The EU Legal Framework on SPCs and its Implications for Turkish Legal Order
Fikri Mülkiyet Hukukunda Güncel Gelişmeler — IV Uluslararası Sempozyum, Balıkesir, Türkiye, 6 - 07 Mayıs 2026, ss.189-191, (Özet Bildiri)
- Yayın Türü: Bildiri / Özet Bildiri
- Doi Numarası: 10.64161/filiz.9786258585643
- Basıldığı Şehir: Balıkesir
- Basıldığı Ülke: Türkiye
- Sayfa Sayıları: ss.189-191
- Ankara Yıldırım Beyazıt Üniversitesi Adresli: Evet
Özet
Among the common traits of intellectual proper rights, rests the temporality. On the one hand background motive of the latter is to equip the right holder only with a limited monopoly (on various theoretical grounds) upon the lapse of which the underlying intellectual property shall fall into the public domain and be subject to unrestricted enjoyment of others. Therefore, the protection comes as a reward and an opportunity to recoup the financial and other manners of investment in that intellectual property through exclusivity. On the other hand, the time interval of such exclusivity (the term of protection) might fall short of securing that objective.
In the patent context, this landscape is particular problematic where the subject matter of protection, i.e. inventions, are characteristically complicated, cost and labor-intensive and require extensive time for research & development. To top up idiosyncratic hurdle, some genres of inventions (pharmaceutical and plant protection products) are, before being brought to market in the form of actual products, encumbered by bureaucratic procedures, clinical trials as well as regulatory approvals. Considering the 20 – year term of patent protection, such delays are -and the resulting deprival of exclusive protection- liable to create dramatic economic consequences for the patentee whereupon the ‘incentive to create’ narrative would be simply rendered unworkable.
To offset this problem in European Union (EU) legal order, supplementary protection certificates (SPCs) were implemented in early 90s with a view to levelling out the loss of effective patent terms caused to patentees in the pharmaceutical field due to the delay in obtaining regulatory approval for the marketing of such products. The EU's legal framework for SPCs is delineated and codified by Regulation (EC) No 469/2009 (concerning medicinal products) and Regulation (EC) No 1610/96 (concerning plant protection products). These regulations aim to harmonize the protection of innovative medicines across the Member States to prevent the fragmentation of the internal market. The core objective is to provide sufficient incentive for high-cost research and development without unduly delaying the entry of generic and biosimilar competitors whilst not dictating the patentee to bear the cost of the bureaucratical tardiness.
In that the Regulation seek out the conditions (i) the existence of a basic patent in force for that invention; (ii) a valid authorization to place the product on the market (marketing authorization); (iii) a prior SPC must not have been granted; (iv) the marketing authorization is the first authorization to place the product on the market as a medicinal product. Provided these conditions are met, a SPC is grated for a period calculated based on the time elapsed between the patent filing and the first marketing authorization in the EU, however no exceeding 5 years period.
Turning to Turkish legal order, statutory provisions of Turkish Industrial Property Code No. 6769 (SMK) does not set out any general provisions regarding the extension of patent protection periods. That is to say, a mechanism corresponding to or creating an equivalent effect to the SPC is not explicitly defined or regulated in the SMK. However in the lack of direct legal provisions, it is crucial to seek out whether there are open (legal doctrinal) doors in SMK and interpretation thereof allowing the applicability of the SPC in Turkey.
Considering Turkey's relations with the European Union and the -long- harmonization process, the country has committed to aligning with EU legislation on industrial property rights under the Customs Union Agreement with the EU. Furthermore, its accession to international agreements such as the Paris Agreement, the Patent Cooperation Treaty (PCT) and The Agreement on the Trade Related Aspect of Intellectual Property Rights (TRIPS) demonstrates its efforts to harmonize its patent protection regime with global standards and beyond. With that, the fact remains that SPC application is an EU-specific regulation, operating (under EU Regulations 469/2009 1610/96) and does not have a direct effect on Turkish legal order.
Against this background, in an attempt to identify the rationale of the silence of Turkish legal framework on this particular matter, the present author seeks to survey the arguments existing in Turkish doctrine supporting and resisting the practice of SPCs. In that the author first attempts to find the answer in international statutory details: despite minimum standards of protection, international legal framework does not mandate SPCs. Moreover, while the EU-Turkey Customs Union agreement mandates harmonization, it does not explicitly require Turkey to adopt the EU's specific SPC regulations, leading to ongoing bilateral discussions during trade negotiations. Secondly, the author sets about devising whether the answer to the question at hand could be found in some economic - strategical narratives such as the said silence has the potential of creating an advantageous position for the creation of generic medicines for which there still is a wide market globally.