Procedures and strategies for pharmaceutical brands: Turkey
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Selection, clearance and registration
IP Law 6769 applies to the application and registration process for pharmaceutical trademarks which are handled by the Turkish Patent and Trademark Office (TPTO) in common with any other trademarks. There is no special provision for pharmaceutical trademarks in the IP Law; however, there are some peculiarities regarding the evaluation of pharmaceutical trademarks based on absolute and relative grounds as related to public health.
Relevant national and international regulatory bodies and requirements
Conducting a clearance search before filing for a pharmaceutical trademark application is not mandatory, but it is beneficial to conduct a full availability search which includes identical and similar trademarks covering both the same and similar goods and services for determining any earlier trademarks constituting a risk for the registration and use of the applied for trademark. The search must also include the pharmaceutical products approved by Ministry of Health in order to determine unregistered pharmaceutical trademarks that are being used in the market.
When an applied for sign is to be registered for pharmaceuticals, it is ex officio reviewed by the TPTO on the basis of absolute grounds (eg, distinctiveness, descriptiveness, delusiveness and being identical or indistinguishably similar to an earlier trademark). In addition, the TPTO also evaluates whether the applied for sign is identical with or confusingly similar to an international non-proprietary name (INN). If no absolute ground is found, the trademark application is published in the Official Trademark Bulletin and remains open to third-party oppositions for two months following the publication date. It usually takes eight to 10 months for straightforward applications with no ex officio refusal or third-party opposition until registration.
During the evaluation of likelihood of confusion regarding a third-party opposition, the TPTO looks for indistinguishable similarity, since it takes a narrower approach here than for the similarity evaluation between pharmaceutical trademarks and ordinary trademarks. This approach usually finds the small differences sufficient to distinguish trademarks from each other. The reason behind the TPTO’s narrow approach is that the targeted consumers of pharmaceuticals are considered to be professionals (ie, doctors and pharmacists) who have a medical education and are therefore deemed to have a high level of attention and circumspection so as to avoid easy confusion between trademarks. A number of recent Court of Appeal decisions involving pharmacy technicians as the targeted consumers held that the technicians’ level of attention was not considered to be high because, while they do sell pharmaceuticals at pharmacies, they have no medical education. However, such findings regarding pharmacy technicians have not yet been established by either the TPTO or the IP courts.
If a pharmaceutical trademark designating Turkey is applied for through the World Intellectual Property Office, it is extremely important to follow up the status of the application through local representatives. The TPTO does not notify the applicants of international registration applications with third-party oppositions, as there is no such procedure with the Madrid Protocol. The TPTO only notifies the applicant if the opposition is partially or totally accepted. Even if the applicant has a right to appeal the refusal of its application, it is not possible to claim a non-use defence against the opponent’s trademark which is registered for more than five years at the time of the application at the appeal stage. Non-use defence can be claimed only at the opposition stage. Accordingly, following up the status of the application before the TPTO may be beneficial if a third-party opposition is filed against the application and it is possible to overcome the opposition with the non-use defence, which can be claimed by submitting a counter-statement.
Several pharmaceutical trademarks exist that have not yet been put to use, mostly as a result of licensing problems, and are therefore vulnerable to non-use defence. Any opposition on the basis of such kinds of trademark can be overcome by non-use defence.
If the application passes the opposition period without any opposition or refusal, it is registered after the payment of the registration fee for national applications, or directly without further payment for international registration applications. However, the registration of a pharmaceutical trademark is not sufficient for the use of a trademark on a product in the market unless the product is approved by the Ministry of Health in accordance with the Regulation on Licensing of Medicinal Products for Human Use. The ministry does not ex officio make an evaluation based on similarity with an earlier trademark recorded at the TPTO; it only checks the pharmaceutical names that are listed in the Pharma in Use database and the names of products that have been previously approved by the ministry.
There used to be a ‘three-letter rule’ for pharmaceutical products that is mentioned in the doctrine, but there is presently no legislation in Turkey that explicitly regulates such a rule. Through this rule, pharmaceutical trademarks were required to differ from an earlier dated trademark by at least three letters. However, there are numerous trademarks registered with the TPTO that fail to abide by this rule. The Ministry of Health also no longer applies the three-letter rule.
Confusion with INNs
Turkey has been a member of the World Health Organisation (WHO) since 1949 and is required to comply with its principles. Accordingly, the national regulations were also revised in line with such principles. Article 4 of the Implementing Regulation on the Labelling, Package Leaflet and Tracing of Human Medicinal Products regulates that “the international name of an active substance, accepted or recommended by the [WHO], does not have international proprietorship and should not be used in brand registration in line with the rules of the WHO”. This is applied by Ministry of Health while granting marketing authorisation and also by the TPTO while deciding on the mark’s registration.
The aim of the criteria is to avoid the use of INNs, INN stems or the signs derived from them in a way that may cause confusion between pharmaceutical products. Although there is no explicit regulation providing measures for avoiding the use of such terms as a pharmaceutical trademark, the Ministry of Health is intent on applying it and has even demanded that the TPTO ensure that INNs are not registered as trademarks. The TPTO keeps records of the INNs in its database by giving them a specific number beginning with ‘ILAC’ (meaning ‘drug’ in Turkish).
The TPTO ex officio rejects trademark applications that are identical to INNs. It is possible for third parties to oppose applications based on a similarity to an INN. Nevertheless, the TPTO is strict in this respect and requires such marks to be almost identical. The TPTO has refused some trademark applications that were merely fairly similar to an INN in their overall aspect (eg, Metoglaptin and the INN Melogliptin).
Non-traditional trademarks (eg, shape, taste and colour)
According to the IP Law, trademarks, including pharmaceutical marks, may consist of any sign such as words (including personal names), figures, colours, letters, numbers, sounds and the three-dimensional shape of goods or packaging. The taste or a scent of a product may not be registered before the TPTO. Non-traditional trademarks are subject to the same registrability conditions as traditional trademarks.
Parallel imports and repackaging
The IP Law accepts the ‘exhaustion of rights’ concept. Following the release of an IP right-protected product onto the market by the rights holder or authorised third party, the actions relating to that product remain outside the scope of the IP right. A trademark right is exhausted once a product is released onto the market by an authorised person, and imports of genuine products do not constitute infringement. Although parallel imports of genuine products that have already been sold in the market cannot be prevented as per the subject provision, trademark owners have the right to prevent the import of the products provided that a third party aims to use it for commercial purposes by means of changing or deteriorating the products.
Under Decree Law 556 on the Protection of Trademarks, the principle of exhaustion of a trademark right contains the term “after it is put on the market in Turkey”. In practice, this resulted in a number of discussions regarding the understanding that the term did not cover ‘international exhaustion’. In the new IP Law, this limitation has not been set out and international exhaustion is thereby put in practice.
Pharmaceutical imports into Turkey are regulated under the Pharmaceutical and Medical Preparations Law 1262. In respect of pharmaceutical products, it is mandatory to obtain an import licence from the Ministry of Health before importing products. Article 19 of Law 1262 states that the import of pharmaceutical products without a market authorisation constitutes smuggling and will be punished according to the Anti-smuggling Law 5607. In principle, import licences are given to a marketing authorisation holder and the parallel import of pharmaceutical products is therefore not possible.
The Pharmaceutical and Medical Preparations Law and the Implementing Regulation on the Labelling, Package Leaflet and Tracing of Human Medicinal Products provides strict regulations regarding the packaging and labelling of the pharmaceuticals. Pharmaceutical products must be marketed with a package or label in Turkish. However, the repackaging of a pharmaceutical is prohibited unless it is permitted by the Ministry of Health because it is deemed necessary for public health.
Anti-counterfeiting and enforcements
The use of an identical or similar registered trademark on the same or similar goods or services constitutes trademark infringement, according to the IP Law. Such use also constitutes unfair competition as per the general provisions of the Commercial Code. A trademark owner can initiate civil and criminal actions, including a preliminary injunction and a demand for compensation.
The Pharmaceutical and Medical Preparations Law regulates that the sale of counterfeit pharmaceuticals is subject to an administrative fine. If a counterfeit pharmaceutical is imported into Turkey without being subject to customs procedures, the Pharmaceutical and Medical Preparations Law states that such products will also be subject to the Anti-smuggling Law.
Counterfeiting and the illegal distribution of pharmaceuticals also constitutes a crime under the Penal Law, which carries the risk of one to five years’ imprisonment and a fine for up to 1,500 days to those who sell, procure or store decayed or transformed foodstuffs, beverages or pharmaceuticals that carry risk to life or health. The punishment increases by one-third where the offence is committed by a person who is a qualified health professional (eg, a physician or pharmacist).
In case of the sale or distribution of counterfeit pharmaceuticals online, access to the infringing website will be blocked. Although, according to the Law Regulating the Electronic Commerce, the intermediary service provider will not be held liable for monitoring or investigating the lawfulness of the content, they are also required to remove the unlawful content after being notified of the infringement. If the intermediary service provider refuses to comply with such notification, they will also be liable for the infringement.
Rights holders may register their IP rights before the Ministry of Commerce, which has authority over the Turkish borders and customs authorities. Customs generally notifies trademark owners and attorneys of suspicious activity, even if the trademark is not registered with Customs. In case the products are counterfeit, a complaint can be filed to start criminal proceedings, or a preliminary injunction can be requested from the civil IP courts for civil proceedings. If no proceeding is started, the suspected goods will be released by Customs.
In addition, the Ministry of Health’s Drug Tracking System operates, along with its other functions, as a monitoring system for dangerous counterfeiting. The system tracks pharmaceuticals with the corresponding identification number at each step from production until consumption by the patient or its disposal.
Regulatory framework and considerations
There are several regulations in Turkey containing provisions that concern advertising and the promotional activities of pharmaceuticals, including the Pharmaceutical and Medical Preparations Law and the Regulation on Promotional Activities of Medicinal Products for Human Use. It is not permitted for pharmaceuticals, whether prescribed or non-prescribed, to be advertised to the public.
Promotional activities regarding pharmaceuticals may be carried out only towards healthcare professionals under strict conditions. The information provided to healthcare professionals via promotional activities must be objective, informative and factual. It is possible to use promotional materials to organise and support scientific and product-promotion meetings; to visit physicians, dentists and pharmacists; and to conduct certified product promotions to such staff. There are different approval and permission procedures and budget limits for different activities. Promotional activities must not be used as an incentive for the unnecessary use of a product. Promotion of a product must be related only to the approved indications and the therapeutic area identified by the Ministry of Health.
The promotional activities of pharmaceuticals are also subject to other regulations, such as the Law on the Protection of Consumers, the Regulation on Principles and Fundamentals of Practices Regarding Commercial Advertisements and Announcements and the Law on Establishment and Broadcasting of Radio and Television Institutions, among others. In case of any breach of such provisions, the marketing authorisation holder will face certain administrative monetary fines.
In Turkish law, there are two types of pharmaceutical:
- original/reference pharmaceuticals; and
- generic pharmaceuticals.
Original/reference pharmaceuticals are registered by the innovator company after conducting clinical trials and are a reference for the generic pharmaceutical. Generic pharmaceuticals are substitutes for the original/reference pharmaceutical and may be marketed only after the expiration of the data exclusivity period covering the reference drug, relying on the clinical trials performed for the original/reference drug.
A generic pharmaceutical should be equivalent to the reference drug by its qualitative and quantitative features. A generic product is scientifically proven to be the bio-equivalent to an original drug having the identical therapeutic effect, except for certain products for which a bio-equivalence study is not required.
Turkish law recognises and regulates generic products.
An original drug that is prescribed by physicians may be switched with a generic product at the pharmacist’s discretion, provided that a generic product is scientifically proven to be the bio-equivalent to an original drug and to have identical therapeutic effects.
As pharmacies are allowed to give generic products which will create the least burden on the reimbursing bodies, it is widely discussed whether the interchangeability of the products at the pharmacy level is the best solution for maintaining public health. The policies of the regulatory bodies with respect to this matter must ensure that physicians have:
- the freedom to choose the best treatment for their patients; and
- the sufficient flexibility for the continuance of the treatment and for patients to request the product of their choice.
Strict regulations in Turkey mean pharmaceutical products are sold only in pharmacies. The Pharmaceutical and Medical Preparations Law and the Law on the Pharmacies and Pharmaceutical Warehouses explicitly states that the sale of pharmaceutical products in places other than pharmacies and pharmaceutical warehouses is forbidden. In case pharmaceutical products are sold online, the Ministry of Health immediately prevents access to the particular website and notifies the Communication Technologies Authority of its decision. The sale of pharmaceuticals online constitutes a crime under the abovementioned laws.
In Turkey, there is no regulation preventing pharmaceutical trademarks from being registered as a domain name. However, due to strict prohibitions regarding the advertising and promotional activities of pharmaceuticals, such websites must be designed only for the access of the healthcare professionals and access by the general public must be denied.
Where a domain name consists of a pharmaceutical trademark, this constitutes trademark infringement against the rights of another owner arising from a prior industrial property right. A successful legal action or a Uniform Domain Name Dispute Resolution Policy complaint may result in the transfer, cancellation or suspension of the domain name.