Clinical trials are scientific studies conducted within the framework of specific ethical and legal rules in order to demonstrate the safety and efficacy of a medicinal product. In Türkiye, clinical trials are carried out pursuant to the legislation of the Ministry of Health, upon obtaining ethics committee approvals and ensuring the informed consent of volunteers.
From the perspective of patent law, clinical trials raise the question of whether the medicinal product subject to the trial has been disclosed to the public and, consequently, whether the novelty requirement has been satisfied. Indeed, if clinical trial documents are considered to fall within the state of the art, it will be concluded that the requirements for patentability are not met. In this context, the nature of clinical trial documents and the manner in which clinical trials are conducted are of great importance for patentability, both theoretically and practically.
Within this framework, the impact of clinical trials on patentability under European and Turkish patent law will be examined jointly in terms of the criteria of novelty and inventive step.
I.The Impact of Clinical Trials on the Novelty Criterion
1. Clinical Trials and the State of the Art under European Patent Law
Pursuant to Article 54 of the European Patent Convention (“EPC”), the decisive criterion in the assessment of novelty is whether the information has been made available to the public. Accordingly, for information to be considered as part of the prior art, it must have been made accessible to persons skilled in the art prior to the application or priority date. In the practice of the European Patent Office (“EPO”), this criterion in relation to clinical trials does not focus solely on the fact that the trial has actually been conducted; rather, it also examines whether the technical information relating to the trial satisfies the requirements of accessibility and reproducibility.
Within the scope of the decisions of the Enlarged Board of Appeal and the Boards of Appeal of the EPO, it is consistently accepted that clinical trials conducted under confidentiality obligations cannot be included as prior art unless they are freely accessible to persons skilled in the art. The fact that data obtained within the scope of a clinical study are known only to a limited number of participants and that such persons are subject to explicit or implicit confidentiality obligations prevents the information from being regarded as publicly available.
This approach was concretely reflected in decision T 670/20. In the said decision, although patients participating in the clinical study were permitted to take the pharmaceutical product home in tablet form, taking into account the detailed clinical trial protocol that participants were obliged to comply with, it was concluded that the medicinal product could not be deemed to have been made available to the public. Accordingly, it was held that the claims relating to the relevant pharmaceutical composition retained their novelty.
On the other hand, it is also accepted that disclosures relating solely to the fact that a clinical trial is being conducted or planned do not, in themselves, destroy novelty. Indeed, in decision T 1859/08, it was explicitly established that the public disclosure that a particular antibody was already under investigation did not have novelty-destroying effect insofar as it did not contain concrete clinical results or data relating to the clinical benefit obtained.
2. Clinical Trials and the Novelty Criterion under Turkish Patent Law
Under Turkish patent law, the assessment of novelty is based on the criterion set forth in Article 83 of the Industrial Property Code No. 6769 (“IPC”), namely whether the information has become accessible to the public prior to the application or priority date. This regulation adopts an approach parallel to that of Article 54 EPC.
Similarly, under Turkish law, the mere fact that clinical trials have been actually conducted does not, in itself, lead to the conclusion that the information falls within the state of the art. For information or documents relating to a clinical trial to be taken into account in a novelty assessment, such information must be accessible to an indefinite number of members of the public without any legal or factual restrictions.
The fact that clinical trials are generally conducted under ethics committee approvals, volunteer information forms, and confidentiality obligations may prevent the data obtained within the scope of such trials from acquiring the quality of being publicly accessible. In Turkish judicial practice as well, it is accepted that information disclosed under confidentiality obligations or whose use is restricted cannot be considered as part of the prior art.
By way of example, in its decision numbered E.2018/691, K.2021/814, the 16th Civil Chamber of the Istanbul Regional Court of Appeal discussed whether clinical trials could be regarded as part of the state of the art. In this context, it was also argued by the plaintiff that the document relating to the clinical trial was not subject to any confidentiality obligation.
The dispute subject to the Istanbul Regional Court of Appeals decision stems from claims of invalidity of patents relating to the administration of zoledronic acid at specific dosage ranges. In the case, it was argued that the patent claims in question were not novel due to clinical studies and scientific publications conducted prior to the priority date.
In the first instance court’s decision in the joined case numbered 2013/185, it was concluded that certain documents related to clinical studies should be evaluated within the scope of the prior art, and the patents were declared invalid. This decision was appealed. During the appeal proceedings, the plaintiff argued that the document relating to the clinical trial did not contain any explicit statement requiring patients to keep the form they read confidential, claiming that this document negated the novelty element. The Regional Court of Appeals has upheld the decision of the court of first instance within the scope of the consolidated lawsuit filed seeking the invalidation of the defendant’s patents. Although the Regional Court of Appeals did not examine the plaintiff’s claim in detail, the decision is significant in that it raises the issue of confidentiality in clinical trials in relation to the novelty requirement.
ıı. The Impact of Clinical Trials on Inventive Step
1. The “Reasonable Expectation of Success” Approach under European Patent Law
One of the concepts of central importance in EPO practice with regard to the impact of clinical trials on inventive step is the criterion of “reasonable expectation of success”. This criterion aims to distinguish whether disclosures relating to clinical trials or clinical trial protocols merely create a speculative hope of experimentation for the person skilled in the art, or whether they give rise to an objectively substantiated expectation of success based on existing scientific and technical data.
In the established case law of the EPO Boards of Appeal, it is generally accepted that clinical trial protocols, as a rule, give rise to a reasonable expectation of success for the person skilled in the art. In decisions T 2506/12 and T 239/16, it was emphasized that clinical trials are designed not through a random or speculative approach, but on the basis of positive preclinical data, including in vitro and animal studies, taking into account ethical and economic constraints. Accordingly, in cases where the existing technical knowledge does not clearly create an expectation of failure, it is accepted that a published clinical trial protocol gives rise to an objective and reasonable expectation for the person skilled in the art that the invention will be successfully achieved.
Nevertheless, it is also recognized that not every clinical trial automatically creates a reasonable expectation of success. By way of example, in decision T 2963/19, despite the existence of a published Phase III clinical trial protocol, it was concluded that the existing technical knowledge and the nature of the disease did not justify an automatic expectation of success for the person skilled in the art. The decision explicitly stated that even the advanced stage of a clinical trial would not be sufficient to support a conclusion of lack of inventive step where technical uncertainties or conflicting data exist.
2. Clinical Trials and Inventive Step under Turkish Patent Law
Under Turkish law, the assessment of inventive step is carried out pursuant to Article 83/4 of the IPC, based on whether the invention is obvious to the person skilled in the art. However, the concept of “reasonable expectation of success” is not explicitly regulated in Turkish patent law legislation.
However, the mere fact that a clinical study has been planned or conducted is not considered sufficient to conclude that the technical solution in question is obvious to a person skilled in the art. The content of the clinical study, the scientific data on which it is based, and the current level of knowledge in the technical field must be evaluated together. If clinical studies do not contain results demonstrating that the invention actually achieves the claimed technical effect, or if they contain uncertainties in light of the current technical knowledge, it should be accepted that they do not have an effect that would eliminate the inventive step.
III. Conclusion
Clinical trials are not regarded as disclosures that automatically produce definitive results in the assessment of novelty and inventive step in pharmaceutical patents. Both in the practice of the European Patent Office and under Turkish patent law, the impact of clinical trials on patentability is determined on a case-by-case basis, taking into account the public accessibility of the information, the clarity and reproducibility of the technical teaching, and the assessment to be made from the perspective of the person skilled in the art in light of the existing scientific and technical data.
In this context, for patent holders operating in the pharmaceutical sector, the meticulous implementation of confidentiality measures during the clinical trial process and the strategic planning of the timing of patent applications are of decisive importance for the effective protection of patent rights.
