Intellectual Property,Genetics, and MedicineVineeta AgarwalaFinal Project, BIO118QProfessor BrutlagSpring Quarter 2005Patentable or Not• Genetically modified bacteria?• A DNA sequence? Sequence with identified function?• A gene sequence whose function is determined by computationalcomparison to known sequences rather than by traditional laboratorymethods?• A process that can be used to manipulate genetic information?• Discovery of a protein and its function in a disease?• A drug that can potentially save millions of lives in the developing world?The Major QuestionsAs outlined recently by the WHO, there are two primarypressing questions that scientists and scholars mustwork to answer:(1) “a general worry surrounding the appropriateness ofintellectual property (IP) regimes for developingcountries juxtaposed by an impetus toward increasedglobal harmonization of patent policy”(2) “more specific to genomics, a concernaround the adequacy and appropriatenessof current national patent regimes toaddress questions of DNA patenting andcommercialization of the human genome inboth developing and developed countries”The Challenge: Genomic IP• NHGRI (National Human Genome ResearchInstitute) has identified addressing intellectualproperty issues as one of the “Grand Challenges”for the future of genomics.• In 2003, in a document entitled “A Vision for theFuture of Genomics Research,” the Institute calledfor “the development of policy options in the area ofintellectual property that will facilitate thewidespread use of genetic and genomic informationin both research and clinical settings.”What is Intellectual Property (IP)?• Definition (from WIPO):Intellectual property refers to creations of the mind:inventions, literary and artistic works, and symbols, names,images, and designs used in commerce.• It is the first category – inventions – under which geneticdiscoveries fall and become eligible for patent protection• Purpose of a patent is two-fold:a) Protect the work of any inventor, whether it is anindividual, an institution, or a multinational businessconglomerate, so that an incentive structure is in place(inventor gets benefits for a fixed period of time – about 20years)b) Requires adequate disclosure of information about newinventions which would otherwise remain secret asproprietary information• Patents have been instrumental in increasing the generalbody of technical knowledge in the world, but some of theterms under which a patent is granted become unclear in thecase of genetic discoveriesRelevant Patent Law• A patent is an exclusive rightgranted for an inventive product ORprocess• Patents are awarded for new, usefuland non-obvious inventions• Must be adequately described inorder that others can use theinvention• Specific, substantial, and credibleutility must be demonstratedLegal Precedents• 1966 – Chemical compounds must have real world utility in orderto be patentable.• 1980 - Diamond v. Chakrabarty – Genetically engineeredbacteria used to clear oil spills were patented. Courtemphasized that patents could be awarded to “anything underthe sun made by man.”• 1988 – First transgenic animal patented: the “HarvardOncoMouse” developed with increased susceptibility to tumors• 1991 – Amgen v. Chugai – DNA encoding erythropoietin (redblood cell production stimulant) is treated as a chemicalcompound that is patentable and distinguishablefrom other chemical compounds. The judge ruledthat genetic material had never existed in nature inits inventive form until it was “removed, isolated,purified, and understood by man.”• However, the nucleotide sequence is required inaddition to knowledge of the polypeptide whichthe gene encodes.How can we patent DNA?• Question that most people have asked: How canDNA be considered an invention when it residesnaturally within our bodies?• Answer given by Rebecca Eisenberg, leadingexpert on biotechnology patent law:“Those of us who simply use the DNA in our owncells, as our ancestors have been doing for years,should not and need not worry about patentinfringement liability. On the other hand, those ofus who get shots of recombinant erythropoietin can in fairness expect to pay a premium to theinventors who made these interventions possible.”Patentability of Genes• Description - the nucleotide sequence• Obviousness – even if polypeptide sequence is known, the DNAsequence is not obvious because there are many possiblenucleotide sequences resulting in same protein (1993 – courtawarded patent for discovery of genetic sequence in humanswhich encodes insulin)• Novelty – genetic sequence must be one that has not beendescribed before. If a new amino acid sequence is discovered, alegitimate patent may be awarded for the class of geneticsequences that may give rise to that polypeptide• Utility – need demonstrated function in research methods and/ortools in medicine• Many object that this law is fundamentally ignorant of theimportance of DNA as information rather than a chemical andphysical entityObjections to Gene Patents• Many objections are made because peopledisagree with the actual biomedical science, notits patentability• Stem cells provide a key example – two patentswere awarded to the University of Wisconsin forpurifying and isolating primate embryonic stemcells• Others believe that genetics breakthroughs are“discoveries” rather than “inventions” becausethey are naturally occurring phenomena• However, this view is less understandable sincethere was much less opposition to the patentingof chemical compounds that were naturallyoccurring (i.e. aspirin)Religious Opposition• Many religious groups became vehementlyopposed to patenting genes• 180 religious leaders representing various groupssigned a joint appeal in 1995 and issuedstatements including:“By turning life into patented inventions, thegovernment drains life of its intrinsic nature andsacred value.”– Jeremy Rifkin, Foundation on Economic Trends“Altering life forms…is a revolt against thesovereignty of God.”– Baptist cleric• Similar sentiments to those being voicedright now in the debate over stem cellsExpressed Sequence Tags (ESTs)They are useful inprobing for thepresence of certaingenes in various cellsand tissues invariousdevelopmentalstages, and allowscientists to studyonly those portions ofthe genome that are“important”ExpressedSequenceTags
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