THE EVERGREENING STUDY OF UKRAINIAN PHARMACEUTICAL MARKET

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 thepatentability'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.

Changing paradigm of supplementary protection of inventions in the national legislation of Ukraine

Key words: patent term extension, supplementary protection, supplementary protectioncertificate, drug patents, patent legislation reform The article is mainly aimed at distinguishingtwo mechanism: patent term extension which used to be applied inUkraine before the patent reform, and supplementary protection certificates whichwere introduced to national legislation in 2020.Patent term extension in the way it was provided in the Ukrainian Patent Law is arather simple mechanism that didn’t require much regulations. It used to provide additionalperiod of patent monopolies which was equal to the period which elapsed betweenthe date on which the patent application was filed and the date of the marketingauthorisation, not more than 5 years. Since there were no limitation on the type ofpatent (basic patent) or requirement of the first marketing authorization, this regimeprovided an opportunity to extend not only basic patent term, but also all secondarypatents related to one drug. This created a situation when duration of patent monopolyfor one drug exceeded 35 years.Provided that national pharmaceutical industry is oriented on manufacturing ofgeneric drugs, supplementary protection certificates are more appropriate forUkraine. Firstly, this is due to the limitation of effective patent life to 15 years whichis more feasible considering the national context. Another positive thing about SPCsis some uncertainty in relation to definition of the subject matter and scope of SPCprotection. That means that the country can have some freedom in determining theways of its interpretation. However, it should be noted that such indeterminacy is agrey zone. Thus, it is necessary to consider how the country can benefit from the supplementaryprotection regimen. Since the pharmaceutical sphere is very sensitive,the SPC issues have direct effect on public health and access to treatment. So, the articlejustifies the general idea that implementation of new legislation provisions shallbe aligned with both ensuring pharmaceutical innovations and guaranteeing that thepublic health needs are still a priority. Therefore, considering the long-term negativeeffect of the patent term extension regimen, the new SPC approach should be as balancedas possible.

Ukrainian patent reform: render harmless a utility model

The patent is an amazing thing, it’s like a narcotic: nothing but a chemical formula known for more than one century, registered as a utility model, but can subjugate all other licenses and permits in a way that no other “gun” can. According to Article 1 of the Law of Ukraine “On Protection of Rights to Inventions and Utility Models”, a utility model (just as an invention) is the result of human intellectual activity in any sphere of technology i.e. the object of the utility model (UM) may be any product (device, substance etc.) or a process (unlike us, unfortunately our Russian colleagues severely limited innovation activity. For example, Article 1351, Paragraph 1 of the Civil Code of the Russian Federation allows you to protect as a utility model only a technical solution relating to an apparatus).

Features of performing arteriography in patients with diabetes mellitus with critical ischemia of the lower limb

Objective — to study the features of performing arteriography in patients with diabetes mellitus with chronic critical ischemia of the lower limb with stenotic-occlusive lesions of the arteries of the popliteo-tibial segments. Materials and methods. The arteriography experience in 108 patients with diabetes mellitus 2 type with chronic critical ischemia of the lower limb has been analyzed. All patients had stenotic-occlusive lesions of the arteries of the popliteo-tibial segments for the passable arteries of the ilio-femoral segments.The first group included 56 patients, who performed arteriography according to the proposed methodology (Ukrainian patent for utility model No. 114970 dated March 27, 2017, «Method of angiographic examination of lower extremity arteries in patients with ischemic form of diabetic foot syndrome»), the second group included 52 patients, who performed arteriography by Seldinger’s method. Results. With the help of ultrasound examination it was proved that 63.1 % of the common femoral artery blood volume in patients with diabetes mellitus with chronic critical ischemia of the lower limb with stenotic-occlusive lesions of the arteries of the popliteo-tibial segments is divided to the superficial femoral artery and 36.9 % in the deep femoral artery. Application of the developed method of arteriography has allowed to reduce the amount of active ingredient of contrast, which was administered to patients in the first group 2.16 times in comparison with the second group. In the first group the percentage of hemorrhagic complications was significantly lower than in the second group. Conclusions. The developed method of performing arteriography should be used in patients with diabetes mellitus with chronic critical ischemia of the lower limb with stenotic-occlusive lesions of the arteries of the popliteo-tibial segments.