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随着分子生物技术的进步,个人化医疗(Personalized Medical)与分子诊断的医疗照护方式,已成当今医疗的新方向。然而去年(2012)三月由美国最高法院的一个案例的判决,却使得和个人化医疗发展最相关的临床诊断专利的专利适格标的争议,再度地成为众所注目的焦点。据了解该判决认Pro-metheus公司的医疗诊断专利,因为不具备美国专利法第101条规定的专利标的适格性(Patentable Subject Matter),属于自然现象之一,不应获得专利的保护。Prometheus案判不仅让医疗检测相关方法发明,未来取得专利保护的可能性受到限缩,而自然法则不受专利保护原则的阐释,亦对美国生技医药产业专利布局的未来走向,产生深刻的影响。
With the advancement of molecular biology, personalized medical care and molecular diagnosis of medical care have become the new direction of medical treatment. However, a case last year (March 2012) by the Supreme Court of the United States of America resulted in the re-emergence of a controversy over the patent eligibility criteria for clinically diagnosed patents most relevant to personalized medical development. It is understood that the judgment recognized Pro-metheus’ patent for medical diagnosis because it does not have the Patentable Subject Matter as set forth in Article 101 of the U.S. Patent Law. It is a natural phenomenon and should not be protected by a patent. The Prometheus trial not only allowed the invention of medical test-related methods, but also limited the possibility of patent protection in the future, while the natural law was not explained by the principle of patent protection and had a profound impact on the future direction of the patent layout in the biopharmaceutical industry in the United States .