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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...

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