Re-boxing of parallel traded medicinal products under EU Falsified Medicines Directive

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In a recent case, the Patent and Market Court of Appeal (PMCA) elaborated on the concept of objective necessity to re-box medicinal products subject to parallel distribution, in light of the implementation of the EU Falsified Medicines Directive (the FM Directive),(1) which came into force on 9 February 2019.(2) In the first Swedish decision of many to come over the next year, the PMCA held that it was not objectively necessary to re-box the products at issue and thus found for the original manufacturer.

While the parallel import industry awaits the outcome in the parallel pending cases before the European Court of Justice (ECJ),(3) where the principal issue of re-boxing versus relabelling under the FM Directive is currently being litigated, the outcome in the Swedish case – which is fully in line with Advocate General Szpunar’s opinion in the ECJ cases – is a victory for original manufacturers. It confirms that relabelling should be regarded as the starting point for parallel trade to Sweden and that re-boxing remains the exception only when objectively necessary.

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