Theory and practice of intellectual property
№ 6 / 2021

ISSN (Print) 2308-0361
ISSN (Online) 2519-2744

PDF (Ukrainian)

DOI: https://doi.org/10.33731/62021.249108

Published      2021-12-27

Key issues of legal regulation of the supplementary protection of inventions in the field of pharmacy in the national legislation of Ukraine

Anastasiia Homeniuk
Ukraine
https://orcid.org/0000-0002-6431-918X

Abstract
The article is devoted to the study of key issues of legal regulation of supplementary protection of inventions after the adoption of the Law of Ukraine «On Amendments to Certain Legislative Acts of Ukraine on Patent Legislation Reform» in the absence of bylaws to regulate the procedure for issuing supplementary protection certificates. The study also highlights the main shortcomings and gaps in the regulation of certain issues of application of supplementary protection certificates in the current Law of Ukraine «On protection of rights to inventions and utility models».

The author in details analyses European Union approaches to definition of the subject matter of the supplementary protection, providing criteria which are recommended to use in order to decide whether the product is covered by the basic patent in force. Also, the paper is focusing on the issues related to verification of data and materials provided together with the application for a certificate — such as whether the requirement that the medicinal product must be submitted for marketing authorization in Ukraine no later than during one year after it’s first marketing authorization in the world, whether the authorization provided is the first authorization in Ukraine, etc.

Another problem which is highlighted in the study is the application of the rule to submit the petition for obtaining supplementary protection to those patents and marketing authorizations which were issued before the amendments to the Law came in force, as this question remained unresolved due to the lack of transitional provisions in the Law. Also author points out the necessity to align the provisions of the Article 271 of the Law of Ukraine «On Protection of Rights to Inventions and Utility Models» regarding the definition of the subject matter of supplementary protection in accodance with patent legislation by excluding application of the medicinal product from the list as it is not patentable according to Ukrainian law. In addition, the author emphasized the urge to adopt relevant bylaws (procedure) regulating the issue of certificates of supplementary protection.

Keywords: supplementary protection certificate, basic patent, procedure for obtaining supplementary protection certificate

References

European Commission, Explanatory Memorandum to the Proposal for a Council Regulation (EEC), of 11 April 1990, concerning the creation of a supplementary protection certificate for medicinal products (COM(90) 101 final – SYN255).
https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A51990PC0101

Wenzel R. Analoge Anwendung der Verordnung über das ergänzende Schutzzertifikat fürArzneimittel auf Medizinprodukte? / Robert Wenzel., 2017. 253 с.

Про охорону прав на винаходи і корисні моделі : Закон України від 15.12.1993 р. № 3687-XII.
https://zakon.rada.gov.ua/laws/show/3687-12/ed20200816#Text

Silverman A. The Relationship Between Basic and Improvement Patents [Електронний ресурс] / Arnold B. Silverman // JOM, 47 (1) (1995), p. 50. 1995.
https://www.tms.org/pubs/journals/JOM/matters/matters-9501.html

Judgment of the Court (Fifth Chamber) of 16 September 1999. (Farmitalia Carlo Erba Srl.). Case C-392/97.

Order of the Court (Eighth Chamber), 14 November 2013 (Glaxosmithkline Biologicals SA). Case C 210/13.

Капіца Ю. Сертифікат додаткової охорони лікарських засобів ЄС та продовження строку чинності патенту на винахід в Україні. Теорія і практика інтелектуальної власності. 2016. № 5. С. 49–56.

Judgment of the Court (Fourth Chamber) of 30 April 2020 (Royalty Pharma Collection Trust). Case C 650/17.

Judgment of the Court (Third Chamber) of 12 December 2013 (Eli Lilly and Company Ltd). Case C 493/12.

Examination Guidelines for supplementary protection certificate, as of 23 January 2015.
https://www.dpma.de/docs/service/formulare_eng/patent_eng/p2799_1.pdf

Рішення Конституційного Суду України у справі за конституційним зверненням відкритого акціонерного товариства «Концерн Стирол» щодо офіційного тлумачення положення абзацу першого пункту 1 частини першої статті 12 Господарського процесуального кодексу України (справа про оспорювання актів у господарському суді) від 2 липня 2002 року № 13-рп/2002. Вісник Конституційного Суду України. 2002. № 4. С. 4.

Приватне право в сфері охорони здоров’я: виклики та перспективи. Київські правові читання. Матеріали міжн. наук.-практ. конф. Київ, 17 вересня 2020 р. [Електронне видання] / Р. А. Майданик, К. В. Москаленко та ін. ; відп. ред. Р. А. Майданик. Львів : Медицина і право, 2020. 264 с.

Supplementary Protection Certificates Guide For Applicants. Intellectual Property Office. 2013.
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/309167/spctext.pdf