Bolar Exemption, Data Exclusivity and Patent Term Extensions in Türkiye

Introduction

The development and commercialization of pharmaceutical products require substantial investments in research, testing, clinical trials and regulatory approvals. In addition to patent protection, pharmaceutical innovators may benefit from regulatory mechanisms designed to protect the data generated during the authorization process.

In Türkiye, two concepts play a central role in this area: data exclusivity and the Bolar exemption. While data exclusivity protects the clinical and pre-clinical data submitted for marketing authorization, the Bolar exemption permits certain activities necessary for obtaining regulatory approval before patent expiry.

This article provides an overview of these mechanisms and examines the current position regarding patent term extensions in Türkiye.

Data Exclusivity in Türkiye

Data exclusivity was introduced into Turkish pharmaceutical legislation in 2005 and is currently regulated under the Regulation on Licensing of Medicinal Products for Human Use.

Under the current framework, data exclusivity applies to reference medicinal products that are licensed for the first time after 1 January 2005 in a country within the Customs Union Area.

The principal features of the system are as follows:

• The protection period is six years.
• The six-year period begins on the date of the first marketing authorization within the Customs Union Area.
• Data exclusivity cannot extend beyond the term of the relevant patent.
• No separate application is required to obtain protection.
• Protection arises automatically upon the granting of marketing authorization.
• The Turkish Medicines and Medical Devices Agency takes data exclusivity into account ex officio.

During the exclusivity period, generic applicants may not rely on the protected clinical and pre-clinical data submitted by the originator company for the purpose of obtaining marketing authorization.

Data exclusivity exists independently from patent protection and constitutes a separate form of regulatory protection.

Bolar Exemption Under Turkish Law

The Bolar exemption is regulated under Article 85/3(c) of the Industrial Property Code No. 6769 .

According to this provision, activities involving tests, experiments and other preparatory acts necessary for obtaining regulatory approval do not constitute patent infringement.

The exemption allows generic pharmaceutical companies to:

• conduct studies and tests relating to a patented pharmaceutical product;
• prepare regulatory dossiers;
• submit applications for marketing authorization; and
• complete administrative approval procedures before patent expiry.

The purpose of the exemption is to allow generic products to enter the market immediately after the expiration of patent protection without additional delays resulting from regulatory procedures.

Marketing Authorization Applications During the Data Exclusivity Period

In practice, generic pharmaceutical companies may submit abridged marketing authorization applications before the expiration of the data exclusivity period.

The Turkish Medicines and Medical Devices Agency generally accepts such applications for examination. However, marketing authorization cannot become effective for commercial purposes until the relevant data exclusivity period has expired.

Accordingly:

• regulatory review may take place during the exclusivity period;
• marketing authorization procedures may be completed before exclusivity expires; but
• commercial market entry remains restricted until the end of the protection period.

This approach allows regulatory assessment to proceed without extending the practical duration of data exclusivity beyond the period established by legislation.

Turkish Court Practice Regarding the Bolar Exemption

Turkish courts have generally interpreted the Bolar exemption as covering activities necessary for obtaining marketing authorization.

Court decisions have consistently recognized that:

• conducting clinical studies and tests;
• preparing regulatory submissions; and
• filing abridged marketing authorization applications

fall within the scope of the exemption.

In addition, Turkish courts have frequently concluded that the filing of a marketing authorization application during the data exclusivity period does not, by itself, constitute patent infringement or unfair competition.

Certain judicial decisions have also examined activities associated with pricing approvals and reimbursement procedures. The assessment of whether such activities fall within the scope of the exemption depends on the specific circumstances of each case.

Supplementary Protection Certificates (SPCs)

In the European Union, pharmaceutical products may benefit from Supplementary Protection Certificates (SPCs).

SPCs were introduced to compensate patent holders for the period consumed by regulatory approval procedures before a medicinal product can be marketed.

Under the EU system:

• an SPC may provide additional protection after patent expiry;
• the extension may last for up to five years; and
• the combined duration of patent protection and SPC protection is generally limited to fifteen years from the first marketing authorization within the European Union.

The SPC system operates independently from data exclusivity and serves a different purpose.

SPCs and Türkiye

Türkiye does not currently have a supplementary protection certificate system.

Although discussions regarding legislative harmonization with the European Union have occasionally referenced SPC protection, Turkish patent legislation presently provides only the standard patent term of twenty years from the filing date.

As a result:

• pharmaceutical patents in Türkiye expire at the end of the ordinary patent term;
• no additional protection period comparable to an SPC is currently available; and
• pharmaceutical innovators primarily rely on patent protection and data exclusivity to protect their products.

Conclusion

The Turkish pharmaceutical regulatory framework incorporates both data exclusivity and the Bolar exemption.

Data exclusivity provides six years of protection for the clinical and pre-clinical data supporting a reference medicinal product, while the Bolar exemption allows generic manufacturers to undertake activities necessary for obtaining marketing authorization before patent expiry.

At the same time, unlike the European Union, Türkiye does not currently provide a supplementary protection certificate system capable of extending the duration of patent protection beyond the standard patent term.

Together, these rules form the principal framework governing the interaction between pharmaceutical patents, regulatory approvals and generic market entry in Türkiye.