Papers by Dr. Kshitij K. Singh
Intellectual Property Rights in Agricultural Biotechnology and Access to Technology: A Critical Appraisal
Innovation Law & Policy eJournal, 2017
IP protection to agricultural biotechnology has remained a contentious issue in India having seri... more IP protection to agricultural biotechnology has remained a contentious issue in India having serious implications for stakeholders and agricultural innovation. Farmers and plant breeders made strong resistance against the extension of IP monopoly to agriculture sector and were sceptical that their rights could be compromised against the interest of giant agro-based companies. However, the growing need to enhance food production, improve the quality of seeds, experiment the nutritional content of food crops and attract investment in agricultural field necessitated the conjunction of IPR and agricultural biotechnology. India has adopted a dual form of IP protection for agricultural biotechnology; plant varieties are protected through the Protection of Plant Variety and Farmers’ Rights Act 2001, while the genetic traits of plants are protected through the Patents Act 1970. Though the line of demarcation as to the application of both the laws is theoretically drawn, enormous confusion p...
Human Genome and Human Rights: An Overview
Human Therapeutic Cloning and Stem Cell Research: Ethical, Legal and Policy Implications
Kshitij Kumar Singh, "Ownership Puzzle in Human Genetic Material: Legal Perspective" Judicial Training & Research Institute Journal 33rd Issue (Dec 2012) 202-213. Full text of the published article available at http://www.ijtr.nic.in/JTRI%20Journal%202012.pdf
Bioinformatics has emerged as a new discipline to manage biological information by applying infor... more Bioinformatics has emerged as a new discipline to manage biological information by applying information technology tools so that useful results could be produced. Bioinformatics databases and software contain information bearing great potential for medical research. As a new emerging field, bioinformatics needs intellectual property (IP) protection to attract investors and promote innovation. Bioinformatics pose unprecedented challenge before the existing IP regime as the subject matters covered under it differ significantly from traditional subject matters of IP and sometimes they fall under the exclusions. Given the multifarious nature of bioinformatics, it is often difficult to suggest the best form of intellectual property protection to it. Technologies used in bioinformatics are interdependent and can be used as platform technologies and research tools by potential researchers. Aggressive assertion of IP over platform technologies and basic research tools may retard the innovat...
Implications of Patents on Innovation: A Biotechnological Perspective
Implications of Genetic Patents on Human Genetic Resources: Issues of Ownership, Benefit Sharing and Informed Consent
Biotechnology and Intellectual Property Rights, 2014
With the increasing commercialization of human genetic research, human genetic material has becom... more With the increasing commercialization of human genetic research, human genetic material has become a source for patenting. The increased extension of patent rights to human genetic material has serious implications for research subjects and patients whose genetic material is used in the research. The ownership of human genetic material has become a controversial issue as a variety of proprietary rights are claimed over it such as patent rights, personal rights, sovereign rights and academic rights. Among these claims, the ownership rights claims of patients, researchers and research subjects has been contested in courts and started an open debate among legal scholars and policy makers. In genetic research, researchers and sponsors thereof are basically concerned to exploit the human genetic material to earn credit by claiming their exclusive rights. It raises the question, whether may researchers obtain patent rights through observation, isolation and manipulation of the human genetic material, without recognizing and admitting contribution of research subjects and patients who have given their genetic material for the research? The commercial exploitation of human genetic material is not confined to an individual but it also extends to human genetic resources of countries. Trade-Related Aspects of Intellectual Property Rights (TRIPS) does not contain any explicit reference to genetic material, and the laws that restrict access to genetic material to obtain remuneration for the nation such as Convention on Biological Diversity (CBD) exclude human genetic material from their ambit. This has led to a growing exploitation of human genetic resources for scientific or commercial purposes.
Intellectual Property Protection to Bioinformatics and Genomic Databases and Open Source Analogy to Biotechnology
Biotechnology and Intellectual Property Rights, 2014
The recent advances in the field of biotechnology, particularly the development of human genomics... more The recent advances in the field of biotechnology, particularly the development of human genomics and the success of Human Genome Project, make a gene more important because of its informational content rather than its material qualities (physical attributes). The vast amount of genetic and genomic information unleashed by biotechnological advances necessitated devising methods to manage, arrange and catalogue it in a manner that may facilitate its use. This has led to the emergence of a fairly new discipline, bioinformatics, and development of genetic and genomic databases. Intellectual property protection varies according to the technology used in the bioinformatics field such as biological databases, algorithms, complex software etc. While some of these technologies may fit into the existing framework of intellectual property law, others fall outside the scope of current legal protections e.g. databases per se, as collections or arrangements of raw data are generally not patentable. Bioinformatics and genomic databases as new fields need a continuously open and collaborative process for data collection and analysis. In such a situation, strict proprietary protection to genetic and genomic databases may restrict public access to genetic and genomic information. These important aspects of bioinformatics are in direct conflict with the proprietary protection given to it. The most viable option to meet this situation is seen in the open source biotechnology, inspired by the success of open source movement in the field of information technology.
Legal, Social and Policy Implications of Genetic Patents: Issues of Accessibility, Quality of Research and Public Health
Biotechnology and Intellectual Property Rights, 2014
Patenting of human gene and gene fragments has significant legal, social and policy implications ... more Patenting of human gene and gene fragments has significant legal, social and policy implications as it exerts a wide range of effects on the accessibility of genetic research tools, genetic innovation, health policies, patients’ rights, clinical practice and the society at large. The potential of genetic research to produce commercial results has led to the rapid commercialisation of basic genetic research through commercial agreements and patents. The commercialisation of basic genetic research has threatened the free flow and open sharing of academic knowledge. The increased commercialisation of upstream (basic) genetic research has led to patenting of gene fragments such as expressed sequence tags (ESTs) and single nucleotide polymers (SNPs), which are basically research tools. Patenting of these genetic research tools may stifle genetic innovation as a researcher has to negotiate with the patentee about the license terms before using such a research tool. Patenting of genetic testing especially in the field of diagnostics has also become a very controversial issue. Overbroad patent claims and aggressive licensing strategies stifle the innovation process. A US-based multinational healthcare company Myriad Genetics’ patents on breast and ovarian cancer genes, BRCA1 and BRCA2, reflect various social and policy implications involved in patenting of genetic testing.
Patentability of Biotechnology: A Comparative Study with Regard to the USA, European Union, Canada and India
Biotechnology and Intellectual Property Rights, 2014
Modern biotechnological advances have posed new challenges before the existing patent laws of cou... more Modern biotechnological advances have posed new challenges before the existing patent laws of countries as biotechnological inventions differ markedly from chemical and mechanical inventions that have been the traditional subject matter of patents. With the development of human genomics and success of the Human Genome Project, the gene becomes more important because of its informational content rather than its material qualities (physical attributes). Patent is a subject primarily concerned with questions inside a jurisdiction. Although the adoption and ratification of trade-related aspects of intellectual property rights (TRIPS) has brought a unified character to patent laws of member countries of the World Trade Organization (WTO) to a certain extent, these countries have adopted different approaches regarding biotechnology patents in tune with their national policies. As a result, the scope and coverage of biotechnology patents vary from country to country. Even in countries having similar patent laws such as the USA and Canada, interpretations of such laws by courts vary significantly. These variations among countries are important for the proper understanding of the trends in biotech patents. Therefore, the present chapter makes a comparative study of patent laws and practices relating to biotechnology patents in the USA, Canada, European Union and India in order to collate the common issues and the differences among and between them. The USA being a pioneer in biotechnology research exerts great influence upon other countries; the European Union reflects the unified approach of different member states in a politically diversified system; Canada makes a distinction between patenting of higher life forms and lower life forms and India represents the concerns of developing countries.
Patentability of Biotechnology Under the International Patent Regime: Differentiation v. Harmonisation
Biotechnology and Intellectual Property Rights, 2014
International patent regime faces a great challenge to cope up with the new biotechnological adva... more International patent regime faces a great challenge to cope up with the new biotechnological advances. The international patent regime struggles to provide effective patent protection to biotechnology inventions (especially genetic inventions). The TRIPS Agreement sets minimum standards for the member nations to follow while granting patents; however, it leaves potential gaps and uncertainties as to the scope of numerous terms such as invention, microorganisms, microbiological processes and essentially biological processes. These gaps and uncertainties affect developing countries seriously given their relatively slow pace of scientific and technological development. The technology-neutral character of TRIPS does not allow special treatment to biotechnology inventions. International patent regime is the result of the efforts made by member nations to harmonise the patent laws and provide a uniform set of standards for the world. However, in the context of biotechnology patents, the divergence in patent practices among member nations makes it difficult to provide a uniform standard for the whole world. Moreover, there is a political divide between developed and developing countries as developed countries push for expanding the scope of patent eligible subject matter boundary by eliminating the exceptions from the text of TRIPS while developing countries are against this approach. In the biotechnological context, creating a single set of patenting guidelines for the entire world has proved very difficult to achieve given the controversy over issues such as patenting plants and animals. Both uniformity and diversity have potential and pitfalls, and the relevant question is to what extent inter-jurisdictional diversity and competition should be sacrificed to achieve global uniformity.
The author would like to thank all the peer-reviewers for their valuable comments and suggestions... more The author would like to thank all the peer-reviewers for their valuable comments and suggestions. Abstract: IP protection to agricultural biotechnology has remained a contentious issue in India having serious implications for stakeholders and agricultural innovation. Farmers and plant breeders made strong resistance against the extension of IP monopoly to agriculture sector and were sceptical that their rights could be compromised against the interest of giant agro-based companies. However, the growing need to enhance food production, improve the quality of seeds, experiment the nutritional content of food crops and agricultural biotechnology. India has adopted a dual form of IP protection for agricultural biotechnology; plant varieties are protected through the Protection of Plant Variety and Farmers' Rights Act 2001, while the genetic traits of plants are protected through the Patents Act 1970. Though the line of demarcation as to the application of both the laws is theoretically drawn, enormous confusion persists on practical level. The IP protection to agricultural biotechnology has not produced desired results in India due to asymmetrical innovation model, complex regulatory structure and confusing regulatory approach. The exclusive licensing practices with exorbitant licensing fee on uneven licensing terms
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Papers by Dr. Kshitij K. Singh