인간 유전자와 유전자 진단 방법의 특허대상발명 여부

Abstract

In March 2010, the United States District Court for the Southern District of New York held that Myraid Genetics, Inc.’s patents on the breast cancer genes (“the BRCA1/BRCA2 genes”) and the methods analyzing and comparing the DNA sequences should be invalidated because they are not patent-eligible subject matter under U.S. patent law. The court has found that isolated and purified genes are not patentable because they are “not markedly different” from their counterpart in nature, i.e., a product of nature. It has also found that the methods for genetic diagnosis are unpatentable because they involve no physical “transformations” associated with the process, i.e., noncompliant with the machine or transformation test set in Bilski. The decision delivered by Judge Robert Sweeet was quite unexpected because the courts and the U.S. patent office have been routinely granting patents on genes and methods for genetic diagnosis for the past several decades, not to mention the patent examination standards and practices of other industrialized countries on genes and methods for genetic diagnosis today. Myriad Genetics, Inc. in fact holds about 20 patents on the BRCA1/BRCA2 genes and the BRCA1/BRCA2 diagnostic methods internationally. Since they were all very broad-scoped patents and Myriad Genetics, Inc. strictly exercised its patents against others to establish an international monopoly on the BRCA1/BRCA2 genetic testing, the validity of them have been challenged by many genetics laboratories, genetics societies, and even governments around the world. The BRCA1/BRCA2 gene patents were first challenged in Europe, and as a result, the scope of them have been significantly narrowed. Then, the Ontario government fought against the patents in Canada, and this has eventually made Myriad Genetics, Inc. leave the Canadian BRCA1/BRCA2 genetic testing market. The BRCA1/BRCA2 gene patents are now being challenged in Australia. However, none of the challenges made so far has resulted in or is going to result in the invalidation of the whole patent claims to the BRCA1/BRCA2 genes and the BRCA1/BRCA2 genetic testing, except the U.S. challenge. This article, therefore, reviews, analyzes, and makes comments on the U.S. challenge to the BRCA1/BRCA2 gene patents, Association for Molecular Pathology v. United States Patent and Trademark Office. To better analyze the U.S. case, it comparatively reveiws patent examination standards and practices on the patent eligibility of genes and methods for genetic diagnosis under European, Canadian, Australian, and U.S. patent law. It also reviews the European, Canadian, and Australian challenges to the BRCA1/BRCA2 gene patents as well as the U.S challenge. Based on those analyses, this article finally makes comments on the implication of the case and predicts the results of the appeal.