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Patentability of Human Embryonic Stem Cells: Finding the Balance between the Moral Hazard in Europe and the Wide Scope in the US

Thorstenson, Anna (2008)
Department of Law
Abstract
Stem cells are the first type of cells developed in an embryo. They have the ability to divide, self-replicate, for indefinite periods. Under the right conditions or given the right signals, stem cells can give rise to the many different cell types. The isolation of human embryonic stem cells (HESC) and the ability to cultivate them in a laboratory has given hope to treat diseases like cancer, Alzheimer's, diabetes, HIV, Parkinson's, spinal cord injuries and heart diseases. Stem cell research not only creates possibilities but also raises fundamental ethical issues concerning what constitutes human life and the value of such research compared to the feared violation of human life. In the EU, there is no unified law for patents, both the... (More)
Stem cells are the first type of cells developed in an embryo. They have the ability to divide, self-replicate, for indefinite periods. Under the right conditions or given the right signals, stem cells can give rise to the many different cell types. The isolation of human embryonic stem cells (HESC) and the ability to cultivate them in a laboratory has given hope to treat diseases like cancer, Alzheimer's, diabetes, HIV, Parkinson's, spinal cord injuries and heart diseases. Stem cell research not only creates possibilities but also raises fundamental ethical issues concerning what constitutes human life and the value of such research compared to the feared violation of human life. In the EU, there is no unified law for patents, both the intergovernmental European Patent Convention (EPC) and national laws govern. The EPC provides for a centralized search and examination process by the EPO, which results in the issuance of a European patent that translates into national patents for the states designated in the application. The issued patents are then governed by the respective national laws. The Biotech Directive, addressed the patent protection of biotechnological inventions. While the EPO did not need to comply with the Directive because it is independent of the EU, it voluntarily decided that the Directive was essentially a summary of its case law, and thus reframed its interpretation to comply with the Directive. EU members have been slow to adopt the Directive based on moral concerns, and there may be deviations from the Directive even in countries that have adopted it. The goal was harmonization among EU members, which was seen as necessary to encourage investment in biotechnology and avoid barriers to trade that, would arise from different members offering different protections. However, the interpretation of the Directive has led to divergent implementation of the moral clauses, and since there is no European definition of the term ''embryo'', controversial national legislation is met. The principal problem seems to be the destruction of the embryo, which at present is necessary for derivation of embryonic stem cells. There are however new technologies advancing towards creating embryonic stem cells without destroying the embryo. In the US, the human embryonic stem cells are patentable subject matter. The WARF patents and all what they include, have undoubtedly a hindering effect on the research climate on the other side of the Atlantic. This broad patent grants, makes it more or less impossible to continue research on embryonic stem cells, no matter their origin or the way they are produced, without the consent of WARF. The question whether those stem cells should be regarded as research tools and kept in the public domain and how to narrow their scope, is widely discussed. This thesis investigates the patentability of human embryonic stem cells in Europe and the US. It focuses on Europe and the interpretation of the Biotech Directive in relation to the lack of integration between EC law and the EPO system, and shows the difficult task to define a European moral norm on the embryo itself. The divergent approaches leads to the question whether HESC are excluded from patentability on moral grounds in Europe, while in the US, the patent on HESC is too broad to be effective. Conclusively, the isolated stem cells are in a completely different state than their origin and should therefore be a patentable subject matter. (Less)
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author
Thorstenson, Anna
supervisor
organization
year
type
H3 - Professional qualifications (4 Years - )
subject
keywords
EG-rätt, Immaterialrätt
language
English
id
1562558
date added to LUP
2010-03-08 15:55:30
date last changed
2010-03-08 15:55:30
@misc{1562558,
  abstract     = {Stem cells are the first type of cells developed in an embryo. They have the ability to divide, self-replicate, for indefinite periods. Under the right conditions or given the right signals, stem cells can give rise to the many different cell types. The isolation of human embryonic stem cells (HESC) and the ability to cultivate them in a laboratory has given hope to treat diseases like cancer, Alzheimer's, diabetes, HIV, Parkinson's, spinal cord injuries and heart diseases. Stem cell research not only creates possibilities but also raises fundamental ethical issues concerning what constitutes human life and the value of such research compared to the feared violation of human life. In the EU, there is no unified law for patents, both the intergovernmental European Patent Convention (EPC) and national laws govern. The EPC provides for a centralized search and examination process by the EPO, which results in the issuance of a European patent that translates into national patents for the states designated in the application. The issued patents are then governed by the respective national laws. The Biotech Directive, addressed the patent protection of biotechnological inventions. While the EPO did not need to comply with the Directive because it is independent of the EU, it voluntarily decided that the Directive was essentially a summary of its case law, and thus reframed its interpretation to comply with the Directive. EU members have been slow to adopt the Directive based on moral concerns, and there may be deviations from the Directive even in countries that have adopted it. The goal was harmonization among EU members, which was seen as necessary to encourage investment in biotechnology and avoid barriers to trade that, would arise from different members offering different protections. However, the interpretation of the Directive has led to divergent implementation of the moral clauses, and since there is no European definition of the term ''embryo'', controversial national legislation is met. The principal problem seems to be the destruction of the embryo, which at present is necessary for derivation of embryonic stem cells. There are however new technologies advancing towards creating embryonic stem cells without destroying the embryo. In the US, the human embryonic stem cells are patentable subject matter. The WARF patents and all what they include, have undoubtedly a hindering effect on the research climate on the other side of the Atlantic. This broad patent grants, makes it more or less impossible to continue research on embryonic stem cells, no matter their origin or the way they are produced, without the consent of WARF. The question whether those stem cells should be regarded as research tools and kept in the public domain and how to narrow their scope, is widely discussed. This thesis investigates the patentability of human embryonic stem cells in Europe and the US. It focuses on Europe and the interpretation of the Biotech Directive in relation to the lack of integration between EC law and the EPO system, and shows the difficult task to define a European moral norm on the embryo itself. The divergent approaches leads to the question whether HESC are excluded from patentability on moral grounds in Europe, while in the US, the patent on HESC is too broad to be effective. Conclusively, the isolated stem cells are in a completely different state than their origin and should therefore be a patentable subject matter.},
  author       = {Thorstenson, Anna},
  keyword      = {EG-rätt,Immaterialrätt},
  language     = {eng},
  note         = {Student Paper},
  title        = {Patentability of Human Embryonic Stem Cells: Finding the Balance between the Moral Hazard in Europe and the Wide Scope in the US},
  year         = {2008},
}