Dmytro Taranchuk

Director of Legal Support Farmak

Mar 01, 2019

Allowing generic manufacturers to conduct research before the patent for original medicines expires is in the interests of consumers.

Farmak produces generic drugs, therefore, the company’s strategy is to produce branded generics that have proven efficacy and are available to the public. According to the strategy, the product enters the market the next day, week or month after the patent’s expiration date. The strategy of our company has never intended to enter the market before such date or to do anything related to a direct violation of the patent holder rights. We build our business transparently and strictly adhere to the established laws. For the purposes of development, we carry out a patent search and monitor the types of patents, their validity periods and areas of application. It is important for us to timely plan the process in order to be the first, this is the essence of the generic company operation. Let me note that the pharmaceutical development of the drug takes from 2 to 5 years. Without being able to do a complete preparation, the company fails to keep pace with the launch of the product on the market.

We can see that today our Law on the Protection of Rights to Inventions and Utility Models does not contain a separate provision that would describe the developer’s right to conduct any research with the right to import samples, to form a dossier before filing for the state registration. Considering the peculiarities of our legislation, we cannot import samples for research due to the availability of a specific patent in the registry. This leads to a shift in terms of development or to a search for alternatives abroad, which is not always financially justified.

Another option is to seek changes in legislation that would legally allow for legal research and development and would not violate the rights of patent holders. The law is outdated, and now there are attempts to reform this area, in particular, the Ministry of Economy has prepared an appropriate draft of amendments. All these changes correspond to the interests of consumers and give them the opportunity to purchase the necessary drugs for less money. 

Amendments to the legislation will increase competition and allow consumers, upon the expiration of the patent for the original drug, to have the right to choose it, leading to lower prices for these drugs.

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