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自1992年《生物多样性公约》确立事先知情同意原则以来,国际社会一直为建立更有效的生物材料国际保护机制而努力。本文认为在国际生物材料特殊保护机制确立之前,在充分发展的国际专利法体系中有所落实的事先知情同意原则,可以满足广大发展中国家的现实需要,是较为现实的选择。修订后的专利法可以要求生物材料的利用者在申请专利时,揭示实施发明方案所必需的生物材料的来源,并提交已获生物材料所有人事先知情同意的证据。不过,专利法不应让专利机关对事先知情同意的证据进行实质审查,也不应要求申请人提交利益分享方面的证据。
Since the principle of prior informed consent was established by the Convention on Biological Diversity in 1992, the international community has been working hard to establish a more effective international protection mechanism for biological materials. This paper argues that prior to the establishment of a special mechanism for the international protection of biological materials, the principle of prior and informed consent that is implemented in the fully developed system of international patent law can satisfy the real needs of the vast number of developing countries and is a more realistic choice. The revised patent law could require users of biological materials to disclose the source of the biological material necessary for the implementation of the inventive step when applying for a patent and to submit evidence of prior informed consent of the owner of the biological material. However, the patent law should not allow the patent office to substantively examine the evidence of prior informed consent, nor should the applicant be required to submit evidence of benefit-sharing.