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Excellence Everywhere - National University of Ireland, Galway

Excellence Everywhere - National University of Ireland, Galway

Finally, the patents

Finally, the patents have been challenged ontechnical grounds. In 2007, the USPTO ruled thatthe patents failed the non-obviousness requirement.The challenge referenced multiple casesof prior art (the teachings of two patents and fourarticles published prior to the filing of Thomson’sfirst patent in 1996), assuming that a “personhaving ordinary skill in the art” would be able toaccomplish what Thomson and his laboratory did.Both the challengers and the research institutewill battle back and forth for years before the issueis finally resolved. During that time, the patentsremain fully in force.Everybody into the PoolThe development of new drugs, devices and toolscomes at an astonishing price. A Tufts Universitystudy estimates the 2006 cost of bringing a drugto market at $1.2 billion. Those costs are passedon to patients and health care systems. The higherthe development cost, the more difficult it is tobring new biomedical products to underservedmarkets.One of the problems associated with the increasedtime and cost are “patent thickets,” when companiesneed to license many bits and pieces of acomplex chain of technology in order to successfullyimplement their own intellectual property.Nowhere is this more apparent than in vaccinedevelopment, where separate licenses may berequired for specific genes, animal models, bioprocessing,and delivery systems. “Stacking” royaltypayments in this fashion becomes very expensive.One of the mechanisms put forward to deal withpatent thickets is patent pools. A “patent pool”is an agreement between two or more patentowners to license patents to one another or tooutsiders. Most are voluntary, devised when companiesor organizations find their ability to innovatestifled by key technical patents owned by others.Members of the pool share royalties paid by thirdparties. Proponents argue that such arrangementscan help stimulate innovation.In response to the SARS outbreak, the WHOfunded a network of laboratories to develop avaccine. Several of the researchers filed patentapplications on inventions related to the viralgenomic sequence. Further research by largegroup of public and private sector entities led toadditional patent applications. The agency proposeda patent pool strategy that would avoid potentialSARS-related intellectual property conflictsand speed the development of vaccines. If thenegotiations among the parties succeed, the firstpool will be set up in the U.S., followed by otherjurisdictions.Patent pools attempt to speed development bysharing risk and reward, but one intriguing modelabandons the concept of intellectual propertyaltogether. For example, a non-governmentalorganization, the Drugs for Neglected Diseasesinitiative (DNDi), and the French pharmaceuticalcompany Sanofi-Aventis have developed a newanti-malarial therapy—fixed-dose combination(FDC) of artesunate and amodiaquine (AS/AQ),which will be available in Sub-Saharan Africa andelsewhere for less than $1 per dose. Becausethere are no patents, other companies are free tomake cheaper versions of the therapy, also calledgenerics. The patent-free model could becomeone way to treat the world’s neglected diseases.shared resourcesAt the prompting of Icelandic corporation deCODEgenetics, Iceland’s parliament passed the HealthSector Database Act in 1998. It authorized a12-year, exclusive license to deCODE to createa database of the medical records of all Icelandiccitizens. Iceland’s advantage was its small, isolatedpopulation and its fastidious practice of medicalrecord-keeping. The country has kept medical andgenealogical data on all of its citizens for more thana century. The act stated that while the governmenthas access to the database, deCode could use itfor commercial purposes, such as diagnostics ordrug discovery.The Icelandic government has concluded thatgenetic information is a national resource, andthat citizens have no individual rights to it. Othersworried whether the government and deCODEcould be relied on to properly protect geneticinformation. Though confidentiality was promised,improper release of information could have devastatingconsequences, such as denial of healthinsurance or employment discrimination. Grantinga proprietary right to one’s own genetic information,164 excellence everywhere

some said, would help individuals control its use.Others responded that the information belongedto all Icelanders, and as such decisions about itsuse should have come from the community.Another worry concerned the delay of publications.Kari Stephansson, deCODE’s CEO, wrote in theNew England Journal of Medicine, “The primarygoal is to use medical discoveries to develop bettermethods to diagnose, prevent, and cure diseases.Today, this often requires that an intellectualproperty be secured, which may delay publicationof a discovery. The choice between early publicationand the development of a product for thebenefit of patients with a particular disease is, inour minds, an easy one.” The biotech industryargued that without exclusive rights there wouldbe no incentive to invest, and granting individualownership might cause hundreds or thousands ofpeople to demand royalties from companies usingthe data to develop products.The textbook example of genetic property rights isfound in the case of Moore v. Regents of California(the Regents of California is the governing bodyof the University of California at all of its multiplecampuses.) Moore claimed that his property rightshad been violated when inventors did not sharethe commercial gains made from the commercialuse of his cancerous spleen cells. The courtconcluded—as the Icelandic Government did withits citizens—that Moore did not have a validownership claim, and that giving him one wouldhinder biomedical research.What lies ahead for Iceland? Some call for betterbalance between financial incentives and greateraccess to the information, such as compulsorylicensing to certified genetic researchers. Privatesector advocates say that any future financial returnnegotiated on behalf of the country’s 280,000citizens will be vanishingly small. As the debatecontinues, scientists at deCODE have recentlydiscovered genes associated with cancer, sleepdisorders and heart disease.Indigenous KnowledgeA team of Western researchers learns of an herbalremedy used by a remote tribe of Amazon villagers.The group travels to Ecuador, where they workwith local shamans and elders to identify the rightplant cultivars. The herbs are brought back to thelaboratory, where the active ingredient is isolatedand purified. The company receives a patent onthe product and manufactures it to industrial scale,making a blockbuster drug with a billion dollar profit.Some critics say abuse of traditional systems ofIP rights devalues indigenous cultures, reducesbiodiversity and steals the “pharmacy fromthe poor.” Called biopiracy, the practice usesintellectual property to legitimize the ownershipand control of biological resources used bydeveloping countries. The 1992 Rio Convention onBiodiversity (CBD), ratified by 187 countries andthe European Union, recognized that indigenouscultures have long contributed to global wealthgenerated by the commercialization of their nativeplants and animals.Under the rules of the CBD and other internationalguidelines:1. New intellectual policies and laws must involvecommunity participation.2. Access to traditional knowledge and resources(especially genetic resources) may only beobtained by informed consent.3. Communities have the right to share the benefitsof commercialization, and use by others can onlyproceed on the basis of mutually agreeable terms.It hasn’t always worked that way. The textbookcase is neem, a common Indian tree whose seedshave been long used for medicines, cosmeticsand pesticides. Because agricultural products arenot patentable in India, a foreign company patenteda neem extract and began manufacturing a pesticidein India in the late 1980s. The company’s demandfor seeds drove the price beyond the reach ofordinary Indians, including farmers who enjoyedfree access to stocks. Thus there were social,economic and ethical factors driving an EPO actionin 2000, which revoked the patent based on lackof novelty, inventive step and theft of prior art.The neem case has been characterized as plunderby many, but others say nothing prevented Indiancompanies from manufacturing the pesticide andexporting it, and there was little evidence that thetransnational conglomerate had asserted its rightsin India to prevent local companies from competing.intellectual property165

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