European Court of Justice (CJEU) In relation to parallel imports 4 The case was ruled in favour of the pharmaceutical company, Practitioner representation, These results will protect patients from their unfamiliar packaging.

11 month 17 day, European court of justice ruling, If there's a significant change in the generic's packaging, The owner of the trademark of a reference or generic drug may object to the sale of the generic drug by a parallel importer.

Among them 3 The case involves Novartis, a Swiss company (Novartis) , The other involves Bayer, a German company (Bayer) , The focus is on the EU "Forgery of medicines directive (FMD) " Whether parallel importers are allowed to completely repackage the drug.

2011 introduced FMD To coordinate measures, To ensure that the safety of medicines and trade is controlled.

These measures include mandatory safety features, Examples include the use of unique identifiers and tamper-proof devices on outer packaging, And implementing stricter import rules for active pharmaceutical ingredients.

But David, Novartis's global head of brand legal protection．Rossignol (David Lossignol) representation, Some parties have tried to FMD On the pretext of, A big change in product packaging.

He added that, These are landmark decisions, clarified FMD The impact on parallel trade, And will protect consumers from unfamiliar packaging.

The European Court of Justice is in Belgium, The decision was made after the cases were transferred by the national courts of Denmark and Germany.

It involves Novartis 2 The cases are against each other Paranova Danmark And the Belgium-based Impexeco and PiPharma. The Danish Maritime and Commercial Court and the Brussels Court of Appeal sent cases to the European Court of Justice.

Another case against Novartis Abacus The pharmaceutical case was filed by the Hamburg District Court. Bayer and Kolpharma The dispute was also filed by the Hamburg District Court.

In each case, The rulings have focused on the extent to which parallel-imported drugs can be repackaged.

For example, In Novartis v Abacus In the case, Headquartered in Germany Abacus According to, To sell Novartis's Pazopanil in a package suitable for sale in Germany (Votrient) medicine, It needs to be opened in its original packaging, Including tamper-proof devices attached to them, And then repackage.

Abacus The company claims, It is impossible to install a new tamper-proof device on the original packaging without leaving a visible mark of opening. Novartis disputes that.

The European Court of Justice ruled, In each case, "If the product uses the new outer packaging, And the outer package pasted the trademark of reference drug" , The trademark owner of a reference product or of a generic drug can object to parallel imports.

Rossignol said, After these verdicts, FMD "Will no longer be able to be used to justify systematic repackaging of parallel-imported medicines" .

Medical relief

Bayer (Bayer) s trademark executive, Frank．Megner (Frank Meixner) representation, This decision involves Bayer, Very welcome clarifications have been made to the rules on the parallel import of medicines.

He explained that, In the last few decades, A very complex body of case law has developed in this area——When the importer adjusts the imported product to meet the regulatory requirements of the destination country, The least invasive method of repackaging must be chosen.

Mekner points out: "In this case, Relabelling is the norm, Complete replacement of the original packaging is permitted only under special circumstances. "

however, He pointed out that, Importer's argument FMD Is a game changer.

Mr Megner said: "A considerable number of parallel importers have used the directive to challenge the current system, And think that FMD New security features are a game changer, In principle, making relabelling impossible, Because it's not considered safe. "

He added that: "We are very happy that, The European Court of Justice confirmed, In spite of FMD, Existing rules on parallel imports still apply. In this case, Re-labeling imported products is just as safe as repacking them. "

The ruling also made clear that, Generic drugs cannot be withdrawn from EU countries where they are needed, And sold under the original brand under the new name at a higher price in another EU country.

Rossignol added, After Novartis decided to take Sandoz, its generic drug company (Sandoz) In the context of separation from the main business, This decision is particularly important. The decision was made this year 8 monthly.

He indicated, If the European Court does not reach a conclusion, It could affect the way Sandoz and Novartis operate products sold under different brands in different countries.

He added: "finally, The decision is logical, Because companies like Novartis can't be punished for certain actions, For example, improving access to medicines for patients in some EU countries through Sandos-branded products. More chances to be punished, And be authorized to remove the products from targeted patients who need them, Rebranded under the Novartis brand, And sold in other EU countries, Is not appropriate. " (Compiled from www. managingip. com)

translation: Rason group　proofread: Liu Peng

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