Dmitry Zaitsev, CEO of JSC “Pharmstandard,” believes that a well‑established and well‑functioning patent protection is the most important criterion for the innovative attractiveness of the Russian pharmaceutical market.

The topic of patenting was discussed again at the roundtable organized by Kommersant Publishing House, titled “Innovations in Russian Pharma: Breakthrough or Utopia?”

Dmitry Zaitsev drew attention to the need to resolve the legal collision regarding compulsory licensing. The role of federal executive authorities should be decisive in this matter.

“For years, patent holders found themselves in court left alone when facing the entities infringing their active ingredient patents. But as soon as the regulator focused on this issue, the problem became effectively resolved.” “Today, it’s hard for me to imagine that anyone would risk violating the primary patent for the active ingredient under the threat of a 100 percent fine,” Dmitry Zaitsev emphasized.

He drew attention to the currently existing mechanism for using a patented invention without the owner’s consent with the mandatory payment of a fee (Articles 1360 and 1362 of the Civil Code of the Russian Federation).

In 2024, under Presidential Decree No. 122, a subcommission on the use of inventions for the purposes of economic security was formed under the government commission for economic development. When making decisions, five federal agencies (the Ministry of Economic Development, the Ministry of Industry and Trade, the Ministry of Health, the Federal Antimonopoly Service, and Rospatent) assess how the issuance of a compulsory license will affect the market, taking into account whether there is a real shortage of the original drug and other factors as well.

At the same time, an arbitration court may issue a compulsory licence under Article 1362 of the Civil Code of the Russian Federation, which includes such evaluative concepts as “insufficient use”, “significant technical achievement”, and “substantial economic advantages”. However, no clear, unbiased and easy to understand criteria for these terms have been developed to date. As a result, the courts may interpret these concepts differently, noted Dmitry Zaitsev.

The “Pharmstandard” CEO believes that it is the regulator who understands the way a particular decision regarding compulsory licensing may impact the market as a whole and speaks in favour of developing a unified approach to issuing compulsory licenses.

Read more:

https://www.kommersant.ru/doc/8572053