A New Era for Biotech Patents? Empirical and Theoretical Considerations on the current Patent Dilemma, BioLaw Journal, 2021, pp. 289-303 (original) (raw)
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PATENTING GENOMICS INNOVATIONS:POST-MYRIAD CHALLENGES AND POSSIBILITIES .
Patenting gene and its nucleotide sequence has been a controversial subject since the release of working draft ofthe Human Genome Project. A number of US Supreme Court judgmentspronounced in the recent past and accordingly revisedpatent examination strategies of the United States Patent and Trademark Office (USPTO)created a huge confusion in the field of biotechnology. The present article explores the volatile nature of judicial decision-making inmodern biotechnology arena and attempts to analyze and gaugethe practical impact of the landmark judgment of Association for Molecular Pathology v. Myriad genetics Inc. The present article also reveals how the Myriadjudgmentchanged the USPTO’s long-standing practice of granting patents on isolated DNA molecules and set a new patent-eligibility standard for genes and DNA related innovations. The present article also endeavors to investigate the challenges and possibilities of patenting isolated proteins, sequence homology and protein three-dimensional structure based innovations in post-Myriad US patent regime.
2016
Kamperman Sanders, A., Bostyn, S., Iserentant, H., Sattler de Sousa eBrito, C., Taormino, J., Farquharson, A., Jacob, R., Knuth Lethola, S., Pereira, G., Puigdomènech, P., Schneider, I., Czörgö, S., Then, C., Würtz Lindum, P., & Yates, S. (2016). Final Report of the Expert Group on the development and implications of patent law in the field of biotechnology and genetic engineering. European Commission.
Comparative Law Review, 2014
The paper analyzes the forms and limitations of patent protection recognition for biotechnological inventions. In this perspective, the paper compares the American model, traditionally based on technical evaluations, and the European model, inspired by fundamental rights. Intellectual property law, and especially biotechnological patent law, in fact, often involves and/or faces off with the exercising of fundamental rights. In particular, the issues analyzed and the considerations proposed highlight how the regulation of biotechnological inventions should guarantee a fair balance between protection of investment and access to information which is essential for research and innovation. In this framework, the recent US Supreme Court decision in Myriad and Mayo (and the subsequent USPTO Patent Eligibility Guidance), along with the European ECJ's decision in Brüstle and that of the EPO in WARF, appears to lead toward a common "Western approach" to the regulation of biotechnological inventions, with specific regard to the limits of patentability. Such an approach could be based, indeed, on the balance of fundamental rights and public and private interests, which are relevant on a case-by-case basis, resorting to the criteria of hierarchy and proportionality in order to regulate value-based choices and functional interactions between them. Finally, the same approach would be particularly relevant to the current perspective, which is aimed at enhanced transatlantic cooperation on the matter of intellectual property, specifically within the framework of the "Transatlantic Trade and Investment Partnership"(TTIP) that is presently being negotiated.
Patents in the Era of Genomics: An Overview
Recent Patents on DNA & Gene Sequences, 2012
The recent developments in biotechnology are the emerging science of "omics"-genomics, proteomics, transcriptomics and metabolomics. The state of the art sequencing technology has led to the deciphering of whole genome sequences of various microbes, plant, human and animals. The outcomes of genomics in the form of various genes, gene fragments, single nucleotide polymorphism, promoters and other regulatory sequences are a subject matter for patents based on its applications spanning agricultural, biomedical and industrial sectors. The patenting of genes and sequences is a debatable issue which has led to several controversies over recent years. With the accumulation of huge amount of sequences in various databases as a result of various genome sequencing projects worldwide, there is an immediate need for clarification of patenting genes and sequences. This review article gives an insight into patents based on development of genomics highlighting some of the patents based on deoxyribonucleic acid, genes, sequences and other related genetic material and gene technologies. Patents on single nucleotide polymorphism, stem cells, biomarkers for cancer diagnosis and treatment, microbial genes and plant genes are also discussed.
Patents in genomics and human genetics
Annual review of genomics and human genetics, 2010
Genomics and human genetics are scientifically fundamental and commercially valuable. These fields grew to prominence in an era of growth in government and nonprofit research funding, and of even greater growth of privately funded research and development in biotechnology and pharmaceuticals. Patents on DNA technologies are a central feature of this story, illustrating how patent law adapts-and sometimes fails to adapt-to emerging genomic technologies. In instrumentation and for therapeutic proteins, patents have largely played their traditional role of inducing investment in engineering and product development, including expensive post-discovery clinical research to prove safety and efficacy. Patents on methods and DNA sequences relevant to clinical genetic testing show less evidence of benefits and more evidence of problems and impediments, largely attributable to university exclusive licensing practices. Whole-genome sequencing will confront uncertainty about infringing granted p...
Patents and Genetic Engineering Technologies: A Review of Judicial Decisions
IIUM Law Journal, 2021
Different classes of people have raised moral objections on a number of times against granting patents on living organisms. There has been a recent focus on patents partly because the corporate world is only concerned with economic returns and the market prospect of a genetic product. The purpose of this article is to revisit the debate on the patent of genetic engineering technologies and provide partial recommendations on rationalising patent protection while mitigating moral arguments. This article re-examines the intellectual property frameworks as well as case laws regarding biological materials in selected countries i.e., Europe, the United States of America, Australia, Malaysia, and under international agreements such as the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). This article is based on primary as well as secondary materials that have been written on the patent of life forms and genetic research. There is an inconsistency between phil...