Kurzbeschreibung

Patents on medical indications have gained enormous economic significance in recent decades. However, pharmaceutical development focuses less on new active ingredients and more on new therapeutic applications of known active ingredients. In this context, patents for reference medication may expire, but independently patents may exist for the utilisation. Many of the ‘blockbuster products' are protected by utilisation patents.

This approach has given rise to ‘skinny labelling’, whereby generic medicines can be approved for non-patented indications where labelling does not include certain specific, patent protected, uses. As the practice becomes more widespread globally, questions arise about the different national approaches towards ‘skinny labels’ and conformity with patent law.

This Handbook views the legal treatment of second medical use in numerous jurisdictions worldwide, providing key information on

- Intrepretration of patent claims
- Direct and indirect infringement
- Statutory provisions