Data Exclusivity for Pharmaceutical Companies in Türkiye - Healthcare Series 11

It is essential to establish a fair balance between the interests of originator pharmaceutical companies, who bear all the costs and effort required for inventions, and the interests of generic pharmaceutical companies, which enable the public to access affordable medicines. Both serve the public’s right to health, either by finding new treatments for diseases or enabling affordable access to these treatments for everyone. There are various legal and administrative regulations and mechanisms, including data exclusivity, that aim to protect this balance.

Originator companies bear all the material and moral expenses when conducting the necessary research and development processes, seeking pharmaceutical patents, conducting clinical tests and trials to demonstrate the therapeutic effectiveness and safety of newly invented pharmaceuticals, and obtaining governmental licenses for market release. Pharmaceutical companies submit all the results of clinical tests and trials, which prove the efficacy, safety, and quality of the original drug, to the competent authorities for market authorization. Since the repetition of costly and lengthy periods of clinical trials and tests would artificially extend an originator’s monopoly in the market and retard the public’s access to affordable medicines, generic companies are provided with the opportunity for abbreviated license applications. Through abbreviated applications, generic companies can give reference to the results of clinical tests and trials submitted by originator companies for the reference molecule and release their equivalent generic drugs without bearing the costs.

Abbreviated license applications provide a great advantage for generic companies due to the fact that they are not obliged to submit their own toxicological and pharmacological tests and clinical trial results; they can give reference to the previously submitted clinical test and trial data from the original drug. This means they do not have to repeat clinical trials and only bear the cost of proving the similarity of their generic with the reference drug. When generics are released to the market, the originators lose their monopoly in the market, and cheaper generics become available to the public. In order to encourage originators to keep inventing new treatments, their interests must be protected by establishing a fair balance.

Data exclusivity ensures the protection of pharmacological and toxicological test results and clinical trial data from use by any other pharmaceutical company for a specific period of time following an innovator drug’s release onto the market. During this time, generic companies cannot give reference to these test results and clinical trials, nor can they use this data for abbreviated drug applications. Data exclusivity actually determines how long generic drugs can be prevented from being granted market authorization. The longer the period, the more originators can protect their monopoly in the market. It must be noted that data exclusivity only protects the confidentiality of data that has been submitted and prevents any third party from giving reference to it. It does not, however, prevent the generation of the same data by generic companies. This means that generic companies can still run their own clinical tests and trials to obtain pharmacological and toxicological test results to apply for a drug license.

What is the Difference between the Protection Provided by Data Exclusivity and a Patent Right?

For a molecule or method to be subject to patent protection, it must meet the patentability criteria: novelty, the inclusion of an inventive step, and applicability in the industry. A patent right provides its owner with an exclusive monopoly right to prevent other parties from selling, importing, and exporting the patented products for 20 years as of the patent application date. Data exclusivity concerns the data submitted by originator companies to competent authorities and ensures the confidentiality of this data. Data exclusivity prevents other pharma companies from using or relying on submitted clinical test and trial results, for a period of approximately 5–10 years.

Whereas a patent right must be claimed by the patent holder, ensuring the confidentiality of data that has been submitted and refusing any reference given to such data, is an administrative responsibility due to the fact that data has been submitted to competent authorities in order to fulfill legal requirements. Besides, a patent right protects the patented product or method; data exclusivity only protects data that has been submitted to the competent authorities. It does not prevent the generation of the same data by other companies.

Data Exclusivity in Türkiye

In Türkiye, in order for a pharmaceutical product for human use to be released to the market, market authorization must be granted by the Ministry of Health ("MoH"). Pharma companies must submit the results of pharmacological and toxicological tests and clinical trials proving the safety, efficacy, and quality of a drug to obtain market authorization, and to commercially exploit their drug. During the data exclusivity period, generic drug companies cannot refer to the data submitted to the MoH for generic drug applications for market authorization.

Data exclusivity is regulated within the scope of abbreviated drug applications in Türkiye. According to Article 9 of the Regulation on Licensing of Medicinal Products ("Regulation"), which regulates "abbreviated drug applications", applicants can obtain marketing authorization from the MoH without submitting the above-mentioned pre-clinical tests or clinical trials, if:

1) The medicinal product is basically similar to a medicinal product previously registered in Türkiye, and the marketing registration holder of the original medicinal product gives consent to the use of the toxicological, pharmacological and/or clinical references contained in the file of the original medicinal product for the purpose of evaluating the referred application,

2) Any constituent of the medicinal product has a well-established medical use, determined by means of a detailed scientific bibliography and with reasonable efficacy and acceptable level of reliability,

3) The medicinal product is essentially similar to a medicinal product that has been registered in accordance with the current legislative provisions and has completed its data exclusivity period.

As stated in the Regulation, generic pharma companies are not required to present the results of toxicological and pharmacological tests and clinical trials in the scope of abbreviated applications. They can refer to the submitted clinical data, provided that the reference medicinal product has completed its data exclusivity period.

The data exclusivity period in Türkiye is six years, as of the date that the drug obtains a license for the first time in the Customs Union Area[1]. If the drug has obtained a license in another country in the Customs Union Area, then the six-year period of data exclusivity in Türkiye will start as of its first registration date in that country.

For products that benefit from patent protection in Türkiye, the data exclusivity period is limited to the product’s patent protection period in Türkiye, even if the term ends within six years of the date that it first obtained a license. This means that the rights provided by patent protection cannot be extended through data exclusivity.

It must be noted that data exclusivity is only provided for a new active ingredient that is licensed for market authorization for the first time. That is to say, the same active ingredient’s different dosage forms, ways of implementation, or indications do not benefit from data exclusivity.

How is Data Exclusivity Implemented in Türkiye?

Data exclusivity requires the competent authority to object to any abbreviated market authorization applications that rely on the submitted confidential clinical data during the data exclusivity period. However, due to the fact that the Bolar Exception is widely accepted and implemented in Türkiye to prevent the extension of a 20-year period of patent protection, the same principle is implemented to prevent the extension of the six-year period of data exclusivity.

In practice, the MoH does not directly reject abbreviated applications made within the data exclusivity protection period, allowing these applications but withholding the marketing authorization until the expiration date of the reference product's data exclusivity period.[2] The rationale here is that if the MoH only accepts marketing authorization applications after the expiration of a six-year data exclusivity period, the process for a market authorization application and the MoH’s period for evaluating the application would have to start after the completion of six years. Such a practice would result in originator companies benefitting from a longer period of monopoly in the market, and the de facto data exclusivity period being longer than the six years provided in the Regulation. The main aim here is, again, to prevent any retardation in the public’s access to affordable generic medicines. The Supreme Court of Appeals rejects data owners’ appeals asserting any unfair competition or data exclusivity claims asserted against the usage of their submitted data during the data exclusivity period without their permission and finds the generic companies’ applications appropriate in terms of their rights provided by laws. [3]

[1] Customs Union Area: The Customs Union Area defined in paragraph 3 of article 3 of the Association Council Decision No. 1/95 establishing the Customs Union between Türkiye and the European Union.

[2] Uğur ÇOLAK, Fikri Mülkiyet Yıllığı, 2009, “Kısaltılmış Ruhsat Başvurusundan Kaynaklanan Hukuki Uyuşmazlıklar ve Veri İmtiyazı Uygulaması”

[3] The settled decisions of 11th Chamber of Supreme Court of Appeals: Decision numbered 2015/6706 E. - 2016/4935 K. dated 02.05.2016; the decision numbered 2007/6358E - 2009/1166K. and dated 03.02.2009.