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Who owns our genes?

Genes are the constituent elements of a human body. Genetic research has been carried out to find answers to several questions pertaining to diseases, drug discovery, diagnostics and therapeutics. It is an expensive mode of research and development. As a result, many researchers and developers see the need to secure intellectual property protection by means of patents. This not only secures their expensive invention from being duplicated elsewhere but also provides collateral for funding. But genetic patenting has been in news for quite some time. For many, it is difficult to fathom how a third party can claim ownership over ones genes. Moreover, patenting restricts access to knowledge which in turn provides a setback to the research community. In the light of the above mentioned, the United States Supreme Court deliberated on the celebrated case of Association for Molecular Pathology v. Myriad Genetics. The decision changed to quite an extent the patent eligibility requirements for a naturally occurring gene. It left several previously granted patents vulnerable to be invalidated. The United States Patent and Trademarks Office laid down guidelines for examination of such patent applications, post this decision. The research service highlights such details in the field of gene patenting.

Research Scope
-Can a third party own my genes? Are they no longer mine? These are very mind boggling questions.
-It seems that with the advent of technical/technological inventions and their protection by various means, it is possible that market players can not only make use of an individual’s genes for research but also extract economic gains out of it, when the individual stands to gain nothing, apparently, out of it.
-Through this research service, an effort has been made to study the developments in the field of gene patenting.
-The various benefits and issues regarding gene patenting have been highlighted.
-There are several controversies, both social and legal, which throw light on this subject.
-The matter proves to be extremely intriguing for every participant in the value chain of gene patenting.
-Over the years, the standpoint has undergone several modifications, further adding to the curiosity.
-A recent US Supreme Court judgment provided a valid dais for several interesting debates pertaining to whether genes should be patented or not.
-The research service provides the details of this thought provoking decision and its impacts.
-The US Patent and Trademark Office (USPTO) has provided a new set of guidelines to judge if such matter forms a part of the patent eligibility criteria.
-United States has been chosen as the country of study to understand the legal jurisprudence of gene patenting.

Expensive Biotechnology R&D
-According to Research America, in 2012, the United States of America spent $ billion on medical and health research, which forms % of the gross expenditure on R&D; estimates place the cost of developing and testing a new pharmaceutical entity at around $ billion.
-Due to the high expenses involved in pharmaceutical innovations, it is essential for the industry to seek intellectual property protection.
-The incentive effect of patents is highly pronounced in the pharmaceutical industry.
-As per research carried out by Southern Polytechnic State University, biotechnology firms are able to earn between to % more on inventions that are patented when compared to those inventions which are not.
-For startups working with genes, patents form a collateral to obtain investments for the enormously expensive R&D.
-Therefore, to recover the expenses involved in genetic R&D, patents serve as an important instrument.

Table Of Contents

Genes and Patents: Evolution; Controversies and Perspectives (Technical Insights)
Research Scope 3
Benefits of Gene Patenting 5
History of Genes and Gene Patenting 8
Statistics 12
Standards of Gene Patentability 17
Issues Regarding Gene Patenting 23
Gene Patents and Bioethics 27
Understanding Association For Molecular Pathology v. Myriad Genetics 31
Aftermath of The Myriad Ruling 43
Key Findings 49
The Frost and Sullivan Story 52

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