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Inside Life Sciences

Issue 7: March 2019

Inside Life Sciences
Editor's Note Post

Editor's Note

Welcome to the Spring 2019 edition of Inside Life Sciences.

No protection for new formulation of old active ingredient News

No protection for new formulation of old active ingredient

The CJEU has adopted a narrow interpretation of Article 3(d) of the SPC Regulation, finding that a supplementary protection certificate cannot be granted where a product protected by a marketing authorisation is a new formulation of an active ingredient which is protected by an earlier marketing authorisation.

SPC Reform: Manufacturing Export Waiver and EU Day One Launch Agreed News

SPC Reform: Manufacturing Export Waiver and EU Day One Launch Agreed

Representatives of the European Commission, Council and Parliament have reached agreement on a compromise text relating to an exception to infringement of an SPC for the purposes of exporting to third countries, and also, significantly, for the purposes of stockpiling medicines in the six month period before the SPC expires to allow for a Day One EU launch.

Artificial intelligence – the future of clinical trials News

Artificial intelligence – the future of clinical trials

As discussed in Part One of this review on the potential of artificial intelligence (AI) and machine learning (ML) in the early stages of drug development, there is clearly a long way to go before they will genuinely make drug development cheaper, faster and more efficacious.

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