Pharmaceutical innovations patenting: the experience of the Russian Federation, the United States of America, the European Union
- Authors: Lebedeva D.A.1
-
Affiliations:
- National Research University “Higher School of Economics”
- Issue: Vol 65, No 3 (2021)
- Pages: 269-275
- Section: LITERATURE REVIEW
- Submitted: 25.10.2024
- URL: https://hum-ecol.ru/0044-197X/article/view/637755
- DOI: https://doi.org/10.47470/0044-197X-2021-65-3-269-275
- ID: 637755
Cite item
Full Text
Abstract
Introduction. When patenting pharmaceutical innovations, in the context of rapid technological progress, pharmaceutical companies often have to face identifying patentable objects both in the Russian Federation and in the United States of America and the European Union.
The aim of the study is to review the possibilities for patenting pharmaceutical innovations in the Russian Federation, the United States of America and the European Union, as well as to identify the advantages and disadvantages of legal regulation of innovative solutions of pharmaceutical companies in the context of the specifics of legal systems.
Material and methods. The national legislation in patenting medical innovations was studied, and the relevant experience of the USA and the European Union was analyzed. The methodological basis of the research is made up of both general scientific and private scientific legal methods: systemic, method of concretization, methods of synthesis and analysis, as well as the comparative-legal method.
Results. Depending on the legislator’s position, a basis is being formed for the legal regulation of innovative solutions of pharmaceutical companies, which may not yet be named in regulatory legal acts due to their fundamental novelty. Legal gaps and conflicts in the US and the EU are resolved through in-depth analysis and consideration of each specific dispute by the court. In Russia, the settlement of this issue is on the way to solving it through local regulations and the position of the relevant federal executive bodies.
Conclusion. Patenting in the pharmaceutical field is mainly of a stimulating nature, since it allows protecting innovative solutions at the stage of their development. However, the legislator has particular difficulties in identifying patentable objects in the context of rapid technological progress.
Acknowledgements. The study had no sponsorship.
Conflict of interest. The author declares no conflict of interest.
About the authors
Diana A. Lebedeva
National Research University “Higher School of Economics”
Author for correspondence.
Email: lebedevady@yandex.ru
ORCID iD: 0000-0003-0070-8300
Bachelor of Law Programme, National Research University “Higher School of Economics”, Moscow, 101000, Russian Federation.
e-mail: lebedevady@yandex.ru
Russian FederationReferences
- Attaran A. Physicians and patent law. Lancet. 2003; 361(9357): 613–4. https://doi.org/10.1016/s0140-6736(03)12538-x
- Fasse W.G. Basic patentability requirements in the United States and Germany. J. Pat. Off. Soc. 1962; (44): 27.
- Guidelines for Patent Examination. State Intellectual Property Office of the Peoples’ Republic of China; 2010. Available at: https://wipolex.wipo.int/en/legislation/details/5484
- Gurgula O. Strategic patenting by pharmaceutical companies – should competition law intervene? IIC. 2020; 51: 1062–85. https://doi.org/10.1007/s40319-020-00985-0
- Henry D., Lexchin J. Patent law. Lancet. 2003; 361(9357): 1059. https://doi.org/10.1016/s0140-6736(03)12810-3
- Kaushik S. In or Out. Method of treatment. Patent perspective. Available at: https://www.patentwire.co.in/wp-content/uploads/2019/05/Method-of-Treatment.pdf
- Melzer D. Patent protection for medical technologies: why some and not others? Lancet. 1998; 351(9101): 518–9. https://doi.org/10.1016/s0140-6736(97)02432-x
- Tuominen N. Patenting strategies of the EU pharmaceutical industry crossroad between patent law and competition policy. Research Paper in Law. 2011; (1). Available at: https://aei.pitt.edu/44320/1/researchpaper_1_2011_tuominen.pdf
- European Commission. Pharmaceuticals: EU refines intellectual property rules. Available at: https://ec.europa.eu/growth/content/pharmaceuticals-eu-refines-intellectual-property-rules_en
- Pressman D. Patent it yourself: your step-by-step guide to filing at the U.S. Patent office. 15th ed. Nolo; 2012: 10–3.
- State Register of Medicines. Available at: https://grls.rosminzdrav.ru (in Russian)
- Eurasian Economic Commission Available. Common Market for Medicines. Available at: https://portal.eaeunion.org/_layouts/15/cit.eec.impop/portal.landings/drugs.aspx (in Russian)
- Tolkacheva D.G., Torgov A.V., Margazova A.S. International approaches to the government price control over generics and biosimilars: a review. Sovremennaya farmako-ekonomika i farmakoepidemiologiya. 2017; 10(4): 15–42. https://doi.org/10.17749/2070-4909.2017.10.4.015-024 (in Russian)
Supplementary files
