Protection of an expensive molecule or what will change in the generic market of Russia

The human body is subject to many diseases, so without drugs it simply can not cope. The health of people, the improvement of the quality of life and its duration are the main goals of pharmaceutical companies. The development, testing, production and marketing of innovative products is aimed at improving the quality and longevity of the population.

Innovator invests enormous intellectual and financial resources, and wants to protect his products. Business invests in those projects that can bring profit. Therefore, the protection of intellectual property in the field of pharmaceuticals is one of the primary directions. “Today, the development of one medicine takes up to 15 years and spends about $ 3 billion. The path of the drug from the molecule in a laboratory test tube to the pharmacy shelf is long and complicated, so every investor ultimately wants to understand when and in what amount the investment will return, ”said General Director of the Association of Russian Pharmaceutical Manufacturers Victor Dmitriev.

Improvement of current legislation is necessary. “If we do not respect intellectual property rights, then not only foreign, but domestic producers will suffer from this. Given the practice of litigation, the law should specify the subtleties and nuances so that it is impossible to “break a patent” by describing different physical properties, thereby presenting the patented chemical substance supposedly in a new form. The history of the development of the pharmaceutical market knows many such examples. But from the point of view of the current legislation, there are no violations in them, ”emphasized Victor Dmitriev.

In addition, modern developed economies cannot do without market incentives to innovate. The main of which is the exclusive right.

To minimize the risks of unfair competition, it is necessary to regulate the procedure for making decisions on issuing a compulsory license. Making such decisions is possible only with mandatory public discussion with interested market participants, in order to exclude the possibility of the uncontrolled transfer of the exclusive rights of patent holders. Market participants should clearly and unequivocally understand “When is this possible? Who is this possible to? And what does the patent owner get? ”

By compulsory licensing is meant a measure when patent owners are forced to transfer a license to use their rights in exchange for compensation, the amount of which is determined by the law in force in the country or by some arbitration mechanism.

Usually compulsory licenses are considered as a means of preventing the abuse of exclusive rights granted by a patent. In addition, they are a tool that allows the state to ensure national security and respond to emergency situations.

In the absence of emergency situations, the issues of market regulation should be addressed by economic measures. However, in the event of epidemics, man-made, natural disasters and any other threats, the state must have a mechanism to protect national interests. Such a mechanism, primarily compulsory licensing, is held by the United States, the European Union countries and BRICS, where this mechanism serves as a tool for balancing intellectual rights and public interests.

The state itself can use the patent without the consent of the patent holder. Developing and least developed countries use compulsory licensing mainly for the purchase of antiretroviral drugs under government HIV / AIDS programs.

The members of the World Trade Organization (WTO) are required to comply with the provision of Article 31 of the TRIPS regarding the conditions for granting compulsory licenses. This document contains a number of possible grounds for issuing compulsory licenses, and the reasons specified in the agreement can be interpreted fairly freely.

Almost all countries comply with these requirements. But the specific features of the application of compulsory licensing in each country are determined by patent laws, and often quite substantially differ from each other.

In Russia today, Rospatent has set up an Interdepartmental Working Group on Intellectual Property Issues in the Field of Pharmacy. The group included representatives of ministries, departments, the State Duma, the Eurasian Patent Office, pharmaceutical associations, representatives of business circles and large pharmaceutical manufacturers.

It is planned that a unified register of active substances with pharmacological activity protected by a patent for an invention will be created. And the final proposals and decisions of the working group will be included in a separate block of the action plan — the strategy for the development of the pharmaceutical industry of the Russian Federation for the period till 2030 “Pharma 2030”.

Пресс-служба АРФП