The Danger of De Facto Abolishment of the Right to Preliminary Injunction by the Determination of Evidence in Terms of Pharmaceutical Patents

Determination of evidence, which is one of the most important temporary legal protection measures regulated in our law, is an institution that ensures the protection of evidence that will assist the proving of the matter. Considering that the adversarial trial process is adopted in our civil procedure law, the significance of the right holder being able to have the evidence which will help them prove their rightness effectively determined is clear. However, as will be explained below, in disputes regarding pharmaceutical patents, the determination of evidence institution is also a prerequisite for benefiting from the preliminary injunction, which is another interim measure institution.

The general provision regarding the determination of evidence institution is included in Article 400 of the Code of Civil Procedure No. 6100 (“CCP”). In this context, it is established that the determination of evidence can be conducted for the purpose of determining a fact that has not yet been examined in a case or that will be asserted in a case to be filed in the future. Further, it is sought that legal benefit in the determination of evidence is acknowledged and there is the possibility that the evidence will be lost or will be significantly more difficult to assert if not determined immediately.

However, Article 150 / (3) of the Industrial Property Law No. 6769 (“IPL”) foresees that for the determination of evidence before the right holder files for indemnity based on violation of intellectual property rights, the right holder may request that the court order for the submission by the indemnity obligee the documents regarding the unjustified and unauthorized use of the intellectual property right. In parallel, pursuant to The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which serves as a law pursuant to Article 90 of the Constitution, judicial authorities have the power to order immediate and effective interim measures to protect the evidence related to an alleged infringement.

As it can be seen, considering the importance of the determination of evidence in industrial property rights and related cases, it has become required for the legislator to regulate the determination of evidence institutions separately in indemnity cases, in international conventions regarding the determination of evidence, and in special laws.

This particular requirement is at a quite different level, especially for drug patent holders. Because drug patent holders can only actively benefit for 7 to 10 years from the patent rights that give an absolute right for twenty years from the date of application due to the long R&D and licensing processes of their original drugs, which enable them to benefit from their patents economically. Moreover, with the introduction to the market of the product infringing the patent, the price of the original drug of the patent holder is automatically reduced by 40 %, and following this price decrease, a rapid market loss begins with the introduction of generic products with a much higher price competitive margin.

In order for drug patent holders to benefit from their limited-term patent rights in accordance with the law; it is essential that they can avoid this damage by preventing the infringing product from being released to the market, with a preliminary injunction to be ordered before its release to the market. Article 159 of the IPL, which regulates the conditions of the request for a preliminary injunction, foresees that to provide for the effectiveness of the verdict, individuals with the right to file a lawsuit may request the court to order a preliminary injunction, under the condition that it is proven that the use subject to the lawsuit is taking place within the country in a way that constitutes an infringement of their industrial property rights or that serious and effective studies have been carried out for the realization of the infringement.

However, most of the time, it is not possible without a court decision to access the information about the infringing drug, which is the main evidence for the patent holder to prove that the preliminary injunction conditions have been met. It is not possible for the patent holder to access the evidence that is not even on the market yet, namely the infringing drug, and to prove their claims by reverse engineering tests before the infringing drugs are actually on the market. Moreover, even after the infringing drug is put on the market, the patent holder cannot access without a court decision the registration dossier of the relevant drug, submitted to the Ministry of Health for obtaining a license and containing information on patent infringement.

As it can be seen, while there is an actual problem of proving for drug patent holders with the IPL, on the other hand, the right holder is required to prove that the industrial property rights will be infringed or that serious and effective studies have been carried out for the realization of the infringement, in order to grant the preliminary injunction request. At this point, the importance of an evidence-determination decision ordered by the Court becomes evident once again. Because, without a decision to determine the evidence, it will not be possible for the drug patent holder to prove that the conditions for granting a preliminary injunction in Article 159 of the IPL are met in the concrete case and to benefit from the preliminary injunction institution.

On the other hand, it is seen that different courts have different approaches to the subject of determination of evidence. One of the main problems is manifested in the form of tying the exercise of the right to a determination of evidence to the conditions for issuing a preliminary injunction. However, as revealed by the courts that make accurate legal assessments, the determination of evidence is a first step in terms of determining the right and rightfulness and it should be evaluated independently of the exceptional circumstances that prevent the assertion of patent rights.

Tagged with: Life Sciences & Healthcare, Pharmaceuticals, Pharmaceutical patents, Licensing processes, Preliminary injunction, Gün + Partners, Aysel Korkmaz Yatkın, Selin Sinem Erciyas, Zeynep Çağla Üstün