system is too rigid to cater for these development priorities and needs to be reformed.
Another reason is that the current system does not help developing countries benefit from their own assets and resources. Their traditional knowledge in medicines, their genetic resources, or the names of high-quality products are often patented by foreign companies, which capture all the gains without having to return a fair share of their profits to the origin countries and populations.
A clear illustration of this problem is Ethiopia's Sidamo coffee, which is one of the best coffees in the world. Whilst earning coffee companies higher prices due to its quality and name, it still fails to produce enough returns for coffee farmers to make a decent living. The Ethiopian government wants to trademark this and other Ethiopian coffee names, to build its coffee industry and help its own farmers. However, this trademark is being opposed in the United States by the National Coffee Association of America, of which Starbucks is a member.
Fact: In 2001, less than 1 percent of US patents were granted to applicants from developing countries, nearly 60 percent of which were from seven of the more technologically advanced developing countries.
R&D expenditure is heavily concentrated in developed countries, and in a few of the more technologically advanced developing countries. Few developing countries have been able to develop a strong indigenous technological capability. This means that it is difficult either for them to develop their own technology, or to assimilate technology from developed countries.
Fact: In sub-Saharan Africa in 1998 (excluding South Africa), 35 patents were granted to residents compared to 741 for non-residents. By contrast in Korea, 35,900 patents were issued to residents, compared to 16,990 to non-residents. In the US, the corresponding figures were 80,292 and 67,228.
]]>But lately that medicine has become harder to come by as pharmaceutical corporations have priced poor people out of the market. Five years after the World Trade Organization's members unanimously reaffirmed developing countries' rights to produce, export, and import affordable copies of patented drugs, rich country governments keep breaking their promises.
Countries like the US are forcing developing nations to accept free trade agreements that violate the spirit of the WTO's decision on medicine patents. The provisions contained in US-negotiated free trade agreements would restrict the availability of generic drugs; people who can't afford brand-name medicines for infectious diseases like HIV/AIDS or for chronic illnesses like diabetes or heart disease would have to go without.
This fall, Oxfam's partner, the Educational Network for Global and Grassroots Exchange, brought three Thai HIV/AIDS activists to New York, Washington DC, Pennsylvania, Texas, Illinois, Minnesota and California to speak out against the proposed US-Thailand Free Trade Agreement. The tour was part of Oxfam's campaign to change trade rules that favor rich countries over poor people and company profits over public health.
"Americans don't know much about the HIV/AIDS epidemic in Thailand or the negative impact that a US free trade agreement would have on the cheap drugs that the government makes," said Matthew Coghlan, Oxfam's Regional Trade Policy Officer in East Asia. "This tour gave the Thai speakers the chance to educate Americans about what's really at stake."
Boripat Donmon, or Pii Muu as he's known, has been living with HIV for 13 years. During that time, he has become an instrumental leader in the fight for greater access to HIV and AIDS medicines in Thailand. His organization, the Thai Network of People Living with HIV/AIDS, gathered 50,000 signatures from the Thai public to lobby the Thai government to revise its national health policies. With pressure from hundreds of other organizations mounting, the Thai government announced last year that it would include treatment for HIV and AIDS in the national health insurance plan, commonly known as the "30 Baht Scheme."
Since then, though, people like Pii Muu have been forced to stop treatment. As they become resistant to older drugs that are manufactured by the Thai government, they must take newer drugs still under patent to prolong their lives. But currently patent rules give brand-name companies exclusive rights to market their medicines for 20 years, which allows them to charge more than most sick Thais can afford.
"The situation will only worsen if the US-Thailand FTA is approved," Pii Muu said during a stop on the tour in New York City. US free trade agreements severely restrict the ability of developing countries to ensure availability of generic versions of patented medicines—the only proven way to lower prices. "Most Thais make $140 a month—way below what patented medicines cost," he continued. "I don't know how anyone will be able to afford them with an FTA."
Sang-Siri Teemanka, also known as Pii Tui, agreed. An organizer with Thailand's Aids Access Foundation, she has also spent much of her career campaigning to get the Thai national health system to offer affordable anti-retroviral medicines.
"The problem now in Thailand is that the basic treatment manufactured ... at the cheap price will become ineffective for some patients after just three to five years. They will need to change medicines, and the new drugs are patented by the giant foreign pharmaceutical companies," Pii Tui said. "These drugs are very expensive."
Negotiations for a free trade agreement with the US are a contentious issue in Thailand. In January 2006, thousands of people took to the streets in Chiang Mai, Thailand to protest their lack of involvement.
The Thai activists touring the US said they want their government to recognize the people's rights to shape the trade rules that would have real effects on their daily lives. Specifically, the Thai activists asked that the government educate the people about the US-Thailand FTA, consult with them when negotiating it, and invite them to participate in decision-making.
They also asked that Americans lobby the US government and the WTO to help poorer countries like Thailand assert their right to make available generic versions of the patented drugs.
"We want the US to understand that the FTA is not balanced," Pii Tui said. "Access to medicine is very important to Thailand. It is not like CDs or computer software. People's lives are at stake."
]]>Patented medicines continue to be priced out of reach for the world's poorest people. Trade rules remain a major barrier to accessing affordable versions of patented medicines (generic medicines).
The prevalance of debilitating and life-threatening diseases in poor countries is growing, but medicines are simply not available. Urgent action is needed.
]]>Furthermore, they will weaken existing regional processes of integration and co-operation. Trade rules with the Andean region need to be substantially modified in order for development to become a priority once again.
]]>This document is available for download (below) in English, French, Thai, Khmer, Vietnamese, and Indonesian translations.
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