人體基因序列與診斷方法之專利適格性——以美國 AMP v. USPTO & Myriad Genetics案為中心

The Patent Eligibility of Human Gene and Diagnostic Method: Issues on U.S. Case: AMP v. USPTO & Myriad Genetics

美國專利商標局則從1980年代起，開始核發與基因有關之專利。其在2001年公布的「實用性檢查指引」中，認為人類單離DNA或純化DNA分子，均可賦予專利，且對這些DNA分子的應用，符合其他專利要件時，也可賦予專利。2010年起，美國有一爭議的Myriad案，持續纏訟，該案涉及的是與乳癌基因有關的三項專利。2010年3月29日，紐約南區聯邦地區法院，判決這三項專利都不具有專利適格性。被告不服，提起上訴，2011年7月29日，美國聯邦巡迴上訴法院判決，認為人體單離DNA與自然產物不同，具有專利適格性。最後於2013年6月13日，美國最高法院作出判決，指出單離DNA不具專利適格性。由於此一案件，挑戰了從1980年代起，美國專利商標局就開始核發基因相關專利的作法，引起許多討論。因此，本文打算先對此一爭議做一介紹，讓國人了解美國該案的來龍去脈，以及法院判決的討論。當然，在判決介紹完後，也會適度將美國學者的批判論述，做一整理介紹。最後則簡單比較美國與臺灣專利法規之異同。

United State Patent and Trademark Office (USPTO) have granted gene patents since 1980s. Human isolated DNA and purified DNA both are considered as patent subject matter and could be granted patent if those DNA applications are correspond to the statutory criterion in the Utility Examination Guidelines published in 2001. Association for Molecular Pathology v. Myriad Genetics was a case challenging the validity of gene patents in the United States in 2010, specifically focus on certain claims in issued patents owned by Myriad Genetics that cover isolated DNA sequences which is related to breast cancer and two methods to diagnose. On March 29, 2010, Judge Robert W. Sweet of the United States District Court for the Southern District of New York declared all of the contested claims invalid. On June 16, 2010, Myriad filed its Notice of Appeal. The appeal was granted, and the case was heard in United States Court of Appeals for the Federal Circuit. On July 29, 2011, the Federal Circuit overturned the district court's decision in part and affirmed its ruling in part. Judge Lourie reasoned that isolated DNA is chemically distinct from the natural state of gene in body and there are markedly different between isolated DNA and a natural one. The case finally appealed to the Supreme Court. Justice Thomas, on June 13, 2013, delivered the opinion of the Court that isolated DNS is not patent eligible. This decision is challenging the long standing criterion the USPTO held since 1980s. This article will start from the prior history and bring the exhaustive case background and judgments, and then followed by some comprehensive dissertation. The comparison of patent law between the U.S.A. and Taiwan will described systematic at the end of the article.