European Proposals Outline Compulsory Licensing And SPC Changes

EU Patent Package Follows Pharma Legislation Overhaul From European Commission

 
• By Dave Wallace

A fresh EU patent package launched by the European Commission proposes an EU-wide compulsory licensing mechanism in times of crisis, as well as a unitary SPC for medicines, centralized SPC grants and a clearer framework for issuing standard essential patents.

Close-up of EU flag under magnifying glass
Medicines For Europe has urged “improved quality and transparency of granting procedures” • Source: Shutterstock

Hot on the heels of revealing proposals to overhaul the EU’s pharmaceutical legislation, the European Commission has published an EU patent package that includes several elements that could have a significant impact on the generics and biosimilars industry – including an EU-wide compulsory licensing mechanism to be used in times of crisis, a unitary supplementary protection certificate for medicines, centralized granting of SPCs and a clearer framework for issuing standard essential patents.

The patent package comprises four draft regulations that the Commission says will complement Europe’s new unitary patent regime, which is due to come into force from 1 June

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