The Competition Board’s Unconditional Clearance of the Transfer of Seroquel’s Drug License and Trademark Rights

Parties to the Transaction

The transaction concerns the transfer to Humanis Sağlık A.Ş. (“Humanis”) of the drug license and trademark rights in Türkiye for Seroquel, a pharmaceutical product used in the treatment of psychiatric disorders. Humanis is active in the manufacture of pharmaceutical products (including antibiotics, analgesics, hormone-containing medicinal products, and similar therapeutics). All shares of Humanis are held by Saya Holding A.Ş. (“Saya Holding”), which operates in various sectors such as energy, pharmaceuticals, construction, motor and reducer manufacturing, and technology.

The seller, AstraZeneca, is an international pharmaceutical company engaged in the discovery, development, and commercialization of prescription medicines in the fields of oncology; cardiovascular, renal & metabolism diseases; respiratory and immunology; vaccines & immune therapies; and rare diseases[3]. AstraZeneca has previously divested its rights to Seroquel in Europe, Russia, the United Kingdom, Japan, and other major international markets[4], and the present transaction represents the Türkiye component of this global restructuring process.

The Transfer of Seroquel’s Drug License and Trademark Rights

The transaction concerns the transfer of the drug license and trademark rights of Seroquel in Türkiye. This transaction, which results in a permanent change in the control of these rights, qualifies as an acquisition under Article 7 of the Law No. 4054 on the Protection of Competition (“Law No. 4054”). Pursuant to Article 5/1(b) of 2010/4 on Mergers and Acquisitions Calling for the Authorization of the Competition Board (“Communiqué No. 2010/4”), an acquisition may also concern the transfer of part of an undertaking’s assets. However, the acquisition of control over assets is deemed an acquisition under Article 7 only where the assets constitute a part of an undertaking to which market turnover can be attributed. As clarified in the Guidelines on Cases Considered as Mergers and Acquisitions and the Concept of Control, “a transfer limited to elements within intellectual property rights (such as brands, patents, designs, or copyrights) may also be considered a transaction within the scope of Article 7 of the Law, provided that such rights constitute a business to which market turnover can be attributed.” [5]

Although the parties’ turnovers do not exceed the turnover thresholds set out under Article 7(1) of Communiqué No. 2010/4, the transaction was deemed to constitute the acquisition of a “technology undertaking” within the meaning of Article 4 of the Communiqué No. 2010/4, given that the product subject to the transfer, Seroquel, falls within the field of pharmacology. Accordingly, the transaction was considered subject to the Board’s approval. Pursuant to Article 4 of Communiqué No. 2010/4, undertakings operating in the fields of digital platforms, software and gaming software, financial technologies, biotechnology, pharmacology, agricultural chemicals, and health technologies, or assets related thereto, are defined as “technology undertakings.”[6] Under Article 7(2) of the Communiqué No. 2010/4, the turnover thresholds do not apply to transactions concerning the acquisition of technology undertakings that either operate in the Turkish geographic market, conduct R&D activities in Türkiye, or provide services to users in Türkiye. For this reason, the transaction was regarded as notifiable and subject to the Board’s approval requirement.

Within the scope of the transaction, Seroquel (the product subject to the transfer) is an atypical antipsychotic medicine containing the active substance quetiapine, used in the treatment of schizophrenia, bipolar disorder, and major depressive disorder, and also utilized for sleep regulation due to its sedative effect. Under the ATC (Anatomical Therapeutic Chemical) classification system, which is commonly employed in the assessment of concentration transactions in the pharmaceutical sector, Seroquel falls within the ATC-3 class “N05A – Antipsychotics” and the ATC-4 class “N05A1 – Atypical Antipsychotics.” Saya Holding, which exercises sole control over Humanis, does not market any products in either the ATC-3 class “N05A – Antipsychotics” or the ATC-4 class “N05A1 – Atypical Antipsychotics,” in which the transferred product Seroquel is categorized. In other words, there is no horizontal or vertical overlap between the activities of the acquirer, Saya Holding, and the transferred product Seroquel. In light of this assessment, the Board concluded that the transaction would not result in a significant lessening of effective competition and, accordingly, unanimously granted unconditional clearance.

[1] Attorney Gülce Korkmaz is the external competition law consultant of Baş | Kaymaz Law Firm. After completing her master’s degree at Bilkent University, she is currently pursuing her doctoral studies in the field of competition law at the Faculty of Law of Lüneburg Leuphana University (Germany) as a PhD researcher with the scholarship of the Joachim Herz Foundation.

[2] For the Board’s reasoned decision on the case, please see here.

[3] Please see the Board decision dated 01.04.2021 and numbered 21-18/219-92 para. 9.

[4] Please see: https://www.astrazeneca.com/media-centre/press-releases/2019/astrazeneca-divests-rights-to-seroquel-and-seroquel-xr-in-europe-and-russia-30102019.html#

[5] Please see: Guidelines on Cases Considered as a Merger or an Acquisition and the Concept of Control, para. 17.

[6] For further information on the exception for technology undertakings under the Turkish merger control regime, please see: https://www.baskaymaz.av.tr/merger-control-in-turkiye-5-technology-undertakings-exception/

For our recent information notes on Competition Board decisions in which the technology undertaking exception was applied, see: (i) The information note on Apple/Pixelmator acquisition decision: https://www.baskaymaz.av.tr/the-turkish-competition-boards-apple-pixelmator-decision-a-killer-acquisition/

(ii) the Take-Two/Gearbox acquisition decision: https://www.baskaymaz.av.tr/turkish-competition-board-unconditionally-cleared-take-twos-acquisition-of-gearbox/

(iii) The information note on Google/Galileo acquisition decision: https://www.baskaymaz.av.tr/the-turkish-competition-boards-decision-on-the-google-galileo-acquisition-what-doesnt-kill-you-makes-you-stronger-or-does-it/

As Baş | Kaymaz Law Firm, we provide comprehensive competition law, advice and representation services to both national and multinational companies with our specialized and experienced lawyers.

If you have any questions on this topic or any matter related to Turkish competition law, you may contact us via [email protected].