The dangers of basing preliminary injunctions on determination of evidence

Determination of evidence is a key temporary legal protection measure in Turkish law, which can be used to address IP infringements by ensuring the preservation of evidence that could help to influence a potential future dispute. Considering that Turkish civil procedure law includes an adversarial trial process, right holders’ ability to obtain evidence to help prove their position is crucial. In pharmaceutical patent-related disputes, determination of evidence appears as a prerequisite to have preliminary injunctions granted – which is another interim measure.

Determination of evidence is regulated in Article 400 of the Code of Civil Procedure (6100), which sets out that it can be used to determine a so-far unexamined fact in an action not yet filed. In addition, the code puts forward that in order to request determination of evidence, the possibility must be present that the evidence will be lost or will be increasingly difficult to assert if not determined immediately.

Article 150(3) of the Industrial Property Law (6769) outlines that before the right holder files a compensation action based on violation of their IP rights, they may request a court order for the submission by the infringing party of documents or facts related to the alleged infringement of IP rights. In parallel, and in accordance with the Agreement on Trade-Related Aspects of Intellectual Property Rights, judicial authorities retain the power to order immediate and effective interim measures to protect and preserve the evidence related to an alleged infringement.

This importance of the determination of evidence tool is much more significant for pharmaceutical patent holders, as they can only actively derive economic benefits from their pharmaceuticals for between seven to 10 years due to the long R&D and licensing processes. Moreover, the patent-infringing products entering the market reduce the price of the patent holder’s original pharmaceutical by approximately 40%. Another rapid market loss takes place if generic products with a much higher price-competitive margin are introduced.

For pharmaceutical patent holders to legally benefit from their limited-term patent rights, it is thus essential that they prevent any infringing products from being released to the market. This can be achieved through a preliminary injunction.

Article 159 of the Industrial Property Law sets out that in order to establish an effective verdict, individuals with the right to file an action may request the court to order a preliminary injunction under the condition that it is proven that the use is taking place locally in a way that constitutes an infringement of the filer’s IP rights, or that serious and effective studies have been carried out to realise the infringement.

It is extremely difficult to access information about an infringing pharmaceutical without a court order, but such information is the patent holder’s main evidence to prove that the conditions for a preliminary injunction have been met. It is impossible for the patent holder to access evidence that is not yet on the market (namely the infringing drug) and also challenging to prove their claims by reverse-engineering tests before the infringing pharmaceutical is actually on the market. Even after the infringing drug is put on the market, the patent holder cannot access its registration dossier without a court order. While it is a problem under the Industrial Property Law for pharmaceutical patent holders to prove infringement, the right holder is nonetheless required to prove that their rights will be infringed or that thorough studies have been carried out to realise the infringement in order to have their preliminary injunction request granted.

At this point, the importance of a determination of evidence decision ordered by the court becomes clear, since without such a decision it is impossible for the pharmaceutical patent holder to establish that the conditions for granting a preliminary injunction under Article 159 of the Industrial Property Law have been met.

However, different courts have different approaches to determination of evidence. One key problem is attaching the exercise of the right to determination of evidence to the conditions for issuing a preliminary injunction. However, as court decisions have revealed, 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.