Parallel Trade

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On 5 April 2024, the MHRA updated various guidance documents on the impact of the Windsor Agreement (the Agreement) on parallel imports into and within the UK. Since the end of the Brexit transition period, EMA-issued parallel distribution notices (PDNs) ceased to be valid in Great Britain (GB). A PDN must be obtained by a parallel distributor prior to engaging in parallel distribution in the EU. In GB, PDNs were replaced by Parallel Import Licences (PLPIs), which allowed distribution of products in GB only; while PDNs continued to be valid in Northern Ireland (NI).

As of 1 January 2025, when the Agreement is due to take effect, PDNs will no longer be valid in NI. All parallel imports into GB and NI will require a PLPI from the MHRA that will apply across the whole UK, and any PLPIs that were previously limited to GB will automatically convert into UK-wide PLPIs from this date.Continue Reading Brexit update: Changes to parallel imports in the UK

In three separate preliminary rulings delivered by the Court of Justice of the European Union (CJEU) on 17 November 2022 (Novartis v Abacus Medicine, Bayer v kolpharma, and Merck Sharp & Dohme (MSD) v Abacus Medicine), the pharmaceutical industry received welcome guidance as to the extent to which brand owners may oppose the repackaging of medicinal products to comply with EU rules on tamperproof packaging.Continue Reading Tampering with the packaging? Further EU Court of Justice guidance for parallel traders

On 17 November 2022, the Court of Justice of the European Union (CJEU) delivered its preliminary ruling in joined cases C-253/20 Impexeco NV v Novartis (Impexeco), and C-254/20 PI Pharma v Novartis (PI Pharma), finding that where a parallel importer affixes the trade mark of a branded reference medicinal product onto the packaging of a generic product, the brand owner may oppose the placing of that generic product by the parallel importer on the market of a Member State. Though the CJEU provides an exception to this general rule, the authors query whether the exception will ever apply.

Importantly, this case compares: (i) the rules on when a parallel import licence can be obtained (which is a regulatory question), and (ii) when rebranding can legitimately take place for such products (which is an IP question). As set out below, the need for “identicality” is not the same for these two considerations.Continue Reading Parallel imports: identicality of products when repackaging

As the end of the transition period draws near and new laws and regulations are set to come into effect at 11.00pm UK time on Implementation Period Completion Day (31 December 2020)[1], it is important to appreciate the impact of the changes to businesses navigate through a post-Brexit era. Once the UK is no longer part of the European single market, what will it mean for parallel trade and exhaustion of intellectual property (IP) rights when goods are exported out of the UK into the EU and vice versa.
Continue Reading End of Brexit transition period: Exhaustion of Intellectual Property Rights and Parallel Trade in the UK and EU