Ukrainian Parliament to Consider IP Legislation Amendments – Implications for Pharmaceutical Patents

In December 2018, the Ukrainian Cabinet of Ministers approved a draft law amending certain legislative acts, aiming to bring Ukrainian IP legislation in line with the EU-Ukraine Association Agreement. The draft law was prepared by the Ukrainian Ministry of Economic Development and Trade and released for public review in September 2018. The Cabinet of Ministers has now submitted it to the Parliament, which is expected to further consider the draft law.

While the draft introduces changes relating to patents, utility models, designs and trademarks, amendments relating to pharmaceutical patents are discussed below.

Under the draft law, patent protection will not be granted to diagnostic, therapeutic and surgical methods for the treatment of humans or animals, to new forms of a known medicinal product (including salts, esters, ethers, complexes, combinations and other derivatives, polymorphs, metabolites, isomers, pure forms, particle sizes), to new dosages, new properties or new uses of a known medicinal product.

The draft law introduces supplementary protection certificates. While current Ukrainian patent law provides for a patent term extension procedure for medicinal products and crop protection agents, it does not contain the precise term “supplementary protection certificate”, and the stipulated calculation of the extension period differs from the EU approach. The current patent law sets forth that patent protection can be extended for a period equal to the period between the patent application date and the date of authorization by the competent authority, but for no more than five years. Under the provisions of the draft law, the period of supplementary protection should be equal to the period between the application date and the date of the first authorization by a competent authority, reduced by a period of five years, while the duration of supplementary protection may not exceed a total of five years.

The draft law also introduces the research exemption, according to which the use of patents in tests conducted for preparing regulatory approval will not constitute infringement.

Furthermore, according to the current legislation, a utility model does not need to involve an inventive step and is subject to only a formal examination, which means that it is not required to check if there are any prior rights affecting the new application. These provisions have led to an increasing number of highly similar utility models protecting inventions that are not new. The draft law provides for a pre- and post-grant opposition procedure, expected to eliminate the issuance of ill-founded patents.

It remains to be seen how the law will progress and how the authorities will go about implementing the proposed changes if the law is adopted.

By: Olga Kudoyar and Marina Maltykh

For more information, please contact Olga Kudoyar or Marina Maltykh at our Ukraine office.