Patent law does not specifically address personalised medicine, as it does not differentiate between the technologies. This means that PM has to be accommodated by de lege lata patent law. Therefore, the analysis commences with a general framework reflection on de lege lata, followed by PM-specific analysis. The analysis in the following two sections follows the distinction between PM patentable subject matter: second medical use (PM drugs), and genes and diagnostic methods (PM diagnostics). It examines whether these subject matters can obtain exclusivity rights (patentability) and what protection is provided de lege lata (scope of protection and rights conferred). It also assesses the specificities of PM patent infringement. Each section contains conclusions on de lege lata deficiencies and the risks they pose. Special attention has been devoted to these aspects which make it difficult to accommodate PM de lege lata demonstrating frictions of interpretation and application of the relevant provisions. It provides a de lege ferenda perspective and proposes measures to correct protection inconsistencies and dysfunctions.

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Patents

  • Laura Valtere

摘要

Patent law does not specifically address personalised medicine, as it does not differentiate between the technologies. This means that PM has to be accommodated by de lege lata patent law. Therefore, the analysis commences with a general framework reflection on de lege lata, followed by PM-specific analysis. The analysis in the following two sections follows the distinction between PM patentable subject matter: second medical use (PM drugs), and genes and diagnostic methods (PM diagnostics). It examines whether these subject matters can obtain exclusivity rights (patentability) and what protection is provided de lege lata (scope of protection and rights conferred). It also assesses the specificities of PM patent infringement. Each section contains conclusions on de lege lata deficiencies and the risks they pose. Special attention has been devoted to these aspects which make it difficult to accommodate PM de lege lata demonstrating frictions of interpretation and application of the relevant provisions. It provides a de lege ferenda perspective and proposes measures to correct protection inconsistencies and dysfunctions.