Theory and practice of intellectual property
№ 3 / 2020
ISSN (Print) 2308-0361
ISSN (Online) 2519-2744
PDF (Ukrainian)DOI: https://doi.org/10.33731/32020.214636
Published 2020-11-23
Research on “evergreen patents” in the Ukrainian pharmaceutical market
Oksana Kashyntseva
Ukraine
https://orcid.org/0000-0002-2598-5614
Mykyta Trofymenko
Ukraine
Abstract
The article presents the results of the research on the part of «evergreening patents» in the pharmaceutical market of Ukraine focusing on the daft laws registered in the Ukrainian Parliament (Verkhovna Rada) of Ukraine. The authors analyse the criteria of patent abuse as obstacles to access to treatment, and analyse the novel initiatives aimed at overcoming such abuse. In particular, it concerns the patentability’s criteria of inventions on pharmaceutical products, the possibility to oppose the applications on inventions by a person whose rights or interests are violated by a patent application and prohibition of patenting substances as the utility models.
At the level of the national legislation patent reform was initiated by the Parliament of Ukraine on the first reading by the draft Law of Ukraine «On Amendments to Certain Legislative Acts of Ukraine (on Patent Law Reform)» as of October 10, 2019. For the national experts, drafting the mentioned Law, the necessity to provide evergreening research in the field of health care was obvious from the 2014. In 2014 year, the National Academy of Law Sciences of Ukraine in close cooperation with NGO 100 % of Life started the global research — Harmonization of Human Rights and Intellectual Property Rights in the Field of Medicine and Pharmacy. We have to stress that only the evergreening patent research in the pharmaceutical market of Ukraine took near three years. The Research reflects that the gaps of the Ukrainian patent system which causes the possibility to grant evergreening patents have the straight impact on access to vital treatment. The methodology of the research is based on the Guidelines on Examination of the Patent Application in the field of Medicine and Pharmaceuticals based on the recommendations of the WHO and Guidelines for the Examination of Patent Applications Relating to Pharmaceuticals of the UNDP.
Thus, the subject of the research is 132 patents covering vital medicines in the field of HIV, hepatitis C, tuberculosis, oncology, rheumatoid arthritis and others. The basis for the research is the followings: the patented single-source medicines, the part of which in the centralized procurements exceeded $ 100,000 in 2017 and the medicines that part of which in hospital and pharmacy procurements exceeded 50 million hryvnia (UAH) in 2017. The research also includes the patented medicines which are or which were not available because of the patent status.
Keywords: patents for medicinal products, evergreening patents, abuse of intellectual property rights, human rights, right to life, right to health
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