Inside Life Sciences

Inside Life Sciences

Issue 7
4716Editor's Note

Editor's Note

Welcome to the Spring 2019 edition of Inside Life Sciences.

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6607No protection for new formulation of old active ingredient

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.

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4143SPC Reform: Manufacturing Export Waiver and EU Day One Launch Agreed

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.

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1959Brexit: Guidelines and Legislation for a No-Deal Outlined

Brexit: Guidelines and Legislation for a No-Deal Outlined

After the Parliamentary vote on the Brexit deal in January 2019, Pharma giant Novartis issued a statement that the risk of a No-Deal Brexit will be "hugely impactful for patients, particularly around the supply and safety of medicines."

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1900Commission issues report on competition enforcement in the pharma sector

Commission issues report on competition enforcement in the pharma sector

Almost ten years on from the European Commission's Final Report into the pharmaceutical sector, it has issued a report focussing on enforcement activity in the subsequent period (up to 2017).

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1960Artificial intelligence – the future of clinical trials

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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4142A new UK defence to patent infringement? Not quite yet…

A new UK defence to patent infringement? Not quite yet…

In a recent decision in the Intellectual Property Enterprise Court (Technetix B.V. v Teleste Limited), HHJ Hacon might have opened the door to a new so-called 'Formstein' defence to patent infringement.

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1961High Court ruling clarifies the legal position of parallel imports of medical devices

High Court ruling clarifies the legal position of parallel imports of medical devices

A recent High Court ruling (Dansac and ors v Salts Healthcare Limited and ors) has clarified the law relating to relabelled imported pharmaceutical and medical products following the 2018 ruling of the Court of Justice of the European Union (CJEU) in Junek v Rauscher (discussed in our July 2018 edition).

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