فناوری ویرایش ژن کریسپر ـ کَس 9 از منظر حقوق مالکیت فکری و ایمنی زیستی

In recent years, inexpensive and fruitful gene editing techniques such as CRISPR-Cas9 and NaAgo have revolutionized the biotechnology industry. Genetically edited organisms, gene therapy, treatment of diseases such as AIDS and editing human cells are some of the marvelous applications of such technologies. Using such technologies in large scale or granting exclusive rights on their products or their application in living organisms might challenge biosafety regulations and patent system principles. The aim of the present article is to analyze the two crucial aspects of CRISPR-Cas9 through a comparative analytical study of the relevant international documents, the procedures of the competent authorities in EU, US and current Iran’s regulations. From biosafety point of view, the main question that we intend to respond is whether gene-edited products can be considered as GMOs or not? The response to this question considering both legal and technical aspects, will determine applicability of the biosafety regulations governing GMOs on the products resulted from CRISPR-Cas9. From intellectual property angle, we discuss the most important challenges with respect to patenting inventions based on CRISPR-Cas9 including inventive step, sufficiency of disclosure, ordre public and morality requirements. At the end, we conclude that trying to match "Gene-Editing Technology" with "Genetic Engineering" through different interpretations of the Cartagena biosafety protocol without considering the Article 31 of the Vienna Conventions on the Law of Treaties (VCLT) which offers clear guidance for the interpretation of treaties also without considering the technical nature of such technologies will have undesirable outcomes. Meanwhile, protecting the Gene Editing Technologies under patent system involves passing patentability requirements and CRISPR-Cas9 based inventions are not excluded from this rule. Therefore, what can be effective in development and appropriate regulating of such technologies from biosafety point of view, also in legal protection of these technologies is indeed development of doctrines. Please cite this article as: Parvin MR, Seyedin A. CRISPR-Cas9 Gene-Editing Technology from Intellectual Property and Biosafety Law Perspective. Iran J Med Law 2017; 11(42): 191-228.