The deputies propose to improve the measures for the protection of intellectual property rights adopted during martial law by preventing the possibility of baseless extension of intellectual property rights to inventions (utility models), which expired during martial law and can not be extended.
According to the draft law No. 9383 registered by deputies of different factions, the initiative will improve the affordability of medicines for the population and create conditions for the entry of generic medicines on the market of Ukraine.
The bill specifies, in particular, that intellectual property rights expiring on the day of martial law in Ukraine or during martial law, remain in force until the day following the day of termination or cancellation of martial law, but no longer than until the expiry date of intellectual property rights determined by the law of Ukraine “On Protection of Rights to Inventions and Utility Models”.
In a comment to Interfax-Ukraine one of the initiators of the bill, the head of the Parliamentary Committee on National Health, Medical Care and Health Insurance Mykhailo Radutskyi specified that the bill proposes to modify the rules of the law adopted after the full-scale invasion to extend patents during martial law and return to the regulation previously in force.
Radutskyy reminded that at the beginning of the full-scale invasion the country adopted a number of amendments to the legislation aimed at simplifying the work of business and state structures. In particular, the law “On the protection of interests of persons in the field of intellectual property during martial law, imposed in connection with the armed aggression of Russia against Ukraine,” extended the validity of all property rights of intellectual property end of martial law. Including the intellectual property rights for medicines were extended.
“In April 2022 such a decision was logical. After all, there were potential risks of losing intellectual property rights, including due to the fact that a significant number of lawyers went to serve in the AFU, the state body for registration of patents did not work regularly. But now there are no significant obstacles to extending patents on medicines. In fact, extended patents have become an obstacle for competitors to enter the market and launch production of some generic drugs in Ukraine, which makes it impossible to reduce prices for some drugs,” he said.
Radutskyy said that in mid-April, the Committee held a working meeting on this issue with representatives of the Association of Drug Manufacturers of Ukraine (ADMU), the European Business Association (EBA) and the American Chamber of Commerce in Ukraine, and bill number 9383 reflects the common position of the Committee and market participants.
At the same time, Radutsky clarified that the main committee dealing with the bill No. 9383 is the Committee on Economic Development.
“The Health of the Nation Committee, which I chair, plans to provide recommendations to my colleagues. We will initiate their early consideration in the parliament,” he said.
As reported, earlier participants of the pharmaceutical market said that the attempt to regulate intellectual property rights for the duration of the war, undertaken after the full-scale invasion of Ukraine by Russia, has led to problems in the pharmaceutical market, the inability to bring to market and launch production of new drugs. At the same time, some companies made attempts to unfairly restrict possible competition by blocking the entry of competitors’ preparations to the market.
Then the All-Ukrainian Union for the Protection of Patients’ Rights and Safety addressed the head office of the Merck Sharp and Home Corp with a demand to influence its representative office in Ukraine and to stop blocking patients’ access to the antifungal generic drugs “Caspofungin” from different manufacturers. Thus, the Ukrainian branch of the pharmaceutical company, taking advantage of the legislative changes, adopted after the full-scale invasion of Russia, actually blocked the patients’ access to a number of products by artificially extending the term of their patent, which expired on April 16, 2022. In particular, we were talking about generic drugs Caspofungin-Teva, Caspofungin Acetate manufactured by Gland Pharma Limited, Caspofungin Rompharm manufactured by K.T. Rompharm Company, and Kasmig manufactured by Pharmaten UV.
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