The active ingredient ouabain and its use for the treatment of heart disease have been known for more than 100 years. Patent protection on ouabain and the use of ouabain to treat heart diseases in order to safeguard the investment is no longer possible. Nevertheless, there are sufficient opportunities to ensure exclusive rights and thus a comprehensive protection of the investment.
Currently, worldwide there is no approval for ouabain. This results in the unique possibility to achieve exclusivity and protection of investments by the German Drug Law. According to this regulation a second applicant can refer to the toxicological, pharmacological and clinical documentation of the first applicant only after a period of 10 years since the approval of the original preparation. Within this period, no competitor can access the submitted documents. Due to the long research and development cycles more than ten years of exclusivity is hardly achieved in the marketing of patented drugs as well.
It is intended to develop ouabain as an oral formulation. An analysis of the different dosages of enteral formulations described in the scientific literature indicates that it is possible to achieve serum concentrations of ouabain by means of oral administration, which are similar to those observed after intravenous administration. Specific plans for the development of new formulations have been prepared. Corresponding patent applications are in preparation and will be submitted following experimental verification after the founding of Cornavita. These patents will substantially extend exclusivity and thus the protection of the investment.