美國生物科技新專利適格性原則之研究

A Study on the Biotechnological New Patent Eligibility Doctrine under U.S.

鑑於美國最高法院重新激活了專利適格性標的要件，其認為涉及發明的自然法則、自然現象或抽象概念，除非它們也包含「發明的概念」，否則不具專利適格性，因而引發了巨大爭議。因為新專利適格性原則不當削弱了美國在創新中的領導地位，而且它們已經給美國專利制度注入了巨大的法律不確定性，所以美國應重新思考生物技術產業創新的激勵措施生物技術公司的專利適格性在不同的國家面臨不斷的改變，故必須發展保護生物技術創新的全球策略，可行的發展策略應是根據國家的法律標準申請專利。

In view of the United States Supreme Court has reinvigorated the patent-eligible subject matter requirement, holding that inventions directed to laws of nature, natural phenomena, or abstract ideas are not eligible for patenting unless they also contain an ''inventive concept.'' As a result, the Supreme Court has sparked tremendous controversy. Since the new patent eligibility doctrine is undermining U.S. leadership in innovation, so the U.S. shall reconsider the incentives for innovation in the biotechnologyindustry. Biotech companies facing constant changes in patent eligibility in different countries have to develop global strategies for protecting biotechnology innovations, and a recommended strategy is to file patent applications tailored to the legal standards of the countries of interest.