유전자 특허에 대한 Myriad 판결의 의의와 시사점

Abstract

On June 13th 2013, the U.S. Supreme Court announced a historic decision which dealt with the issue of whether isolated DNA or cDNA (complimentary DNA) is a patent eligible subject matter or not. In the midst of tense conflict over the issue, the United States Patent and Trademark Office (USPTO) continued to grant patent registration of isolated DNA. The objective of the USPTO was to achieve technical progress by providing an incentive of monopoly on patent rights. However, such practice was heavily criticized on the ground that it hinders technical progress by making related research more difficult and increases the costs of related medical diagnosis. Under these circumstances, researchers, patients and other organizations brought action against the Myriad company (patentee) seeking a declaration that Myriad's patents including the product claims and method claims (process claims) are all invalid. Parties in the ensuing lawsuit were engaged in a long battle. The U.S. District Court granted a summary judgment to the plaintiffs based on a conclusion that Myriad's patents including the product claims and method claims were all invalid because they covered products of nature and abstract ideas. However, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court's decision in part and reversed it in part. The Federal Circuit held that both the product claims in relation to isolated DNA and cDNA and the method claim for screening potential cancer therapeutics were patent eligible, but method claims for comparing or analyzing isolated DNA sequences were not patent eligible. The U.S. Supreme Court granted the second petition for certiorari only on the question of whether isolated DNA and cDNA production claims were valid. Thereby, the Federal Circuit's decision on method claims became final. The U.S. Supreme Court held that (1) isolated DNA is not patent eligible because it is a product of nature but (2) cDNA is patent eligible because it is not naturally occurring. The decision of the U.S. Supreme Court is significant because it ended the long period of controversy by denying the patent eligibility of isolated DNA. However, in spite of the Myriad decision, some issues over gene patents remain unresolved and Myriad decision may lead to disputes hereafter: (1) cDNA exists in natural state or not, (2) method claims held to be patent eligible satisfy the novelty or non-obviousness requirement, (3) DNA not only isolated but also purified is a patent eligible subject matter, etc.