Pharmaceutical IP and competition law in Turkey: overview

A Q&A guide to pharmaceutical IP and competition law in Turkey.

The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports.

For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in Turkey: overview.

To compare answers across multiple jurisdictions, visit the Pharmaceutical IP and competition Country Q&A tool.

The Q&A is part of the global guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-guide.

Kayra Üçer, Gülbin Olgun and Mert Bölükoğlu, Hergüner Bilgen Özeke Attorney Partnership
Contents

Patents

1. What are the legal conditions to obtain a patent and which legislation applies? Which products, substances and processes can be protected by patents and what types cannot be patent protected?

Conditions and legislation

Decree Law No. 551 on the Protection of Patent Rights (Patent Decree Law) is the primary legislation regulating patents. To be granted a patent, an invention must (Article 5, Patent Decree Law):

  • Be new.

  • Exceed the level of current technical knowledge in that area (state of the art).

  • Be applicable to industry.

Turkey is a party to the following international agreements regarding patents;

  • Paris Convention for the Protection of Industrial Property (including London text and Stockholm text).

  • European Patent Convention.

  • Patent Cooperation Treaty.

  • Patent Decree Law Treaty.

  • Strasbourg Agreement Concerning the International Patent Classification.

  • Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Scope of protection

The following are not covered by patent protection, because they are not an invention (Article 6, Patent Decree Law):

  • Discoveries, scientific theories, mathematical methods.

  • Plans, procedures or rules regarding mental, commercial or game related activities.

  • Literary and artistic work, scientific work, aesthetic creations, and computer software.

  • Procedures regarding classification, organisation, presentation and transfer of knowledge which does not have a technical aspect.

  • Surgical and medicinal procedures to be applied on human and animal bodies and diagnostic procedures regarding human and animal bodies.

However, products, compositions and processes regarding these products or compositions used in connection with human and animal health are protected by patents. Pharmaceutical product formulas are protected under patents.

The following inventions also cannot be protected by patents:

  • Inventions against public order or generally accepted moral values.

  • Plant and animal species or procedures for breeding/planting plants or animals that mainly rely on biological grounds.

 
2. How is a patent obtained?

Application and guidance

Patent applications must be made to the Turkish Patent Institute (Patent Institute). Its website provides fees and regulations on the application procedure in both Turkish and English (www.tpe.gov.tr/TurkPatentEnstitusu/?lang=en).

It is also possible to apply for international or European patents from the World Intellectual Property Organisation (WIPO) (under the Patent Co-operation Treaty) (www.wipo.int/portal/en/index.html) or the European Patent Office (EPO) (www.epo.org/index.html) and extend the application to cover Turkey as a region, under international treaties that Turkey is a party to. This route also grants patent protection in Turkey as soon as a patent is granted. This is generally the way chosen by international pharmaceutical patent owners to extend their patent protection into Turkey.

Process and timing

The key stages of a patent application, which typically takes two to six years, are as follows:

  • A formal examination is conducted by the Patent Institute to check the necessary documents for the application are included. The applicant is given three months to provide any missing documents.

  • The applicant must request a state-of-the-art search within 15 months from the date of application or the date of priority, if claimed.

  • After receiving the search report, the applicant must within three months choose registration either without substantive examination (seven years of patent protection), or with substantive examination (20 years of patent protection).

  • The Patent Institute will proceed with patent registration without substantive examination if the applicant fails to provide the Patent Institute with its preference.

 
3. How long does patent protection typically last? Can monopoly rights be extended by other means?

Duration and renewal

Patent protection lasts for seven or 20 years from the application filing date, depending on the type of examination requested (see Question 2).

The subject of the patent will become public property following expiry of the patent protection period (Article 133, Patent Decree Law). Turkish law does not allow the renewal of a patent. Patent holders must pay annual fees to maintain patent protection. Patent protection will lapse if the annual fees are not paid.

Extending protection

Turkish law does not allow the extension of patent protection, and supplementary protection certificates are not granted or applied in Turkey. It is only possible to change from a patent without examination with seven years of protection to a patent with examination with 20 years of protection.

 
4. How can a patent be revoked?

The owner of a patent can revoke a patent by giving up his/her patent rights by applying to the Patent Institute.

Courts can revoke a patent if one of the following conditions is proven (Article 129, Patent Decree Law):

  • The subject of the patent does not meet the patentability criteria.

  • The subject matter of the invention is not described in a sufficiently explicit and comprehensive way to enable a person skilled in the technical field to use/apply the invention.

  • The subject of the patent does not fit into the scope of the patent application.

  • The patent holder does not have the right to request the patent.

 
5. How is a patent infringed? How is a claim for patent infringement made and what remedies are available?

Conditions for infringement

The following acts are patent infringement (Article 136, Patent Decree Law):

  • Imitating the invention product, by producing the product partly or fully without the consent of the patent holder.

  • Selling, distributing, commercialising, importing, possessing for commercial purposes or use by applying products known or should be known to be produced through imitation that cause patent infringement.

  • Using the patented process or selling, distributing or commercialising the patented product in any other way, or use by applying the patented products.

  • Extending the scope of the rights granted through a licence or a compulsory licence, or transferring such rights to third parties without the permission of the patent holder.

  • Participating in the actions stated above by assisting, inducing, encouraging, or facilitating them in any way.

  • Refraining from stating where a product, which is unlawfully manufactured or commercialised, was obtained from.

Claim and remedies

A patent holder or applicant can file infringement lawsuits in specialised IP courts in Istanbul, Ankara and Izmir, and commercial courts in other cities. The claimant can claim (Article 137, Patent Decree Law):

  • Cessation of the actions infringing the rights granted through the patent.

  • Elimination of the infringement and reimbursement of material and immaterial damages.

  • Confiscation of produced or imported products causing infringement and the devices used to produce the infringing products.

  • Ownership or destruction of confiscated products.

  • Preliminary measures to prevent infringement.

  • Announcement of the infringement decision to the relevant parties and to the public.

The prescription period for civil law claims is two years from the date when the infringement is learned by the right holder, and ten years following the date of the infringement (Code of Obligations).

The prescription period for filing criminal law based claims for actions defined as offences under the Patent Decree Law is subject to the prescription periods in the Criminal Code.

 
6. Are there non-patent barriers to competition to protect medicinal products?

Patent protection prevents generic entry into the market if the patent protection period still continues. However, patent protection does not cover marketing authorisation applications or other activities to obtain a marketing authorisation, due to the express regulation under Article 75/1(f) of the Patent Decree Law (known as the Turkish Bolar exception). Therefore, it is not possible to prevent generic marketing authorisation applications or other activities by generic manufacturers for the purposes of filing such applications.

At that point, the only available route is to apply data exclusivity provisions. According to the Regulation on Licensing of Human Medicinal Products, the data exclusivity period is six years from the date on which a product received marketing authorisation for the first time in the Turkish-EU Customs Union area. It is only applied for products which received marketing authorisation after 1 January 2005 (and for products authorised for the first time after 1 January 2001 and for which no generic application is filed until 1 January 2005).

During this term, no abridged application can be made by using the clinical data obtained from clinical trials performed during the marketing authorisation application of the original pharmaceutical. Under Turkish law, the data exclusivity period for medicinal products is linked to the patent protection period which commences after the application for patent protection. The data exclusivity period is limited by the patent protection period applicable in Turkey, and ceases if the patent protection period expires. Since patent applications are filed long before application for marketing authorisation, data exclusivity periods may not prove useful in practice when limited by the patent protection period.

There is no marketing exclusivity in Turkey. Generic companies can make abridged applications for obtaining marketing authorisation once the data exclusivity period ends.

 

Trade marks

7. What are the legal conditions to obtain a trade mark and which legislation applies? What cannot be registered as a trade mark and can a medicinal brand be registered as a trade mark?

Conditions and legislation

Decree Law No. 556 on the Protection of Trade marks (Trade mark Decree Law) is the primary legislation regulating trade marks. The following can be registered as a trade mark, provided they are distinctive (Article 5, Trade mark Decree Law):

  • Names, words, shapes, letters and numbers.

  • Device marks.

  • Signs that can be imaged with drawings (such as a shape of goods or packaging) or reproduced by printing.

Turkey is a party to the following international agreements regarding trade marks;

  • Singapore Treaty on the Law of Trade marks (signed but not ratified).

  • Trade mark Law Treaty.

  • Nice Agreement Concerning the International Classification of Goods and Services for the Purposes of the Registration of Marks.

  • Vienna Agreement Establishing an International Classification of the Figurative Elements of Marks.

  • Paris Convention for the Protection of Industrial Property (including London text and Stockholm text).

  • Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Scope of protection

The following cannot be registered as a trade mark (Article 7, Trade mark Decree Law):

  • Signs without a distinctive aspect.

  • Signs that are similar or indistinguishably similar to trade marks which are already registered.

  • Signs that incorporate the commercial type, variety, characteristic, quality, amount, goal, value, geographical source or the characteristic property of the goods and services.

  • Signs that may deceive the public about the goods or services' properties, quality, manufacturing location or geographic source.

  • Trade marks not authorised by the competent authorities that are to be refused under Article 6ter of the Paris Convention.

  • Trade marks containing badges, emblems or escutcheons other than those covered by Article 6ter of the Paris Convention, which have not been authorised by the competent authorities and are of particular historical and cultural public interest.

  • Signs that incorporate religious values and symbols.

  • Signs that are against public order and principles of morality.

Medicinal brands can be registered as trade marks in Turkey. However, international non-proprietary names (INN) cannot be registered as trade marks, since they are not distinctive and not capable of being accepted as an original trade mark. It is also not possible to register phrases which are similar to INNs.

Pharmaceutical product brand names are controlled by the Patent Institute during the trade mark registration process, and by the Pharmaceutical Product and Medical Device Institution (Institution) during the marketing authorisation process.

 
8. How is a trade mark registered?

Application and guidance

Trade mark applications must be made to the Patent Institute. Its website provides fees and regulations on the application procedure in both Turkish and English (www.tpe.gov.tr/TurkPatentEnstitusu/?lang=en).

It is also possible to apply through the WIPO or EPO for an international or European trade mark, choose Turkey as a designated country, and extend a trade mark application to Turkey within the scope of the international treaties that Turkey is a party to.

Process and timing

The key stages of a trade mark application, which take ten to 12 months (if no opposition is filed) are as follows:

  • A formal examination by the Patent Institute to check the necessary requirements for the application are included. The applicant is given two months to amend any missing documents or information.

  • The application is published in the Patent Institute's Official Trade mark Bulletin.

  • Third parties can submit their opposition, stating why the application must not be accepted, within three months from the date of publication. If no third party opposition is submitted, the trade mark is granted.

  • If the Patent Institute accepts an opposition, the applicant is given two months to appeal (before the Patent Institute decides the opposition, the applicant can file a response to the opposition. However, the practice of the Patent Institute can vary, due to ambiguity in the regulations). The appeal is evaluated by the Patent Institute's Re-Examination and Evaluation Board (REEB).

  • If the REEB declines the appeal, the applicant can only request cancellation of the Patent Institute's decision through a lawsuit.

 
9. How long does trade mark protection typically last?

A trade mark right is valid for ten years from the application date. This period can be renewed at the end of each ten year period for another ten year period. There is no limit on the number of renewals. Registration of a trade mark is renewed on payment of the renewal fee at the request of the trade mark owner, or the person authorised by him.

A request for renewal must be submitted within six months before the last day of the month in which the trade mark protection ends. If this deadline is not met, the request can still be submitted within six months from the date of expiry, on payment of an additional fee.

Trade marks that are not renewed within six months after expiry of the protection period become invalid.

 
10. How can a trade mark be revoked?

A trade mark can be revoked by a court on the occurrence of the following (Article 42, Trade mark Decree Law);

  • Breach of absolute grounds for refusal, as stated in Article 7 of the Trade mark Decree Law (see Question 7).

  • Breach of relative grounds for refusal, as stated in Article 8 of the Trade mark Decree Law. Relative grounds of refusal are if the trade mark applied for:

    • is identical with a registered trade mark, or a trade mark with an earlier application date, for identical goods and services;

    • is identical or similar with a registered trade mark or a trade mark with an earlier application date, for similar goods and services, and there is a likelihood of confusion by the public;

  • The trade mark becomes generic for certain products and services, due to acts of the trade mark owner.

  • Possible confusion by the public as to the nature, quality, manufacturing place or geographical source, due to acts of the trade mark owner or the person authorised by the owner.

  • Use of a guarantee mark against the technical specification.

Although there is no explicit provision in the Trade mark Decree Law, according to High Court decisions, a lawsuit to cancel a trade mark must be filed within five years following the registration date of the trade mark (different to the protection date starting from filing of the application). A cancellation lawsuit can be filed at any time if the trade mark has been registered with malicious intent.

 
11. How is a trade mark infringed? How is a claim for trade mark infringement made and what remedies are available?

Conditions

The following are considered trade mark infringement (Article 66, Trade mark Decree Law):

  • Violation of the rights of the trade mark owner, as stated in Article 9 of the Trade mark Decree Law.

  • Imitation of the trade mark by using an identical trade mark without the trade mark owner's consent, or using another trade mark which is indistinguishably similar.

  • Selling, distributing or otherwise trading products with the trade mark, or indistinguishably similar marks in violation of trade mark rights, or placing such products in Turkish customs territory, which are known or should be known to be causing trade mark infringement.

  • Extending the scope of rights granted through a licence, or transferring these rights to third persons without the consent of the trade mark owner.

Claim and remedies

The following remedies can be requested by the trade mark owner through a civil lawsuit:

  • Cessation of the acts of infringement.

  • Termination of infringement and indemnification of both material and moral damages.

  • Confiscation of the products and equipment and machinery used to produce them.

  • Ownership of products confiscated. In this case, the value of the products is deducted from the compensation awarded. If the value of the products turns out to be above the compensation awarded, the owner of the trade mark repays the balance to the infringing party.

  • Enforcement measures to prevent continued infringement of rights, deletion of the trade mark from products and vehicles or, if essential to prevent acts of infringement, destruction of confiscated products and vehicles.

  • Disclosure to the public and to those related to the court's judgment, the costs of which to be paid by the infringing party.

Under Article 66 of the Trade mark Decree Law, the trade mark owner is also entitled to claim compensation for damages and loss of income incurred by infringements under the Trade mark Decree Law. When calculating lost profits, the following in particular will be taken into consideration:

  • Economic value of the trade mark.

  • Term of protection remaining at the time of infringement.

  • Type and number of outstanding licences.

Under Article 61/A of the Trade mark Decree Law, on a complaint from the trade mark owner, the infringing party can be sentenced to imprisonment and a judicial fine.

 
12. Outline the regulatory powers and enforcement action against counterfeiting in the pharmaceutical sector.

Producing, distributing or selling counterfeit pharmaceuticals is trade mark infringement, given that the pharmaceutical brand is registered as a trade mark. The trade mark owner can take action in the civil and criminal courts (see Question 11).

Counterfeit pharmaceuticals also create patent infringement, as the pharmaceutical is patented protected. The patent owner can take action in the civil and criminal courts.

IP and competition law issues

13. Briefly outline the competition law framework in your jurisdiction and how it impacts on the pharmaceutical sector. In particular, the competition authorities and their regulatory powers, key legislation, whether pharmaceutical investigations are common, key recent activity and case law.

The Competition Authority (www.rekabet.gov.tr/en-US/Pages/Turkish-Competition-Authority) is responsible for enforcing the Law on Protection of Competition No. 4054 (Competition Law). The Competition Board is its executive body and its final decisions can be challenged in administrative courts.

The primary piece of legislation governing anti-competitive practices is Competition Law. The following block exemption communiqués also apply:

  • No. 2002/2 on Vertical Agreements.

  • No. 2003/2 on Research and Development Agreements.

  • No. 2008/2 on Technology Transfer Agreements.

  • No. 2013/2 on Specialisation Agreements.

As stated in the Competition Authority's Report on the Pharmaceutical Sector, the pharmaceutical sector was one of the first sectors to be subject to competition law in Turkey. Merger control and anti-trust issues are major aspects of the Competition Board's workload in this sector. In 2014, 13 negative clearance and exemption decisions and 11 merger control rulings were made by the Competition Board for the pharmaceutical sector. Between 1999 and 2014, the Competition Board imposed TRY31,312,527 of fines on companies in the pharmaceutical and health services and products sector.

The Competition Board has recently approved the acquisition of GlaxoSmithKlein's portfolio of oncology related pharmaceutical products (excluding manufacturing) by Novartis (Decision 4-43/796-357, 4 November 2014).

 
14. Briefly outline the competition issues that can arise on the licensing of technology and patents in a pharmaceutical context.

Under Article 6 of Block Exemption Communiqué No. 2008/2 on Technology Transfer Agreements, technology transfer agreements that include the following restraints cannot benefit from a block exemption:

  • Restriction of a party's right to determine its sales prices.

  • Restriction of production and sales volumes of contract products.

  • Allocation of markets and customers.

  • Restriction of a licensee's right to use its own technology or the restriction of a

party's right to carry out research and development activities, unless the restriction is necessary to prevent the disclosure of licensed know-how to third parties.

Market shares of parties are essential in determining whether an agreement with restraints can benefit from the technology transfer block exemption. To benefit from the exemption, the total market share of the parties must not exceed 30% (for competitors) to 40% (for non-competitors) of the relevant technology and product market. The exemption will continue as long as the protection granted to the intellectual property rights regarding the licensed technology is valid.

 
15. Are there competition issues associated with the generic entry of pharmaceuticals in your jurisdiction?

Based on the Competition Authority's Report on the Pharmaceutical Sector, in general terms, there are no specific competition issues associated with the generic entry of pharmaceuticals. In theory, an abuse of dominant position could occur if the undertaking with rights over the original pharmaceutical product decides to prevent the generic entering the market.

Although patent litigation is initiated by original product owners in Turkey against generic manufacturers, the Turkish Bolar exception (see Question 6) prevents these actions against generic product applicants for marketing authorisations which are in the application phase. In this respect, there are no specific and dominant barriers against generic entry.

 
16. Have abuse of dominance issues arisen in the pharmaceutical sector in your jurisdiction?

Although the Competition Law prohibits the abuse of dominant position, it does not provide a certain percentage of market share as a benchmark for a dominant position. The Guideline on Market Abuse states that it is very unlikely for entities with a market share of less than 40% to be considered to have a dominant position in the market. However, the Competition Board has issued a number of decisions where it has held that an entity with a market share of less than 40% had a dominant position. In these decisions, it took the structure, specialities and dynamics of those markets into consideration.

Article 6 of the Competition Law lists several types of market abuse as follows:

  • Preventing, directly or indirectly, another undertaking from entering into the area of commercial activity, or actions aimed at complicating the activities of competitors in the market.

  • Making direct or indirect discrimination by offering different terms to buyers with equal status for the same and equal rights, obligations and acts.

  • Purchasing another good or service together with a good or service, or subjecting a good or service demanded by buyers acting as intermediary undertakings to the condition of displaying another good or service by the buyer, or imposing limitations on the terms of purchase and sale in case of resale, such as not selling a purchased good below a particular price.

  • Actions which aim at distorting competitive conditions in another market for goods or services by means of exploiting financial, technological and commercial advantages created by dominance in a particular market.

  • Restricting production, marketing or technical development to the prejudice of consumers.

The Competition Board has decided that Sanofi Aventis decreasing its payment terms from 60 to 180 days down to 15 days was a clear abuse of its dominant position. Sanofi Aventis was ordered to pay an administrative fine of TRY3,648,045 (Decision 09-16/374-88, 20 April 2009).

 
17. Have parallel imports of pharmaceuticals raised IP and competition law issues in your jurisdiction?

The Trademark Decree Law and the Patent Decree Law do not directly address the status of parallel imports.

However, Article 76 of the Patent Decree Law states that patent protection does not apply to actions regarding patented products sold in Turkey by the patent holder or with his consent. Similarly, Article 13 of the Trade mark Decree Law states that trade mark protection does not apply to actions regarding products labelled with registered trade marks which are already offered to the market with the consent of the trade mark owner.

Therefore as long as such products are not put on the market in Turkey by the patent or trade mark owner or with his consent, it is possible to prevent parallel imports. As soon as they are put on the market by the owner or with his consent in Turkey, it is usually possible to block parallel imports of them.

However due to the special status of pharmaceutical products, which require a local marketing authorisation or similar authorisation from the Institution, parallel imports of pharmaceutical products are not allowed, except by persons or entities with such authorisations.

However for CE marked medical devices, free circulation cannot be prevented as long as the registration obligation for the importer company and for certain devices is met by registration in the National Database of the Institution (TITUBB). Other medical devices are subject to the general conditions with regard to other products, as long as the registration obligation is met by the relevant importer.

The Competition Law does not specifically regulate parallel imports. However, Article 4 of the Competition Law specifically prohibits an entity from applying boycotts or other activities to exclude opponents from the market and to prevent additional entries to the market. Similarly, abuse of dominant position is also prohibited by Article 6 of the Competition Law.

 
18. Does a patent or trade mark licence and payment of royalties under it to a foreign licensor have to be approved or accepted by a government or regulatory body? How is such a licence made enforceable?

Under Turkish Law, patent or trade mark licences or payments of royalty fees do not have to be approved or accepted by a regulatory body. Such agreements become enforceable when put into force between the parties. However, patent or trade mark licences can be registered with the Patent Institute, regardless of whether the parties are foreign, if the parties wish to make their licence enforceable against third parties.

 

Contributor profiles

Kayra Üçer, Partner

Hergüner Bilgen Özeke Avukatlık Ortaklığı

Büyükdere Caddesi
199 Levent
34394 Istanbul
Turkey
T +90 212 310 18 27
F +90 212 310 18 99
E kucer@herguner.av.tr
W www.herguner.av.tr

Professional qualifications. Georgetown University Law Center (LL.M., 2000); Marmara University School of Law (Law Diploma, 1998)

Areas of practice. Corporate and commercial matters, including mergers and acquisitions, labour law, compliance law and anti- corruption practices.

Languages. English, French

Professional associations/memberships.

  • Istanbul Bar Association.

  • Saint-Joseph Alumni Association.

  • Georgetown Alumni Association.

  • Transparency International Association.

  • Turkish Corporate Governance Association.

  • President of ILI, the Istanbul International Law Association.

Gülbin Olgun, Associate

Hergüner Bilgen Özeke Avukatlık Ortaklığı

Büyükdere Caddesi
199 Levent
34394 Istanbul
Turkey
T +90 212 310 18 14
F +90 212 310 18 99
E golgun@herguner.av.tr
W www.herguner.av.tr

Professional qualifications. London School of Economics and Political Science (LL.M., 2015); Galatasaray University Faculty of Law (Law Diploma, 2009)

Areas of practice. Special focus on pharmaceutical and life sciences areas and intellectual property law; corporate and commercial matters, including mergers and acquisitions; labour law; compliance law and anti- corruption practices and white-collar crime.

Languages. English, French, Spanish

Professional associations/memberships. Istanbul Bar Association; Galatasaray University Alumni Association.

Mert Bölükoğlu, Associate

Hergüner Bilgen Özeke Avukatlık Ortaklığı

Büyükdere Caddesi
199 Levent
34394 Istanbul
Turkey
T +90 212 310 16 55
F +90 212 310 18 99
E mbolukoglu@herguner.av.tr
W www.herguner.av.tr

Professional qualifications. Istanbul Bilgi University Faculty of Law (Law Diploma, 2014)

Areas of practice. Corporate and commercial matters, including mergers and acquisitions and labour law.

Languages. English, German

Professional associations/memberships. Istanbul Bar Association; American Collegiate Institute Alumni Association.


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