The event was dedicated to the consideration of the government’s legislative initiatives reflected in the draft law 7538 “On Amendments to Certain Legislative Acts of Ukraine on Improving the Legal Protection of Inventions and Utility Models”. Farmak JSC and the Scientific-Research Institute of Intellectual Property of the National Academy of Legal Sciences of Ukraine were initiators of the round table discussion.
Following the round table, a Resolution on recommendations for further work on the Draft law No. 7538 “On Amendments to Certain Legislative Acts of Ukraine on Improving the Legal Protection of Inventions and Utility Models” was signed.
The round table was attended by V. Kostiuk – acting Executive Director of Farmak JSC, Academician O. Orliuk – Director of the Scientific-Research Institute of Intellectual Property of the National Academy of Legal Sciences of Ukraine, O. Doroshenko – Deputy Director for Expert Work, O. Kashyntseva – Director of the Center for Harmonization of Human Rights and Intellectual Property Rights, V. Chumak – Vice-President of the Association of Employers of the Medical and Microbiological Industry, representatives of the Ministry of Economic Development and Trade of Ukraine, the Ministry of Health of Ukraine, the State Expert Center of the Ministry of Health of Ukraine, the Antimonopoly Committee of Ukraine, forensic experts, patent attorneys, representatives of the public.
During the round table, the participants developed a joint position on the strategy of formation of the national legislation in the field of legal protection of inventions in order to establish effective mechanisms for preventing the abuse of intellectual property rights. In particular, they discussed the need for the adoption of the Draft law No. 7538 “On Amendments to Certain Legislative Acts of Ukraine on Improving the Legal Protection of Inventions and Utility Models” supported by the Cabinet of Ministers of Ukraine on 25 January 2018.
The Draft law was registered in the Verkhovna Rada on 01 February 2018. “According to the World Intellectual Property Organization, Ukraine holds one of the leading places in the world by the share of patents issued in the field of medicine (about 9.91- 12.2%) and medicinal products (about 3.54-5.54%) of the total number of patents issued in all areas of technology from 1998 to 2016. Considering these indicators, our medicine should be one of the most innovative in the world. However, the high percentage of patents issued in the field of medicine and pharmacy is not consistent with available scientific and technical capacities of Ukraine and demonstrates the imperfection of the national patent system. The Draft law No. 7538 is crucial and to some extent revolutionary. Its positive effects will be perceptible at the level of both domestic patients and domestic pharmaceutical industry”, stated Academician Olena Orliuk, Director of the Scientific-Research Institute of Intellectual Property of the National Academy of Legal Sciences of Ukraine.
“This is probably the first time for the entire history of Ukraine’s independence that the state has made efforts to develop legislative acts for the benefit of the economy, the Ukrainian people and domestic manufacturers. As the leader of the Ukrainian pharmaceutical industry, Farmak supports the positive changes in the legislation regarding inventions and utility models. The government has developed a pro-social draft law placing the national level of patent protection on the proper international level and considering the national interests. Adoption of the Draft law No. 7538 will enable domestic manufacturers to compete in the pharmaceutical market on equal terms with foreign ones, which are currently in a privileged position. Domestic generics are high-quality drugs. Over the past 7 years, Farmak invested USD 184 million in innovative technologies and production upgrades”, emphasized Volodymyr Kostiuk, acting Executive Director of Farmak JSC, during the round table.
Volodymyr Kostiuk’s opinion was also supported by Viktor Chumak, Vice-President of the Association of Employers of the Medical and Microbiological Industry: “The gaps in the patent law place the domestic manufacturers on an uneven playing field with foreign companies and considerably restrict competition. The connection of the patent law with the pharmaceutical business is implemented through Art. 9 “State Registration of Medicinal Products” of the Law of Ukraine “On Medicinal Products”. This article is currently extremely burdened by lobbying standards that protect the interests of foreign pharmaceutical companies through the simplified procedure for registration of imported medicinal products. At the same time, in their countries of origin, the drug marketing authorization systems and legislation differ significantly from the Ukrainian”.
In her speech, Oksana Kashyntseva, Director of the Center for Harmonization of Human Rights and Intellectual Property Rights, noted that access of generic drugs to the domestic market can be accelerated by implementing a provision, whereby the registration procedures in respect of generic drugs can be carried out during the validity of patents for the reference drugs. “Indeed, it is impossible to enter the market and offer a generic drug for sale during the validity of the respective patent, but all the required procedures can be carried out in advance, so as to launch the drug on the market the next day after the expiration of the patent. Such provisions are envisaged by US, Canadian, and European law, and I can see no reason why this cannot be implemented in Ukraine”.
“We have studied the experience of the EU and the USA. Thus, only the main patent for the respective medicinal product is subject to extension; if a drug is protected by several patents, the patent holder should choose only one of them and only once for extension”, stressed Viktor Margitych, MD, Chief Scientific Advisor of Farmak JSC.
Forensic expert Sergiy Petrenko, Director of the Center for Expert Research of the Scientific-Research Institute of Intellectual Property, told about the great harm of ‘evergreen’ patents and their impact on public access to treatment.
Summing up the results of the Round table, the participants expressed their support for the presented draft law and rely on the political will of MPs, which has already been demonstrated by the government.
