Article 85(3)/(c) of the Industrial Property Law No. 6769 (“IPL”) regulates the Bolar Exemption, which stipulates the exclusion of experimental acts containing the invention subject to the patent from the scope of the patent right, including the licensing of pharmaceuticals and the necessary tests and experiments thereof. Undoubtedly, the purpose of the Bolar Exemption is to ensure that a generic medicinal product can be put on the market without losing time once the patent expires and to prevent the de facto extension of the protection period granted for the patent.
Even though the wording of the article limits the scope of the Bolar Exemption to the licensing of pharmaceuticals and the tests and experiments necessary for this, the decisions of not only the intellectual and industrial property rights law courts in Istanbul, Ankara and Izmir but also District Court and Court of Cassation decisions indicate that the relevant provision is interpreted differently.
The courts interpret the Bolar Exemption very broadly and reject the request for determination of evidence and preliminary injunction grounding on the Bolar Exemption, even in cases where sales permission is granted to a generic medicinal product when price approval is obtained, and also when the product is included in the reimbursement list of the Social Security Institution (“SSI”). However, almost none of the above decisions include legally satisfactory and guiding reasoning and the uncertainty in the current situation the cause of a profound loss of rights for both patent rights holders and pharmaceutical companies manufacturing generic medicinal products.
Some courts consider the inclusion of the generic medicinal product on the reimbursement list of the SSI, which is not even a prerequisite for the launch of the medicinal products to the market, as being within the scope of the Bolar Exemption; however, such interpretations expand the implementation scope of the exemption granted to the right holders for a limited period.
Some courts interpret the Bolar Exemption in a way that prevents even requests for determination of evidence made after the grant of the marketing authorization of the generic medicinal product. This situation eliminates the only way provided to the patent owner with the IPL to determine evidence that the court can only collect on the patent infringement.
Patent owners are unable to properly exercise their patent rights because they cannot obtain evidence only available through the courts, such as: information on price approval, sales permission of the generic products and the product’s inclusion to the SSI’s reimbursement list, and examination of the marketing authorization dossier of the generic medicinal product. As a result, in accordance with the current legislation, without considering whether there is any patent infringement, medicinal products for human use may be launched on the market, and following the release of a generic version of the patented medicine, the price of the patent owner’s product automatically decreases by 40% in accordance with the Ministry of Health legislation. Moreover, even if it is determined that the generic medicinal product infringes the patent rights after the said price decrease decision, the price decrease decision cannot be reversed.
In addition to all of these, uncertainties about the point at which the actions of pharmaceutical companies that make significant investments in the production and marketing of generic medicinal products will constitute patent infringement adversely affect their market entry strategies.
The lack of unity in the interpretation of the Bolar Exemption and the erroneously broad interpretation of the relevant provision is the biggest obstacle for patent owners wanting to protect and enforce their property rights and also for manufacturers of generic medicinal products looking to launch their products on the market without the threat of patent infringement. Therefore, the fair implementation of the Bolar Exemption by the courts in accordance with the wording and purpose of the exemption is essential for developing and protecting the health sector in Turkey.