In the case of genes, the public has certainly contributed to the knowledge base that is producing innovations through government funding of the Human Genome Project and other scientific endeavors. Ethical issues. It states that: “The human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity”. It is the first universal instrument in the field of biology. A low bar might allow applications to rest on the theoretical possibility that a gene might have a certain utility. “A discovery involves new knowledge whereas an invention is a practical application of knowledge”. But raise the question of granting intellectual property rights over pieces of the human genome in any gathering of regular folks, and the initial response is probably going to be, "Yuck. But still these patents are necessary to promote research and investment in biotechnology, or in the prevention and cure of human suffering. Like the technology that intellectual property (IP) protection is applied to protect, IP protection is a system that needs to be subjected to ethical analysis and examine whether it is suitable for a moral society. John Barton, professor of law at Stanford University , described intellectual property protections as "a set of statutory exclusion rights." Under Article 27.1 of TRIPS, ‘patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application’. And this rests on two confusions about patent law. A patent is not received on just a gene. This is known as the `enablement` requirement, LEGAL FACTS AND QUESTIONS REGARDING GENE PATENTING. These limitations on the rights of individuals to transfer, donate, or control commercialization of their genetic material and, possibly, to seek some kinds of medical care, clash with the constitutional right to privacy. Given such circumstances, if Judge Sweet’s decision is upheld in further proceedings asserting that isolated genes are a product of nature and therefore not patentable, it is likely that it may impact Indian patent practice to the extent that it would further affirm the rejections of claims directed towards isolated genes, DNA etc under section 3(c) of the Indian Patents Act. With regards to India, there exist a large number of issues that need to be dealt with. As a result, information taken from the human genome (DNA information) is being transacted as it has economic value. What is not covered under the meaning of 35 USC 5 101, can be construed to be not an invention and therefore patent ineligible. The patentee could also theoretically prohibit Moore from undergoing a leukemia test with a group of physicians not approved by the patentee because, again, an isolated and purified version of Moore’s genome would be transmitted to a third party without a license . There have been no clear policies on the patenting of genes, and DNA sequences in India, even though Indian inventors working in these areas have been applying for patents in India and abroad. There is a need to be educated in the markets and the technologies and also develop a clear understanding of the importance of intellectual property protection in biotechnology. The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence of a partial gene, cannot constitute a patentable invention. "Patents," Markland Day said, "are the lifeblood of biotechnology. MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. Genetic tests provide physicians with information about that DNA sequence and with this information, a physician can prescribe drugs, special monitoring or preventive measures to treat the disease or reduce the risk. Moreover, the difficulty with the main moral objections to human gene patents is not simply that they confuse legally patentable genes with naturally occurring genes. The biotechnology industry has certain unique aspects that distinguish it from other sectors, such as lengthy product development lifecycles, significant financial resources, and complex intellectual property issues. Christopher Arup –“The new WTO Agreement globalizing law through services and I.P”, 3. The discovery of a sequence that might have represented considerable novelty and inventiveness in the 1990s-such as the connection of the BRCA1 gene with breast cancer-might be less impressive now that technology has made it much easier to identify disease susceptibility genes. How will the direction of research be affected? The first genes were patented in the early 1980s, and the practice has … As the United States and other signatories to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) evaluate whether to grant patents on gene sequences, they must decide whether to apply these standards stringently (that is, to set the bar high) or loosely (to set the bar low). Other arguments included that: Myriad’s patents and its position as the sole provider of BRCA1/2 testing has hindered the ability of patients to receive breast cancer genetic testing; it has impeded the development of improvement to BRCA1/2 genetic testing; and that the human genes are the common heritage of mankind whose use should not be restricted by patent grant. They are made up of tightly coiled threads or polymers called as deoxyribonucleic acid (DNA). In other words, the holder of a DNA patent does not own the gene sequence; he or she simply has the right, for a limited period of time, to prevent … It was also held in the well-known case of Diamond v. Chakrabarty by the United States Supreme Court that genetically manipulated organisms are subject matter under section 101. Actually it is the proteins that do the actual work in our bodies. Although Article 27.3(b) of TRIPS allows governments to exclude plants, animals and ‘essentially’ biological processes from the requirement of Article 27.1 that patents be available in ‘all fields of technology’, isolated organisms are unlikely to fall within the exception. It was contested that the patent claims covered products of nature, law of nature and/or natural phenomena and abstract ideas or basic human knowledge or thought. It is a chemical that, when placed in an appropriate environment, will direct the synthesis of particular and specific proteins, which make up the structural components of cells, tissues and enzymes (molecules that are essential for biochemical reactions). This is one reason some people prefer not to take tests that may indicate they could develop a serious disease in the future, especially if there are at present no effective preventive measures or treatments. Myriad Genetics, based in Salt Lake City, Utah, along with the University of Utah Research Foundation holds several patents on two breast cancer genes, BRCA1 and BRCA2 and is the sole provider of the full sequencing of BRCA1 and BRCA2 genes in the US on a commercial basis. ESCO at its 29th session on November 11, 1997, refers to the human genome as the heritage of humanity in a symbolic sense. a replacement gene). How do Genes Control the Characteristics (or Traits) of the organism? The United States and European countries have so far taken divergent approaches to gene patenting. Therefore, Isolated and purified genes are patentable. Biotechnology law is mostly considered to be the judge made law or courts established law. Not without tradeoffs, said June Carbone, Presidential Professor of Ethics and the Common Good at SCU and one of the conference organizers: The real public policy question is whether we want: a) the existing system, which places a premium on the development of life-saving drugs, even if they are so costly they cannot realistically be made available to everyone; b) greater redirection of government-subsidized research toward products of more general utility or accessibility, even if that means the development of some life-saving drugs will be delayed or discouraged; or c) dramatically higher overall public health expenditures. The Patent Office’s seems to be reluctant to deny legal protection where a significant investment of time and effort has been made. The Indian Patent Office’s draft manual 2008 does not explicitly elucidate the same, but under the guidelines for the unity of invention, the following example is included: when a genetically modified gene sequence/amino acid sequence is novel, involves an inventive step and has industrial application, the following patents can be claimed: This makes it evident that the genetically modified gene sequence is patentable and so is such a sequence.
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