Volume 18, Issue 59 (4-2024)
MLJ 2024, 18(59): 516-545 |
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Jabbari A R, Parvin A R J M R. A Comparative Analysis on the Assessment of Novelty and Inventive Step of New Forms or Derivatives of Known Substance or Drugs,
Case Study: Enantiomers and Active Metabolites. MLJ 2024; 18 (59) :516-545
URL: http://ijmedicallaw.ir/article-1-1789-en.html
URL: http://ijmedicallaw.ir/article-1-1789-en.html
1- Department of Intellectual Property Law, Faculty of Law, Shahid Beheshti University, Tehran, Iran.
2- -Department of Microbial Biotechnology, Agricultural Biotechnology Research Institute of Iran (ABRII), Agricultural Research, Education and Extension Organization (AREEO), Karaj, Iran.
2- -Department of Microbial Biotechnology, Agricultural Biotechnology Research Institute of Iran (ABRII), Agricultural Research, Education and Extension Organization (AREEO), Karaj, Iran.
Abstract:
Background and Aim: Patentability of salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and new derivatives of known substance as examples of second-generation pharmaceutical innovation developed from the prior art or basic innovations, have been the subject of fierce legislative, judicial and academic debates. The present paper aims to examine novelty and inventive step requirements of enantiomers and active metabolites as two important examples of new forms or derivatives of known substance or drug in the United States, the European Union, India and Iran.
Method: The research method is Analytical-Comparative. It has been prepared and compiled by library method using note-taking techniques.
Ethical Considerations: In this research, the authenticity of the texts, honesty and fidelity have been observed.
Results: The United States and the European courts assess the novelty and inventive step of an isolated enantiomer based on several factors such as prior disclosure of the racemic mixture, known stereochemical effects in the prior art, the degree of difficulty in separation of enantiomers and secondary considerations. However, in contrast to the enantiomers, disclosure of prodrug in the prior art destroys novelty of active metabolites. In India, the mere enhancement of the known efficacy is sufficient for patenting new forms or derivatives such as enantiomers and active metabolites.
Conclusion: Considering the challenges we discussed, the silence of the Iranian Patent, Industrial Design and Trademark Law of 2007 and the exclusivity of Article 4(2) of the new Industrial Property Protection Parliamentary Plan concerning the exclusion of the new use of known products or processes from patentability, could be resulted to obtain a patent for other examples of secondary pharmaceutical inventions, especially new forms or derivatives of known substances or drugs such as enantiomers, but the patentability of such inventions is still needed to address serious and interdisciplinary considerations in the legislative field.
Please cite this article as:
Jabbari AR, Parvin MR. A Comparative Analysis on the Assessment of Novelty and Inventive Step of New Forms or Derivatives of Known Substance or Drugs, Case Study: Enantiomers and Active Metabolites. Medical Law Journal. 2024; 18: e36.
Method: The research method is Analytical-Comparative. It has been prepared and compiled by library method using note-taking techniques.
Ethical Considerations: In this research, the authenticity of the texts, honesty and fidelity have been observed.
Results: The United States and the European courts assess the novelty and inventive step of an isolated enantiomer based on several factors such as prior disclosure of the racemic mixture, known stereochemical effects in the prior art, the degree of difficulty in separation of enantiomers and secondary considerations. However, in contrast to the enantiomers, disclosure of prodrug in the prior art destroys novelty of active metabolites. In India, the mere enhancement of the known efficacy is sufficient for patenting new forms or derivatives such as enantiomers and active metabolites.
Conclusion: Considering the challenges we discussed, the silence of the Iranian Patent, Industrial Design and Trademark Law of 2007 and the exclusivity of Article 4(2) of the new Industrial Property Protection Parliamentary Plan concerning the exclusion of the new use of known products or processes from patentability, could be resulted to obtain a patent for other examples of secondary pharmaceutical inventions, especially new forms or derivatives of known substances or drugs such as enantiomers, but the patentability of such inventions is still needed to address serious and interdisciplinary considerations in the legislative field.
Please cite this article as:
Jabbari AR, Parvin MR. A Comparative Analysis on the Assessment of Novelty and Inventive Step of New Forms or Derivatives of Known Substance or Drugs, Case Study: Enantiomers and Active Metabolites. Medical Law Journal. 2024; 18: e36.
Type of Study: Original Article |
Received: 2024/02/27 | Accepted: 2024/07/25
Received: 2024/02/27 | Accepted: 2024/07/25
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