Nothing new beneath the solar: parallel importers should nonetheless show that it’s objectively crucial to exchange the unique bundle of medicinal merchandise


This publish maybe is a bit off matter because it considerations parallel imports and trademark rights. However it could possibly be fascinating for the readers because it pertains to the the pharma business.

Background

It’s effectively established EU case regulation {that a} parallel importer of medicinal merchandise might solely exchange the unique bundle whether it is deemed objectively crucial with a purpose to successfully entry the market within the importing state (see e.g. C-297/15, Ferring). When making such an evaluation, the nationwide courts should think about the circumstances prevailing on the time of promoting within the importing state. Importantly, it’s the parallel importer who carry the burden of proving that changing the unique bundle is objectively crucial.

On 9 February 2019, new guidelines on medical merchandise went into impact. The related guidelines, that are present in dir. 2011/62/EU (the so referred to as Falsified Medicines Directive) and the Fee Delegated Regulation (EU) 2016/161 (collectively the “Security Guidelines”), was a part of an try from the EU to stifle falsified medicines disguised as genuine merchandise. The brand new guidelines require, inter alia, that the packaging embody security measures that make it attainable to regulate the authenticity of the medication, to establish particular person packages and likewise a tool permitting verification whether or not the outer packaging has been tampered with.

In view of the brand new Security Guidelines – requiring increased safety measures than beforehand – parallel importers have more and more been elevating the argument that it might now, as a primary rule, be deemed objectively crucial to exchange the unique bundle of medicinal merchandise as an alternative of finishing up much less intrusive measures.

The case earlier than the Swedish courts

Novartis AG (“Novartis”) filed a lawsuit in opposition to Abacus Drugs A/S (“Abacus”), claiming that Abacus infringed its logos by changing the unique bundle of sure parallel imported medicinal merchandise. Abacus defended itself inter alia by claiming that the regulatory adjustments required alternative of the unique bundle to ensure that Abacus to keep away from sanctions from the Swedish Medical Merchandise Company (the “MPA”) and thus, making the alternative objectively crucial.

To assist its place, Abacus invoked proof within the type of pointers from the MPA in addition to data from the MPA’s web site. Abacus argued that the proof ought to be interpreted because the MPA holding the place that the brand new Security Guidelines meant that it was now crucial usually to exchange the unique bundle. The corporate additionally invoked correspondence with the MPA and the EMA – it had even utilized to the MPA to get a call regarding one of many merchandise topic to the dispute, on whether or not the corporate wanted to exchange the unique bundle with a purpose to successfully entry the Swedish market. The MPA dismissed the applying on the grounds that it was not licensed to make such a ruling, as a result of product being authorised by way of the centralized process, and due to this fact that the MPA thought-about the EMA to be the competent physique. Nonetheless, the MPA nonetheless knowledgeable Abacus (obiter dictum) in its resolution that it certainly thought-about it crucial to exchange the unique bundle. Additionally, Abacus invoked the listening to of a high quality specialist from a recognized Swedish pharmacy retailer, in assist of how Swedish pharmacies would deal with repackaged medicinal merchandise, and an e-mail despatched from the pinnacle of the Swedish Pharmacies’ Affiliation to the EU Fee, stating that if the parallel importer would retain the unique packaging, that might elevate suspicion with pharmacists and due to this fact proposing that changing the unique bundle ought to grow to be the primary process.

The judgment

After shedding in first occasion, Abacus appealed to the Swedish Patent and Market Courtroom of Attraction (case quantity PMT 8284-20). As the primary occasion courtroom, the Patent and Market Courtroom of Attraction additionally dominated – by remaining and non-appealable judgment on 18 February 2022 – in favour of the trademark holder. The courtroom held that the statements made by the MPA, in its pointers (that are per se non-binding), on its web site and in its resolution to dismiss Abacus’ utility, couldn’t be thought-about a definitive place of the MPA. Subsequently, Abacus had not proved that the MPA’s interpretation and implementation of the brand new laws meant a normal requirement for parallel importers to exchange authentic packages of medicinal merchandise, or that the MPA had requested that Abacus exchange the unique bundle of the merchandise with a purpose to promote them on the Swedish market. The courtroom additionally dominated that neither the statements from the standard specialist, nor the e-mail from the pinnacle of the Swedish Pharmacies’ Affiliation proved that Swedish pharmacies wouldn’t distribute resealed or re-labelled packages, the place the unique bundle was retained, to sufferers.

The Courtroom accordingly discovered, after reviewing Abacus’ proof that Abacus had not confirmed that it was objectively crucial to exchange the unique packages. Abacus had due to this fact infringed Novartis’ logos. The reasoning within the judgment makes it clear that the Courtroom is just not of the opinion that the brand new Security Guidelines requires a change of the established case regulation regarding the parallel importers’ burden to show that repackaging is objectively crucial. It’s nonetheless crucial that the parallel importer should fulfill a excessive commonplace of proof when claiming that such changing is objectively crucial with a purpose to successfully entry the market within the importing state.

Nonetheless, trademark holders ought to be conscious that in a case between Novartis Pharma GmbH and Abacus Drugs A/S in Landgericht Hamburg, a request for a preliminary ruling by the ECJ was lodged on 23 March 2020. The questions referred to the ECJ, which will be present in full right here, handle the core query: can it result in a man-made partitioning of the markets if the required security options of authentic outer wrapping/authentic packaging can, within the occasion that the parallel dealer retains that authentic packaging, get replaced in compliance with dir. 2001/83/EC solely in such a manner that seen traces of opening stay after the initially present security options have been partly or absolutely eliminated and/or lined? The case has been given the quantity C-147/20, and is presently listed as a case in progress. The Advocate Normal has now delivered an opinion in that matter, which could be very a lot according to the view taken by the Swedish Courtroom. The Advocate Normal thus opined that the parallel importer should show, with concrete and particular proof, that any seen traces ensuing from for instance an change of a safety seal, would certainly trigger such a robust resistance from the shoppers in order that the medicines repackaged in such manner de facto can be prevented from accessing the market within the importing Member State. There would thus not, whatever the new Security Guidelines, be any change of the established primary rule that parallel importers should show that it’s objectively crucial with a purpose to be allowed to exchange the unique bundle.

Because it presently stands, it due to this fact stays to be seen whether or not the ECJ will present additional clarification on the chances for parallel importers to exchange outer packaging with out infringing logos sooner or later.

Co-author: Senior affiliate Emil Ekdahl Norling, Gulliksson

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