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专利业务法人HARAKENZO WORLD PATENT & TRADEMARK的商标以地图为背景,在这张地图中,以陆地的大小及形状表示1991年登记的发明专利件数。

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On Human Cloning

February 21, 2003
HARAKENZO WORLD PATENT & TRADEMARK Intellectual Property Law Firm
Patent and Trademark Attorney In Korea, Jungsook CHO

Table of Contents

Introduction
1. What is human cloning?
2. Pros and cons of human cloning
3. World's responses to human cloning
4. Human cloning and the patent system
5. Conclusion

Introduction
On December 27, 2002, a religious organization in the United States officially announced that the first cloned human being-a baby girl-was born. Although it was not scientifically proved that this baby was genuinely a cloned human being, it was highly likely that a cloned human being was actually born, in view of the advancement of life science in the past more than fifty years. The religious organization expects four more cloned babies. It seems that human cloning is not a dream for the distant future, but a real problem to be dealt with now.
Human cloning is copying a human embryo, which is in a cell stage after an egg is fertilized by sperm and before it is grown to be a fetus, so that babies having the same genes are born in succession.
After the New York Times first reported this in 1993, human cloning became an issue of global attention. At that time, the New York Times used the term "cloning of human embryos." In the following, the meaning of human cloning is discussed first. Then, conflicting views are presented as to whether to support or oppose human cloning. Finally, the relationship between human cloning and the patent system is analyzed, although the situation surrounding human cloning may be too premature to discuss this topic.

1. What is human cloning?
(1) Human cloning as an abstract notion
As an abstract notion, human cloning means producing human beings having not only the same genetic traits, but also the same appearance, personality, emotions, hobbies, abilities, memories, etc.
This may be the reason why most people express a distaste for the word "human cloning". However, the human cloning in question today is biological human cloning, that is, creating an individual genetically identical to another individual. Here, the term "individual" has dual meanings: an individual human being or an embryo.

(2) Human individual cloning
Human individual cloning is a method for creating a human being genetically identical to another human being. There are two kinds of human individual cloning technologies: fertilized egg division and body cell nuclear transfer. The cloned sheep "Dolly," which was made public by Dr. Ian Wilimut of the United Kingdom in February 1997, was created by the body cell nuclear transfer method.

(3) Human embryonic cloning
Human embryonic cloning is technically the same as human individual cloning. However, its purpose is not to obtain an individual, but to obtain embryonic stem cells before they are completely differentiated, and to study their formation process. Many scientists are interested in the formation process of embryos because of its significance for the advancement of clinical medicine and basic biology. Embryonic stem cells can be used to treat intractable diseases, such as diabetes.

(4) Organ cloning
Organ cloning means cloning an entire organ using a cell that is a part of the organ. Since fertilized eggs are not used for this research, no serious ethical problem has been caused.

2. Pros and cons of human cloning
(1) Arguments that support human cloning
Some scientists argue that human cloning should be allowed for the rights and freedoms of sciences. According to them, the body cell nuclear transfer method, which is a human individual cloning method, makes it possible to fertilize eggs without sperm, and is therefore a hope for couples suffering from sterility. The researches on human embryonic cloning allows for the incubation of organs for transplantation, the regeneration of skins damaged, for example, by burn injury, and the regeneration of brain cells. In addition, human cloning is also effective to treat diabetes, cancers, dementia, and incurable hereditary diseases. For these reasons, the scientists argue that human cloning should basically be allowed.

(2) Arguments against human cloning
Those who are against human cloning fear that it may cause religious/ethical, legal and social problems. The religious/ethical problem is that the artificial manipulation of human lives is an insult and a challenge to God, and that it ruins human dignity. The legal problem is that human cloning may disrupt the legal order based on blood ties and family communities. The social reason is about marriage and family system as a basis of the human society, which may face serious crisis if human cloning becomes available.

3. World's responses to human cloning
So far, no consensus has been reached to establish a global norm to prohibit human cloning. Different countries have different views as to whether to prohibit or allow researches on body cells for the treatment of intractable diseases and hereditary diseases. However, no country allows human cloning.
At present, those who support the researches on embryos argue that embryos younger than 14 days old are not living things in the strict sense, and therefore experiments in human embryonic cloning for medical purposes, such as the treatment of intractable diseases, should be allowed. Further, the Human Genome Organization declared in September 30, 1999, "HARAKENZO more" are against human cloning, but human embryonic cloning for research purposes should be allowed." On the other hand, the United Kingdom, where the first cloned sheep was born, prohibits intrauterine embryonic transfer and the incubation of cloned embryos, while being the first in the world to legalize the researches on human embryonic cloning.
Moreover, an international convention prohibiting human cloning was adopted and ratified by the member states of Council of Europe. This convention prohibits human cloning using embryonic separation, nuclear transfer and other technologies, allowing only cell cloning and organ cloning for research purposes under strict conditions.

4. Human cloning and the patent system
None of these arguments as to whether or not human cloning should be allowed is conclusive. In my opinion, such all-or-none kind of thinking can be stopped by discussing, instead, how to set the scope of the term "human being" and the ethical status of embryos.
These days, fewer and fewer scholars and scientists who predict the future deny that organ producing and storing banks, frozen cell storing banks, and life cloning services will be universalized in light of the expected industrial structure of the new century.
That being the case, isn't it now inevitably required to establish ethical principles as to all the researches related to life ethics, such as the researches on human cloning and embryos and the researches on gene manipulation, and to provide a guideline on the scopes and methods of these researches, and appropriate legal protective measures?
Once such a basis is established, it will be possible to determine the scope of achievements of these researches that can be protected by the patent system.
Until now, those inventions related to methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body have not been patentable because the Japan Patent Office has considered them as industrially inapplicable (Examination Guidelines).
However, in recent Japan, there are moves toward changing this policy so as to grant patents to new medical technologies, such as the methods of regenerating skins and organs. Furthermore, there is growing awareness that protection in the form of patents is necessary to generate funds to be reinvested for developing new technologies of the next generation and to motivate developers, since advanced medical technologies require large budgets for research and development.
From this viewpoint, it would be necessary to protect, by patents, at least those achievements of researches on human embryonic cloning such as the incubation of organs for transplantation, the regeneration of skins damaged, for example, by burn injury, and the treatment of intractable diseases.
I hope that the patent policy will change according to the changing social needs.

5. Conclusion
Among today's advanced technologies, what I expect will have the greatest impact on human lives are those technologies related to life science. Life cloning technologies are dangerous in that it can lead to human individual cloning, and, at the same time, are medically beneficial.
In my personal opinion regarding the pros and cons of human cloning, I find it inappropriate to think only one standpoint is absolutely right. In order to overcome the negative effects of advanced technologies that may occur in the future, why not calmly study human cloning, which has already become our reality, and lead it in the right direction, rather than unconditionally oppose it?

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