The Novartis Impexeco judgments, C-253/20 and C-254/20, relate to the repackaging and rebrandingof generic medicinal products by parallel importers. The remaining three judgments analyse to what extent the rules on unique identifiers and anti-tampering devices for medicinal products can justify the replacement of the original packaging of parallel imported medicinal products.

The Novartis Impexeco cases

Background

Novartis marketed reference medicines Femara® (letrozole) and Rilatine® (methylphenidate) in the Netherlands and Belgium. Sandoz (then Novartis’ generics division) marketed the generic versions of Femara® and Rilatine® (Letrozole Sandoz and Methylphenidate HC1 Sandoz) in the Netherlands. Parallel importers purchased the generic versions of the products in the Netherlands, repackaged them using the Femara® or Rilatine® brands and, subsequently, marketed them in Belgium as reference medicines.

Novartis applied to a Belgian court for injunctive relief, as it considered that parallel importers had infringed its trademark rights. The Court of first instance accepted Novartis’ arguments and ordered the cessation of imports. The parallel importers appealed the decision, and the Court of Appeal decided to refer several questions to the CJEU for a preliminary ruling.

Requirements for the repackaging of medicinal products

The CJEU holds that the trade mark owner may oppose the application of its trade mark to a repackaged product unless two cumulative conditions are met.

The first requirement is that the reference medicinal product is “identical in all respects” to the generic version. The CJEU stressed that a medicinal product may be repackaged in new packaging bearing the brand name of another medicinal product if, and only if, they are identical. Otherwise, there would be a risk of misleading healthcare professionals and patients as to the exact composition of the medicinal product.

When are reference medicinal products and a generics considered identical? The CJEU does not analyse this question thoroughly, but merely states that “identity” exists in the case of a “common origin”. In other words, when the reference medicinal product and the generic medicinal product are manufactured by the same entity or by economically linked undertakings. But can there be identity without common origin? The CJEU does not resolve this point.

In the case at hand, the CJEU assumes that “identity in all respects” existed between the reference medicinal products and the imported generics as determined by the referring court.

The second requirement to enable repackaging of parallel traded medicinal products is a set of five conditions stemming from the landmark Bristol-Myers Squibb ruling of 1996.

According to the Bristol-Myers Squibb judgment, the parallel importer may repackage the imported product if (1)  repackaging is objectively necessary to commercialise the product in the Member State of importation, (2)  repackaging does not alter the original condition of the product; (3) the entity who repackaged the product and the name of the manufacturer of the repackaged product are clearly indicated on the new packaging; (4) the new presentation of the repackaged product does not cause damage to the reputation of the trademark or the owner; and (5) the importer warns the owner before the product is placed on the market and provides the latter, upon its request, with a copy of the repackaged product.

However, in the case at stake, the Court only analyses the first condition and queries whether it is objectively necessary to present the products as reference medicinal products for parallel importers to market generic medicines in Belgium.

The CJEU puts forward the following three ideas to enable the national court to answer this question.

Firstly, the condition of objective necessity is not met “where the parallel importer is able to market the product under its brand of origin by adapting, where necessary, the packaging to meet the requirements of the Member State of importation”.

Secondly, a Member State may not, in principle, refuse to grant a parallel import authorisation for a generic medicinal product where the corresponding reference medicinal product holds a marketing authorisation in the Member State of importation (CJEU judgment in the Delfarma case).

Thirdly, the owner of the trade mark may oppose repackaging “where the replacement of the original trade mark by another trade mark of the owner is motivated exclusively by the pursuit of an economic advantage”. This may be the case, for example, “where an economic operator seeks to take advantage of the reputation of the brand name of a reference medicinal product or to position a product in a more profitable category”.

The Novartis Pharma, Bayer and Merck Sharp & Dohme cases

Background

These cases concern the repackaging of parallel imported medicinal products in Germany/Denmark. Here we explain the dispute between the parallel importers and the trademark holders of the imported products.

Parallel importers, on the one hand, argued that, in order to market the products in the Member States of importation, the original outer packaging of the products had to be replaced in its entirety. According to these importers, the opening of the sealing label can lead to visible and irreversible changes in the outer packaging, which would require replacement. 

The trademark owners, on the other hand, argued that repackaging was not necessary and that, in order to market the products in Germany/Denmark, it would be sufficient to place “on the original outer packaging the bar code with the unique identifier (…) by means of an adhesive label and, (…) new anti-tampering device covering the traces of the opening of the packaging”.

Relabelling as a preferred option to repackaging

The CJEU begins by addressing two basic questions recognised by its case law. First, repackaging of a medicinal product is a more significant interference than relabelling. Secondly, a trade mark owner may oppose repackaging if the parallel importer is able to market the product by simply relabelling it.

However, the key question is: do the rules on security features (unique identifier/anti-tampering device) justify the replacement of the original packaging of products by parallel importers?

The CJEU holds that, with a few exceptions, the answer is no. Parallel importers cannot justify the replacement of the original packaging of imported goods on the grounds that the handling of the original packaging required by local regulations causes visible and irreversible changes to that packaging, thus necessitating a complete replacement.

The CJEU makes two clarifications to this position.

Firstly, relabelling must be possible in such a way that wholesalers and persons authorised to dispense medicinal products have no doubt that traces of opening in the original packaging are attributable to the parallel importer. In case of doubt, it may be justified to replace the original packaging.

Secondly, the replacement of the original packaging may be considered objectively necessary (and therefore permitted) where a significant proportion of consumers in the importing Member State strongly object to relabelled medicinal products with replaced anti-tampering devices. In such cases, repackaging may be considered necessary to achieve effective market access. However, parallel importers cannot rely on a “general presumption of consumer resistance”, as resistance must be assessed on a case-by-case basis.

Conclusions

The above judgments help to clarify the already well-developed regime of parallel imports for medicinal products. With respect to the rebrandingof generic products, the CJEU holds that trade mark owners may, in principle, oppose rebrandingunless the reference and generic products are “identical in all respects” and the conditions of the Bristol-Myers Squibb and subsequent judgments (in particular the requirement of objective necessity) are met.

As regards the rules on unique identifiers and anti-tampering devices for medicinal products, the CJEU concludes that, with some exceptions, they are not sufficient to justify the total repackaging (with replacement of the original packaging) of products.

Although the clarifications provided by the judgments are extremely useful, other questions remain to be resolved, namely: Can “identity in all respects” exist between a reference medicinal product and a generic without a “common origin”? What requirements must be met so as to consider that there is resistance in the importing country to relabelled medicinal products with replaced anti-tampering devices?

La entrada Repackaging and relabelling of parallel imports of medicinal products aparece primero en Faus Moliner.

This judgement is about a question referred for preliminary ruling by the Regional Administrative Court of Warsaw (Poland) regarding the compatibility of the Polish legislation on parallel imports with EU law. Polish national law requires imported medicinal products to: (i) have the same active substance, the same strength, the same route of administration, and the same form and therapeutic effect as the medicinal product authorised in Poland; and (ii) have been approved in accordance with the same legal basis than the medicinal product authorized in Poland; that is, both the product authorized in Poland and the one to be imported must have been approved as generics (abridged dossier) or as reference medicinal products (full dossier).

Position of the Polish authorities

Polish authorities rejected the application placed by Delfarma for the issue of a license for parallel import of a medicinal product (Azithromycin) from the UK after stating that such product to be imported was a generic medicinal product authorised in the UK on the basis of an abridged dossier, whereas the product authorised in Poland (Sumamed) was a reference medicinal product. According to the Polish authorities, such circumstance made it impossible for them to determine whether the differences between Azithromycin and Sumamed  could be considered significant from the point of view of safety and efficacy. The Polish Court, however, had doubts about the compatibility of these national provisions with the EU case-law regarding the free movement of goods and referred a question to the CJEU for preliminary ruling.

Judgment of the CJEU

According to Polish authorities, Polish national provisions are necessary in order to guarantee that both the product authorized in Poland (in this case Sumamed ) and the one to be imported (in this case Azithromycin) are sufficiently similar, as well as to prevent the risk that, through a parallel import, the standard authorisation and registry procedures of medicinal products are avoided. The CJEU, however, concluded that the EU law does not allow national authorities to reject an application for parallel import merely because two medicinal products have been authorised in the EU under different procedures. The CJEU recalled that, according to EU case law, the Member State of importation must ensure that the medicinal product imported as a parallel product and the medicinal product which is the subject of the marketing authorization in the Member State of importation, even if not identical in all respects, have the same therapeutic effect, and that the imported medicinal product does not pose a problem of quality, efficacy or safety. If the result of this assessment is satisfactory, there should be no obstacle for the imported medical product to benefit from an abridged approval procedure in the Member State of exportation.

As long as national Polish law prevents this assessment from being completed, the CJEU concluded that such national law is incompatible with EU law.

La entrada The differences in the procedures for the authorisation of medicinal products are not sufficient to reject a parallel import aparece primero en Faus Moliner.

Roche Diagnostics markets in vitro diagnostic medical devices in Germany. Servoprax purchased said devices in the United Kingdom, where they were also marketed, and then added a label and instructions in German and sold them in Germany. The product’s label in Germany made reference to two units of measurement (“mmol/l” and “mg/dl”), whilst in the United Kingdom, the label only featured one unit (“mmol/l”). Given that the units that Servoprax distributed in Germany only made reference to the latter unit (“mmol/l”), Roche Diagnostics believed that Servoprax could not sell them in such country without previously submitting them to an additional compliance assessment. Servoprax submitted the products to said assessment in December 2010 but, nevertheless, Roche Diagnostics brought suit for alleged damages caused theretofore. The local court, believing that the case was dependent on the interpretation of Directive 98/79/EC, suspended the main proceedings and raised the issue before the CJEU.

Freedom of movement covers the actions of Servoprax

Given that Directive 98/79/EC establishes that in vitro diagnostic medical devices that have been assessed and have obtained the CE marking must be able to enjoy free movement within the EU and given that German laws do not prohibit their distribution when the product information included is solely provided in the “mmol/l” unit of measurement, the CJEU ruled that there was no reason to demand that Servoprax submit the units resold in Germany to a new compliance assessment. In this regard, it asserted that the product compliance assessment is an obligation of the manufacturer who places the product onto the Community market for the first time, and not of the parallel importers purchasing a product in a Member State before subsequently reselling it in another. The foregoing applies, according to the Court, even if the information on the product has to be translated into the official language of the country to which the product is imported to, as established in Directive 98/79/EC.

Inclusion of a label and instructions in German does not involve reconditioning

The Court’s comments on the position of the European Commission are worth noting, given that the latter sustained that the parallel importer was obliged to communicate operations to the manufacturer, by way of analogy with the criteria set out in European case law in connection with medicinal products. The CJEU, on the other hand, concluded that the mere fact that a label and instructions translated into the official language of the importing country were included on the product, without changing its packaging or presentation, does not mean it was reconditioned. As a result, it asserted that in such cases, there is no legal basis that calls for the manufacturer to be informed of such operations.

La entrada Parallel import of in vitro diagnostic medical devices aparece primero en Faus Moliner.