Science technology innovation №1(9) 2019


Androshchuk H.O. — PhD in Economics, Associate Professor, Chief Senior Researcher, Head of Laboratory of Legal Support of Science and Technology Research Institute of the National Academy of Legal Sciences of Ukraine Intellectual Property, 11 Kazуmirа Malevуchа Str., 4 Bldg., Kyiv, Ukraine, 03680; +38 (044) 200-08-76;

Rabotiahova L.I. — Head of the Patent Law Branch of the Industrial Property Department Research Institute of the National Academy of Legal Sciences of Ukraine intellectual property, 11, Kazуmirа Malevуchа Str., Bldg. 4, Kyiv, Ukraine, 03680; +38 (044) 200-08-76;


Abstract. An economic and legal analysis of the state and development trends of patenting inventions in the pharmaceutical industry has been carried out. Analyzed the dynamics of investment in research and development in the pharmaceutical industry in the US and the EU, the cost of developing new drugs and their profitability. The innovative cycle of creating a medicinal product at the stages of preclinical and clinical trials, the effectiveness of inventive activity in the pharmaceutical industry has been investigated. The practice of introducing additional protection evidence in the EU has been studied. Considered in detail the regulatory framework and the practice of regulating the extension of the term of a patent in the United States. The growing importance of generic drugs is shown, ensuring a balance of competing interests between promoting medical innovation and providing access to them, which are the main focus of public policy makers, health activists and the private sector. It is emphasized that the foreign practice of extending the additional term of a patent for medicines to five years in developing countries leads to additional costs from national health budgets and adversely affects patients’ access to medicines.

Keywords: invention, generic, medicinal products, national security, patent, innovations, additional protection certificate, pharmaceuticals.


  1. The pharmaceutical industry and global health: facts and figures. Retrieved from:
  2. Androshchuk, H.O. (2015). Stratehii patentuvannia u farmatsevtytsi yak zasib blokuvannia dostupu na rynok [Patenting strategies in pharmacy as a means of blocking access to the market] Problemy nauky [Problems of science], 4-5 (172-173), 60-66.
  3. Promoting Access to Medical Technologies and Innovation Intersections between public health, intellectual property and trade. Retrieved from:
  4. Vorozhevich, A.S. (2017). Kruglyy stol «Intellektualnaya sobstvennost na farmatsevticheskom rynke» [Round Table «Intellectual Property in the Pharmaceutical Market»]. Zhurnal Suda po intellektualnym pravam [Journal of the Court on Intellectual Property], 15, 14-20.
  5. Androshchuk, G.A. (16–18 Sep. 2013). Innovatsionnaya politika i strategii farmatsevticheskikh kompaniy: aspekty intellektualnoy sobstvennosti. XII Mizhnarodna naukovo-praktychna konferentsiia «Aktualni pytannia intelektualnoi vlasnosti» [Innovative policy and strategies of pharmaceutical companies: aspects of intellectual property. XII International scientific and practical conference «Actual issues of intellectual property»] (pp. 11–30). Yalta (AR Krym, in. Ukr.).
  6. Kondratiuk, S. (2018). Chomu potribna patentna reforma shchodo likarskykh zasobiv v Ukraini? [Why is Patent Reform for Drugs in Ukraine Needed?]. Intelektualna vlasnist v Ukraini [Intellectual Property in Ukraine], 4, 26-31.
  7. Androshchuk, H.O., Rabotiahova, L.I. (2017). Prodovzhennia stroku dii patentu na vynakhid: mizhnarodnyi dosvid pravovoho rehuliuvannia [Prolongation of the patent for an invention: international experience of legal regulation]. Monograph. Scientific-Research Institute of Intellectual Property of the National Academy of Sciences of Ukraine. Kyiv: Interservis, 128 p.
  8. Lybecker, K. Embrace IP That Works: Importance of Supplementary Protection Certificates (SPCs) in the European Union. Retrieved from:
  9. Survey on the grant and publication of “Supplementary protection certificates” for medicinal and phytopharmaceutical products or equivalent industrial property rights (SPCs). Handbook on industrial property information and documentation: Appendix 21 US. Retrieved from:
  10. Androshchuk, H.O. (2014) Hromadske zdorovia, likarski zasoby y intelektualna vlasnist: stan i problemy [Public Health, Medicines and Intellectual Property: Condition and Problems]. Teoriia i praktyka intelektualnoi vlasnosti [Theory and Practice of Intellectual Property], 1, 72-84.
  11. Tthe Benefits of Competition for Patients. Retrieved from:
  12. Brachmann, S. China extends drug patent exclusivity to 25 years. Retrieved from:
  13. Drug Pricing. Retrieved from:
  14. Genericheskie medikamenty [Generic medicines]. Retrieved from:
  15. Kucherenko, S. Dovholittia na prodazh: yaki liky y tekhnolohii Ukraina postavliaie do inshykh derzhav i v chomu eksportna tsinnist farmatsevtychnoi haluzi [Longevity for sale: what drugs and technologies Ukraine delivers to other countries and what is the export value of the pharmaceutical industry]. Retrieved from:
  16. Stefanyshyna, O. Rynok likiv v Ukraini: derehuliuvannia chy kastruvannia [Drug Market in Ukraine: Deregulation or Casting]. Retrieved from: