Merck Sharp & Dohme Corp. won a lawsuit in Ukraine against the pharmaceutical company JSC “Farmak” regarding the registration of a medicinal product whose active substance is the compound sitagliptin, protected by patents for inventions owned by the American company.
According to Merck, the actions of both submitting documents for state registration of a medicinal product and (or) obtaining state registration of a medicinal product in which the invention is used, the rights to which are valid, are preparations for their introduction into civilian circulation, and therefore constitute an infringement on his rights.
In its decision, the Supreme Court of Ukraine supported the conclusions of the courts of previous instances regarding the fact that state registration is a mandatory prerequisite for the introduction of a medicinal product into civilian circulation on the territory of Ukraine. Accordingly, submitting an application for the registration of a medicinal product in which an invention is used, the rights to which belong to another person and are valid, in its essence is preparation for the introduction of such a medicinal product into civilian circulation and therefore is an infringement of the rights of the patent owner.
Therefore, the plaintiff, taking into account the specifics of disputed legal relations in the field of intellectual property, has the legal right to demand the termination of the infringement of his invention rights, without waiting for the actual introduction of the product into civilian circulation. In the case of the introduction of the product into civilian circulation, the termination of the infringement of intellectual property rights to invention and restoration of the situation that existed before the violation will require significant efforts and the need to involve an unlimited number of persons who will acquire the right to ownership of such goods.