Pitfalls of patenting and state authorization of medicines

During the lifecycle of a medicine - from its development to consumption - the developer has to go through several stages, such as obtaining the exclusive right for a medicine, obtaining permission to produce the medicine, obtaining permission to distribute and use the medicine, i.e. the developer h...

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Main Authors: V. I. Semenov, E. B. Gavrilova, N. B. Lyskov
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2018-02-01
Series:Регуляторные исследования и экспертиза лекарственных средств
Subjects:
Online Access:https://www.vedomostincesmp.ru/jour/article/view/64
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author V. I. Semenov
E. B. Gavrilova
N. B. Lyskov
author_facet V. I. Semenov
E. B. Gavrilova
N. B. Lyskov
author_sort V. I. Semenov
collection DOAJ
description During the lifecycle of a medicine - from its development to consumption - the developer has to go through several stages, such as obtaining the exclusive right for a medicine, obtaining permission to produce the medicine, obtaining permission to distribute and use the medicine, i.e. the developer has to patent and register the invention and obtain a marketing authorization for it. In order to accomplish these procedures that fall within the remit of the Federal Service for Intellectual Property and the Ministry of Health of Russia, developers have to submit documents described in relevant legislative acts. The article describes the patenting procedure used by the Federal Service for Intellectual Property, including examination as to form and substantive examination. It also addresses some problems associated with patenting medicines and their state authorization. A conclusion is drawn on the importance of searching for unexpired patents and their analysis in order to prevent situations in which developers of medicines infringe the rights of others.
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publisher Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
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series Регуляторные исследования и экспертиза лекарственных средств
spelling doaj.art-80d991c59aaa48069ee0fa556dc291a72025-03-02T10:46:39ZrusFederal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)Регуляторные исследования и экспертиза лекарственных средств3034-30623034-34532018-02-0104434662Pitfalls of patenting and state authorization of medicinesV. I. Semenov0E. B. Gavrilova1N. B. Lyskov2Federal State Budgetary Institution «Federal Institution of Industrial Property» of Federal Service for Intellectual PropertyFederal State Budgetary Institution «Federal Institution of Industrial Property» of Federal Service for Intellectual PropertyFederal State Budgetary Institution «Federal Institution of Industrial Property» of Federal Service for Intellectual PropertyDuring the lifecycle of a medicine - from its development to consumption - the developer has to go through several stages, such as obtaining the exclusive right for a medicine, obtaining permission to produce the medicine, obtaining permission to distribute and use the medicine, i.e. the developer has to patent and register the invention and obtain a marketing authorization for it. In order to accomplish these procedures that fall within the remit of the Federal Service for Intellectual Property and the Ministry of Health of Russia, developers have to submit documents described in relevant legislative acts. The article describes the patenting procedure used by the Federal Service for Intellectual Property, including examination as to form and substantive examination. It also addresses some problems associated with patenting medicines and their state authorization. A conclusion is drawn on the importance of searching for unexpired patents and their analysis in order to prevent situations in which developers of medicines infringe the rights of others.https://www.vedomostincesmp.ru/jour/article/view/64medicinepatentmarketing authorizationлекарственное средствопатентрегистрационное удостоверение
spellingShingle V. I. Semenov
E. B. Gavrilova
N. B. Lyskov
Pitfalls of patenting and state authorization of medicines
Регуляторные исследования и экспертиза лекарственных средств
medicine
patent
marketing authorization
лекарственное средство
патент
регистрационное удостоверение
title Pitfalls of patenting and state authorization of medicines
title_full Pitfalls of patenting and state authorization of medicines
title_fullStr Pitfalls of patenting and state authorization of medicines
title_full_unstemmed Pitfalls of patenting and state authorization of medicines
title_short Pitfalls of patenting and state authorization of medicines
title_sort pitfalls of patenting and state authorization of medicines
topic medicine
patent
marketing authorization
лекарственное средство
патент
регистрационное удостоверение
url https://www.vedomostincesmp.ru/jour/article/view/64
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