분리된 유전자의 특허적격에 대한 연구

Abstract

According to Supreme Court Decision to BRCA gene in U.S.A, an isolated gene has no patentability because the isolated gene is not significantly more from that of nature. Therefore an isolated gene is not patentable according to Article 101 of U.S. patent law. However, as cDNA is markedly different from that of nature, it is patentable. Following the Supreme Court Decision, U.S. Patent and Trademark office made Interim Guidance on Patent Subject Matter Eligibility (IGE). According to the IGE, solely purified microorganism, antibody and enzyme are not patentable. If there is a significantly more variation than that of nature, it is regarded as to be patentable. Australian High Court found that the nature of BRCA gene is information, which is not discernable from the nature’s pre-existed gene. Therefore an isolated BRCA gene is not patentable. In the same way, the nature of cDNA is not discernable from the nature’s pre-existed gene, thus, it also unpatentable. As to microorganism, enzyme and antibody, Australian patent office did not issue special Examination Guideline. However Australian patent office noted that the Australian High Court Decision did not mention that isolated biological materials are not patentable. According to newly issued Australian Examination Guideline, a isolated microorganism is patentable, therefore, it is regarded that there is no big change in the eligibility to the microorganism, enzyme and antibody. In U.S.A and Australia which countries give patent for human diagnostic or treatment method, however, isolated gene is not regarded as patentable. When it is considered that one of the reasons for filing suit for invalidation to the isolated gene in U.S.A and Australia is raised from the Myriad’s strong patent right execution, the big burdens of patent protection in human diagnostic and treatment methods may have effect on the Supreme or High Court decisions to deny the patentability of isolated gene in U.S.A and Australia. The attitudes of U.S.A and Australia to the patentability of isolated gene are not accord with international patent practices which protect isolated gene so far by legal interpretation or substantive enactment. In addition, according to U.S.A and Australia’s positions to isolated gene, the one who first identify the function of a gene could not have patent, but, other one who modify the isolated gene slightly may have patent. This will deprive original-patentee’s rights by improvement-patentee’s rights because original invention is not protected by patent, however, slightly improved invention is protected by patent. For protecting their rights, original inventor may not open their technology to public. This situation is not meet with the purpose of patent system which promotes industrial development by disclosing technology. Therefore, it is more reasonable to protect isolated gene on the contrary to U.S.A and Australia’s Supreme or High Court decisions, however, to restrict patent rights to human diagnostic or treatment methods. Supreme Court Decision in U.S.A and the High Court Decision in Australia give much confusions to the patentability of isolated gene. For the harmonization to the patentability of isolated gene, it is need to make international agreement.