An Overview of the Regulation and Patentability of Human Cloning and Embryonic Stem Cell Research in the United States and Anti-Cloning Legislation in South Korea

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I. INTRODUCTION

Scientists in South Korea have succeeded in obtaining embryonic stem ("ES") cells from cloned human embryos. (1) A report published by the journal Science describes the work, in which thirty embryos, of about one hundred cells each, were created and used to harvest ES cells that later differentiated into a variety of tissue types. (2) While the findings offer hope for treating disease through so-called therapeutic cloning, they have revived legal and ethical debates in the United States. (3)

In this work, a team of researchers led by Woo Suk Hwang of Seoul National University collected two hundred forty oocytes (4) from sixteen unpaid volunteers, who knew their oocytes would be used for scientific experiments. (5) The researchers transferred the nucleus of a somatic cell (6) into an oocyte, which had had its nucleus removed, from the same donor. (7) They used a slightly different technique to extract the contents of the egg--a gentle extrusion technique (8) instead of the more commonly used suction technique (9)--which, together with the optimization of several critical steps, including careful timing and the freshness of the donated eggs, may have aided their success. (10)

Even with these improvements, the researchers could culture only thirty hollow balls of cells called blastocysts, which yielded just one ES cell line. (11) The resulting ES cells differentiated into three tissue types. (12) Furthermore, when transplanted into mice, the cells became more specialized, turning into cartilage, muscle, and bone. (13)

Recent developments in biotechnology confirm the rapid advances in cloning research, exacerbating fears that the specter of human clones looms in the near future. (14) If scientists continue to overcome the technological difficulties, a legal regime that can address human cloning issues may be the only means of controlling the use of this revolutionary technology.

The scientific "society opposes reproductive cloning but strongly supports studies related to stem cells." (15) The National Academy of Sciences declared that therapeutic cloning has scientific potential and should be allowed to continue under appropriate guidelines. (16) The National Institutes of Health and forty Nobel Laureates also attest to the value of this important research. (17) Professor Hwang, who led the research, said, "Our inspiration is to treat incurable disease," and "[a]s scientists, we think that this is our moral obligation [to treat incurable disease]." (18) However, Professor Hwang's work has global political implications, and legislators in many countries remain sharply divided on how to regulate cloning advances or whether to permit them at all. (19) Cloning is not safe. For example, Dolly the sheep was the result of two hundred and seventy-seven attempts to create a living clone. (20) Some believe that cloning treats human life like a commodity. (21) Although it is broadly agreed upon that cloning should not be used to reproduce humans, the technology's use in the laboratory for making ES cells continues to provoke strong feelings on both sides of the debate. (22)

Human cloning is explicitly banned in many countries, including South Korea. (23) Many regulatory positions distinguish between creating a cloned embryo for reproductive purposes (reproductive cloning) and for other purposes such as therapeutic or research cloning. (24) No jurisdiction has adopted legislation or guidelines permitting reproductive cloning. (25) However, with regard to the banning of non-reproductive cloning, countries have taken different positions. (26) According to a report, out of thirty countries studied, seventeen prohibit non-reproductive cloning and thirteen permit it. (27) The regulatory approaches of countries that have adopted regulatory measures on cloning vary greatly and the legal position in some countries remains uncertain. (28)

The patentability of inventions created via human cloning and stem cell research raises another issue, specifically the United States Patent and Trademark Office's ("USPTO") human being exception. …