| Abstract [eng] |
This Master's thesis analyses the problematic issue of secondary pharmaceutical patents related to the grant of secondary pharmaceutical patents for follow-on pharmaceuticals (generic-biosimilar medicals). Essential problematic aspects identified in this Master's thesis are refers to the application of the patentability criteria for follow-on pharmaceuticals and to the imposition of additional restrictions on the granting of secondary pharmaceutical patents in the laws of individual states. In order to reveal the major problematic aspects of secondary pharmaceutical patents, the purpose of this Master's thesis was to analyse the main criteria for patentability of follow-on pharmaceuticals and its additional restrictions. With regard to the purpose of the Master's thesis, it is divided into three main parts: the first part analyses the definition of secondary pharmaceutical patents as well as differences of follow-on pharmaceuticals; in the light of the differences of follow-on pharmaceuticals found in the first part, the second part analyses their patentability criteria as laid down in the laws of the of individual states; the third part examines the additional restrictions imposed by individual states on the grant of secondary pharmaceutical patents. Also, the fruitfulness of a prohibition of the grant of secondary pharmaceutical patents taking their (non)benefit to the public into consideration is analysed. After analysing the patentability criteria for the follow-on pharmaceuticals and the additional restrictions on the grant of secondary pharmaceutical patents, this Master's thesis concludes that existing patentability criteria for follow-on pharmaceuticals are stringent and construed narrowly. Meanwhile, additional restrictions imposed by individual states on the grant of secondary pharmaceutical patents are largely ineffective. Therefore, standard patentability criteria nowadays is the most appropriate measure to limit the grant of secondary pharmaceutical patents for follow-on pharmaceuticals that are not the result of inventive activity. This Master's thesis concludes that the prohibition of secondary pharmaceutical patents may lead to a stagnation in the development of pharmaceutical science with respect to biological – biosimilar medical products. The state of art of these medical products is not as abundant nowadays as it is in the case of chemical medicines. As a result, the prohibition of granting secondary pharmaceutical patents for the biosimilars may negate the existing concept of the invention when for a new invention that meets all the patentability criteria, a patent is not granted. |
