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Patenting Human DNA Sequences; Absolute Product Patents - A Reasonable Degree of Protection?

Gustafsson, Andreas (2007)
Department of Law
Abstract
The legal controversy on ''patents on life'' is not new but in the last two decades, we have seen the debate be intensified. Although patents on biological material have been allowed in the United States since the emergence of Diamond v. Chakrabarty in 1980, it was not until scientists at the National Institute of Health tried to patent thousands of gene fragments in the early nineties that the debate was really infected. Today, most people with insight to the patent system agree that the patenting of DNA sequences is an instrumental factor to spur innovation in the biotechnological field and provide a higher standard of healthcare. However, the patent system comes with a cost&semic it provides a legal monopoly for a certain amount of... (More)
The legal controversy on ''patents on life'' is not new but in the last two decades, we have seen the debate be intensified. Although patents on biological material have been allowed in the United States since the emergence of Diamond v. Chakrabarty in 1980, it was not until scientists at the National Institute of Health tried to patent thousands of gene fragments in the early nineties that the debate was really infected. Today, most people with insight to the patent system agree that the patenting of DNA sequences is an instrumental factor to spur innovation in the biotechnological field and provide a higher standard of healthcare. However, the patent system comes with a cost&semic it provides a legal monopoly for a certain amount of years for an inventor to recoup the expenses and profit on the invention. While the protection is essential for the patent system to work, the question is: How big of a reward should the inventor receive for his invention? Is it fair to allow protection not only for the disclosed functions of the invention or should the scope of protection be limited only to those functions? Advocators for allowing an absolute product patent claim that a limited protection is not sufficient for the inventor to recoup the expenses and if the inventor cannot profit from the invention he will find no incentives to invest in the field. On the other side are the proponents of a purpose-bound protection claiming that the absolute product patent provides such a broad scope that it deters investors from entering the field anyway. Product patents are allowed by the EPC and it is not a requirement to allow patents only on purpose-bound basis. However, with the arrival of the Biotech Directive in 1998, many leading experts called for the purpose-bound protection to be introduced. Consequently, when all member states of the European Union finally managed to implement the Directive in national law, we saw many countries that only permitted purpose-bound patents. Amongst others, France and Germany decided to take this approach. The effect of their action is yet to be seen, however it adds an extra dimension to the debate seeing these big and influential countries decide against the absolute product patent. In more recent time, with the beginning of the issuance of new stricter utility guidelines in the United States in 2001, we have seen a more stringent approach to the patentability requirements that has led to a considerably higher patentability threshold. As a result, the stricter appliance of the patentability requirements and the disclosure requirement now exclude those gene fragments without known utility that money-hungry companies claimed in masses during the ''patent gold rush'' in the nineties. At the same time, it means that the majority of the patents today are narrower than those issued in the early days of gene patenting, thus giving the inventor a reward that corresponds more appropriately to the contribution made to the society. The stricter patentability requirements along with the prediction that fewer absolute product patents will be granted due to the subject matter not being able to meet the patentability requirements makes me argue that there is no need to limit the protection given to an inventor should he be able to meet the requirements. Another important factor is that the patenting of DNA sequences per se seems to stagnate, statistics supports the view that most of the claims in the future relating to human DNA sequences will not claim the DNA sequence per se, rather the sequence will be regarded as a part of the invention. In the end, there is a good chance that we will see a shift in the way human genes are claimed without the legislator having to intervene. (Less)
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author
Gustafsson, Andreas
supervisor
organization
year
type
H3 - Professional qualifications (4 Years - )
subject
keywords
Immaterialrätt
language
English
id
1557904
date added to LUP
2010-03-08 15:55:21
date last changed
2010-03-08 15:55:21
@misc{1557904,
  abstract     = {{The legal controversy on ''patents on life'' is not new but in the last two decades, we have seen the debate be intensified. Although patents on biological material have been allowed in the United States since the emergence of Diamond v. Chakrabarty in 1980, it was not until scientists at the National Institute of Health tried to patent thousands of gene fragments in the early nineties that the debate was really infected. Today, most people with insight to the patent system agree that the patenting of DNA sequences is an instrumental factor to spur innovation in the biotechnological field and provide a higher standard of healthcare. However, the patent system comes with a cost&semic it provides a legal monopoly for a certain amount of years for an inventor to recoup the expenses and profit on the invention. While the protection is essential for the patent system to work, the question is: How big of a reward should the inventor receive for his invention? Is it fair to allow protection not only for the disclosed functions of the invention or should the scope of protection be limited only to those functions? Advocators for allowing an absolute product patent claim that a limited protection is not sufficient for the inventor to recoup the expenses and if the inventor cannot profit from the invention he will find no incentives to invest in the field. On the other side are the proponents of a purpose-bound protection claiming that the absolute product patent provides such a broad scope that it deters investors from entering the field anyway. Product patents are allowed by the EPC and it is not a requirement to allow patents only on purpose-bound basis. However, with the arrival of the Biotech Directive in 1998, many leading experts called for the purpose-bound protection to be introduced. Consequently, when all member states of the European Union finally managed to implement the Directive in national law, we saw many countries that only permitted purpose-bound patents. Amongst others, France and Germany decided to take this approach. The effect of their action is yet to be seen, however it adds an extra dimension to the debate seeing these big and influential countries decide against the absolute product patent. In more recent time, with the beginning of the issuance of new stricter utility guidelines in the United States in 2001, we have seen a more stringent approach to the patentability requirements that has led to a considerably higher patentability threshold. As a result, the stricter appliance of the patentability requirements and the disclosure requirement now exclude those gene fragments without known utility that money-hungry companies claimed in masses during the ''patent gold rush'' in the nineties. At the same time, it means that the majority of the patents today are narrower than those issued in the early days of gene patenting, thus giving the inventor a reward that corresponds more appropriately to the contribution made to the society. The stricter patentability requirements along with the prediction that fewer absolute product patents will be granted due to the subject matter not being able to meet the patentability requirements makes me argue that there is no need to limit the protection given to an inventor should he be able to meet the requirements. Another important factor is that the patenting of DNA sequences per se seems to stagnate, statistics supports the view that most of the claims in the future relating to human DNA sequences will not claim the DNA sequence per se, rather the sequence will be regarded as a part of the invention. In the end, there is a good chance that we will see a shift in the way human genes are claimed without the legislator having to intervene.}},
  author       = {{Gustafsson, Andreas}},
  language     = {{eng}},
  note         = {{Student Paper}},
  title        = {{Patenting Human DNA Sequences; Absolute Product Patents - A Reasonable Degree of Protection?}},
  year         = {{2007}},
}