Intellectual property rights in animal breeding and genetics
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And, by that we mean to develop an IP strategy that will protect your genomic innovation in all your major markets. A breeding program can be broken down into a number of components. These components include the methods and processes utilized in the program, the genomic material produced or applied in the program and the progeny resulting from the program. It is important to consider what will be your IP strategy for each of these components, both individually and holistically.
Developing an IP strategy for each component as well as the program as whole will ensure that your IP provides you with the maximum protection as well as placing you in the best position possible to monetize and so gain a return on your investment in your breeding program. The question of what aspects of your breeding program you should seek to cover in your IP strategy cannot be considered in a vacuum. It must be considered in the context of whether, and if so, how, IP can be used to protect each of these components and also be used to generate revenue. This leads us to the second question of what form of IP should be deployed in relation to each component of the breeding program as well as the breeding program as a whole.
IP comes in a number of different forms, including patents, confidential information and copyright, each with their pros and cons. However, using a confidential information strategy does not prevent someone else from later and independently developing the same genomic innovation. On the other hand, a patenting strategy gives you a statutory monopoly over your genomic innovation for the patent term.
So you can then rely on your patent rights to prevent others using the genomic innovation the subject of your patent. A foundation consideration here is which forms of IP are available to you, and this may differ from country to country — so think globally. For example, the position on the patentability of biological materials and methods utilizing these materials differs from country to country, so it is vital that you are alive to this issue.
The Myriad litigation played out globally. In Australia, the High Court was asked to consider whether claims directed to the isolated nucleic acid sequences coding for the BRCA1 mutant polypeptide were patentable. The High Court unanimously held that such claims were not patentable. The High Court found that, despite the formulation of the claimed invention as a class of product, in substance the claims were to information embodied in arrangements of nucleotides.
Intellectual Property Rights in Animal Breeding and Genetics - Google книги
The information was not made by human action, it was discerned. It must be brought about by human action. The requirement in each claim that the sequence in the isolate bear specified mutations or polymorphisms was a characteristic of the human being from whom the nucleic acid was isolated. According to the High Court, it had nothing to do with the person who isolated the nucleic acid bearing the mutant sequence.
The High Court, however, left open the question of whether other types of genomic inventions, such as methods which use or apply genomic material, are patentable.
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Here, the Court held patent claims directed to a specified method of identifying a bovine trait from a nucleic acid sample are patentable. The Australian position on the patentability of biological materials and methods utilizing these materials is in contrast to the US position on these issues. In the field of human medical diagnostics, US Courts have considered the patentability of biological materials and methods utilizing these materials in a series of cases including Mayo Collaborative Services v Prometheus Laboratories, Inc.
The net outcome of these cases is that in the US both biological materials as well as methods utilising biological materials or biological markers are not patentable. Who will own the IP? As we have already mentioned, genomic innovation in the livestock sector is being conducted both separately and collaboratively by private companies engaged in the livestock breeding sector, livestock industry associations, universities, private research institutes and government agencies.
So, who will own the IP? It is important to get this right from the outset, so that it is clear who owns the IP in Norton Rose Fulbright — April 09 Genomic innovation in livestock breeding — what is your intellectual property strategy? Under the contract. Following termination of the contract, however, DNAS advertised that it had a database of over , deer genetic profiles and could offer comparisons and lineages for particular types of deer in North America. DNAS argued that it was permitted to use this information as it owned the database.
Stakeholders in the livestock breeding sector are using, and should be using, IP to protect and generate revenue from their investment in genomic innovation. This article has considered three issues which need to be at the forefront of your thinking when planning your IP strategy. In doing so, you will be able to maximize the protection afforded by your IP strategy as well as the revenue that can be generated. The authors would like to acknowledge the invaluable contribution of Anthony Brzoska, Norton Rose Fulbright Australia clerk, who conducted background research on the science underlying the legal issues discussed in this article.
The second, and more important shortcoming was the failure of global political and legal identification of the responsible parties and beneficiaries of any value deriving from the costly conservation actions. After the introduction of the CBD the legal status of AnGRs changed globally as they were politically identified falling under the sovereign power of the signatory parties to the Convention—a major change and complication in access and benefit sharing relations that was later affirmed by the GPA in and later by the Nagoya Protocol.
Understanding the latter is especially important as this understanding exposes the new overarching paradigm under which the value most of the AnGRs today are to be governed. First, the failure to provide a clear direction for conservation relates to the arguments about the overall role of different kinds of AnGRs in animal production.
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When the concept of AnGRs were first introduced among the animal scientist, they were framed in and through two different ways both scientifically informed of demonstrating the role of AnGRs in animal production. Hodges report on genetic resources explained the main differences between the two approaches:.
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This view emphasizes the value of preserving the widest possible spectrum of genetic diversity to be prepared for unpredictable changes of future needs. The greatest possible number of breeds are to be preserved as purebreds. Although analytically distinct from animals or breeds, the animal scientists first presented the issue of AnGR conservation as a choice between isolated genetic components immediately useful in the production of high performance animals or as the maximization of genetic diversity by the conservation of local breeds in their animal forms.
Second, the failure to identify parties responsible for the conservation irked the conversations as this related directly to the economics of conservation, or more generally, to the political economy of global animal production. One can think of live animals, being preserved in situ, or in some semi-artificial situation; alternatively one may think of cryogenic storage of sperm or fertilized ova or other tissues or gene segments.
The economic problems are difficult with both live animals and with haploid or diploid cells. Who is to pay? Although plant varieties and their genetic material were protected by various intellectual property systems since s see Kloppenburg, , AnGRs were used by farmers and breeder associations alike without generalized and specified rights or restrictions imposed at global level. Since there was no definition on the ownership rights over the genetic materials of animals, the global attribution of conservation responsibility through political processes proved to be impossible without more specific consideration.
Yet, for pigs and chicken, ownership and responsibility questions have been more straightforward.
Intellectual Property Rights in Animal Breeding and Genetics
This reflects what Tvedt et al. For poultry and pig breeding, however, where farmers often buy hybrids whose genetics are more difficult to reproduce. The sale of hybrids is thus an important strategy for maintaining physical control over the genetic material by physical control over the material.
For other breeds, in particular cattle, the physical ownership is often combined with a register, a herd book that maintains a protocol for the generations of animals fulfilling the criteria for registration.
The failure to spur action was not based on the scientific challenge to demonstrate the value of AnGRs in animal production or the lack of consensus in setting the priorities of conservation. Instead, and above all, it was a problem of political economy: who is to pay? And even more importantly, who is to benefit?
What become clear over the years was that a global binding framework was needed.
Patent Landscape Report on Animal Genetic Resources
The Convention had been long in preparation and FAO had been involved in its drafting phases influencing, among other issues, the inclusion of genetic resources to and their definition in the Convention text. There were two important re-framings in the Convention.
Genetic resources become genetic material that could be attributed with demonstrable or imaginable value. But the question then arises: who has the right to attribute any value claims to AnGRs? The other reframing answered to this question. With the convention, also AnGRs became tightly nested within the sovereignty of nation-states and their geography. A global cartographic demarcation of nonhuman life took place as these novel objects of nature were grafted to the foundations of national sovereignty.
They became a new part of the body of nations, a novel form of nonhuman nationhood. The convention assumes significant amount of power over AnGR and their governance to signatory nation-states.
Tvedt et al. From the perspective of an exporting country, one of its main concerns is to maintain any property rights it may wish to retain over the AnGR after the resources have left the country. The most prominent rationale for a country to regulate export of AnGR would be to secure a right over that particular material in the future, including preventing that countries or companies gain control over these resources e.