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Attention: Counterfeit! There are Attempts to Falsify Белый уголь®!

18.10.2017

Irina Kirichenko, lawyer at Ilyashev & Partners Law Firm, Patent Attorney of Ukraine
Source: Apteka

In the interests of the Client — Omnifarma Kyiv LLC, the developer and manufacturer of original medicinal product БЕЛЫЙ УГОЛЬ®, the leader of the Ukrainian market of absorbents — Ilyashev & Partners Law Firm alerts all the operators of pharma market in Ukraine that there is a counterfeit product distributed on the market — the sorbent “Белый Уголь-Zdravofarm” manufactured by Zdravofarm LLC (6 Sovetskaia Str., Sorokivka, Kharkiv District, Kharkiv Region, 62430).

This product without any registration by the Ministry of Health of Ukraine as a medicinal product, is not only similar to the registered and well-known trademark БЕЛЫЙ УГОЛЬ®, but also possesses the similar content based on silicon dioxide, just as the original product БЕЛЫЙ УГОЛЬ® (registration certificate No UA/16126/01/01, Order of the Ministry of Health of Ukraine dated 04 Jule 2017 No 761). It is worth to mention that the contents and manufacturing technology of the original product БЕЛЫЙ УГОЛЬ® are also protected by Patents of Ukraine No 41849, 75203, 85371, 99890, 113442. Labelling and design of the packaging of this sorbent significantly duplicate the blister and secondary packaging design of the medicinal product БЕЛЫЙ УГОЛЬ® and confuse the consumers regarding the manufacturer of the brand — Omnifarma Kyiv LLC that is famous for its spotless reputation in the Ukrainian market.

It is worth noting that the popularity of the original sorbent Белый уголь® among the consumers and its acknowledgement by healthcare professionals in gastroenterology has long ago exceeded the boundaries of Ukraine — the medicine is successfully marketed in Belarus, Kazakhstan, Georgia, Azerbaijan, Lithuania, Poland, Serbia, Spain, Russia, Uzbekistan, and Moldova.

Since 01 January 2011 the trademark БЕЛЫЙ УГОЛЬ (Біле Вугілля)® has been recognized as a well-known mark for the goods of Class 5 of the International Classification of Goods and Services (ICGS) (enterosorbents) by the decision of the Appeals Chamber of the State Intellectual Property Service of Ukraine dated 15 July 2011, approved by the Order of this Service dated 19 September 2011 No 864-Н.

Omnifarma Kyiv LLC also holds the ownership of other trade marks БЕЛЫЙ УГОЛЬ/Біле Вугілля®, the patentable subject matter of which are the brand name, design and labelling of the sorbent Белый Уголь.

Pursuant to Articles 16 (2) and 20 (5) of the Law of Ukraine “On the Protection of Trademarks” the trademark certificate issued by the State Intellectual Property Department, entitles its holder with the right to use the registered mark and to forbid others to use it without the holder’s consent.

In accordance with Article 20 (1, 2) of the Law of Ukraine “On the Protection of Trademarks” any infringement of the certificate holder’s rights, envisaged by Article 16 therein, to include the committing of actions requiring the holder’s consent without such consent, shall be the violation of the rights of the certificate holder that entails the liability under the applicable laws of Ukraine.

Please be aware that Omnifarma Kyiv LLC did not provide any consent neither to Zdravofarm LLC, nor to any other pharma market player to use the trademark БЕЛЫЙ УГОЛЬ/Біле Вугілля® throughout Ukraine.

Therefore, the marketing of the pharmaceutical product under the abovementioned trademark, the storage of product labeled with this trademark for its further sale, promotion and sale of the product are illegal bearing the signs of unfair competition — the deliberate abuse of another’s trademarks in the interests of own business activity aimed at the obtainment of unlawful competitive advantages due to the use of someone else’s business reputation (Omnifarma Kyiv LLC).

It is worth to mention that the abuse of the trademark БЕЛЫЙ УГОЛЬ (Біле Вугілля)® (that implies the distribution and RETAIL SALES) constitutes an offence under Article 229 of the Criminal Code of Ukraine (hereinafter — CC of Ukraine) (Abuse of Another’s Trademark). Pursuant to CC of Ukraine the abuse of another’s trademark (for goods and services) or any other deliberate abuse of the rights to these subject matters in case this caused large-scale pecuniary damages, shall be charged with the penalty in the amount between one thousand and two thousands of non-taxable minimum wages of individuals.

Pursuant to Article 229 (3) of the Criminal Code of Ukraine actions envisaged by paragraph 1 or 2 of this Article committed by an official using his/her position or by an organized group or if they caused large-scale pecuniary damages, are subject to penalty of 10-15 thousand on nontaxable income with the deprivation of right to occupy certain positions and to conduct certain activities for the term up to three years.

In accordance with the note to Article 229 of the Criminal Code of Ukraine the pecuniary damages is considered to be inflicted in especially large scale if its amount exceeds the nontaxable income in a thousand and more times (in 2017 amounts to UAH 800 000).

However, illegal sales of counterfeit medicine Біле Вугілля- Zdravofarm has one more aspect exceeding the framework of the violation of the exclusive right of Omnifarma Kyiv LLC to sell the products with the abovementioned brand. As the labeling of packaging of both sorbents has differences only in secondary considerations, and a common consumer will not notice the differences between the package of the well-known to him/her sorbent БЕЛЫЙ УГОЛЬ®, whose quality, safety and efficiency have been proven as provided by law, and the package of the same-name product manufactured by Zdravofarm LLC of unknown quality, there are all signs of the counterfeit medicine.

Pursuant to Article 2 of the Law of Ukraine “On Medicinal Products” counterfeit medicinal product is a product, which was deliberately non-identically (inconsistently) marked according to the materials (one or some of them) about medicinal product with the relevant name, which had been entered to the State Register of Medicinal Products of Ukraine as well as a medicinal product deliberately faked otherwise and not corresponding to the materials (one or some of them), including composition, about medicinal product with the relevant name, which had been entered to the State Register of Medicinal Products of Ukraine.

Based on this definition and the definition on the World Health Organization, counterfeit medicinal products are products that are deliberately improperly marked in relation to their identity and/or manufacturer’s name. Such products may contain correct active ingredients, wrong dosage, may be without active ingredients, or may be expired.

The relevant information on the registered medicine БЕЛЫЙ УГОЛЬ (Біле Вугілля)® of Omnifarma Kyiv LLC entered the State Register of Medicinal Products of Ukraine, whereupon the manufacturer of the counterfeit product Белый Уголь-Zdravofarm is trying to speculate.

Pursuant to Article 44-2 of the Code of Ukraine on Administrative Offences (Falsification of Medicinal Products or Selling of Falsified Medicinal Products) the intended manufacturing, purchase, transportation, shipment or storage of knowingly falsified medicinal products committed in especially large scale involve the penalty amounting to 20-50 nontaxable minimum incomes.

Moreover, the falsification of medicinal products and the usage of someone else’s trademark entail criminal liability: manufacturing, storage and dissemination of falsified medicinal products represent a great social danger as they threaten life and health of the population. Such criminal actions and crimes of omissions cause significant losses to the state and society.

Thus, according to Paragraph 1 Article 321-1 of the Criminal Code of Ukraine the manufacturing, purchasing, transporting, shipping, storing aimed at selling or selling knowingly falsified medicinal products shall be punished by imprisonment of three to five years.

Pursuant to Paragraph 3 Article 321-1 of the Criminal Code of Ukraine, acts provided for in Paragraphs 1 and 2 of this Article if causing the death of individual or other severe consequences, or if committed in especially large scale shall be punished by imprisonment of eight to ten years or life imprisonment with confiscation.

Consequently, the acts on selling the medicinal product Белый Уголь- Zdravofarm, including its manufacturing, packaging, storage, promotion and selling are illegal and should be seized as provided by law.

Therewith, such criminal acts committed by the officials with the abuse of powers are subject to criminal liability under Article 364-1 of CC of Ukraine, in particular: abuse of powers, in other words a willful use of authority or official position contrary to the official interests by an official for mercenary motives or other personal benefit or benefit of any third person where it caused substantial damages to legally protected rights or interests of individual citizens, or state and public interests, or interests of legal entities shall be punished by penalty from 150 to 400 nontaxable incomes, or by arrest for the term up to 3 months, or by imprisonment for the term up to 2 years, with the deprivation of right to occupy certain positions or engage in certain activities for the term up to 2 years.

In order to demonstrate that the abovementioned norms of applicable law on medicinal products are actionable it is worth providing the examples of law enforcement practices on counteracting the falsified medicines/selling the falsified medicinal products:

• http://www.reyestr.court.gov.ua/Review/32243528
• http://www.reyestr.court.gov.ua/Review/55173281
• http://www.reyestr.court.gov.ua/Review/50752895
• http://www.reyestr.court.gov.ua/Review/34242298
• http://www.reyestr.court.gov.ua/Review/37425572
• http://www.reyestr.court.gov.ua/Review/66068563
• http://www.reyestr.court.gov.ua/Review/46088843
• http://www.reyestr.court.gov.ua/Review/55231709
• http://www.reyestr.court.gov.ua/Review/53641743
• http://www.reyestr.court.gov.ua/Review/32785230

In particular, delivering the verdict on 06 October 2016 in case No. 643/17066/15-к (http://www.reyestr.court.gov.ua/ Review/61819984), the Moskovskyi District Court of Kharkiv (criminal proceeding on charges for committing crimes under Paragraph 1 Article 321-1, Paragraph 3 Article 28, Paragraph 2 Article 321-1 of CC of Ukraine), determined that between March 2014 and 18 February 2015 the accused, having the criminal intent aimed at the manufacturing, purchasing, transporting, shipping and selling of knowingly falsified medicines in large scale, understanding the advantages of these crimes commitment as part of the organized group in Kharkiv and Kharkiv Region and other cities of Ukraine, acting I intentionally with mercenary motives, decided to organize, organized and led the organized group consisting of 3 citizens of Ukraine that preliminary arranged into a stale alliance for the preparation and systematic conduct of capital offences combined by the common plan with the allocation of functions of all group participants, in particular — organization and conduct of illegal manufacturing, purchasing, transporting, shipping and storing of knowingly falsified medicines in large scale.

Within the pretrial investigation the law enforcement authorities carried out numerous investigating actions, in particular assigned and conducted forensic expert evaluations of different expert specialties regarding the examination of samples of the confiscated products.

Thus, according to the combined forensic chemical and pharmaceutical expertise of the medicinal products conducted by Kyiv Scientific Research Institute of Forensic Expertise of the Ministry of Justice of Ukraine dated 10 June 2015 No. 8255/15-34 the medicinal product М-с does not correspond to samples of original medicines concerning its materials and features of manufacturing.

According to another report of combined forensic expertise conducted by Kyiv Scientific Research Institute of Forensic Expertise of the Ministry of Justice of Ukraine dated 02 October 2015 No. 10281/15-34, seized medicines of famous trademarks are falsified and may be dangerous to life and health of individuals.

The court, having heard the participants of litigation, witnesses, having carefully studied the evidence in the case, determined them as proper and admissible; and the guilt of the accused of criminal offenses — proven.

According to cumulative charges, the accused of the falsification of well-known trademarks’ medicines was sentenced to 6 (six) months of imprisonment with the confiscation of property.

Taking into consideration the abovementioned, we apply to all players of the Ukrainian pharmamarket to refrain from the participation in the circulation of the counterfeit product and to take all appropriate measures to withdraw the falsified product Белый Уголь-Zdravofarm from the circulation in order to prevent the infliction of harm to the health of Ukrainian consumers, as well as pecuniary damages to other operators of pharmamarket of Ukraine that may be inflicted if the case falls under the competence of the law enforcement authorities of Ukraine.

 
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