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DOI :10.26650/mecmua.2018.76.2.0014   IUP :10.26650/mecmua.2018.76.2.0014    Tam Metin (PDF)

Sınai Mülkiyet Kanunu Madde 85/3 Hükmü Kapsamında Bolar İstisnasının Uygulanması

Barış Kaya

İlaç patenti alanında bir yandan bilimsel gelişimin sağlanması, diğer yandan ise, kamunun ilaca erişimi arasında hassas bir dengenin kurulması gerekmektedir. Patentten doğan korumanın kapsamı SMK uyarınca en başta istemlerle belirlenir. Patent hakkı eşdeğerleri de kapsadığından yüksek maliyetli araştırma geliştirme faaliyetinin söz konusu olduğu ilaç piyasasında istemlerin tartışmasız bir şekilde düzenlemesi gerekir. SMK m. 85/3 hükmünde patent hakkını ihlal etmeyeceği düzenlenen ticari ve sınai amaç taşımayan özel maksatlı fiiller, deneme amaçlı fiiller ve reçete üzerine ilaç hazırlanması temelde, ortak özellik olarak ticari amaç taşımayan, daha ziyade bireysel ihtiyaç ve istifadenin söz konusu olduğu fillerdir. Aynı hükümde düzenlenen ve Bolar istisnası olarak da anılan ilaçların ruhsatlandırılması ve bunun için gerekli test ve deneyleri de içeren deneme amaçlı fiiller ise, özellikle ilaç patenti alanı açısından kritik bir öneme sahiptir. Bu istisna sayesinde, eşdeğer ilaç firmaları orijinal ilacın patent süresi içerisinde ruhsat alabilmek amacıyla gerekli test ve deneyleri yapabilmekte, böylelikle patent süresinin bitimini takiben derhal piyasaya girerek rekabetçi ortamı sağlayabilmektedirler. Bolar istisnasının veri imtiyazına uygulanması sayesinde ise, eşdeğer ilaç firmalarının orijinal ilaca ilişkin verilere dayanarak kısaltılmış başvuruda bulunma, bu sayede zorlu ve uzun zaman alacak ruhsat süreci engelini aşmaları söz konusu olmaktadır. 

Anahtar Kelimeler: İlaç patenti, İstemler, Eşdeğer ilaç, Bolar istisnası, Veri imtiyazı
DOI :10.26650/mecmua.2018.76.2.0014   IUP :10.26650/mecmua.2018.76.2.0014    Tam Metin (PDF)

Application of Bolar Exemption Under The Scope of Article 85/3 of The Industrial Property Law

Barış Kaya

In the field of pharmaceutical patent there must be a fair balance between scientific developments and the public interest to access (new) pharmaceuticals. In accordance to Industrial Property Law (IPL), the scope of patent prevention shall primarily be determined by the claims of the applicant. As high-budget research and development activities occur in pharmaceutical industry and by taking into account that the patent right includes the rights on generics, the claims on patent must be clearly defined. Activities listed under article 85/3 of IPL and exempted from patent prevention are consisted of acts undertaken privately for non-commercial purposes, acts undertaken for experimental purposes and preparation of medicine in accordance with medical prescription which have non-commercial nature and are undertaken for personal needs and purposes. Experimental acts listed under the said provision including those undertaken for obtaining pharmaceutical authorization and other related tests and trials are also classified as Bolar exemption and have critical importance in the area of pharmaceutical patent. As a result of this exemption generic pharmaceutical companies can execute the required trials and experiments for authorization, thus immediately after the expiration of patent term, they can participate in the market which may bring about a competitive medium. In addition the application of Bolar exemption to data exclusivity enables generic pharmaceutical companies to file abbreviated application for authorization by depending on the data of the original pharmaceuticals which will result in accomplishment of the difficult and long-term authorization process.

Anahtar Kelimeler: Pharmaceutical patent, Claims, Generic pharmaceutical, Bolar exemption, Data exclusivity

GENİŞLETİLMİŞ ÖZET


In the field of pharmaceutical patent there must be a fair balance between scientific developments and the public interest to access (new) pharmaceuticals. On one hand access to pharmaceuticals is directly related with public health and on the other, as a consequence of pharmaceutical researches, improvements occur both in the field of medical treatment and public health. Thus, the nature of pharmaceutical patent differs from product and process patents related to other fields of industry and includes some special characteristics. As a result, it is important to research both the general patent laws and special regulations concerning pharmaceutical patent. In accordance to Industrial Property Law (IPL), the scope of patent prevention shall primarily be determined by the claims of the applicant. As high-budget research and development activities occur in pharmaceutical industry and by taking into account that the patent right includes the rights on generics, the claims on patent must be clearly defined. Rights on product patent of a pharmaceutical provide to its owner exclusive authority for manufacture, sale, use, import and possession of pharmaceutical for professional purposes. On the other hand, process patent of a pharmaceutical includes authority for use of the patented process, prohibition of making of offer by third parties for the unauthorized use of the patented process, prohibition of sale, distribution and commercial use of the products manufactured directly by implementation of the patented process by third parties, import, possession, implementation of the patented process for commercial use and offering to be made by third parties for execution of contracts for unauthorized use. In terms of prohibition of indirect use, patent owner of a pharmaceutical patent may also prohibit unauthorized delivery of items and instruments related to essential part of the patent by third parties which enables implementation of patent. Notwithstanding the above-mentioned wide scope of rights and powers arisen from patent, activities listed under article 85/3 of IPL and exempted from patent prevention are consisted of acts undertaken privately for noncommercial purposes, acts undertaken for experimental purposes and preparation of medicine in accordance with medical prescription which have non-commercial nature and are undertaken for personal needs and purposes. Acts undertaken privately for non-commercial purposes can be defined as acts including the use of patented product for personal needs and use for the needs of neighborhood. The legal grounds of this exemption can be specified as; use of patent for personal needs does not violate patent rights or constitute any risk for such and scientific advancements can be achieved by such use. Educational activities and gifting can be considered in the scope of this exemption. Acts for experimental purposes may also cause scientific advancements and ease inspection of the patent invention by third parties. The exemption concerning to preparation of medicine by a pharmacist in accordance with medical prescription which is outside the scope of commercial production can be based on customary law. Experimental acts listed under article 85/3 of IPL including those undertaken for obtaining pharmaceutical authorization and other related tests and trials are also classified as Bolar exemption and have critical importance in the area of pharmaceutical patent. As a result of this exemption generic pharmaceutical companies can execute the required trials and experiments for authorization, thus immediately after the expiration of patent term, they can participate in the market which may bring about a competitive medium. In case if Bolar exemption is not accepted by applicable law, generic pharmaceutical companies can realize manufacture and authorization of their products after a long period of time following the end of the patent term, as a result, the competitive medium which is necessary for public interest cannot be achieved at the end of the patent term. As a consequence of the specified reasons, in US law, Bolar exemption which is named after the court decision having the same name is accepted and following this incident such exemption is adopted by the EU law. Under Turkish law Bolar exemption is also recognized by the courts. Bolar exemption provisioned under Turkish law consists tests and trials required for authorization but excludes commercial production, storing and manufacturing prior to the end of patent term. In addition the application of Bolar exemption to data exclusivity enables generic pharmaceutical companies to file abbreviated application for authorization by depending on the data of the original pharmaceuticals which will result in accomplishment of the difficult and long-term authorization process. Under Turkish law Bolar exemption includes both abbreviated and standard applications for authorization and also obtaining of authorization falls under its scope.


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DIŞA AKTAR



APA

Kaya, B. (2018). Sınai Mülkiyet Kanunu Madde 85/3 Hükmü Kapsamında Bolar İstisnasının Uygulanması. İstanbul Hukuk Mecmuası, 76(2), 417-442. https://doi.org/10.26650/mecmua.2018.76.2.0014


AMA

Kaya B. Sınai Mülkiyet Kanunu Madde 85/3 Hükmü Kapsamında Bolar İstisnasının Uygulanması. İstanbul Hukuk Mecmuası. 2018;76(2):417-442. https://doi.org/10.26650/mecmua.2018.76.2.0014


ABNT

Kaya, B. Sınai Mülkiyet Kanunu Madde 85/3 Hükmü Kapsamında Bolar İstisnasının Uygulanması. İstanbul Hukuk Mecmuası, [Publisher Location], v. 76, n. 2, p. 417-442, 2018.


Chicago: Author-Date Style

Kaya, Barış,. 2018. “Sınai Mülkiyet Kanunu Madde 85/3 Hükmü Kapsamında Bolar İstisnasının Uygulanması.” İstanbul Hukuk Mecmuası 76, no. 2: 417-442. https://doi.org/10.26650/mecmua.2018.76.2.0014


Chicago: Humanities Style

Kaya, Barış,. “Sınai Mülkiyet Kanunu Madde 85/3 Hükmü Kapsamında Bolar İstisnasının Uygulanması.” İstanbul Hukuk Mecmuası 76, no. 2 (Aug. 2025): 417-442. https://doi.org/10.26650/mecmua.2018.76.2.0014


Harvard: Australian Style

Kaya, B 2018, 'Sınai Mülkiyet Kanunu Madde 85/3 Hükmü Kapsamında Bolar İstisnasının Uygulanması', İstanbul Hukuk Mecmuası, vol. 76, no. 2, pp. 417-442, viewed 29 Aug. 2025, https://doi.org/10.26650/mecmua.2018.76.2.0014


Harvard: Author-Date Style

Kaya, B. (2018) ‘Sınai Mülkiyet Kanunu Madde 85/3 Hükmü Kapsamında Bolar İstisnasının Uygulanması’, İstanbul Hukuk Mecmuası, 76(2), pp. 417-442. https://doi.org/10.26650/mecmua.2018.76.2.0014 (29 Aug. 2025).


MLA

Kaya, Barış,. “Sınai Mülkiyet Kanunu Madde 85/3 Hükmü Kapsamında Bolar İstisnasının Uygulanması.” İstanbul Hukuk Mecmuası, vol. 76, no. 2, 2018, pp. 417-442. [Database Container], https://doi.org/10.26650/mecmua.2018.76.2.0014


Vancouver

Kaya B. Sınai Mülkiyet Kanunu Madde 85/3 Hükmü Kapsamında Bolar İstisnasının Uygulanması. İstanbul Hukuk Mecmuası [Internet]. 29 Aug. 2025 [cited 29 Aug. 2025];76(2):417-442. Available from: https://doi.org/10.26650/mecmua.2018.76.2.0014 doi: 10.26650/mecmua.2018.76.2.0014


ISNAD

Kaya, Barış. “Sınai Mülkiyet Kanunu Madde 85/3 Hükmü Kapsamında Bolar İstisnasının Uygulanması”. İstanbul Hukuk Mecmuası 76/2 (Aug. 2025): 417-442. https://doi.org/10.26650/mecmua.2018.76.2.0014



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Gönderim04.11.2018
Kabul09.01.2019

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