Sufficiency of disclosure and medical use
When a new medical application is found for an already known pharmaceutical product (e.g., a different therapeutic indication, a specific dosage, or a specific patient group), that medical application of the product can be protected. This is the case even if the product is already known.
Unlike a new product, for which it is usually sufficient to describe how it can be manufactured, in the case of a medical application it must be demonstrated that the claimed therapeutic effect is actually achieved.
Substantiation for therapeutic effect
Experimental evidence, and certainly a clinical study, is not necessarily required. As long as the patent application demonstrates that the therapeutic effect is achieved, its practical application is usually considered to be reproducible. In theory, therefore, reproducibility can also be substantiated without experimental data, for example on the basis of a description of the mechanism of action.
In practice, however, it is generally advisable to include some experimental evidence in the patent application. After all, a patent must be reproducible on the filing date. Moreover, the possibilities for remedying a lack of reproducibility with evidence submitted at a later date are very limited.
“In practice, it is generally advisable to include some experimental evidence in the patent application.”“
Nature and suitability of the evidence
In addition, the nature and suitability of the evidence used must be critically examined. If the experimental model used (e.g., in vitro or in vivo) is not considered suitable to substantiate the claimed effect, it may still be judged that the therapeutic effect is insufficiently plausible.
An illustrative example is EP 2 653 873 from Biogen. This patent concerned the use of dimethyl fumarate (DMF; Tecfidera®) in a daily dose of 480 mg for the treatment of multiple sclerosis (MS). Although the patent included in vitro experiments and a mouse study from which the therapeutic activity of DMF could be inferred, there was no evidence that the claimed dosage was effective. According to the Dutch court, it was therefore not plausible that the use of 480 mg/day DMF was effective in MS, and it subsequently invalidated the patent.
It is therefore essential that a patent application contains sufficient evidence of the effectiveness of the claimed medical use, in order to prevent the patent application from being rejected or the patent from being revoked at a later stage.
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