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Excellence Everywhere - National University of Ireland, Galway

Excellence Everywhere - National University of Ireland, Galway

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Most profound for developing countries werechanges related to patents. They include:1. Broad definition of what can be patentable. Thisrequires many countries to extend protection toareas such as chemical and pharmaceuticalproducts and processes, food products, microorganisms,microbiological processes and newvarieties of plants.2. Harmonized patent length at 20 years from thedate of filing.3. Mandated that intellectual property laws not offerany benefits to local citizens that are not availableto citizens of other TRIPS states while they are inthat country (see Indigenous Knowledge, page 165).4. Flexibility for developing countries to allow someoneelse to produce a product without the consentof the patent owner. This “compulsory licensing”can be used in circumstances of extreme “nationalurgency” such as domestic health crises.HIV/AIDS and the TRIPS DebateThe GATT treaty had a rough start and remainscontroversial. The European Union, the UnitedStates and large pharmaceutical companies playeda major role in adopting the TRIPS Agreement.The fact that corporations with an interest in favorableinternational rules on intellectual propertywere themselves part of developing policy wasa focus of intense debate. Developing countriescomplained that they were left out of critical negotiations.The provision that requires poor countriesto extend patent rights on pharmaceutical productsmade in the developing world has also provokedcriticism.New patents promise benefits and incur coststhat differ by disease, and some diseases primarilyaffect poor countries. For those disorders, patentsare not attractive to private investment becausethe purchasing power of developing countries islow. Widely available patent rights could increasethe benefits derived from greater public financingof biomedical research for the underdevelopedworld.The high profile of public health emergencies suchas the sub-Saharan Africa AIDS crisis spotlightsthe tension between public health and global IPprotection. Developed nations want their inventionsprotected, but developing countries want widedistribution of the health benefits of drugs andagricultural advances at low or no cost to theircitizens. A sick or suffering working class does littleto put the country on a road to economic prosperity.In 1997, a South African law called the Medicinesand Related Substances Control Act was put inplace to reduce the price of drugs, especially thoseused against AIDS. The law encouraged use ofgeneric drugs and allowed the government topurchase brand-name drugs abroad if it could getthem at a lower price. A consortium of 39 pharmaceuticalcompanies sued to prevent the import ofcheap generic antiretrovirals into South Africa. Themove was a public relations fiasco for the industry,Open AccessAnother important issue regarding scientificresearch is the availability of software fordata analysis. Given that I work with populationhealth issues, part of my job is to analyzelarge data sets. Statistical software—like SAS,SPSS, JMP, etc.—might seem inexpensive forlarge research projects in industrialized countries,but they tend to be quite expensive forscientists in developing countries. Some softwaredevelopers charge for every statisticalmodule and yearly license renewal, and thesepractices make the software very expensive.However, there is a new “movement” ofOpen Access software developers. OpenAccess software is free software developedby a community of scientists, usually spreadall over the world. There is freeware for differenttasks. The package or language called R isthe most widely used Open Access statisticalsoftware in the world, and includes “cuttingedge”routines that very few statistical packageshave. Open Access software appears tobecome a very valuable tool for scientists indeveloping countries that have very limitedmoney resources for purchasing equipment.”Gilbert Brenes Comacho, Costa RicaThe statistical analysis software R, instructions for use, and informationabout working to improve it are available at www.r-project.org.162 excellence everywhere

and the consortium settled the suit in 2001. Shortlythereafter, Brazil and a group of African countries,working with the NGOs, brought the problem ofdrug access to the global stage at a meeting of theworld’s trade ministers in Doha, Qatar.The declarations of the Doha group affirmed members’right to protect public health and to promoteaccess to medicines for all. Most importantly, itclarified the right to use compulsory licensing tomeet public health concerns, stating that “publichealth crises, including those related to HIV/AIDS,tuberculosis, malaria and other epidemics, canrepresent a national emergency.”Though the TRIPS Agreement is designed to levelthe IP playing field and is necessary to spur developmentin developing countries, major challengesremain. They include the cost of providing therapybroadly across the world, the limited capacity ofmost developing countries to make generic drugs,the potential impact on countries such as Braziland India, which may be required to stop their ownmanufacture of inexpensive generic drugs, andthe impact of requiring companies to license theirexisting drugs on those companies’ future investmentsin drugs of benefit to low-income countries.CASE STUDIESEmbryonic stem cellsAn American scientist, James Thomson, wasawarded three patents by the USPTO for his pathbreakingwork with human embryonic stem cells.The patents, which cover cell lines, are unusual fortwo reasons. First, they were issued based onresearch using a morally controversial source ofmaterial—leftover but viable two-day-old humanembryos obtained through in vitro fertilization(IVF) clinics.The second unusual feature is the patent claimsthemselves. Not only do they assert a right tocharge anyone to use the cell lines Thomsoncreated, they also prevent anyone else from usingany human embryonic stem cell lines, made byany method, in any laboratory, anywhere in theUS. These patent claims are among the broadestever granted in the life sciences.Broad Claims:Embryonic Stem Cell Patents“We claim: 1. a purified preparation ofprimate embryonic stem cells which(i) is capable of proliferation in an in vitroculture for over one year,(ii) maintains a karyotype in which all thechromosomes characteristic of the primatespecies are present and not noticeablyaltered through prolonged culture,(iii) maintains the potential to differentiateinto derivatives of endoderm, mesoderm,and ectoderm tissues throughout culture,(iv) will not differentiate when cultured ona fibroblast feeder layer.”Since embryonic stem cells could eventuallylead to treatments or cures for maladies such asheart disease, diabetes, and cancer, the patentshave generated a debate with ethical, social andlegal implications. Because of broad claims andthe aggressive negotiating position the institutewho owns the patents has taken with thosewho want to use the lines, scholars fear that themonopolistic practices could squelch innovationand competition and result in treatments beingdistributed only to those who can afford them. Ifthe keys to use the inventions are given to justa few, there will be little incentive to developcheaper and better products.The controversies have meant a rocky road forboth the patent holder and its exclusive licensees.The European Patent Office (EPO) rejected thepatents on moral grounds. Because they involvethe use of “human embryos for industrial orcommercial purposes,” they consider them animmoral violation of public order. Though thedecision can be appealed, a confirmatory rulingwould mean that no such patents would be issuedby the EPO. Yet a grant of a patent does notautomatically confer rights in EU (European UnionCEU) member states. Each country is free tointerpret the morality clause in its own fashion anddecide whether to issue a patent.intellectual property163

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