In June 2024, the pharmaceutical industry faced a new practice by the Federal Antimonopoly Service (FAS), which began to consistently recognize the introduction of generic drugs onto the market as unfair competition.
It is noteworthy that in a number of cases, the FAS independently established the fact of illegal use of inventions in medicinal products without conducting expert examinations and without relying on previously adopted court decisions on the violation of exclusive rights.
This law enforcement practice has had a significant impact on the pharmaceutical market, especially on the introduction of new medicinal products.
Generic companies found themselves in a situation where bringing a medicinal product to market was accompanied by the risk of administrative liability and the imposition of a multi-million rubles fine on the budget.
At the same time, the FAS's conclusions on the use of the invention were often based on circumstantial evidence, without conducting a patent-technical examination and without relying on court decisions establishing the fact of infringement of exclusive rights.
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