Intellectual Property Genetics and Medicine Vineeta Agarwala Final Project BIO118Q Professor Brutlag Spring Quarter 2005 Patentable or Not Genetically modified bacteria A DNA sequence Sequence with identified function Discovery of a protein and its function in a disease A gene sequence whose function is determined by computational comparison to known sequences rather than by traditional laboratory methods A process that can be used to manipulate genetic information A drug that can potentially save millions of lives in the developing world The Major Questions As outlined recently by the WHO there are two primary pressing questions that scientists and scholars must work to answer 1 a general worry surrounding the appropriateness of intellectual property IP regimes for developing countries juxtaposed by an impetus toward increased global harmonization of patent policy 2 more specific to genomics a concern around the adequacy and appropriateness of current national patent regimes to address questions of DNA patenting and commercialization of the human genome in both developing and developed countries The Challenge Genomic IP NHGRI National Human Genome Research Institute has identified addressing intellectual property issues as one of the Grand Challenges for the future of genomics In 2003 in a document entitled A Vision for the Future of Genomics Research the Institute called for the development of policy options in the area of intellectual property that will facilitate the widespread use of genetic and genomic information in 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 genetic discoveries fall and become eligible for patent protection Purpose of a patent is two fold a Protect the work of any inventor whether it is an individual an institution or a multinational business conglomerate so that an incentive structure is in place inventor gets benefits for a fixed period of time about 20 years b Requires adequate disclosure of information about new inventions which would otherwise remain secret as proprietary information Patents have been instrumental in increasing the general body of technical knowledge in the world but some of the terms under which a patent is granted become unclear in the case of genetic discoveries Relevant Patent Law A patent is an exclusive right granted for an inventive product OR process Patents are awarded for new useful and non obvious inventions Must be adequately described in order that others can use the invention Specific substantial and credible utility must be demonstrated Legal Precedents 1966 Chemical compounds must have real world utility in order to be patentable 1980 Diamond v Chakrabarty Genetically engineered bacteria used to clear oil spills were patented Court emphasized that patents could be awarded to anything under the sun made by man 1988 First transgenic animal patented the Harvard OncoMouse developed with increased susceptibility to tumors 1991 Amgen v Chugai DNA encoding erythropoietin red blood cell production stimulant is treated as a chemical compound that is patentable and distinguishable from other chemical compounds The judge ruled that genetic material had never existed in nature in its inventive form until it was removed isolated purified and understood by man However the nucleotide sequence is required in addition to knowledge of the polypeptide which the gene encodes How can we patent DNA Question that most people have asked How can DNA be considered an invention when it resides naturally within our bodies Answer given by Rebecca Eisenberg leading expert on biotechnology patent law Those of us who simply use the DNA in our own cells as our ancestors have been doing for years should not and need not worry about patent infringement liability On the other hand those of us who get shots of recombinant erythropoietin can in fairness expect to pay a premium to the inventors who made these interventions possible Patentability of Genes Description the nucleotide sequence Obviousness even if polypeptide sequence is known the DNA sequence is not obvious because there are many possible nucleotide sequences resulting in same protein 1993 court awarded patent for discovery of genetic sequence in humans which encodes insulin Novelty genetic sequence must be one that has not been described before If a new amino acid sequence is discovered a legitimate patent may be awarded for the class of genetic sequences that may give rise to that polypeptide Utility need demonstrated function in research methods and or tools in medicine Many object that this law is fundamentally ignorant of the importance of DNA as information rather than a chemical and physical entity Objections to Gene Patents Many objections are made because people disagree with the actual biomedical science not its patentability Stem cells provide a key example two patents were awarded to the University of Wisconsin for purifying and isolating primate embryonic stem cells Others believe that genetics breakthroughs are discoveries rather than inventions because they are naturally occurring phenomena However this view is less understandable since there was much less opposition to the patenting of chemical compounds that were naturally occurring i e aspirin Religious Opposition Many religious groups became vehemently opposed to patenting genes 180 religious leaders representing various groups signed a joint appeal in 1995 and issued statements including By turning life into patented inventions the government drains life of its intrinsic nature and sacred value Jeremy Rifkin Foundation on Economic Trends Altering life forms is a revolt against the sovereignty of God Baptist cleric Similar sentiments to those being voiced right now in the debate over stem cells Expressed Sequence Tags ESTs Expressed Sequence Tags are sequenced portions of cDNA fragments which are produced from mRNA They are useful in probing for the presence of certain genes in various cells and tissues in various developmental stages and allow scientists to study only those portions of the genome that are important Debate over Patenting ESTs ESTs Expressed Sequence Tags are cDNA fragments with known sequence but often unknown function Structure vs function which is enough Current law
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