Fighting against counterfeit medicines in Uzbekistan

Our life is interesting, some create, and others counterfeit! The same exists in pharmaceutical business, and not on a small scale!

As you know, most large pharmaceutical companies invest huge amounts of money in scientific research to develop (create) an effective drug, manufacture and sell it. At the same time, considerable work and time are required to prove effectiveness of the created drug and win the trust of consumers. After promoting the new drug, its counterfeits often appear on the market, because there will always be people eager for easy and quick enrichment at someone’s expense. The latter, in addition to their profit, do not care about reputation of the producer of the original drug, nor the health of people to whom they expose a certain danger. By purchasing counterfeit drugs, consumers do not receive necessary effective treatment, aggravate their illness and put their lives at risk, and producers of original products lose trust of consumers, as a result of which they do not receive their profits.

The purpose of this article is to describe some legal ways to combat counterfeit drugs in Uzbekistan.

According to new edition of Uzbek Law "On Medicines and Pharmaceutical Activity" dated 04.01.2016 No. 399 (hereinafter - the Pharmaceutical Law), production and sale of medicines in Uzbekistan, as well as their import to Uzbekistan territory is permitted only after registration of each medicine and obtaining a registration certificate from the Agency for Development of Pharmaceutical Industry under the Ministry of Health of Uzbekistan (hereinafter - the Agency, https://uzpharmagency.uz). At the same time, the following are not subject to registration:

- substances used for medicines production;

- medicines produced in pharmacies located in Uzbekistan;

- medicines imported to Uzbekistan for research work intended for preclinical, clinical studies, exhibiting at exhibitions, fairs, international forums.

Registration of medicines is carried out in accordance with the Regulation on the procedure for state registration of medicines, medical devices and medical equipment and issuance of a registration certificate, approved by the Resolution of the Cabinet of Ministers of Uzbekistan dated March 23, 2018 No. 213 (hereinafter - the Regulation).

The Pharmaceutical Law prohibits production, sale and import to Uzbekistan of illegal copies of medicines registered in Uzbekistan. This category includes medicines that entered the market with violations of intellectual property laws. Despite this prohibition, the Agency has not considered the presence or absence of a violation of intellectual property laws during registration procedure of a medicine for many years. As a result, there have been a lot of counterfeit medicines in Uzbek market for many years, including medicines belonging to the world-known pharmaceutical companies.

Only after adoption of the Resolution by the Uzbekistani President "On additional measures for further development of intellectual property field" dated April 26,2022 No.PP-221, situation began changing positively and the Agency became responsible for studying and verifying compliance with intellectual property rights (trademark and industrial design) during registration process of medicines. Also, over the past couple of years, Uzbekistan has been actively working to join the World Trade Organization (WTO). In order to bring its national legislation inline with the WTO agreements, the Cabinet of Ministers adopted  amendments to the Regulations on August 31, 2024 No.535, which obliged the Agency to check for compliance with intellectual property rights during registration of medicines.

As a general rule, each medicine has its own commercial (trade) name, and in order to prevent occurrence and distribution of counterfeit products, the producer of original product is recommended to protect the name of its product by registering it as a "trademark".

The Ministry of Justice of Uzbekistan is an authorized state body in the field of intellectual property, whose competence includes, among others, registration of trademarks. Registration of trademarks is carried out in accordance with the Administrative Regulations for the provision of public services for registration of trademarks and service marks (approved by the Resolution of the Cabinet of Ministers dated September 19, 2023, No. 480), and is confirmed by issuing a trademark certificate for 10-year term.

As stipulated in Article 20 of Uzbek Law "On Trademarks, Service Marks and Appellations of Origin of Goods" dated August 30, 2001 No. 267-II (hereinafter - the Trademarks Law), "A trademark certificate certifies the registration fact of the designation declared as a trademark, priority of the trademark and exclusive right of the trademark owner in relation to the goods specified in the certificate". This law grants the trademark owner with exclusive right to use and dispose the trademark.

The trademark owner is entitled to:

a) use it on goods for which this trademark is registered, and(or) on packaging of such goods;

b) use it in advertising, printed publications, on official forms, signs, when demonstrating at exhibitions and fairs held in Uzbekistan;

c) use it in another way not prohibited by law.

Moreover, persons who concluded a license agreement with the trademark owner are also granted the right to use the registered trademark on a preferential basis.

A trademark registered with the Ministry of Justice or having an international registration in accordance with the Protocol to the Madrid Agreement Concerning the International Registration of Marks of June 27, 1989, allows its owner to prevent occurrence of counterfeit products produced by it. At the same time, international registration must cover legal protection in Uzbekistan.

According to Article 26 of the Trademarks Law, the violation of exclusive right to a trademark is an unauthorized production, use, import, offer for sale, sale, other way of bringing into the market or storage for this purpose of a trademark or products designated by this mark, or a lookalike designation in relation to similar goods. However, the use of a registered trademark by other entities in relation to products that were lawfully brought into the market in Uzbekistan directly by the trademark owner or with his consent shall not be considered a violation of exclusive right to this trademark.

In practice, the most common types of violations of  illegal use of a registered trademark are:

1) illegal use by one entity of a designation similar to the point of confusion with the trademark of another entity;

2) illegal use by one entity of the trademark of another entity (i.e. the legal owner) in production and sale of products without obtaining the written consent of the trademark owner;

3) parallel import (gray import), i.e. import of goods into Uzbekistan without consent of the trademark owner.

The Uzbek legislation entitles the trademark owner to address his complain to the following state authorities for protection against unauthorized use of the trademark by third parties:

1) Ministry of Justice;

2) Appellate body of the Ministry of Justice (on certain issues);

3) Courts of Uzbekistan;

4) Committee for Development of Competition and Protection of Consumer Rights of Uzbekistan (hereinafter - the Antimonopoly Authority).

Before taking any action against the violator, it is recommended to find out from the Ministry of Justice whether the lookalike designation used by the violator is a registered trademark, and to what class of the International Classification of Goods and Services (ICGS) the opposed trademark belongs, if it is registered. This fact can be found out by contacting the Ministry of Justice and searching the database of registered trademarks of the Ministry of Justice.

 

In the absence of registration of the designation (name) of a medicinal product, which is lookalike with your registered trademark, the following measures can be taken against the violator.

FIRST: Contact the Ministry of Justice with a written complaint on production (sale, import) of counterfeit products by the violator. It is necessary to take into account that the state body can take measures only if the violator is a resident of Uzbekistan. Actions can be taken against non-residents (foreign companies) if they have a presence in Uzbekistan, for example, in the form of a representative office or subsidiary of a foreign company in Uzbekistan.

If the Ministry of Justice confirms the similarity based on the corresponding analysis of the contrasting signs, the Ministry of Justice issues the violator an order to cease production (sale, import) of counterfeit products, as well as to withdraw the corresponding products from the markets, which shall be mandatory for the violator.

SECOND: Filing a claim with the court for early cancellation of the registration certificate of counterfeit medicine issued by the Agency. In this case, it is recommended to involve the Ministry of Justice to the litigation to obtain its official opinion on similarity of the infringer's designation with your registered trademark. This measure is the most effective, because early cancellation of the registration certificate shall automatically entail a ban on production, sale and import of the counterfeit medicine into Uzbekistan.

THIRD: Filing a lawsuit to the court to establish a ban on import, production and/or sale of the counterfeit medicine in Uzbekistan. In this case, it is also recommended to involve the Ministry of Justice to the litigation to obtain its official opinion on similarity of the infringer's designation with your registered trademark.

In practice, there are also known cases of illegal use of a trademark by foreign entities by producing a counterfeit medicine outside of Uzbekistan, with subsequent import and sale of such drug in Uzbekistan. The Customs Code of Uzbekistan allows for banning importation of certain products into Uzbekistan in order to ensure ownership right, including to the intellectual property. In this case, as noted above, the trademark owner is entitled to file a lawsuit to the Uzbek court to ban importation of counterfeit medicines into Uzbekistan. The court's decision shall be the basis for banning the import of counterfeit medicines into Uzbekistan by the Uzbek customs authorities. An import ban can also be arranged through the court to stop parallel imports.

In addition to above-described options, the applicant may also file a complain to the Antimonopoly Authority on unfair competition by the violator. The Antimonopoly Authority can take measures only if the violator is a resident of Uzbekistan. It is important to note that the applicant may approach  the Antimonopoly Authority even if it does not have a registered trademark. If a third party (the violator) has began to counterfeit and/or sell the applicant's medicine even despite the applicant does not have a registered trademark, the violator can be held liable for unfair competition. Moreover, if the violator registered the medicine name of the third party (the applicant) as his trademark, the applicant is entitled to file a complaint with the Appellate Authority of the Ministry of Justice to cancel the trademark registration of the violator, if the fact of unfair competition is confirmed.

Article 21 of the Uzbek Law "On Competition" dated 03.07.2023 No.ZRU-850 (hereinafter - the Competition Law) prohibits unfair competition, which is considered as "actions of a business entity or group of entities aimed at acquiring advantages in implementation of economic  (business) activities that are contrary to legislation, business customs and cause or may cause losses to other business entities (competitors) or cause or may damage their business reputation." The Methodology for Identifying Unfair Competition (approved by the Resolution of the Cabinet of Ministers of Uzbekistan dated 29.12.2023 No. 694) establishes the following signs of unfair competition to protect the rights of honest entrepreneurs:

"a) the commission by business entities or a group of entities or other persons in their interests of actions aimed at acquiring advantages in implementation of business activities that contradict the law, business customs, as well as actions that cause or may cause losses to other business entities (competitors), including:

- bringing the products to Uzbek market by a competing business entity by copying the external design and form, name, seal, label, packaging and color combination of products, works and services (hereinafter - the Products), previously brought into the Uzbek market;

- sale of Products by a competing business entity through unauthorized copying of advertising materials or part thereof;

- committing actions aimed at restricting the sale of Products previously brought to the Uzbek market by obtaining an exclusive right to the means of individualization of goods, the means of individualization of a competing economic entity"

 

If designation (name) of a medical product similar to your trademark has also been registered as a trademark with the Ministry of Justice, then the only way to protect your registered trademark is to cancel the trademark certificate of counterfeit products by filing a complaint with the Appellate Authority of the Ministry of Justice or in court. Cancellation of the trademark certificate for counterfeit products will allow you to take subsequent measures to ban production, import and/or sale of counterfeit medical products in the Uzbek market.