Patent

The countries of southern Africa have the world's highest rates of AIDS infection.

Most drug discoveries are made by public institutions. Private pharmaceutical companies, however, generally take over the development and commercialisation of the drugs, filing numerous patents in the process. In recent years, cumulative innovation the development of products based on earlier discoveries has meant that more and more patents are being registered.

Something quite remarkable happened a few days ago. On Thursday 25 September, a simple and obvious proposal was made by Stephen Lewis, the passionate Canadian who serves as the UN Secretary-General's Special Envoy for HIV/AIDS in Africa. Speaking at a conference on AIDS in Nairobi, he said that Canada should issue a compulsory license to lift the patent protection that covers most anti-retroviral drugs (ARVs). This would enable generic pharmaceutical companies to produce the drugs and export them for $250-$300 per person per year to poor countries that do not have domestic production capacity. Later that very day, Canadian government ministers with relevant responsibilities told reporters that they agreed with the idea, and that they hoped to get all-party support quickly. Lewis explained that he made his proposal because of the confluence of two significant recent developments. First, in late August the World Trade Organization (WTO) agreed to let poor countries import cheap generic copies of patent-protected drugs as long as they could not make them domestically, were not importing them for commercial purposes, and could find a supplier willing to issue a compulsory license to lift the patent protection. Advocates believe that despite the new WTO concessions, the WTO imposes conditions that could be onerous to some importing countries. In particular, any third country (possibly acting at the behest of major pharmaceutical companies) could challenge the issuing of a compulsory license by issuing a formal complaint within the WTO. Lewis acknowledged this point, but said that such hurdles would be significantly reduced if a major economic power such as Canada were to initiate the compulsory license. The action proposed by Lewis need not be restricted to Canada. There are strong generic drug-manufacturing capabilities in China, India, Thailand and Brazil, among others. Some of these countries probably have the capability to manufacture all the necessary drugs, possibly to the required scale, and possibly at lower cost than companies in Canada. Thus far, these countries have been understandably cautious about taking actions that might be strongly opposed by the US. But the proposed action by Canada might change all that, as might the way in which China and other developing countries found it necessary to work together in the recently-collapsed WTO talks. Moreover, there are further actions that could lead to cost savings by poor countries. For instance, the Global Fund could help recipients of its grants to club together and achieve economies of scale by purchasing their ARV needs jointly. If fifty countries were each going to spend $10 million of Global Fund money on drug purchases, and if those countries jointly commissioned some third party to purchase $500 million-worth of drugs on their behalf, the economic savings could be considerable. No doubt these ideas are all riddled with complexities that will make them hard to implement. But so what? So have been many other great developments in history, not least Kofi Annan's original suggestion that there should be a Global Fund. (Source: Bernard Rivers, GFO Editor Reproduced from the Global Fund Observer Newsletter www.aidspan.org/gfo), a service of Aidspan. //\// For further news see: Big drug companies embrace AIDS plan Oct. 2, 2003 Globe and Mail http://www.globeandmail.ca/servlet/story/RTGAM.20031002.udrug1002/BNStor... Canada to use compulsory licensing to produce HIV drugs for developing world http://www.aidsmap.com/news/newsdisplay2.asp?newsId=2331 Sept 30, 2003, AIDSMAP

The coronavirus that causes the respiratory disease was discovered and sequenced in record time because of unprecedented international collaboration. Now everyone is staking a claim. Who owns it? That's quickly becoming a point of interest now that the genetic makeup for severe acute respiratory syndrome has been sequenced -- raising questions that could ultimately affect the next advances in the development of SARS diagnostic and treatment tools. The answers will also set the precedent for the handling of genetic information of future emerging infections. For now, at least two government agencies have applied for a U.S. patent on the coronavirus that causes SARS, and for its gene sequence. The U.S. Centers for Disease Control and Prevention and Canada's British Columbia Cancer Agency have both publicly acknowledged that they have taken such action. And, according to several news reports, many more public and private entities may be attempting to secure patents on the virus or its various parts. The full list will not be available until at least 18 months after application, in accordance with U.S. Patent and Trademark Office policies. The World Health Organization is very concerned that anything to do with potential patenting should not lead to any drop-off in the unprecedented solidarity amongst researchers on the SARS investigation, including the development of diagnostic tests, drugs for treatment and a vaccine, said Melinda Henry, a WHO spokeswoman. Patent law experts say that fights after this kind of collaboration are common. They mention the battles over HIV and the hepatitis C virus and their gene sequences as the most notable. They also say that in their experience, rival patent filings do not impede future collaborations. The parties will probably come to some kind of amicable agreement. There is also a significant chance that the actual applications may not conflict with each other. Even if these things are legitimate, they're not going to protect anything. Virtually everything is patentable, but not all of them are enforceable, said Jeffrey Oster, PhD, senior vice president of intellectual property at CombiMatrix Corp., a life science company based in Mukilteo, Wash., that has filed patents for molecules that may turn out to be therapeutic against infection with the virus. (Source: Victoria Stagg Elliott, AMNews, May 26, 2003)

WTO ministers meeting here reached a preliminary deal on access to generic medicines in developing countries, according to a copy of a draft text received Tuesday. The text states that a World Trade Organisation agreement on protecting patented pharmaceuticals does not and should not prevent countries taking measures to protect public health. The draft must still be approved at a plenary session scheduled at 14:00 (1100 GMT) of trade ministers and delegates who are then expected to continue final negotiations on a range of issues until midnight. If they agree on the documents, they will serve as a roadmap for fresh trade talks. The WTO accord, known as TRIPS - trade-related aspects of intellectual property rights - has been one of the toughest issues on the agenda at the five-day sesssion in the Qatari capital. Ministers have been locked in hard bargaining since Friday to find consensus on the contents and time frame of a new round of talks on further reductions in trade barriers. Developing countries, especially India and Brazil, sought assurances they would not be prevented by the TRIPS agreement - which offers patent protection to big pharmaceutical companies - from using cheaper, generic medicines to treat a health pandemic such as AIDS. They were opposed by Switzerland and the United States, who argued the current accord was flexible enough to not stand in the way of efforts by poor countries to respond to crises such as AIDS. They also warned that any weakening in the accord would discourage companies from investing in research and development. (Source: SAPA-AFP, 13 November 2001)

Proposals to relax some of the patent provisions on pharmaceutical drugs meant to deal with pandemics, such as HIV/AIDS, tuberculosis and malaria, have been met with scepticism. The proposals, which will be tabled by the US and several other western countries at the World Trade Organisation (WTO) meeting to be held in Doha, Qatar, later this week, offer to extend the window on full compliance of all pharmaceutical-related Trips (trade-related aspects of intellectual property rights) provisions for 10 years till 2016 for the least developed countries. This means that sub-Saharan countries which break patents will be allowed a five-year grace from prosecution when dealing with HIV/AIDS, infections related to AIDS, and other health crises, such as malaria and tuberculosis. Multinational pharmaceutical companies, whose interests have traditionally been well protected by western governments, particularly the US government, are greeting the move with caution. It seems SA makers of generics too will have to wait until the meeting in Doha is over before they assess whether their ability to copy patented drugs has been meaningfully enhanced. Global drug companies and diplomatic sources say the move is meant to seek out some form of middle ground between the position taken by developed countries and the position sought by poorer nations. Developing countries would like to be able to override patents for public health needs when they see it as necessary. Developed countries, and drug companies do not wish to see their patents eroded in this fashion. Jamie Love of Washington's Consumer Project on Technology, which fights for generic copies of drugs to be more widely available, says the moratorium on the dispute settling provisions of the WTO is to be welcomed, but he points to other problems. Countries classified by the United Nations as least developed do not include SA, Brazil, India, Thailand or Kenya. These are the countries where generics would make competition and bring down the price of medicine. (Source: Business Day, 7 November 2001)

Brazil is preparing to issue a compulsory license for an AIDS drug - making it the first country to do so - in case Swiss pharmaceutical giant Roche Group doesn't slash the price of one of its medicines by 45 percent. Brazil and Roche have been negotiating the price of Viracept since the beginning of the year, and Brazil is expecting a new offer next month. If the price is too high, Brazil will likely issue the license in October, when the country expects to have perfected the manufacturing process. The World Trade Organisation allows countries to manufacture or import generic versions of patented drugs in times of health emergencies. Brazil's patent law also allows the country to issue licenses if a patent holder's policy represents an economic hardship on society. The United States had filed a complaint with the World Trade Organisation over Brazil's law but dropped the action Monday under immense international pressure. Pharmaceutical executives have objected to a provision of the law that would allow Brazil to start manufacturing a drug if the company that developed it didn't start to make it locally within three years. Observers said the US decision is likely to pressure Roche to lower its price. Roche said it was working with health authorities in Brazil regarding pricing for Viracept, but would not comment further. Brazil has been widely lauded for its AIDS programs, which give treatment to all patients free of charge. There are currently 12 drugs available to treat AIDS patients and Brazil manufactures seven of them. Brazil is not breaking any world patent agreements because it began manufacturing the medicines before it adopted patent laws aligned with the WTO. Brazil's Health Minister, Jose Serra said that Brazil's generic program presents no threat to American and European pharmaceutical companies because the country has no intention of exporting medicine. Brazil could offer other developing countries technical advice and assistance, he added. (Source: SAPA-AP, 27 June 2001)

Nairobi, Kenya: If South Africans are celebrating the victory in the recent case in which 39 major pharmaceutical firms had challenged a law permitting the making or importation of cheaper AIDS drugs, drugs access lobby groups in Kenya are over the moon. The Kenya Coalition of NGOs on Access to Medicines had, in collaboration with experts on AIDS and other medical and humanitarian bodies, mobilised over 6,000 Kenyans to sign a petition urging the drug firms to drop the case. In a welcome turn of events, the firms withdrew the case and agreed to an out-of-court settlement and to meet the costs. South Africa and other African countries worst hit by AIDS, Kenya included, want to be allowed to manufacture or import the cheaper retroviral drugs. But the drug multinationals have resisted this bid, arguing that it infringes on their patent rights. The South African victory is likely to goad the other Third World countries currently drawing World Trade Organisation (WTO)-compliant laws into giving themselves the same leeway on the generic retrovirals. This WTO category includes East Africa. Tanzania and Uganda are expected to have passed the WTO-compliant law by 2006. Kenya, which is more economically developed by WTO standards, is expected to do so by next December, having published a draft of the intellectual property rights bill last month. The crux of the matter is, however, that Africa's estimated 26 million HIV-infected people, over 4 million of them in East Africa cannot afford the lower drugs prices of 350-500 US dollars per person per year. This means that, despite the celebration, there are still battles to be fought and won by the continent to stem the AIDS tide. (Source: Panafrican News Agency (Dakar), April 24, 2001, Posted to the web April 24, 2001)

The collapse of 39 pharmaceutical companies' court action against the government this week has created the false impression that South Africa will suddenly be awash with cheap AIDS drugs. Kerry Cullinan takes a closer look at the events that unfolded after the court case was dropped.

The companies behind the Pharmaceutical Manufacturers Association of South Africa together have a market capitalisation in excess of $1,3-trillion (about R10,4-trillion) - about 10 times the gross domestic product of South Africa. Yet the industry is on the defensive, fearful of a public mauling that could undermine confidence in the patent system which is its lifeblood. Pressure is mounting for firms to drop the court case and do more to improve access to medicines. Company officials privately admit the vilification of the industry could spiral out of control if more governments questioned their rights to drug patents. The industry argues that the global system of patents on new drugs is essential to ensure investment is made in the costly hunt for new treatments. Critics say it has become an obstacle to treating patients in poor countries who cannot afford western prices. (Source: The Star, 16th April 2001)