Turkish court hands down precedential decision on partial preliminary injunctions in pharma dispute

In 2023, the Civil Court for Intellectual and Industrial Property Rights rendered a striking decision. It determined that a pharma patent had been infringed under the plausible proof condition and issued a partial preliminary injunction until the situation could be clarified by an expert report. This judgment has set an extremely valuable precedent, especially in cases where highly complex legal, technical and procedural disputes exist simultaneously and several laws come into play.

The Turkish Industrial Property Code regulates the Bolar exemption. However, in practice, Turkish courts occasionally erroneously interpret the wording of the law, which leads to applications being made to the Social Security Institution and even included in the institution’s reimbursement list. In such cases, when a generic pharma product is introduced to the market, the original product’s price falls by 40% and it is not always possible to reinstate it. Even if the price can be reinstated, the time-consuming process for achieving this would result in significant financial losses for the rights holder. Therefore, preliminary injunction applications (and granting fair injunctions) are paramount for patent owners to protect their rights in Türkiye, especially in pharmaceutical patent disputes.

Case details

In this case, the patent owner had filed a request before the Ankara IP Court for discovery of evidence and a preliminary injunction against the disputed product. The product had completed all administrative processes necessary for market entry, but the patent owner argued that this product infringed its formulation patents.

One of the formulation patents, which acted as the basis for these requests, was a patent that had been approved by the EPO but was yet to be validated by the Turkish Trademark and Patent Office. The patent owner had informed the generic pharmaceutical company of the invention and its scope in a letter of notice sent via public notary – in accordance with Articles 7 and 8 of the Regulation on Implementing the Convention on the Grant of European Patents in Türkiye and Article 97(4,5) of the Industrial Property Code – and requested cessation of the infringing acts. While the generic company examined and interpreted the invention and its scope, it did not cease its acts.

The court evaluated the discovery and preliminary injunction requests. It deemed the former to be appropriate in the first stage and decided to order an expert examination. While the parties were waiting for the expert report to be prepared, the infringing products entered the market. According to the Decision on Pricing of Medicinal Products for Human Use, the price of an original product decreases by 40% once the generic product enters the market. Taking this decrease into consideration, the patent owner immediately purchased the infringing product with invoices and submitted this as evidence that the infringing product had entered the market.

In light of this, a preliminary injunction request was submitted to prevent the patented product's price decrease by conducting an examination of the file until the expert report became available and that other injunction requests (to prevent commercialisation of the infringing product) be evaluated after the expert report was prepared.

Taking into account that infringement on one of the patents could be confirmed by simply examining the file and evidence of the infringing product on the market, the court decided that the plausible proof condition was met and issued an interim injunction to prevent the legal 40% price decrease with the condition of depositing a security. Thus, the patent owner managed to avoid incurring irreversible damages, but the infringing product was allowed to remain on the market until the expert report established infringement – highlighting that the decision was made in accordance with the principle of justice and balance of convenience.

After the preliminary injunction was implemented, the patent owner filed a case on merits in accordance with Article 397 of the Code of Civil Procedure, which regulates the procedures following a preliminary injunction. However, since the code does not regulate partial preliminary injunctions, there was no clear legal guidance for this case, in which the injunction only covers one of the requests and an expert report is awaited for a decision to be made on the others. However, in line with the legislation, the case file on which a preliminary injunction is granted should be considered as an annex to the case filed on merits. The court applied this provision, and the expert examination process concerning other injunction requests continued to be heard within the scope of the case filed on merits.

Key takeaways

This partial preliminary injunction decision sets a crucial precedent: an injunction can be granted in a way that is fair and that prevents the suffering of damages for both parties, especially in cases where the infringing product is put on the market without an expert report on the infringement.