Anti-counterfeiting and enforcement

Types of proceedings

What types of legal or administrative proceedings are available to enforce against infringing products?

Trademark infringements can be challenged through:

  • civil actions;
  • criminal actions; and
  • administrative measures

 

It is possible to start criminal proceedings against the infringing party by filing a criminal complaint, which is followed by seizure of the counterfeit goods. The confiscation and destruction of counterfeit products and a criminal sentence (which is one to three years imprisonment and a judicial fine of up to 20,000 days, in accordance with the daily limits stated in the law) is rendered against the infringer at the end of the proceeding. However, it is usually expected that an identical or almost identical trademark is used on counterfeit products in order to accept the infringement claim in criminal proceedings.

Apart from trademark infringement, producing and selling counterfeit pharmaceuticals is specifically accepted as a type of crime in article 187 titled Production or Sale of Medicine such as to Risk the Life and Health of Others and article 186 titled the Trade of Decayed or Transformed beverages or pharmaceuticals of Turkish Criminal Law. For these crimes, a penalty of imprisonment for a term of one to five years and a judicial fine is imposed and, if the offence is committed by a physician or pharmacist or in the course of a profession or trade which is subject to official permission, the penalty shall be increased.

Furthermore, as per the reference of Law on Pharmacists and Pharmacies No. 6197, article 43, the act should be punished in accordance with provisions of article 193 of Producing and Trading Toxic Substances crime that is issued under the Turkish Criminal Law.

Since the injured party in all the above-mentioned crimes (excluding trademark infringement) is the public or the state (if the pharmaceuticals are smuggled), those crimes are defined as crimes against public health or the state. In such cases, the owner of the trademark or the licensee is not a party to the criminal proceedings. The investigation would be conducted by the public prosecutor ex officio in favour of the public.

A suspect accused of infringing the products can be charged for all of the mentioned offences that arise out of their single act of producing and selling unlicensed or counterfeit pharmaceuticals. If a criminal proceeding has been initiated ex officio in favour of the public against these products, after that (depending on the nature of each case) a trademark infringement complaint can be filed as well.

Also, the Ministry of Health has an online system named Pharmaceutical Track and Trace System to deal with counterfeiting, smuggling, falsification, bar code scamming, illegal diversion and the distribution of pharmaceutical products within Turkey’s supply chain. Furthermore, the track and trace system enables easy recall procedures when urgent requirements arise – which was a plus during the covid-19 pandemic for collecting the pharmaceuticals that were used during treatment protocols.

The Law on Pharmacists and Pharmacies, article 18, foresees administrative fines for pharmaceutical products that are not produced in accordance with the marketing authorisation files, in case such action does not constitute a crime in terms of the Turkish Criminal Law and the Anti-Smuggling Law.

Remedies

What are the available remedies for infringement?

According to the Turkish Industrial Property Law (IP Law), the following remedies are available (which are subject to a civil action):

  • preliminary injunctions to prevent the infringing act;
  • cessation and prevention of infringement;
  • compensation for:
    • actual loss;
    • material damages; and
    • immaterial damages;
  • disclosure of the court’s judgment by means of publication to the public, the costs of which are to be met by the defendant party;
  • handing over documents in the possession or property of the infringer;
  • delivery up or destruction of infringing products;
  • recall of infringing products and removal from the market; and
  • reimbursement of the official court expenditures and fees for bringing the action.
Border enforcement

What border enforcement measures are available to halt the import and export of infringing goods?

When considering border enforcement measures, note that where counterfeiting activities on pharmaceutical trademarks are on the table, there are other strict restrictions on the export and import of pharmaceutical products. Non-compliance to these restrictions constitutes crimes regulated in the Turkish Criminal Law and Anti-Smuggling Law, which are closely followed by customs officials, police and related bodies of the Presidency. The customs authority is entitled to ex officio act in a smuggling case and the suspected persons belongings, loads and vehicles can be searched by customs officers for customs control purposes. If they detect that the goods are smuggled, they can seize the products immediately. If such a case occurred specifically for pharmaceuticals, it is also subject to an administrative fine pursuant to article 19 of the Pharmaceutical and Medical Preparations Law.

In matters only related to trademark infringement, the customs authority does not take any ex-officio actions against possible counterfeit goods at the borders. The trademark owners should file a customs watch application before the customs authority to monitor the export or import of possible counterfeits. The customs authority has an online system where customs watch applications can be filed. When a trademark owner has applied for a customs watch, the customs authority informs the recorded trademark agent of the holder about the suspicious products bearing the same or almost similar trademarks and suspends these products for 10 working days for any possible trademark infringement claim to be filed. The rights owner has the right to examine the products first and then file a complaint and start a criminal action against these products. If no proceeding is started, the suspected goods are released by customs.

The import of pharmaceutical products is strictly regulated but export proceedings are not the same. This causes the export of parallel imported goods from Turkey into other countries. Controlled pricing policies provide lower prices for pharmaceutical products in comparison to other markets, and this makes Turkey an attractive point for markets where products are priced higher. If parallel import is not available at the destination country, these kinds of activities will be considered within the scope of anti-smuggling laws. In order to circumvent this option, the pharmaceutical companies tend to include non-import clauses in their agreements with relevant parties in Turkey taking into account competition law requirements as well.

Online pharmacy regulation

What rules are in place to govern online pharmacies?

The sale and distribution of pharmaceuticals is strictly regulated by the Turkish Ministry of Health and the online sale of pharmaceutical products is explicitly prohibited by the law. The Law on Pharmacists and Pharmacies regulates that the sale of pharmaceuticals is restricted through the internet or any other online environment and a website cannot be operated on behalf of a pharmacy and pharmacist.

Moreover, this restriction is not only limited to pharmaceuticals but also applied to traditional herbal medical products, homeopathic medicinal products, dietary foods for special medical purposes including enteral nutrition products and special medical purpose baby food. These products can be sold exclusively in the physical store of pharmacies.

There is a notable rise in the sale of pharmaceuticals through online platforms and this raises many concerns about public health since most of them are unauthorised or counterfeit products. In recent years, the Ministry of Health has strictly controlled online markets where these prohibited products are sold and has cancelled these websites and imposed fines.

Recent cases

What are the most notable recent cases regarding the enforcement of pharmaceutical marks?

Covid-19 measures caused delays in supply chains, which, in turn, caused a growing trend in smuggling and counterfeit cases. In this regard, there were many police operations for counterfeit pharmaceutical products.

Many of these police operations made it to the headlines. An extremely high amount of counterfeit pharmaceutical products were seized including ones used in covid-19 treatment protocol and steroids, slimming and fat-burner products. A rising demand for vitamins during the pandemic has increased counterfeiting activities for that area as well. About 1.5 million counterfeit vitamins were seized in a single action.

In addition, owing to its geopolitical position in the Middle East and Europe, Turkey faces serious problems regarding drug diversion and drug trafficking and has become a smuggling route for the illegal drug trade. Beyond the trademark infringement perspective, drug trafficking in Turkey is handled by government and police forces as well as by international operations.

Primarily for pharmaceuticals that are expensive and are for life-threatening illnesses (eg, cancer), there were multifaceted ongoing operations. The essential importance of these mixed counterfeit goods was the fact that they were being sold as original and were overpriced, taking advantage of the shortage caused by the pandemic.

Another drug diversion case involving bribery, peculation and forgery was mostly focused on cancer and organ transplantation pharmaceuticals in the areas where immigrants were located. A few health professionals and pharmacists were involved in these serious crimes, which caused a diversion into the Middle East where the pharmaceutical goods had been diverted.