Patenting Gene Fragments Author(s): Arun Agrawal Source: Economic and Political Weekly, Vol. 28, No.

22 (May 29, 1993), pp. 1089-1093 Published by: Economic and Political Weekly Stable URL: http://www.jstor.org/stable/4399779 Accessed: 23/11/2008 02:55
Your use of the JSTOR archive indicates your acceptance of JSTOR's Terms and Conditions of Use, available at http://www.jstor.org/page/info/about/policies/terms.jsp. JSTOR's Terms and Conditions of Use provides, in part, that unless you have obtained prior permission, you may not download an entire issue of a journal or multiple copies of articles, and you may use content in the JSTOR archive only for your personal, non-commercial use. Please contact the publisher regarding any further use of this work. Publisher contact information may be obtained at http://www.jstor.org/action/showPublisher?publisherCode=epw. Each copy of any part of a JSTOR transmission must contain the same copyright notice that appears on the screen or printed page of such transmission. JSTOR is a not-for-profit organization founded in 1995 to build trusted digital archives for scholarship. We work with the scholarly community to preserve their work and the materials they rely upon, and to build a common research platform that promotes the discovery and use of these resources. For more information about JSTOR, please contact support@jstor.org.

Economic and Political Weekly is collaborating with JSTOR to digitize, preserve and extend access to Economic and Political Weekly.

http://www.jstor.org

Patenting Gene Fragments

Arun Agrawal

In the US, the National Institute of Health'sattempt to patent partial cDNA sequences correspondingto gene fragmentsin human braintissue has sparkedoff a controversywhichimpinges on ethicalissues and is critical to the evolution of the patent law on humaninterventionsin naturallyoccurringsubstances.
TE.CHNOLOGICAL developments and changing concepts of property shape strugglesover ownership.At one level, the emergence of patents, trade-secrets,copyrights, trademarks and mask works' constitute simply a recognition of rights in intellectual property-a reward to innovation. At quite another, patents and similar legally enforceable property rights are another step in what seems the inexorable march of comm6dificatiorn. One can interpret in either manner the latest controversyover intellectual property rights, the attempt by the National Institutes of Health (NIH) in the US to patent nearly 3,000 partial cDNA sequences corresponding to gene fragments (also called 'expressed sequence tags' or ESTs)2 in the human brain tissue.3 Significant ethical issues are involved. At what point do the resultsof human interventionsin naturally occurring substances become patentable? At what point does life itself become patentable? The US is arguably the world leader in biotechnology research. Not only is it the leader,it also remainsthe one world power that has exhibited the greatestwillingness to flex its economic muscle in the cause of stricter worldwide intellectual property regimes.4Fbra country like India, any major development in the US patent law regarding biotechnology signals a potentially profound impact. Precedents about what can be patented will in the long run influence hundredsof millions of households in all developing countries.5 The current controversy may influence the development of crucial drugs for cancer, diseases. At the AIDS and cardio-vascular same time, although the interests of developing countries are vitally at stake, we have little say in the developments in this field because we participateonly to a limited extent in biotechnologicalresearch that uses the latest techniques. The current controversypossesses four aspects that merit attention. First, what is the relatiomshipof the controversy to product devebpment and commercial applications of scientificdiscoveries?Patents are usually seen to promote new product develoDment. But patenting each step in the process of discovery of a useful inventnon may lead to excessive licensing fees. The cumulation of rents as each step of the process is patented, in effect, increases the fixed costs of 'supplying' new, commercially valuable researchand products. Thereby it deters commercial advancement of a new discovery. Second, what problems doe this dispute in the existing patent law in the US? A final decision in this dispute will be critical to the evolution of the patent law. The dispute calls into question a basic issue i n patentingwhether patents can be sought purely on the basis of knowledge about the structure of a substance, rather than on the basis of knowing its function. Indeed, other criteriawhich are used to determine whether a patent is warranted-nonobviousness and novelty-are also being questioned. Third, how will a decision in this case affect communication and exchange of information among scientists? If scientific discoveries begin to be patented, free exchange of information and subsequentlyinnovationare bound to suffer. And finally, what does this controversybode for the interestsof developing countries? Although the controversy is far from being resolved, the most recentchapter in the story came to an end when the Patents and TrademarksOffice (PTO) of the US rejected the patent claims of NIH in August this )car.6 The beginnings of the story can be traced back to 1980(Table 1). That year,in Diamond v Chakrabarty, the US Supreme Court ruled that genetically engineered micro-organisms can be patented,7 overriding the initial patent office determinationthat living organisms cannot be patented. The 1980 ruling boosted the US biotechnology industry enormously. In 1988, the PTO awarded Harvard Uniwrsity a patent for a strain of mice which were highly susceptible to cancer. The susceptibility to cancer had been produced using genetic engineering techniques.Both of these decsions, deemed to facilitate product development and commercialisation of biotechnology, provoked enornmus criticism on ethical grounds. Manycommentatorsarguedthat

it is unethical to patent gene sequences since these are part of the universal natural heritage of humanity. The NIH patent applicaions last year for more than 2,750 partial cDNA sequences isolated in Craig Venter'slaboratorytouch on similar and equally fundamentalissues. While the applications predictably triggered complaints about the detrimental effects on scientific research and communication,8 this time even those who believe in the necessity of patents for product development are divided on the issue. According to NIH, there is little cause for either confusion or concern. It has claimed that its application made policy discussion on the issue possible, without any single individual securing the right to apply for the patents. This public spirited explanation,however,does not hold water. The NIH action has drawn tremendous criticism. The PTO has rejected the application. The Bush administration has expressed its lack of sympathy for the applications. But the NIH director, Bernadine Healy, is publicly committed to pursuing the applications further. Three other factors may be cited in the support of NIH. Since 1986, the US government has encouraged patenting inventions that result from federally fundedresearch The governmentbelieves that exdusivelicences on patents will encourageprivateinvestors to commercially exploit new discoveries. The NIH is, therefore, only following federal policy. Second, if Venter had published his results, it would later have become difficult to patent useful proteins that were based on the sequences that he had derived. Difficulties in patenting would arise especially if his work made the subsequent discovery 'obvious'.9 NIH's insistence to patent thus demonstrates its desire to guard against an uncertain futurewhere because of the diffusion of knowledge into the public domain it would become difficult to gain exclusive rights over new products. Finally, if the NIH did not file for patents, the option to apply would pass on to Venterwho, in the meantime, has left the NIH. It may seem then that the NIH had some justification in pursuing patents for the cDNA sequences that Venter identified. However, such a condusion can be made only if it is indeed the case that patenting the sequences would promote product development. How can that be decided? Statements from the biotechnology industry in the US provide one indicator.A majorityof the companies have indicated that the cDNA patents, if granted to the NIH, would actually hurt the industry. The Industrial Biotechnology Association inl the US '? passed a

Economic and Political Weekly

May 29, 1993

1089

unanimotus resolution in June 1992 that the NIH should pursue patent applications on genes only when the complete coding region (ratherthan fagments) and its biological function are known. -The Association of Biotechnology Companies (ABC) supported the NIH decision to file for patents but qualified its support by suggesting the NIH should grant nonexclusivelicenceson the patents it receives. Such licences will possibly provide the NIH some return on its investment in genome research. But if the NIH grants non-exclusive licences, the cause of product development will surelybe ill-served. Since the stated objective of the NIH is not to seek financial returns but to promote product development, the support from the ABC is ambiguous at best, because the ABC does not believe that the strategyfolloved by the NIH will fulfil the stated objective of encouraging product development in biotechnology companies.1" The third major association in which biotechnology companies are members, the Pharmaceutical Manufacturers Association, also opposes the patenting of genes whose function is not known, sipce it "would inevitably impede the reseach and development of new medicines in this country (the US)".'2 It is inremarkable that tte bWomechnology dustry should feel this way because, quite demonstrably,the success of the industry depends on as strict a patent regime as possible regarding commercialisable
1' products.

probes in identifying new genes. Since the US law grants patents for all possible uses of a patented invention or material, if the NIH receivesthe patents it will benefit not just from the uses it has identified for the isolated cDNAs but for all possible uses for all the sequences of which its cDNAs form a p . The real purposeof the NIH, one feels compelled to condude, seems to be to "control individual DNAs and thereby commerce in the proteins they 8 encode!" This attempt by the NI H to control future developnents in gene identification and to benefit from the efforts of later innovators goes quite beyond the provisions of the US Technology TransferAct of 1986. More importantly, perhaps, it reveals substantial deficiencies in the US patent law which some have, ironically, called the most 'progressivepatent system in the world. It is because of these short-

comings in the law that Ventercan file for patents on 'inventions' that are churned out by the computer at the rate of a thousand a month. The deficiency in the current US law regarding the issue of utility stems from the historical development of the patent law. The system o0 patents was created to providean exclusivebut rmitecontrol over inventions that had a practicaluse so that the inventorwould have incentivesto sink time, finances and effort into a new idea that may finally turn out not to have any practical implication. The patent system is thus designed to distinguish between 'pure research',where the discoveries and findings should remain in the public domain, and applied technological research which is more closely related to the marketplace. In biotechnology, however, it is exceedingly difficult to differentiate between pure and applied research.With

OF BirrTCHNOLOGY STEPS IN THE COMMERCIALISATION TABLE: IMPORTANT

Year 1973 1975 1976 1980

Significant Events First gene cloned First hybridoMfacreated. First firi to exploit rDNA technology founded in the US (Genentech). Genetic Manipulation Advisory group started in the UK. Diamond v Chakrabarty, US Supreme Court rules that micro-organisms can be patented. Cohen/Boyer patent issued on technique for rDNA. Spinks' Report in UK, Biotechnology targeted for Research and Development. FRG targets biotechnology for R&D. Initial public offering by Genentech-sets record bor fastest price increase ($35 to $89 i 20 mins). First Monoclonal Antibody (MAB) diagnostic kits approved for use in the US. Japan targets Biotechnnology. Over 80 new biotechnology firms formed in the US. First rDNA animal vaccine approved for use in Europe. First rDNA drug for human use (insulin) approved in US and UK. First expression of a plant gene in a plant of different species. Advanced Genetic Sciences Inc receives first experimental use permit issued by EPA for controlled environmental release of a genetically altered organism. Technology Transfer Act of the US-allows for patenting of federally-sponsored research. The US Patents and Trademarks Office announces that non-human animals are patentable. NIH establishes programme to map the human gene. First US Patent issued on animals-a transgenic mouse engineered to contain cancer genes. Court in FRG stops construction of a test plant to produce genetically engineered insulin. Bioremediation gains attention as microbe-enhanced fertiliser used to battle Exxon Valdez oil-spill. First bio-engineered food additive approved by the US FDA on Renin, enzyme used to make cheese. FRG enacts Gene Law to govern use of biotechnology. Human gene therapy clinical trials approved. Biotechnology companies sell $17.7 billion in new stock. The US EPA approves the first genetically-engineered biopesticide for sale.

The adverse reaction of the biotechnology industry forms one indicator of the desirability of the NIH applications. We can also investigate the impact of the NIH action on product development analytically. Whether NIH patents will promote the commercial development of products depends on the kind of patents it secures. The NIH application seeks patents for the cDNA that have been isolated and the genes or longer sequences of which they form part. But at present, even Venter has no idea about the function(s) that the cDNAs and associated proteins may perform. ln Brenner v Manson'5 the US Supreme Court held that nothing could be patented that did not possess a use apart from being an object of scientific inquiry.'6 Patenting, in other words, requires that the material or process to be patented possess 'substantial' utility, and that it be of "specific benefit in currently available form".' The NIH has attempted to get around this objection by identifying relatively trivial uses for its se-

1981

1982 1983 1985 1986 1987 1988

1989

1990

1991

quences:it argues,for example,that they can be used as genetic markers,or as

Source: Table adapted from US Congress, Office of Technology Assessment, Biotechnology in a Global Economy, OTA-BA-494, US Government Printing Office, Washington DC, October 1991.

1090

Economic and Political Weekly

May 29, 1993

the possibilitythateachnewdiscovery or advance in tne acadenicis laboratory may lead to futurecommercial applicatiods, ,theboundaries arebecoming increasingly blurred. Thus,although it mayin the past have seemedinconceivable that anyonewould go to the trouble of inventing something that did not have utility, and further, wouldwantto patentsuch'useless' inventions,the mannerin whichdevelopments takeplacetoday in biotechnology means that thereis a significantpossibilityof new uses being discovered for materials that have simply been identified. The observable of this prospect consequence is that patentapplications -are generated on everystepof the way from the initial to thepossible discovery rmalmarketplace application. TheNIH application reflects this phenomenon. It seeks to controlthe usesof theproteins undiscovered encoded in humangenes ratherthan merelythe uses for the cDNAs notedin'its application. Herean analogyis illustrative. The NIHattempt has beencompared to someone claiminghuge plots of land on the possibilitythattheremaybe gold underneath.As Robert Merges, professor of law at Boston University notes, mininglaws in the US protectagainst this kind of action. Thereare limits to what can be claimed,the landmustbe workedfor the rightsto mature,and according to him, a similarlaw is neededin the contextof the cDNA patents. The debateon the NIH patent applicationsis indisputably intricate on grounds of utilityandwith respect to the ethicsof monopolisingthe humane genome. On technical/legalgroundsof novelty and non-obviousness, theapplications areeven '9 Noveltymeansthat moreproblematic. an invention shouldnot haveexisted in the publicdomainpriorto the filingof a patent. Non-obviousness means that a per-

organisation 'Institute for Genomic Research' thathe hasjoined.Theinstitute has been founded to commercialise It will initiallyfocus genome research.2' on sequencingcDNA, the one area of thatmost analysts agree genomeresearch short-term commercial possesses relatively potential.22
MARKET PcVrENTIAL

son of 'ordinaryskill' should not have beenableto come up withtheclaimedinvention using existing knowledge and techniques.The NIH cDNA sequences have been derived using conventional techniquesto cDNAs available from a commercial cDNA library. And whilethe genefragments mayin the futureturnout to possess unexpected properties,the characteristics identified in the patentapat least,areentirely plications, predictable
ones.20

If the NIH is ultimatelygrantedthe patents,this wouldopen the field to all laboratories andresearchers whohaveaccessto the widely-known used technology by the NIH to derivethe patial cDNA sequences.Venter alone has received $70 millionto continuehis workon an even largerscale at the privatclyfundednew

The humangenomehas some 1,00,000 Venter's vowto idengenes.If weconsider tify 2,000genes everyweek, he is clearly in a positionto patentthe entirehuman Wallace Steinberg, genomein shortorder. the financialbackerof the Instituteof GenomicRexarch,believesthatas man} lead! as 20,000of thegenescouldprovide Evenif only a for drug devdopment.23 useful fewof the genes express medically the personswhocanpatentparproteins, tial cDNA sequencesfor themwouldbe Thelong-term commersitting verypretty. cial potentialhas not beenlost on other Bourke, investors on %Il Street.Frederic a wealthy intendsto starta entrepreneur, with an investment company sequencing of $ 50-160 nillions. Otherinvestors are maintaining careful watch (e g, the .24 GeneticTherapyInc) Maryland-based The interest of WallStreetis not misplaced. Several block-buster drugshavebeen and developedemployingbiotechniques are enormous profitsfromnewbio-drugs a distinct possibility.25 However, if patents are grantedon discoveriesthat haveno obviouscurrentutility,not only become mayfuturepiduct development newinvestment moreuncertain, mayalso be deterred. Thecurrent controversy overpatenting cDNA becomesall the moresignificant thatarefinalsincemanyof the bio-drugs will use DNA or messenger ly developed RNA. The internationalpatent regime that will greet the productsof biotechas theproducts aresold nologycompanies in global marketswill determine who and to whatexbenefits,in whatmanner, tent. If the PtO beginsto grantpatents of thecDNAs on thebasisof thestructure alone,it seermobviousthat a verysmall numberof individualswili gain a Full Nelson on the humangenome.It seems equally obvious therefore that when patents are granted for particular substances, only the knownusesof these substances should be patentable-not all usesincluding thosethathavenot possible been discovered. 2 In short, only slim groundsexist for granting patents to the NIH on the cDNAsit has claimed.In lightof this,the theNIH initialruling by the FTC) to reject is heartening. Theappatentapplications

plications were rejected on all the three grounds of utility, novelty and nonobviousness. The sequences lacked obvious utifitysDice their value as probeswas not clear; they lacked novelty since they werederived from a publiclyavailablecollection; and they lackedobviousness since many of the base sequences of the fragments had already been published in the literature.27But at the same time, the NIH director, Bernadine Healy, has asserted that the NIH had anticipated the response of the PFMall along, that such rejections are routine at the first stage of an application, and that the NIH is going to revise and file new applications soon. The dispute, as it unfolds at the level of the major participants in the debate seems to shed little light on how it can be resolved. Even the courts, should the matter be referred to them in the course of time (as it undoubtedly will be), have few legal guidelines in the matter. What is available as guideline is case law. But it makes little sense to rely only on court decisions made in the past for future developments since the past is so inadequate a guide in this rapidlyevolving field. New legislativeremediesmust be provided, and they must take into account the fact that just a few researcherscan use partial cDNA sequences to patent the entire human genome in a matter of years using fairly limited resources.The same techniques used for sequencingthe human DNA can also be used for other organisms that seem to possess commercially potentialproviding a means to gain patent rights on these other organisms too. It makes neither economic, nor ethical, nor political sense then, to effectively grant a few individuals monopoly rights over all possibledrugs developedusingDNA from living organisms. Because this case holds enormous ethical, political and commercial portent, t is regrettable that the US has refused to ;ee any need for new legislative or policy guidelinesin the matter.D Allan Bromley, the science advisor to George Bush, believes that there exists no need for a policy initiative since the PFMwill not approve the NIH application He has also rejected the need for any international treaty on the subject since such a treaty would be like 'using an elephant gun to What Bromley does not kill a butterfly.28 anticipate is that in the absence of a policy, controversies similar to the NIH applications can also be guaranteedin the future. On this issue (as of course on many others), the stand taken by the Bush administrationin the US WhiteHouse seems confounding. One of the primaryreasons cited by the N IH to defend its actions is

Economic and Political Weckly May 29, 1993

1091

policyof encouragng the US government Butif the US results. of research patenting governmentis against the patentingof a clear statement partialgene sequences, to the effect wouldclearmuchconfusion ill will. By exand preventinternational pressingthe hope that the patentclaims whileat the sametimerewillbe rejected, jectingthe need for any ckar or consisis sending tentpolicy,the US government mixedsignalsnot just to the NIH but to in the field,andto the PM all researchers in effect,seemsto itself.Thegovernmept, be saying that case-by-casedecisionmaking is the optimal policy in highly sinceit is difficult situations controversial on the principlesinto reachagreement is an invitationto volved.This, however, the policyopevidently through' 'muddle by bureaucracies tionuniversally preferred and politicians. It avoids unpopular stancesand uses a logic of justification to rationalisedecisions that in the long run often prove harmful.29 effects of the NIH acThe pernicious are genomeresearch tion on international beingfelt. The MedicalResearch already has followedthe action Councilin Britain of NIH and has decided to keep its to itself.3 DavidGalas, genomedatabase the directorof the US departmentof patents that pursuing has warned energy, is likelyto lead of partialgenesequences to furtherdisputes,"inhibitrealinnovation"'and createpatentsthat are "allbut director useless"Axel Kahn,the research of the PrenchScienceAgencyINSERM, oppositionto has expressedfirm French and has acpatentson partialsequences the risks cused the NIH of exaggerating of not patenting.3' Indeed, most Eurothe NIH havedeplored peangovernments At thesametime,France, England policy. and Japanhavesought an international patentingof substances treatyto prevent unknown.Patent remains whosefunction havenot yetincited rights overa discovery situationswherethose usingthe discovearesued research academic riesfor further Butif patentsbegin by the patentholders. forsubstances and'processes to be granted whosefunctionsarebarelyknown,suing those who use a patenteddiscoveryfor would.becomea very scientificresearch real possibility.The adverse impact of and insuch a situationon new research novationcan be readilyimagined. The final decision on this case will influenceissuesof freescientific critically exchangein research,product developinventor's rights, mentand safeguarding patentingof substanceson the basis of structurerather than function, and reregardon patentapplications quirements ing the utilityof the invention,its novelty and its obviousness.For these larger
1092

reasons the case is signiricant. But for the specific issues concerning sequencing an4 mapping of the human genome,32 the case may prove to be less significant because the knowledge about the human genome may be soon available in the public domain.33 The Human Genome Project, an international collaborative research project, is also sequencing and mapping the entire human genome using a structuralapproach to begin with. Once the structureof the human DNA has been identified, research on identifying the functions can proceed. It is interesting to note, therefore,that when the genome project was established, both the Office of TechnologyAssessment, and the National Research Council in the United States decided not to patent gene sequences. iWo of the 24 human chromosomes have already been fully mapped by the Human Genome Project. In view of the vast amount of information that the project is going to uncover,it is reassuringat least from the point of view of developing countries that many of the researchersinvolved with the Human Genome Project believe that the Genome databases they create should be open to anyone with any interest for any reason.? Others criticise the approach of scientists like Venter whose "primaryconcern (is) chipping off profitable pieces of the genome'.35 Many

of the Genome Project scientists argue that the idea is to decode informationthat is valuable to the entire human species. If these researchershave their way much of the knowledge representedby the cDNAs, and relatedly,their commercial potential may pass into public domain. Fittingly, it would be quite independent of the final outcome of the NIH case. For developing countries, the current case promises to set precedents that will significantly affect futuredevelopments in new technologies. There is a large class of diseases that may proveamenable to treatment by drugs developed using bio-technologies. The natural immune system is relatively ineffective in coping with some organismsthat can eithershuffle the genes of their surface proteins, or may be too lare or complex for traditional methods to yield answers.36 of1mfedicine It may be only through the use of highly advanced technologies that any solutions to such diseases becon? available.Similarly, gene technologies we beginning to provide important tools in diagnostics as well as therapeutics.Further,many of the human diseases are of genetic origin The Human Genome Project will therefore, in time, providea pictureof genetic pathology that will prove invaluable in identifying the pretnce of genetic factors that predispose individuals to certain kinds of diseas. A

Shivaji & His Times

Jadunath Sarkar
Shivaji&His Timesis a comprehensiveaccountof the Iife andtimesof one of to the geographyof heroes. Aftera briefintroduction Maharashtra's.greatest of the people of thatland,the book tracesthe Maharashtra, and a description intheserviceof theAdii Shahof Bijapur. riseofFSIhahji Bhonsle,Shivaji'sfather Shlvaji'sboyhood, his earlyvictoriesand hiswars with the Mughalsand the AdilShah, are recountedin detail. A majorportionof the book is devoted to Shivaji's relationswith the Mughal EmperorAurangzib,and his constant coronation,his subsequent territory. Shivaji's struggleto capturethe Maratha foraysinto southernIndia,his effortsto build a strongnavy, his relationswith foreignpowers are all discusseed in the book. The authoralso makes a criticalassessmentof Shivaji'scontributionsand achievements, and his place in historyusing a wide range of sources and historicaldocuments in a varietyof languages,the authordrawsa definitive of the greatMaratha rulerand nation. portrait Hardbound Rs160.00

Orient Longman
Orient Longman Ltd. 3-6-272, Himayatnagar, Hyderabad - 500 029

Economic and Pblitical Weekly May 29, 1993

conclusion of the cDNA patent applications in favotr of the NIH wil; make it that much mnoredificult for the devloping countries to gain the benefits of rnew techinologies and possibly the benefits from tue Human Genome Project.Finally, a decision favouring the NIH may aiso close off for us future options for researching the human DNA that we may wish to keep open. The final decision in this case will alsc affect other genome projects. Computer technology continues to register phenomenal advances in storing data and processing informatlik,n. Electronic chips capable of storing gigabytes of data will be used comnnrciallyin less than 10years. Matching processing speeds for data retrievaland processing are equally imminent. As computer technology makesgene ,sequencing anldmapping more cost-effective, there will be genome projects for other living organisms that possess com37 The U nited States mercia3 valure. of agriculture (USDA) has depai-tnment already iniLiateda plant genome project is plapning,an animal genome pro.apd4 ject with the object of obtaining genome maps for all mnajor crop species important to the US. (These include corn, tomato, rice and soybean. Animal species such as swine and cows are included). Genome projects are also uiider way in the Europear, Community and Japan. Gene maps and sequences obtained from the genome projects will be used to manipulate genes in crop aid aiiinal species that code for desirable trais such as hybrid vigour, disease esitance, drought resistance, resistance to temperature variations and to cold, salt tolerance, better taste, and Since production of specific substances.38 it is now possible to accomplish crossspecies gene splicing using rDNA techniques, the above wish list is not as far. fetchiedas it may seemr. Ignoringtedmologicaland legal developthat take place irtthe US and other nments westernnations will provenot just a shortslghted policy. It is also detrimentalto the interestsof tie developingcountriesin the immediate run. We must attempt to gain technoloical developa share in mernetng ments, createindigenousresearh capacity and match oui legal provisions to changes taking place in the west, especially changes in the US. The only other option is to foreclose future options.
Noteb (1 wrote this paper as a Ciriacy Wantruppostdoctoral fellow in toe department of forestry and resource managemrnt at the University of California, Berkeley. I gratefully acknowledge the comments and support I received from Sabine Engel, Vinay Gidwanj and Jeff Romm while writing the paper.]

a discussion of these five form of intellectual property rights, see Robert M Isherwood, Intellectual Property and E;conomic Development, Westview Press, Boulder, 1990:12-28. 2 See Thomas D Kiley, 'Patents on Random Complementary DNA Fragments?' in Science, 257 (August 14, 1992):915. 3 With a S 9 billion budgt, the NIH is possibly the largest and the most successful research agency in the world. 4 Rohini Acharya, 'Intellectual Property, Biotechnology and Thde: The impact of the Uruguay Round on Biodiversity, ACTS Press, Nairobi, Kenya, 1992. S On this issue see Kenney Martin, 'The University in the Information Age: Biotechnology and the Less Developed Countries: Development, 4, (1987):60-67. 6 Science, September 25, 1992. For a mqre detailed analysisof the rejectionof the N-i claim, see Science, Vol 258, (October 9, 1992):209-10. 7 Diamond v Chakrabarty, 447, US 303 (1980). 8 On the relationship between patenting and free scientific exchange of information in a relatedcontroversy,see Michael MacKenzie,-Peter Keatingand Alberto Cambrosio, 'Patents and Free Scientific Information in Biotechnology: Making Monoclonal Antibodies Proprietary')Science, Technology and Human Values, 15:1, (Winter 1990): 65:83. 9 Patents cannot be granted in the US on discoveries that are obvious-that could be made by a person of 'ordinary skill' using information availablein the public domain, 35 USC 103 (1952). 10 The Indutrial Biotechnology Association (IBLA) controls 80 per cent of the US investment in biotechnology. See R G Adler, 'Genome Research:Fulfilling the Publics Expectations for Knowledge and Commercialisation' in Science, Vol 257 (August 14, 1992): 912. 11 Rebecca S Eisenberg, 'Genes, Patents and Product Development' in Science, Vol 257, August 14, 1992:907. 12 Quoted by Eisenberg, 1992 p 907. 13 It is interesting in this context to note that the NIH director,BernadineHealy, has used the positions taken by the Industrial Biotechnology Association and the Association of Biotechnology Companresto assert that actually the NIH applicationsare supported by the biotechnology industry. See Nature, Vol 357 (May 28, 1992): 270. 14 Thomas D Kiley,'Ptents on RandomComplementary DNA Fragments?, Science 257 (1992).-915. 15 This was a cas in which a novel steroid was involved. 16 Brenner v Manson, 383 US 519 (1966). 17 Brenner v Manson, p 534-35. 18 Kiley:916. 19 In fact, purely on grounds of utility, the patent applications seem to be on somewhat firmer legal grounds-even if the law itself is questioned. 20 Eisenberg, Science, 905. 21 New Scientist (July 11, 1992):7 22 NVature, Vol 358 (July 16, 1992):180. 23 Science, Vol257 (September 18, 1992):1620. 24 See Nature,Vol 355S(1992):483; Vol 358
IFor

the mak of gene-spliced human Ihulin, earned 5210 million in rewnues in 1990 and sparked a '"aade of research into blood clotting" with it t-PA (tissue plasminogen activator). Cetus Corporation's discovery of polymerse chain reaction has "revolutionised diagnostic testing". Amgen, another biotechnology company, is likely to climb into the Fortune 500 on the strength of its patents over the protein called erythropoictin (EPO) and Neupogen (see Scientific American, January 1992:134).In terms of freh investment, 35 biotechnology companies drew more than a bifion dollars in initial public offerings in 199Lending the drought of the late 1980s. The drugs biotechnology companies may discover for treating allergies, cancer and auto-immune and cardiovascular diseases promise to have farreaching impact (see articles contained in the special report on biotechnology in Science, Vol 256, May 8, 1992). 26 This is, indeed, already the case in Europe. See Article 54(5), EuropeanPatentConvention. See 'Hydropyridine', FRG Federal Court of Justice, September20, 1983, Case No XZB 4183. 27 Science, Vol 263 (September 25, 1992). 28 Nature, Vol 358 (July 16, 1992):180. 29 See John Mendeloff, 'Politics and Bioethical eommissions: Muddling Through' and the 'SlipperySlope', Journal of IHealth Politics, Policy and Law, 10:1 (Spring 1985):81-92. 30 Nature, Vol 358 (July 16, 1992):176. 31 Nature, Vol 357 (May 28, 1992):270. 32 'The Genome is the full programme of instructions that directs the development of a complete organism from a single cell, ensures the constant maintenance and repair of its parts, and orchestratesits growth and metabolism' See Office of Science and Technology Poli,cy,'Biotecbnology for the 21st Century: A Report by the FCCSET Committee on Life Sciences and Health, WashingtonDC, US, Government Printing Office, 1992:51. 33 Although, this would again depend to some extent on the policy, NIH decides to adopt because much of the research on the human genome in the US is carried out under the auspices of the NIH. 34 Scientific A merican (April 1992):136. 35 Ibid. 36 See, Burke K Zimmerman, 'The Economic and Social Implications of Gene Technology to Developing Countries' in Biotechnology: Economic and Social Aspects, e J DaSilva,C Ratledgeand A Sasson (eds), Cambridge University Press, Cambridge, 1992. 37 Charles Cantor, '!mplications of the Human Genome Project,-Biotechnology: Science, Education and Commerciolisation, Indra K Vasil (ed), Proceedings of an International Symposium at University of Florida, Gainesville, Elsevier, New York, 1990. 38 See Office of Science and Technology Policy, 1992:51-54; Also, US Congress,
s5

(1992):180.

Office of TechnologyAssessment,Biotcohnologyin a Global E;conomy, OT*ABA-494,US Government PrintingOffice, Washington DC, October1991:104. 1093

Econtmic and Poikical Weeklyt May 29, 1993