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Should human genes be patented? Baird, Patricia A. Feb 28, 1997

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Should Human Genes Be Patented?Patricia A. BairdHPRU1997:15D February, 1997SHOULD HUMAN GENES BE PATENTED?Patricia A. BairdCentre for Health Services and Policy ResearchDiscussion PaperFebruary 1997.'The Centre for Health Services and Policy Research was established by the Board ofGovernors of the University of British Columbia in December 1990. It was officiallyopened in July 1991. The Centre's primary objective is to co-ordinate, facilitate, andundertake multidisciplinary research in the areas of health policy, health servicesresearch, population health, and health human resources. It brings together researchers ina variety of disciplines who are committed to a multidisciplinary approach to research,and to promoting wide dissemination and discussion of research results, in these areas.The Centre aims to contribute to the improvement of population health by beingresponsive to the research needs of those responsible for health policy. To this end, itprovides a research resource for graduate students; develops and facilitates access tohealth and health care databases; sponsors seminars, workshops, conferences and policyconsultations; and distributes Discussion Papers, Research Reports and publicationreprints resulting from the research programs of Centre faculty.The Centre's Health Policy Research Unit Discussion Paper series provides a vehicle forthe circulation of (pre-publication) work of Centre faculty, staff and associates. It isintended to promote discussion and to elicit comments and suggestions that might beincorporated within revised versions of these papers. The analyses and interpretations,and any errors in the papers, are those of the listed authors. The Centre does not reviewor edit the papers before they are released.A complete list of available Health Policy Research Unit Discussion Papers and Reprints,along with an address to which requests for copies should be sent, appears at the back ofeach paper.4 I1Should Human Genes be Patented?1. What are patents?Without major investment of money, time, and skills in research and innovation overthe last several centuries, many technologies and products that enhance our safety, comfort,and quality of life would not exist. Patents were developed to find a way of encouraging thesizeable investment of resources into research and development that is needed if society is tobe able to have such benefits.A patent is a monopoly right, granted for a specific time period to an inventor, inreturn for the publication to the world at large of the details of the invention. The monopolyis the exclusive right to use the invention, and the patent holder can prevent anyone else frommaking, using or selling the patented invention without his permission. As well, he has theright to license others to use it, usually in return for money (a royalty). A patent holdertherefore receives some expectation of profit in return for describing and disclosing theinvention so that other people could duplicate it. The period of market monopoly meansinventors and companies are likely to develop useful products if they are well protected bypatents. On expiry of the patent, it becomes part of the public storehouse of knowledge andthus society benefits in that way as well. In essence, the basic principles of patent law achievea compromise between the broader social desirability of increasing useful technologydevelopments, and the social undesirability of ongoing market monopolies for criticalprocesses or products.[1] The compromise is a way of securing future benefits for thecommon good. The patent monopoly is "property" that is State-created for public purposes,and absent these, there is no justification for a patent system. A very extensive body of lawhas grown up around patenting - in Europe over the last five centuries, in North America overthe last two.With regard to the field of genetics, research into identification of particular DNAsequences and elucidation of their function involves the application of much expertise andwork, and this costs large amounts of money. Some researchers and some of the funders of..2the research want to protect the fruits of their labour - in fact, they would not undertake itunless they judged that they would make a profit from the development and sale of processesor products resulting from the research. There is enormous potential commercial applicationto knowledge gained about human genes, for example the market for DNA diagnostics aloneis conservatively anticipated to exceed one billion dollars by 1998.[2] Private funding fromindustry provides a large proportion of funding for research and development in this field.2. General background on patent lawIn general there are several criteria to be met for patentability. These are that thesubject of the patent must be novel, useful, and non-obvious, and not be simply the discoveryof a pre-existing naturally occurring phenomenon. These criteria were designed at a timewhen some of the issues raised by modem technology were unknown and did not have to betaken into consideration. The above criteria, laid out originally in patent law, were relativelyeasy to interpret in the context of the development of new chemical compounds andpharmaceuticals, and an extensive body of case law already existed when the recombinantDNA era arrived.Some inventions are excluded from patent protection for reasons related to publicpolicy, or to moral concerns. For example, innovative medical treatment performed on thehuman body cannot be patented in many countries. There are public policy reasons for thiswhich include a need for unimpeded access to medical procedures and surgeries, theavoidance of conflict of interest for physicians, and impartial evaluation of the safety andeffectiveness of the treatments. On the other hand, innovative diagnostic tests and medicaldevices used in medical treatments can be patented. Why there is a difference is not entirelyclear, but it is probably partly related to the size of investment needed to develop these. Thisdistinction seems to have worked in practice.There are some limits on a patent holders rights. For example, a patent is notinfringed if the subject matter of a patent is used for purely non-commercial, experimental oreducational purposes.[3] Freedom to use patented inventions as the starting point for further3exploration is important because such follow-up research is likely to be productive. In thepast the liability for infringing patents attached to commercial activities (but not to academicor pure research studies) was not difficult to define as academia and industry boundaries wereclear. However, this has changed with boundaries between university and industry activitiesover the last decade becoming unclear - the dividing line in the field of new genetics between"academic" and "commercial" has blurred. There is a plethora of industry/universitypartnerships, and many academics have ownership or interests in small venture biotechnologycompanies. It is unclear currently as to whether, and in what circumstances exactly, patentson DNA would be infringed by later research projects using that sequence, and it has notbeen clarified in the courts. The pharmaceutical industry asserts the lack of clarity regardingthe limits of this exception and lack of clear patent protection are an undesirable fetter onresearch.There are additional ways that patent rights may be limited, for example compulsorylicensing. Patent holders may exploit their patents themselves or may licence someone else toexploit them, but if they do neither, the government may override the patent holder and granta licence, in order to ensure the invention is developed and used.A patent only protects in the nation in which it is issued - inventors have to patent inmany countries if they wish protection in them all. IT producing it domestically would haveinfringed a domestic patent, most nations do not allow a product to be imported . It isimportant for companies to patent in those countries that represent the major markets for theirproduct. Because of the patent holder's monopoly, prices will initially be higher for newtherapeutic agents, but it is projected that on expiry of the patent, competition will cause theprice to fall, and that in developed nations (because there is competition) there will be netbenefits. In developing countries because there are few biotechnology firms and littlecompetition, this sequence does not hold. To allow patent monopolies in such countries - forexample in the case of an effective therapeutic or preventive agent for a serious disease - hasadverse affects on people who are poor. Industrialized nations have been pressing developingones to strengthen patent protection regimes and "harmonize". The protagonists of patentingin biotechnology are to a large extent multinational corporations such as Hoechst, Bayer,Ciba-Geigy.[4] It may not in fact be in the best interest of third world nations to harmonize.Harmonizing patent regimes across the world, without regard to the various stages oftechnological development of countries' industrial and pharmaceutical sectors may be unfair.There are numerous unclear or inconsistent points in patent laws. For example, theEuropean Patent Convention prohibits patents for "plant and animal varieties", yet geneticallyaltered plants and animals have been and can be patented in Europe as well as in the UnitedStates. "Animal variety" has been interpreted, therefore, as not necessarily referring togenetically altered animals. In fact, the United States Supreme Court has interpreted aspotentially patentable "anything under the sun that is made by man", including geneticallyaltered living organisms.[5]Bacteria and chemical substances that exist in nature only in an impure state may alsobe patented if they are newly isolated and purified. They are then viewed not as a discoveryof something already existing, but as a patentable invention - the "newness" criterion is met.Patents have been issued on proteins and on DNA sequences from the human genome thathave been purified and isolated, so that there now exists a substantial body of case law thatholds that one may patent newly isolated or purified forms of products that exist in natureonly in an impure state. DNA sequences that code for useful proteins (for example interferon,relaxins, insulin) or that can be used as probes to detect genetic susceptibility to disease (forexample diabetes) have been patented since these meet the "usefulness" criterion.[6]As genetic technologies and society have evolved, it is no longer clear how the lawshould be interpreted and it is in a state of flux.[7] The very idea of patenting has becomeless clear, as various ''hybrid'' forms of intellectual property rights have evolved to meet theissues raised by new technology. The basic principles of patent law, designed two centuriesago, did not have to take into consideration some of the issues raised by modem technology.Simply continuing to apply legal statutes and principles that were evolved in an era beforeidentification and manipulation of the human genome was possible is not necessarily4appropriate.3. General background on genesThe human genome is the total of genetic infozmation contained in each cell of thebody in the form of deoxyribonucleic acid (DNA). Along the length of the DNA are specialregions, called genes, that are functionally distinct because they code for instructions for themanufacture of proteins that build and organize everything in the cell. It is estimated that thehuman genome contains about 70tOOO genes, and these in total make up just a fraction (5%)of the total length of human DNA.[8] Efforts have been going on for several years to locateand decode all the infozmation in the human genome.[9, 10]From a practical viewpoint the question as to whether the totality of the humangenome, as such, is patentable is speculative and not likely to arlse.[ll] The human genome,that is, the total of genetic infozmation for the human individual, would not be the subjectmatter of a patent application because there is no technical use, even no potential technicaluse, for the whole of the genome. If there were such a patent application, it would not beacceptable because it probably would not refer to a technical, useful invention. Such aproposal is likely therefore to be considered as a discovery, and it probably would also bechallenged on moral grounds. The relevant issue is whether parts of the genome, particularlygenes or DNA sequences, are patentable (or rather should be patentable, since they clearlycurrently are), and if they should be patentable, under what criteria and conditions.Genes are made up of at least two components - a coding region> consisting ofsequences which code for a specific protein - and a regulatory region - consisting ofsequences which code for making or "expressing" the corresponding protein. The codingregions of genes found in the DNA in the cell (genomic DNA) also contain further sequences("introns") whose function is so far unknown. The isolation of the protein encoding portionsof the genes without the introns (cDNAs) can now be carried out. Using these cDNAs orfragments of them, genes in the human genome may be located and identified, and eventuallyby further study, the proteins they produce and their function may be elucidated. Genes56coding for products with a potential to be used as therapeutic agents are of prime interest toindustrial funders of genetic research. Producing these proteins industrially in quantities forsale as therapeutic or diagnostic agents requires using methods of genetic engineering. Onefeature of such processes is that copies of the corresponding human genes, or at least copiesof the protein encoding portion of the genes, with or without introns, must be used.4. Ap.proach of patent offices to dateWhen the field first opened up, initial patent applications contained claims toparticular human genes or DNA sequences used as means for "expressing" or producing in ahost certain useful products such as interferons, or insulin. In these cases the relevant genehad been identified as encoding a certain useful protein, and the invention in the applicationrelated to the technical use of this finding. As Dr. Christian Gugerell, Director of theEuropean Patent Office (EPO) has said, the practice with regard to this category of patentapplication is to allow claims to human genes or DNA sequences in the genomic form or inthe form of cDNA because they are an integral part of the overall invention yielding usefulproducts.[12] All of the forms of DNA - cDNA, genomic DNA and complete genes - aresuitable for obtaining the desired proteins using conventional methods of recombinant genetechnology.Dr. Gugerell has stated that the EPO never considered it necessary in the past to applyethical considerations with regard to claims for human genes or DNA sequences of the abovetype. The prime reason for this is that the effect of a patent on human genes or DNAsequences is restricted to the exclusion of others from using the genes or DNA sequences inan industrial process. He, and many others, feel that the common heritage of human kind, orthe personality of human beings, is unaffected by such a patent. They do not think it wouldinterfere with the dignity of the human being, as the patent does not apply to genes as theyexist in people. Quite to the contrary, he argues that it would be immoral to prohibit patentprotection on human genes or DNA sequences because there would be less incentive todevelop valuable therapeutic agents which may be made available only with methods ofgenetic engineering.7To the argument that human genes should not be eligible to be patented because theyare simply a discovery of something already occurring in nature, the response of patentoffices in most countries has been that if a substance found in nature has first to be isolatedfrom its surroundings and be purified, it is "new" in the sense of having no previouslyrecognized existence. The "new" substance may therefore be patentable provided a use for ithas been found. Clearly this approach is conditioned by patent offices having dealt over manyyears with other biochemical substances. In short, EPO has consistently held the position thatthe usual requirements of patentability apply to inventions derived from living matter in thesame way as to non-living matter. In most nations, including the U.S., human DNA andprocesses to manipulate it have been dealt with to date as coming under traditional patentlaw, and many genes such as the breast cancer gene BRCAl, genes for relaxins, and forinterferons have been patented.However, questions surrounding the patenting of human genes or DNA sequencesbecame a widely publicized and high profile public issue when the National Institutes ofHealth in the United States (Inventor: Craig Venter) filed a patent application in the U.S.A.and in Europe in 1991 for more than 2,000 human gene segments.[13] The patent applicationwas made even though the function of the corresponding genes was not known and thereforewithout knowing a specific technical use for them.[14] The Medical Research Centre inEngland followed suit and filed a similar application. This type of patent application onhuman genes was a new one, which raised many problems and caused a furore in thescientific and then broader community. The patents were for short segments of cDNA, usuallybetween 150 and 400 base pairs long, which are termed "expressed sequence tags" (ESTs).The sequencing of the cDNA is done by using conventional automated sequencing techniques.and these DNA segments can be used to locate genes. The patent applications that were filedwere silent on specific uses of the ESTs (or the corresponding genes) because they wereunknown at the time of filing. What was disclosed were hypothetical uses - for obtaining thecorresponding genes. the proteins encoded thereby and even antibodies against these proteins.There was an immediate and strong response with the academic scientific research8community in general sharply criticizing these patent activities. The Human GenomeOrganization (HUGO) made a public statement that offering patent rights to those who simplyhave DNA sequence data - whether for gene fragments as Venter had or for whole genes, wasinappropriate.[IS] They stated that determining the function for a DNA sequence is a complexand challenging matter which requires ingenuity and biological experimentation. It was moreappropriate that patents should be reserved for those who also elucidated the biologicalfunction or an application such as a diagnostic or therapeutic use for a sequence. The HUGOposition was that giving patents for sequence alone would close off innovative disease genediscoveries leading to improved diagnostics and therapeutics, because no one would invest indiscovering the function of a gene and potential useful products if the sequence was alreadypatented. They called for the patent office to ensure this does not happen.Others likened allowing patents on gene fragments alone to staking claims on parcelsof land that are unworked - which is prohibited.[16] They felt that if it were to be allowed, itwould pervert the fundamental purpose of the patent system - to encourage development ­because it would lead to rampant patenting - to a biological gold rush where there are patentclaims on the cDNA form of virtually every gene in the human genome. Others stated that"Granting patents for genes or gene fragments based on their unknown future potential wouldhave a destructive impact on the incentives for the industry..." [17] They said that scientistsand financiers would not invest years of work and hundreds of millions of dollars to identifya pathway and protein that is related to a disease, if the gene or fragment coding for it hasbeen locked up by a speculative patent.The U.S. Patent Office eventually denied the patent claim for several reasons includinglack of utility, and the NllI dropped the issue of patenting ESTs by not appealing the ruling.How the European and U.S. patent offices will continue to deal with such applications is notyet known [18]. However, an important consequence of the furore about these applicationswhich will be discussed later, is that they brought the whole topic of patenting human genesto public attention, and they had the effect of mobilizing and crystallizing opposition topatenting from many concerned groups and individuals.9In essence, the situation to date is that patents are routinely granted over human DNAand related processes in most countries. Patent offices in the United States and in Europeclearly view DNA sequences as patentable subject matters like any other complex chemicalsubstance. The EPO has rejected views that patenting human genes is unacceptable and hasfollowed traditional patent law principles, applying them in the new field. Patentability isdetermined by examiners, who apply criteria established in the past to deal with non-livinginventions and chemical processes, on a case by case basis. On the other hand, the Council ofEurope and the European Parliament, influenced by the crystallization of opposition andpublic focus on the debate, have given more consideration to the unique ethical and moralissues surrounding the patenting of DNA. It was in this context of public concern that afterseven years of amendments and discussions, a proposed directive on the patentability ofhuman DNA (following the patent office approach) was defeated in early 1995 by theEuropean Parliament [19] Endnote #1. Another directive was brought forward at the end of1995 [20] but until and if it comes into effect, the current European Patent Office Policieswhich allow patenting of human genes, remain in place.5. Growing OQposition to patenting human DNAIn spite of the established practice of patent offices, and a growing body of case lawapproving it, there are many who object on public policy, ethical or moral grounds topatenting human DNA. Most of the calls for a moratorium on patenting genes and animals donot contest patenting the processes by which DNA is manipulated and studied. They also donot contest patenting the resultant pharmaceuticals or therapeutic agents obtained throughDNA research. They do, however, object to patenting human gene sequences. Many feel thatknowledge about human genes should belong to all human kind, not just to private industrialfirms for a period of time. An analogy is seen here with a private takeover of public parksand wilderness - in the same way, the genetic commons are seen to be being privatelyappropriated. Adding weight to this argument is that much of the groundwork of research andknowledge about DNA has been funded by tax-supported research bodies and medicalcharities.10Corporations and researchers could fight for patent ownership of commerciallyvaluable genes held to be the key to health or intelligence or aging.[21] If the 70,000 genes ofhumans were patented, it would put enormous economic and social power into the hands of afew major international biotechnological companies who would be likely to be the holders ofsuch patents. No gene could be worked on to develop further useful applications withoutpaying royalties to the relevant gene patent holder. As one witness at the hearing of the U.S.Senate Committee on the Ethical Issues of Gene Patenting observed "If we start patentingcells and genes, we take the common heritage of all of us and we allow it to be corporatelyenclosed".[22]Research into serious diseases has taken place in the past without patenting animalsor human genes. Is it the case that we will not make appropriate further advances in geneticstudies unless we allow commercial companies to patent the genome? The British MedicalAssociation does not think so.[23] Their position is that the interests of patients and thepublic would be best served if research on human genes is pursued either in publicly fundedlabs or with private funding that is charitable in nature, not commercial market oriented. Infact, there is little empiric information on the rate of development of new therapies, and thetotal cost of developing these therapies under a privately owned patenting regime compared toa publicly financed open regime.[24] Information on the relative costs and social benefits ofthe two different approaches to developing useful knowledge about human genes would bevery helpful. Some economists have even proposed that different segments of the humangenome should be treated in these two ways so that comparative information could beobtained which could be used to inform public policy.[2S] Endnote #3Even though the patenting system was put in place to encourage innovation and newinventions, paradoxically the actual operation of the system may slow down discovery in afast moving field. This is because any scientist who discloses by publishing findings in ajournal before filing, forfeits patent protection in most of the world (with the notableexception of the U.S.). Continued progress in deciphering the human genome will depend onprompt access to new discoveries. There is a danger that researchers applying for patent rights11will defer publication of their findings and slow down dissemination of new knowledge.Another potential impediment to rapid dissemination of new discoveries is that a patent holderof DNA sequences might want to keep the sequence to himself in order to have an advantageover competitors in finding corresponding gene products and functions.[26] It should berecognized that industrial competitiveness may lead to secrecy even without patenting.[27] Ifthere were no patent system, it is likely businesses would protect their technology by secrecy- "trade secrets". Even though the existence of patenting may slow information exchangebecause the work will not be published until after the patent application has been made, newinformation will nevertheless be made public.6. Two categories of op,positionOpposition to patenting human DNA can be categorized as coming from two mainpositions or perspectives - one a world view about living things, the other a distributionalperspective. The first opposes any patenting of life - including other organisms, not justhumans. The grounds for this may be religious or may come out of a given culture's worldview. Patenting genes is seen as transforming them into a commodity, and this is viewed asbeing against respect for life.From the second, distributional perspective, patenting is opposed because it is likely toconcentrate power and wealth in large corporations; because the people from whom geneticmaterial is taken do not receive any benefit from patenting; and because North/Southinequalities will be increased.[28] People everywhere have a similar range of genes but someparticular mutations may be easiest to identify and study in certain third world populations.For instance, genetically isolated and inbred groups may have a rare mutation that isimportant in providing insight into gene function and disease pathophysiology. Thisknowledge may be applicable to a common disorder with a potentially large world market.Patents on DNA derived from indigenous people have already been applied for and it ispossible that they may be granted. The people (and the communities) from whom the DNAcame stand to gain nothing from these patents, and they are sensitized to this because of pasthistory.12In the past large corporations have collected genetic material from indigenouspopulations and the Third World. These have been used to develop and patent agricultural andpharmaceutical products without benefits accruing to the original donors. For example, morethan 90% of all the plant germ plasm collected in the South in the last two decades has endedup in gene banks in Europe and North America.[29] Products worth billions of dollars in theindustrialized world have resulted. A specific example is the Neem plant, which has beenused by people in Asia and Africa for centuries as medicine and pesticide. This has beenexploited by one u.S. corporation which now has U.S. patents for bioprocessing of neem forinsecticides. These patents built on the knowledge of generations of indigenous people. Thesekinds of "appropriation" are considered unjust by many in Third World countries. Generationsof farmers who had helped identify, select and cultivate the plants got no financial benefit.The same has been true of some pharmaceutical compounds.There is concern the same thing will happen with human genetic material. A particulargroup of indigenous people may give access to their genetic material to a biotechnologycompany which then makes a rare gene's product by genetic engineering. People in thatregion would object when they are expected to buy back the therapeutic agent made possiblebecause they had freely given access to their genetic samples. Companies respond that theyface great costs - they had to identify, clone and sequence the natural gene and had tocommercially develop its product. There is a call for ways be found to allow people in theThird World to be participants in the development of products rather than simply beingsources of genetic material. The UNESCO International Bioethics Committee Working Groupon Human Population Genetics research recommended that mechanisms should be worked outso that indigenous populations giving genetic samples would benefit if patentable products aredeveloped from them.[30] Some have pointed out that developing such mechanisms may havean undesired effect. It could have the consequence of incorporating indigenous peoples into aworld view that includes perceiving living organisms as commodities which can be patented,owned and sold. This world view is common in a global economy dominated by competitionfor markets, and the need for patents on human DNA comes out of this perspective. Yet analternate view and value system is expressed when no remuneration is asked in return for13freely given genetic samples or plant germ plasm. The patent system is in marked contrast toa value system where people see themselves as part of nature and have cooperative ratherthan competitive ways of innovation.Having to pay royalties to use gene sequences would severely limit the possibilities forscientists from poor countries to develop and apply research findings from the North, andfurther widen the gap between North and South. Scientists in Third World countries would beless likely to develop scientific strategies in the field of diagnosis and therapy based onpatented gene sequences. The core of the problem for third world countries is not thatindigenous people would be a source of patentable genes for industrialized countries, but thateconomic consequences of patenting human genes will further exacerbate the north-south gapand may further impede access to medical care products in general in the Third World.[3!]Patenting of genes and development of saleable products by industrial and pharmaceuticalcompanies is likely to lead to large profits in the long term. This will affect how money andpower are distributed both within and between countries, and is a legitimate concern. In fact aproblem for all countries is whether allowing appropriation of human genes by privateinterests will in fact result in securing future benefits for the common good. The distributiveeffects of patent policies - who gains and who loses - are important, but not often discussed.They can be expected to have the effect of redistributing wealth within a society - withbiotechnology companies and their shareholders in particular benefitting. Multinationals haveenormous financial resources and widely distributed and powerful marketing capacities.Another aspect to be considered is whether the marketing strategies of such companies willhave a steering effect on how genetic knowledge is applied so that if the commercial sector isallowed to act unimpeded by regulation then the development and application of genetictechnology may not be in the broad public interest.Practical applications have always been a valued outcome of science, but manyobservers think that science and research in the human genome field are moving toward aworrying aim - financial gain, rather than pursuit of knowledge. Currently in human genomeresearch, there seems to be a very strong focus on the patentability of results and potential14profits. New sources of research funding have come with the increasing involvement of for­profit biotechnology companies in medical research. With this involvement has come a shiftto the operational rules of business rather than science. Keeping new information secret toprotect future patent rights or to prevent competitors obtaining it may be seen as necessaryand justified in order to protect stockholders in the biotechnology company.[32] However, thissecrecy is directly opposed to the goals of medical research, which is to prevent sufferingfrom disease. These opposing tensions need to be addressed. Legislation needs to bedesigned that protects intellectual property rights but also allows free exchange of informationand materials.Objections arising from the two perspectives described above (religious/world view;distributional) are often mixed together in the debate and not separated. It would lead toclearer analysis of the issues at stake, and therefore of what needs to be done, if they are keptseparate. Commentators have tended to focus on the abstract notion of ''human dignity", butthis is interpreted in different ways by different people. Whether allowing patenting ofparticular specific gene sequences will, per se, affect human dignity is perhaps less apparentthan the economic, and particularly distributional, implications. It is important not to losefocus on the opportunity to avoid real distributional harms.The debate is escalating and continues to gain momentum - for example, aninternational campaign to oppose the patenting of genes involved in susceptibility to breastcancer was launched in 1996 by a group led by Jeremy Rifkin and supported by manyprominent feminists such as Betty Friedan, Gloria Steinem and Bella Abzug. They arechallenging a patent application by Myriad Genetics on the BRCAI gene and itsmutations.[33]7. ConclusionsPotential patenting of human genes has led to massive legal and moral dilemmas, andall the consequences have yet to be thought through. Whatever one's view of the ethicalissues surrounding gene patenting, it is clear they are complex and far reaching in nature.15There is a need to meet legitimate public concern about patenting human DNA while at thesame time there is need to do so in a way that does not inhibit innovation by discouragingeconomic investment. A patent issuing office is not the appropriate venue for decision-makingabout the ownership of human genes. A patent office clearly is not the right institution todecide fundamental ethical questions and patent law is not the ground on which to arbitrateand explore complex ethical and social questions. Advances in patent law lag behinddevelopments in science, and new medical and industrial genetic technologies have emergedbefore the basic issues and consequences related to patenting them are clearly framed. To datedecisions have simply been based on older court decisions developed in the past to deal withadvances in organic and pharmaceutical chemistry.[34] This set of legal precedents is notnecessarily appropriate for dealing with human genes with their unique properties. In Europe,although there is a morality exclusion, there are no clear criteria or policy guidelines as towhen an invention is immoral. This morality requirement was rarely invoked and receivedlittle attention until recent years when it has become prominent in the context of patentsrelating to human parts, transgenic animals, and human genes.There is concern that patenting human gene sequences is unethical as it would limitpublic access to our universal heritage by privatizing decisions about how to use human genesequences. There is validity to the concerns that the distribution of benefits from patentingmay be concentrated in large first world corporations, and that developing countries will notbe able to participate in biotechnological advances. Finding policies that ensure a balancebetween personal protection of individuals, private industrial interests, and the general publicinterest is not going to be easy. Can these differing interests be reconciled? Are we yet at astage where conclusions can be drawn and recommendations made? The issues are complex,and while there needs to be some protection of commercial investment in research anddevelopment, exactly how best to structure that without other undesirable consequences is notyet clear. Whether the patent regime could be shaped in a way that promotes research oftherapeutic or diagnostic benefit while avoiding the problems is not immediately apparent.Patenting or intellect property regimes are no longer simple or clear cut legal16categories. Governments can create hybrid regimes and many different kinds of intellectualproperty protection may be possible.[35] For example, governments can put in placeadditional conditions modifying the rights of the patent holder in order to protect the publicinterest.[Endnote #2] It is difficult to assess the appropriateness and adaptability of existinglegal regimes to deal with issues raised by a rapidly moving field of knowledge, especiallyone fraught with moral issues. The possible regimes are many. Technical legal expertise isneeded in evaluating what patent legislation related to the human genome could do, and howit could be drafted. But before drafting, there needs to be public discussion and a democraticprocess to decide what the goals of any legislation or policy will be. Currently, policydecisions that are irreversible, or at least very expensive to reverse, are being taken by bodiesunaccountable to the public.The debate about patenting human genes is likely to continue to intensify. There ismomentum from the struggle for industrial competitiveness, and from philosophical and moralobjections to some implications of genetic research.[36] The issue of patenting human geneshas become a lightning rod for many concerns people have about genetics, but the social andethical implications of applying genetic knowledge to people will not be resolved simply bybanning patents on human genes. Banning such patents will not absolve us of the need toensure genetic testing and identification is not used in exploitive or discriminatory ways, andbanning gene patents will not decide how future abilities to alter genes in humans should beused. Patent policy must operate within a larger regulatory system that deals with issues ofcommodification of people, conflicts of interest, exploitation of people, and ethical review ofresearch. If there are areas of research using human genes or some areas of application thatshould not be developed, appropriate legislation, not patent laws, are indicated.Part of the context to the resolution of some issues is that the legal status of humanDNA and DNA information is yet to be determined. Yet the legal categorization is importantbecause it dictates which area of law applies to the use or transfer of genetic material andinformation.[37, 38] If genes are viewed as an extension of the person, then the law ofpersons applies, but if they fit into the category of a person's property, property (and patent)17law would be relevant. Until recent years the law has had to deal either with persons or withproperty. The advent of new technologies in the life sciences is giving rise to entities thatcannot appropriately be viewed as fitting into either of these dichotomous categories. Entitiessuch as human eggs, embryos, and genes could not exist outside a human person until the lasttwenty years. Technology is forcing us to evaluate whether some other legally recognizedcategory is needed. There is a growing trend to characterize human tissue and body parts(including eggs and sperm) as unique, or "sui generis". This is because there are importantpolicy reasons for assigning them to a new category. Doing so allows the law relating to themto be tailored in a manner more appropriate to their unique character. Since the law relatingboth to property, and to persons has deficiencies with regard to DNA and to an individual'sDNA information, categorizing these too as "sui generis" might permit a variety of legalapproaches to safeguard privacy, respect human dignity, yet allow a flow of geneticinformation needed for scientific research.Some commentators think it unlikely that it will be found immoral to patent humanDNA sequences.[39] A main reason for this is that it is hard to equate giving ownership of apatent on a specific DNA sequence with ownership of a person. Selling a body into slavery isexploitive and violates respect for human dignity because our personal identity is so closelytied to our bodies. Giving rights to exclusive use and development of a specific DNA segmentto a particular laboratory or company is not as likely to be viewed as directly affecting theperson. However the locus of the decision making about whether human genes shouldcontinue to be patented - whether it is made in patent offices, in courts, or in parliaments - islikely to affect the outcome.Some components to a solution on how patenting should relate to human genes havebeen suggested.[40] One of these components is harmonization of patent law protectionsinternationally. In recent years there has been some harmonization of patent laws withinEurope, but European law continues to have important differences from patent law in NorthAmerica and Japan. For example, patent law has a "first to file" system in Europe but a "firstto invent" in the United States. The disparity leads to problems. Numerous treaties and18international agreements have been reached which partially address the need forharmonization, but as alluded to previously this is not a simple matter - the effects ofharmonization may be different for industrialized nations than for third world nations. Othercomponents of a solution would be to evaluate the probable effects of internationalimplementation of agreements regarding patent law; and to make clear the criteria andcircumstances under which use of patented inventions by non patent holders for educational,non-eommercial or experimental purposes is permitted. Many observers judge it defensible toallow patenting of a gene or a cDNA if its function is known and it has an application tosome practical end.[41] However most commentators think that simply identifying genes orpartial gene sequences whose medical or industrial applications are unknown should not bepatentable.But these components alone are not sufficient to address the problem. The scope andapplication of the immorality exclusion should be determined, and not by patent offices. InEurope several suggestions have been made for doing this. A report of the Nuffield Councilon bioethics has suggested the possibility of either using a Europe wide ethics committee aspart of the patent application process, or alternatively, which they favour more, developingand formally adopting a protocol setting out criteria to be used when applying the immoralityexclusion to patents related to human DNA.[42] However, these are not bodies which arepolitically responsible to citizens for their decisions. Although patent offices and manyscientists think they should be able to patent genes, the human genome is not regarded by thepublic as the sum of chemical substances to be patented.In summary, the opposing views - for patenting human genes and against - wereepitomized by an exchange at a Council of Europe Bioethics symposium which can beparaphrased as follows. Dr. J. Elizalde, speaking for patenting, judged that the patent systemrepresents a pragmatic balance; it recognizes the market society in which we live, and thereality that research from which humanity has benefitted, especially in the medical sector, hasan important private profit-driven component. Limited ownership by patent for 17 years ofDNA segments which may lead to benefit, not just for the patent holder but for others, should19be permitted. Dr. Stefano Rodoto in response, on the other hand, said that there are someaspects of patent law that up to now have been accepted which need to be re-thought andreconsidered in the light of what we now know and can do in genetics. We have to avoidprotecting value-added invention to such a degree that it becomes an appropriation, aprivatisation of something which should be accessible to everyone.[43]There does not seem to be a mechanism within the legal system for the broaderethical, social and distributional implications of patenting human genes to be properlyaddressed and responded to, yet there is a need for realistic and balanced policy and law inthis area. It is important that the broad questions be addressed, and in the context of theanswers, patent law and policies applying to human genes be put in place. The issues arecomplex and difficult, and it is important to avoid simplistic positions. We need to seeklegislative and regulatory approaches that safeguard privacy and respect human dignity, yetallow enough intellectual property protection so that innovative research is not discouraged, tothe detriment of future human well being. It is not yet known if it is in the long-term publicinterest to allow human gene sequences to be patented. What policy should be pursued whenit isn't known? Should we continue to give away what we cannot get back? In essence, beforeit is clear what directions to proceed in, further analysis and evaluation of evidence needs tobe done. It would be desirable for publicly elected bodies - such as the U.S. Congress and theEuropean Parliament - to study and further debate the issues so that they can be clarified anddecided in a democratic fashion. How in detail it is best to proceed is not yet clear, butgovernments and the international community have a responsibility to address this area. Thebroader public debate and growing public concerns have not changed the relevant patent lawor its day to day interpretation. The issues are not going to go away, and there is a need todeal with them now - the human genome will be completely sequenced within the next sevenor eight years. Simply avoiding these issues is a policy, in that the current interpretation ofpatent laws, developed to deal with inert matter, will continue to be applied.20Acknowledgements: I would like to thank members of the Population Health Program of theCanadian Institute for Advanced Research and members of my department for helpfulcomments on this paper.21References1. CAULFIELD, T., CHERNIAWSKY, K and NELSON, E. Patent Law and HumanDNA: Current Practice in Legal Rights and Human Genetic Material. Ed. RM.Knoppers, T. Caulfield and T.D. Kinsella. Emond Montgomery Publications Limited.1996.2. Sll..VERMAN, P.H. Commerce and Genetic Diagnostics. Hastings Center Report.Special Supplement, May/June 1995.3. EISENBERG, R.S. Patent Rights in the Human Genome Project. Chapter 14 in GeneMapping: Using Law and Ethics as Guides. Eds. G.J. Annas and S. Elias. OxfordUniversity Press, New York. 1992.4. SAHAI, S. The Patenting of Genes and Living Organisms: The South's View inPatenting of Human Genes and Living Organisms. Eds. F. Vogel and R Grunwald.Springer, Berlin. 1994.5. DIAMOND v. CHAKRABARTY. 447 U.S. 303 (1980) U.S. Supreme Court decision.6. Ethics and Human Genetics. Proceedings of the 2nd Symposium of the Council ofEurope on Bioethics. Strasbourg, 1993. Council of Europe Press, 1994.7. GALLOUX, J-C. The Patentability of the Human Genome - European Approaches.Plenary Session #6. First International Conference on DNA Sampling. Human GeneticResearch: Ethical, Legal and Policy Aspects. Montreal. September 1996.8. VOGEL, F. and MOTULSKY, A.G. Genetics. Problems and Approaches. Third Ed.p.84. Springer-Verlag, Berlin. 1997.9. McKUSICK, V. Mapping and Sequencing the Human Genome. NElM. Vol. 320:913­14, 1989.10. CUTTER, M.A.G., DREXLER, E., McCULLOUGH, L.R, McINERNEY, J.D.,MURRAY J.C., ROSSITER, R and ZOLA, J. Mapping and Sequencing the HumanGenome: Science, Ethics, and Public Policy. BSCS and the American MedicalAssociation, 1992.11. GUGERELL C. Ethics and Human Genetics. Proceedings of the 2nd Symposium of theCouncil of Europe on Bioethics. Strasbourg, 1993. p. 104. Council of Europe Press,221994.12. GUGERALL, C. Ethics and Human Genetics. Proceedings. 2nd Symposium of theCouncil of Europe on Bioethics. Strasbourg, 1993. p. 105. Council of Europe Press,1994.13. HEALY, B. Special report on Gene Patenting. NElM. Vol.327:664-668. 1992.14. KILEY, T.D. Patents on Random Complementary DNA Fragments? Science. Vol.257:915-918, 199215. CASKEY, C.T, EISENBERG, R.S., LANDER, E.S. and STRAUS, J. HUGO statementon patenting of DNA. Genome Digest. p.6-9, April 1995.16. KEVLES, D.J. and HOOD, L. Reflections. Code of Codes. Scientific and Social Issuesin the Human Genome Project. ed. D.J. Kevles and L. Hood. Chapter 14, p.314, 1992.17. CASKEY, C.T. and WILLIAMSON, A.R. Merck, SmithKline and Patents. Nature.Vol. 381:360, 1996.18. CAULFIELD, T., CHERNIAWSKY, K. and NELSON, E. Patent Law and HumanDNA: Current Practice in Legal Rights and Human Genetic Material. Ed. B.M.Knoppers, T. Caulfield and T.D. Kinsella. p. 134 Emond Montgomery PublicationsLimited, 1996.19. Completing the Internal Market: Intellectual Property; Legal Protection:Biotechnological Inventions. January 18, 1995. Commission of the EuropeanCommunities INFO-92.20. ABBOTI, A. Europe tries again on biotechnology patents. Nature. Vol. 378:328,1995.21. DICKSON, D."Gene map" plan Highlights dispute over Public vs Private Interests.Nature. 371:365-66. September 29, 1994.22. KIMBRELL, A. The Genome Project: The Ethical issues of Gene Patenting. Hearingbefore the Subcommittee on Patents, Copyrights and Trademarks of the Committee onthe Judiciary United States Senate. Serial No. J-102-83:p. 164, September 22, 1992.23. Our Genetic Future. The Science and Ethics of Genetic Technology. British MedicalAssociation . Oxford University Press, 1992.2324. EISENBERG, R.S. Genes, Patents, and Product Development. Science. Vol. 257:903­908, 1992.25. GARBER, A.M. and ROMER, P. Evaluating the Federal Role in Financing Health­Related Research. Canadian Institute for Advanced Research ~ Program in EconomicGrowth and Policy, Working Paper No. 89, p. 39, August 1996.26. Ownership and the Human Genome. Nature. Vol. 371:363-364, September 29, 1994.27. DICKSON, D. HGS seeks exclusive option on all patents using its cDNA sequences.Nature. Vol. 371:463, October 6, 1994.28. International Bioethics Committee. UNESCO. Proceedings of the Third Session, Voll:p.48, September 1995.29. Rural Advancement Foundation International Communique "Patents, IndigenousPeoples and Human Genetic Diversity", 1993.30. International Bioethics Committee. UNESCO. Proceedings of the Third Session, Voll:p.50, September 1995.31. International Bioethics Committee. UNESCO. Proceedings of the Third Session, Vol.2:p.57, September 1995.32. ROSENBERG, S.A. Secrecy in Medical Research. NElM. 334(6), February 8, 1996.33. US Coalition counters Breast Gene Patents. Nature. Vol. 381:265, May 23 1996.34. ADLER, R.G. Genome Research: Fulfilling the Public's Expectations for Knowledgeand Commercialization. Science. Vol. 257:908-914, August 14, 1992.35. CHERNIAWSKY, K.M. and LOWN, P.1.M. New Reproductive Technologies:Commercial Protection. Royal Commission on New Reproductive Technologies,Research Vol. 3, Chapter 5:303-399. Canada Communications Group, Ottawa, 1993.36. POSTE, G. The case for genomic patenting. Nature. Vol. 378:534, December 7, 1995.37. LITMAN, M.M. and ROBERTSON, G.B. The Common Law Status of GeneticMaterial in Legal Rights and Human Genetic Material. Eds. B.M. Knoppers, T.Caulfield and T.D. Kinsella. p.51-84. Emond Montgomergy Publications Limited,1996.38. LITMAN, M.M. Sui Generis Status. Plenary Session #2. First InternationalConference.9 DNA Sampling. Human Genetic Research: Ethical, Legal and PolicyAspects. Montreal. September 1996.39. CAPLAN, A.L. and MERZ, 1. Patenting gene sequences. BMJ. Vol. 312:926, April 13,1996.40. Ethics and Human Genetics. Proceedings of the 2nd Symposium of the Council ofEurope on Bioethics. Strasbourg, 1993. p. 96-103. Council of Europe Press, 1994.41. The Code of Codes. Scientific and Social Issues in the Human Genome Project. Eels.D.]. Kevles & L. Hood. Harvard University Press. p. 315, 1992.42. Human Tissue Ethical and Legal Issues. Nuffield Council on Bioethics. London,England. p.99, April 1995.43. Ethics and Human Genetics. Proceedings of the 2nd Symposium of the Council ofEurope on Bioethics, Strasbourg 1993, p. 113-114. Council of Europe Press, 1994.2425Endnotes#1. It excluded from patentability parts of the human body "as such". This meant a gene inthe natural state in the body is not patentable but sequences of nucleotides from human DNAhaving a commercial application could be patented.#2. For example in Canada, patent holders in the pharmaceutical industry face additionalrequirements - they have greater constraints on how they can use their inventions because ofthe larger interests of society. The prices of patented drugs must be reviewed by the PatentedMedicine Prices Review Board to protect the public interest. Another example of limits onpatent rights in the public interest is that in Canada regulations under the Patent Act permitgeneric drug manufacturers to produce and store generic substitutes to patentedpharmaceuticals, in order to sell them when the patent expires.#3. A good may be a rival good - that is, one individual's consumption of the gooddiminishes the quantity available for others - or it may be non-rival, where use does notdiminish its availability. Examples of non-rival goods are software applications, mathematicalformulae, and gene sequences. Some non-rival goods are classified as public goods withmonopoly rights over them being denied, others are not. For example although softwareapplications and mathematical formulae are both non-rival goods - a software application mayhave copyright protection and is not a public good, whereas a mathematical formula is apublic good. As Romer (see Ref. 25) has noted, when there are no monopoly rights for a non­rival good, it leads to appropriate utilization, but there is less incentive for the invention ofnew non-rival goods. At issue is whether human gene sequences should be classified as apublic good or not.


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