Clinical trials are central steps for the development of pharmaceuticals. In early phase 1, safety and pharmacological parameters of pharmaceutical are tested within a small number of test persons. In subsequent phases 2 and 3, the efficacy of a pharmaceutical is established and confirmed by testing within a larger number of test persons.
Protocols of clinical trials from phases 2 and 3 are published in the databases of medical authorities before the actual start of the trials. Usually, the interval between the publication of the trial protocol and the trial results is much longer than one year. Thus, a patent application which is filed at the “protocol stage” before publication of the trial protocol will not contain trial results, and a patent application which is filed at the “result stage” after having obtained the trial results will be confronted with the published trial protocol as prior art.
This is a challenging situation for obtaining meaningful patent protection for the subject-matter of a clinical trial.
Patent application at the “protocol stage” highly recommended
For pharmaceutical companies aiming to obtain patent protection in Europe, the filing of a patent application at the “protocol stage” before publication of the trial protocol is highly recommended. Even if such an application does not contain experimental trial results, patentability may be acknowledged. Description of the trial protocol is considered as providing an enabling disclosure of the invention. A technical effect forming the basis for an inventive step may be supported by providing successful post-published trial results.
However, although the protocols of clinical trials constitute prior art after publication, the filing of subsequent patent applications at the “result stage” after having obtained the trial results is recommended under certain circumstances. This is particularly the case when a clinical trial gives unexpected results which are not obvious from the protocol as such.
Patent applications relating to clinical trials may be directed to different subject-matter depending on the state of the art for the active ingredient to be tested. If the active ingredient is not yet known, the application may be directed to the compound as such and/or to its first use in medicine. In case the active agent used for the clinical trial is known, patent protection based on so-call second medical use claims may be obtained. Here, patentability may be achieved by directing the claims to a specific patient (sub-)population, e.g. defined by patient-specific characteristics such as age, body mass index etc. and/or disease-specific characteristics such as immune status, severity of disease etc., to a specific medical (sub-)indication such as achievement of an unexpected therapeutic effect, prevention of side-effects etc. and/or to a specific treatment protocol such as dosage protocol and/or route of administration.
In case of unexpected results, patent application in the result stage to be considered
In order to obtain patent protection for the subject-matter of clinical trials in Europe it is possible to file a patent application at the “protocol stage” without waiting for trial results and publication of the clinical trial protocol in the database of the respective medical authority. Additional filing of a patent application at the “result stage” after having obtained the trial results should be seriously contemplated in case the trial leads to unexpected results.