Volume 19, Issue 60 (4-2025)
MLJ 2025, 19(60): 538-599 |
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Arabzadeh R, Mirghasem M. Criteria for Determining the Inventive Step in Pharmaceutical Patents;
A Study in the Light of the Jurisprudence of the United
States of America and the European Union. MLJ 2025; 19 (60) :538-599
URL: http://ijmedicallaw.ir/article-1-1883-en.html
URL: http://ijmedicallaw.ir/article-1-1883-en.html
1- Department of Private Law, Faculty of Law, Shahid Behehshti University, Tehran, Iran.
Abstract:
Background and Aim: Undoubtedly, assessment the inventive step can be considered the most important challenge of the patent system. The administrative procedure of the patent offices as well as the courts dealing with lawsuits related to patents in various countries show that the method of assessment the inventive step is still confused and has become more serious over time. Since this challenge is more pronounced in some technological fields, including pharmaceutical inventions, due to the inherent complexity of this field as well as its human rights aspects, a specific analysis of the administrative and judicial procedure in this category of inventions seems necessary. Based on this, because identifying and explaining the criteria for determining the inventive step of the patent can be a light for patent experts and lawyers for this category of inventions, in this article, the criteria for determining the inventive step in pharmaceutical patents in the light of the United States of America and the European Union As two leading jurisdictions in patent laws, they are extracted and studied and compared with each other in a transparent manner and finally the efficiency of the Iranian patent system is evaluated.
Method: This research is of a theoretical type and has been written with a descriptive-analytical method and information collection in a library format and by referring to sources, books and documents.
Ethical Considerations: This research has been carried out in compliance with ethical and trustworthy principles.
Results: The jurisprudence of leading countries in the field of patent law shows that special criteria have been considered for evaluating the inventive step of pharmaceutical patents. The mentioned criteria show that in this category of inventions, patent offices and courts have considered the public interest, the right to health and the right to research in a more special way.
Conclusion: The known criteria of the inventive step in the jurisprudence of the studied countries for pharmaceutical patents seem to be ineffective, because they ignore the specific characteristics of this industry. In the field of pharmaceutical patents, we need criteria that, in addition to considering the importance of this field, also take into account the research and executive processes of reaching pharmaceutical products.
Please cite this article as:
Arabzadeh R, Jafarzadeh M. Criteria for Determining the Inventive Step in Pharmaceutical Patents; A Study in the Light of the Jurisprudence of the United States of America and the European Union. Medical Law Journal. 2025; 19: e39.
Method: This research is of a theoretical type and has been written with a descriptive-analytical method and information collection in a library format and by referring to sources, books and documents.
Ethical Considerations: This research has been carried out in compliance with ethical and trustworthy principles.
Results: The jurisprudence of leading countries in the field of patent law shows that special criteria have been considered for evaluating the inventive step of pharmaceutical patents. The mentioned criteria show that in this category of inventions, patent offices and courts have considered the public interest, the right to health and the right to research in a more special way.
Conclusion: The known criteria of the inventive step in the jurisprudence of the studied countries for pharmaceutical patents seem to be ineffective, because they ignore the specific characteristics of this industry. In the field of pharmaceutical patents, we need criteria that, in addition to considering the importance of this field, also take into account the research and executive processes of reaching pharmaceutical products.
Please cite this article as:
Arabzadeh R, Jafarzadeh M. Criteria for Determining the Inventive Step in Pharmaceutical Patents; A Study in the Light of the Jurisprudence of the United States of America and the European Union. Medical Law Journal. 2025; 19: e39.
Type of Study: Original Article |
Received: 2024/10/21 | Accepted: 2025/01/6
Received: 2024/10/21 | Accepted: 2025/01/6
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