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The BookPatents 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
Advantages at a Glance
- International team of experts
- Uniform structure
- Key national legislation and case law
The Target GroupFor in-house counsel in the pharmaceutical industry and legal practitioners.
Summary
The Book
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 onIntrepretration of patent claimsDirect and indirect infringementStatutory provisionsAdvantages at a GlanceInternational team of expertsUniform structureKey national legislation and case lawThe Target Group
For in-house counsel in the pharmaceutical industry and legal practitioners.
