Features of legal protection of medical inventions: present and future

Authors

  • V. I. Teremetskyi Ternopil National Economic University, Ukraine,
  • A. V. Matviichuk International University of Economics and Humanities named after academician Stepan Demianchuk, Rivne, Ukraine,
  • O. M. Muzychuk Kharkiv National University of Internal Affairs, Ukraine,
  • M. H. Shcherbakovskyi Kharkiv National University of Internal Affairs, Ukraine,
  • O. V. Oderii Donetsk Law Institute of Ministry of Internal Affairs of Ukraine, Kryvyi Rih, Ukraine,

DOI:

https://doi.org/10.14739/2310-1237.2019.3.188972

Keywords:

Invention, biotechnological inventions, method of treatment, patent holder, treatment, ethics

Abstract

 

The modern legal doctrine of intellectual property practically does not investigate the terms of legal protection of inventions in medical practice.

Aim. Therefore, the purpose of the article is to clarify the features of the legal protection of medical inventions, the prospects for its improvement.

Materials and methods. The study of the peculiarities of the legal protection of inventions in medical practice is based on a systematic approach, in particular, a critical analysis of the state of modern patent law in Ukraine and the prospects for its improvement through the implementation of European legislation in the field of medical inventions. Through comparative legal method the analysis of the Specialized Database of Ukrpatent “Inventions (Utility Models) in Ukraine” concerning the identification of patents for medical discoveries has been carried out.

Results. Inventions within medical practice have a specific feature that is manifested in their industrial suitability (sphere of application – medicine) and possibility of fair use only after examination, in particular, medical and biological or clinical trials (experiments) involving human being. Types of inventions in medical practice are: methods of human treatment, devices for the treatment and diagnosis of a person, medicines, strains of microorganisms used to diagnose a person’s disease or for treatment, biotechnological inventions.

Conclusions. The peculiarity of medical inventions is as follows: they have their own distinctive division due to the scope of invention’s application (the method of treatment, diagnosis, etc.); must undergo medical and biological or clinical trials (experiments); they must meet ethical requirements. It is established that it requires legislative consolidation at the level of the Law of Ukraine “On Protection of Rights to Inventions and Utility Models”:  Ethical Requirements Regarding Biotechnological Inventions; balance of interests, rights of patients and patent holders; the grounds and conditions for granting a compulsory license for medical inventions; the implementation of Directive 98/44/EC of the European Parliament and Council of 07/06/1998 on the legal protection of biotechnological inventions.

 

References

Konstytutsiia Ukrainy [The Constitution of Ukraine]. Zakon Ukrainy No. 254к/96-VR (1996). Retrieved May 7, 2019 https://zakon.rada.gov.ua/laws/show/254%D0%BA/96-%D0%B2%D1%80?lang=en [in Ukrainian].

Schwertner, H. A. (1994). Patenting Medical Inventions. Military Medicine, 159(12), 729-732. doi: 10.1093/milmed/159.12.729

Dyke, T., & Anderson, W. P. (2014). A history of health and medical research in Australia. Medical Journal of Australia, 201(S1). https://doi.org/10.5694/mja14.00347

Tran, V.-T., & Ravaud, P. (2016). Frugal innovation in medicine for low resource settings. BMC Medicine, 14(1). https://doi.org/10.1186/s12916-016-0651-1

Demetska, O. (2017). Reformuvannia sfery okhorony zdorovia mekhanizmamy prava intelektualnoi vlasnosti [Healthcare reformation by intellectual property mechanisms]. Farmatsevt Praktyk, 7-8. 4-5.

Poriadok nadannia Kabinetom Ministriv Ukrainy dozvolu na vykorystannia zapatentovanoho vynakhodu (korysnoi modeli), shcho stosuietsia likarskoho zasobu. Postanova Kabinetu Ministriv Ukrainy vid 04.12.2013 no. 877 [Cabinet of Ministers of Ukraine. (2013, December 4). On the procedure for granting authorization for the use of the registered invention (useful model), concerning the medicinal agent by the Cabinet of Ministers of Ukraine (No. 877). Retrieved from http://zakon3.rada.gov.ua/laws/show/877-2013-%D0%BF [in Ukrainian].

Pro utvorennia robochoi hrupy z pytan intelektualnoi vlasnosti ta dostupu do likarskykh zasobiv. Nakaz MOZ vid 28.09.2012 No. 165/1 [Ministry of Health of Ukraine. (2012, September 28). On working group formation concerning intellectual property and access to medicine remedies (No. 759, No. 165/1)]. Retrieved from https://zakon.rada.gov.ua/rada/show/ru/v0759282-12 [in Ukrainian].

Poiasniuvalna zapyska do proektu Zakonu Ukrainy “Pro vnesennia zmin do deiakykh zakonodavchykh aktiv Ukrainy shchodo vdoskonalennia pravovoi okhorony vynakhodiv ta korysnykh modelei” vid 01.02.2018 No. 7538 [Explanatory memorandum to the draft law of Ukraine “Concerning the Introduction of Amendments to Certain Legislative Acts of Ukraine on Improvement of Legal Protection of inventions and utility models (2018, February 1 No. 7538)]. Retrieved from http://search.ligazakon.ua/l_doc2.nsf/link1/GH5TE00A.html [in Ukrainian].

Latimer, M. T. (2005). Patenting inventions arising from biological research. Genome Biology, 6(1). https://doi.org/10.1186/gb-2004-6-1-203

Petrenko, V. M., Korzhov, V. I., Haiovych, A. I., Kunichkina, S. A., & Sokyrko, T. O. (1994). Ukrainian Patent No. 1808. Sposib likuvannia tuberkulozu lehen [Method for treatment of pulmonary tuberculosis]. Retrieved from https://base.uipv.org/searchINV/search.php?action=viewdetails&IdClaim=39553

Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (OJ L 213, 30.7.1998, p. 13). Retrieved from http://www.wipo.int/wipolex/ru/text.jsp?file_id=126957

Mehta, H., Tidwell, L., & Liotta, L. A. (2017). Inventions and Patents: A Practical Tutorial. Methods in Molecular Biology Molecular Profiling, 379-397. https://doi.org/10.1007/978-1-4939-6990-6_25

Miladinovic, Z., Varga, S., & Radojkovic, M. (2013). Patent law protection of inventions in medicine and pharmaceutical industry. Vojnosanitetski Pregled, 70(6), 600-605. https://doi.org/10.2298/vsp1306600m

Italian Code of industrial property: Leglislative Decree No. 30 (2005, February 10), as amended by Legislative Decree No.°131 (2010, August). Retrieved from http://www.wipo.int/edocs/lexdocs/laws/en/it/it204en.pdf

Salitskaya E. A. (2016). Razgranichenie ponyatii "izobretenie" i "otkrytie" v kontekste pravovoi okhrany dostizhenii v oblasti gennoi inzhenerii [Demarcation of the concepts ‘invention’ and ‘discovery’in the context of legal protection of genetic engineering developments]. Nauka. Innovatsii. Obrazovanie, 2, 104-121. [in Russian].

The European Patent Convention (n.d.). Retrieved May 11, 2019 from European Patent Office website https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/index.html

Raza, M., Dharamshi, H. A., Ahsan, S. Z., Naqvi, Z., Naqvi, T., Ali, A. A. M., & Abbas, J. M. (2016). The Future of Ethics in Medicine. Iranian Red Crescent Medical Journal, 18(6). https://doi.org/10.5812/ircmj.26900

Pro okhoronu prav na vynakhody i korysni modeli. Zakon Ukrainy No. 3687-XII [Verkhovna Rada of Ukraine. (1993, December 15). On Protection of Rights to Inventions and Utility Models (No. 3687-XII)]. Retrieved from http://zakon5.rada.gov.ua/laws/show/3687-12/page [in Ukrainian].

Pro zakhyst suspilnoi morali. Zakon Ukrainy No 1296-IV (20, November 2003). [Verkhovna Rada of Ukraine. (2003, November 20). On Protection of Public Moral (No. 1296-IV)]. Retrieved from from http://zakon3.rada.gov.ua/laws/show/1296-15 [in Ukrainian].

Pravyla rozhhliadu zaiavky na vynakhid ta zaiavky na korysnu model. Nakaz Ministerstva osvity i nauky Ukrainy No 197 (15 March, 2002). [Ministry of Education and Science. (2002, March 15). Rules for Considering an Application for Invention and Usable Model Application (No. 197)]. Retrieved from https://zakon.rada.gov.ua/laws/show/z0364-02 [in Ukrainian].

Pro likarski zasoby. Zakon Ukrainy No. 123/96-ВР (4 April, 1996) [Verkhovna Rada of Ukraine. (1996, April 4). On Medicinal Products (No. 123/96-ВР)]. Retrieved from https://zakon.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80?lang=en [in Ukrainian].

Pavlov A. V. (2012). Patentovanie metodov lecheniya pri nalichii usloviya patentosposobnosti “tekhnicheskoe reshenie” [Treatment methods patenting in the presence of patentability “technical solutions” condition]. Vestnik Rossiiskogo novogo universiteta, 3, 72-75. [in Russian].

How to Cite

1.
Teremetskyi VI, Matviichuk AV, Muzychuk OM, Shcherbakovskyi MH, Oderii OV. Features of legal protection of medical inventions: present and future. Pathologia [Internet]. 2019Dec.23 [cited 2024Nov.23];(3). Available from: http://pat.zsmu.edu.ua/article/view/188972

Issue

Section

Review