Today, the issue of bringing generics to the Russian market and offering them in public procurement before the expiry of the original drug’s patent protection is highly urgent. At the end of 2024, the Federal Antimonopoly Service of Russia issued several precedent-setting orders to cease the circulation of generics before the original drug patents expire. Larisa Matveeva, the Executive Director of the Association of International Pharmaceutical Manufacturers, explained how intellectual property can and should be protected.
The issues of intellectual property protection in the Russian pharmaceutical market are more relevant than ever. What can be done to avoid intellectual property rights violations and the negative consequences for patients and bona fide market participants?
Let’s try to define what intellectual property is. It is, first and foremost, a form of social contract. If an inventor creates something useful for society, they have the right to a monopoly on selling their invention for a certain period, gaining profit from it. We understand very well that all new medicines are the result of lengthy, costly research and development conducted by pharmaceutical companies. It takes an average of 12–13 years from the synthesis of a new active substance to the launch of a drug onto the market, according to reports like EFPIA’s The Pharmaceutical Industry in Figures 2022. An innovator – whether Russian or foreign – must be protected to be able to continue breakthrough developments. This is why a patent must have the longest possible effective duration and be eligible for extension, if possible. Furthermore, the inventor absolutely must be able to generate revenue from it, thereby ensuring the necessary resources for future product development.
The dispute about generic drugs vs. originator drugs is going to continue forever. However, a reputable company decides to launch a generic onto the market only after verifying its patent clearance and conducting a risk assessment. Such a company will then either seek to have the patent revoked or reach an agreement with the originator. This is an absolutely civilized scenario.
Is this scenario viable given the geopolitical situation Russia is now in?
Today, the geopolitical situation is prompting the Russian government to make decisions aimed, on one hand, at developing the industry, and on the other hand, at considering the possibility of compulsory licensing for inventions needed to protect the life and health of our citizens. And if foreign companies refuse to fulfill their commitments, there must be an alternative scenario for introducing their drugs to the market, but compulsory licensing must be based on clearly defined criteria and conditions.
However, there are also problems with generic production. In several high-profile cases in 2024, the Federal Antimonopoly Service sided with the foreign manufacturers. Sales of generic versions of original drugs under patent protection discontinued. The industry is awaiting decisions from higher judicial authorities.
It is important to note that if these cases are upheld in court, which we very much hope for, the main issue will be ensuring their proper enforcement. Effective interaction between regulators is crucial here, in particular, between the Federal Antimonopoly Service and its territorial bodies, Roszdravnadzor, and the Ministry of Health. Protecting intellectual property is a necessary condition for stimulating innovation. If we cannot protect it, there will be no innovations. But to do this competently, we need to establish proper enforcement practice.
Patient communities also say that intellectual property rights must be respected, as they see it a guarantee for the availability of innovative therapies. Court proceedings related to this issue block drug procurement, leaving patients without necessary treatment.
This is indeed a question of drug availability and access to therapy. If patent disputes are ongoing, and auctions are canceled, there is a risk that the drug will not be available for patients, which means people’s lives are at risk. So it is important to prevent any delays in supplies. Let me emphasize once again: without innovative original drugs, there will be no generics either.
If the producers of innovative drugs do not try to enter the Russian market, no clinical trials of such drugs are held here either.
Yes, many foreign companies have suspended clinical trials, but here the situation is evolving too. And the regulator has the power to help companies have trials in Russia again. We are glad to see some examples of such comebacks now. It is necessary to have an honest and open dialogue with international manufacturers, demonstrating in practice that our state is ready to ensure the protection of their developments and investments. And if they bring innovations, they will be guaranteed protection of their intellectual property.
You lead the Association of International Manufacturers. What is the current position of the association’s members?
I joined the Association in April 2024, when it saw numerous changes that evidenced the decision of international companies to stay in Russia and have a strong association. Today, the Association comprises more than 50 international companies; I think that’s a strong indicator, don’t you agree?