2nd International Conference on Fostering Interdisciplinary Research In Health Sciences (ICFIRHS) 2019 (01-May-2019)        |

Journal :   Research Journal of Pharmacy and Technology

Volume No. :   11

Issue No. :  7

Year :  2018

Pages :   3081-3086

ISSN Print :  0974-3618

ISSN Online :  0974-360X


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Formation of patent strategy at all stages of biosimilar development and Implementation



Address:   Elena Vyacheslavna Litvinova1*, Olga Viktorovna Posilkina2, Nataliia Fedorovna Maslova3
1Candidate of Biology (PhD), Associate Professor of the National University of Pharmacy, National University of Pharmacy, Ukraine, 61002, Kharkov, 53 Pushkinska str.
2Doctor of Pharmacy, Professor of the National Pharmaceutical University, National University of Pharmacy, Ukraine, 61002, Kharkov, 53 Pushkinska str.
3Doctor of Biology, Professor of the State Enterprise “State Scientific Center of Drugs”, State Enterprise “State Scientific Center of Drugs”, Ukraine, 61085, Kharkov, 33 Astronomicheskaya str.
*Corresponding Author
DOI No: 10.5958/0974-360X.2018.00566.8

ABSTRACT:
The aim of this study is to analyze the specificities formation of patent strategy at all stages of biosimilar development and implementation. Due to the complexity of biological medicinal product structure and the impossibility of accurate reproduction of technology, biosimilar can not be identical to a copy of the original biological medicinal product. The dependence of biological medicinal product from living cells, the functions of which inevitably vary, as well as the presence of impurities can significantly change the properties of biological medicinal product of different manufacturers. On the basis of the above, it follows that when creating a biosimilar there is a possibility of obtaining a new invention. It has established the possibility of biosimilar patent protection at all stages of the life cycle depending on the stage of preparation of registration dossier. It contributes to rational management of the intellectual capital of pharmaceutical companies and more effective drug provision of the population. It has been proved that various stages of the development and implementation of biosimilars should be accompanied by different types of their patenting (pharmaceutical composition, new dosage form, delivery method, optimization of the purification process, increase of stability, new indications for application or new treatment), etc. It has proposed author's algorithm for the formation of patent strategy of biosimilar development and implementation depending on the stage of preparation of the registration dossier.
KEYWORDS:
Biosimilar, registration dossier, patent, strategy.
Cite:
Elena Vyacheslavna Litvinova, Olga Viktorovna Posilkina, Nataliia Fedorovna Maslova. Formation of patent strategy at all stages of biosimilar development and Implementation. Research J. Pharm. and Tech 2018; 11(7): 3081-3086.
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