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Thursday, 28 July 2011

No surprise as pharma repackaging rulings rush through

The labels on the box never troubled the IPKat,
but the contents sometimes caused surprise ...
Not every case which is bound for the Court of Justice of the European Union for a preliminary ruling takes forever.  The two cases noted here, Joined Cases C‑400/09 and C‑207/10, Orifarm v Merck Sharpe & Dohme; Paranova v Merck Sharp & Dohme, sped through in pretty good time.  One was referred in October 2009, attracting a ruling in substantially less than two years, while the other hurtled past the judges' noses at almost the speed of light, having been referred as recently as April 2010.  Speedy cases aren't usually the sign of an efficient court, though: they're an indication that the questions referred for a reference were too easy to spend a lot of time on -- as is the case here.

In Case C‑400/09 pharma giant Merck made trade mark-protected medicinal products which Orifarm imported in parallel on to the Danish market by the Orifarm group. Orifarm and another company, Handelsselskabet, held the authorisations to market and sell those medicinal products, while Orifarm Supply and Ompakningsselskabet, which carried out the repackaging, held authorisations to do so. All decisions concerning the purchase, repackaging and sale of these products, including decisions relating to the design of the new packagings and their labelling, were taken by Orifarm or Handelsselskabet. Ompakningsselskabet and Orifarm Supply bought and repackaged the medicinal products, assuming liability for compliance with the requirements for repackagers laid down by the Danish Medicinal Products Agency. The packaging of the products indicated that they had been repackaged by Orifarm or Handelsselskabet, as the case may be.

Merck sued Orifarm, Handelsselskabet and Ompakningsselskabet, on the ground that the name of the actual repackager did not appear on the packaging of the products. The trial court agreed that the defendants had infringed Merck’s trade mark rights by failing to indicate on the packaging the name of the undertaking which had actually performed the repackaging, ordering them to pay damages. The defendants appealed to the Danish Supreme Court, which decided to stay the proceedings and refer the following questions to the Court for a preliminary ruling:
‘(1) The Court of Justice is requested to clarify whether [Bristol-Myers Squibb and Others and MPA Pharma --earlier ECJ decisions] are to be interpreted as meaning that a parallel importer which is the holder of the marketing authorisation for, and possesses information on, a medicinal product imported in parallel, and which issues instructions to a separate undertaking for the purchase and repackaging of a medicinal product, for the detailed design of the product’s packaging and for arrangements in relation to the product, infringes the rights of the trade mark proprietor by indicating itself – and not the separate undertaking which holds the repackaging authorisation, has imported the product and has carried out the physical repackaging, including (re)affixing of the trade mark proprietor’s trade mark – as the repackager on the outer packaging of the medicinal product imported in parallel. 
(2) The Court of Justice is requested to clarify whether it is of significance in answering Question 1 that an assumption might be made that, where the marketing authorisation holder indicates itself as the repackager instead of the undertaking which physically carried out the repackaging to order, there is no risk that the consumer/end user might be misled into assuming that the trade mark proprietor is responsible for the repackaging. 
(3) The Court of Justice is requested to clarify whether it is of significance in answering Question 1 that an assumption might be made that the risk of misleading the consumer/end user into assuming that the trade mark proprietor is responsible for the repackaging is excluded if the undertaking which physically carried out the repackaging is indicated as being the repackager. 
(4) The Court of Justice is requested to clarify whether it is only the risk that the consumer/end user might be misled into assuming that the trade mark proprietor is responsible for the repackaging which is of significance in answering Question 1, or whether other considerations regarding the trade mark proprietor are also relevant, for example 
(a) that the entity which undertakes the importation and physical repackaging and (re)affixes the trade mark proprietor’s trade mark on the product’s outer packaging potentially on its own account infringes the trade mark proprietor’s trade mark by so doing, and 
(b) that it may be due to factors for which the entity that physically carried out the repackaging is responsible that the repackaging affects the original condition of the product or that the presentation of the repackaging is of such a kind that it must be assumed to harm the trade mark proprietor’s reputation (see, inter alia, … Bristol-Myers Squibb and Others …). 
(5) The Court of Justice is requested to clarify whether it is of significance in answering Question 1 that the holder of the marketing authorisation, which has indicated itself as being the repackager, at the time of the notification of the trade mark proprietor prior to the intended sale of the parallel imported medicinal product once repackaged, belongs to the same group as the actual repackager (sister company).’
In Case C‑207/10 much the same thing happened, but the same court referred slightly different questions:
‘(1) Are Article 7(2) of [Directive 89/104] and the associated case-law, in particular the judgments of the Court of Justice in … Hoffmann-La Roche … and … Pfizer … and … Bristol-Myers Squibb and Others … to be interpreted as meaning that a trade mark proprietor may rely on these provisions in order to prevent a parallel importer’s marketing company, which is the holder of a marketing authorisation for a medicinal product in a Member State, from selling that product with an indication that the product is repackaged by the marketing company, although the marketing company has the physical repackaging carried out by another company, the repackaging company, to which the marketing company gives instructions for the purchasing and repackaging of the product, for the detailed design of the product’s packaging and for other arrangements in relation to the product, and which holds the repackaging authorisation and reaffixes the trade mark on the new package in the course of repackaging? 
(2) Is it of significance in answering Question 1 that an assumption might be made that the consumer or end-user is not misled with regard to the origin of the product and will not be led to believe that the trade mark proprietor is responsible for the repackaging through the indication by the parallel importer of the manufacturer’s name on the packaging along with the indication as described of the undertaking responsible for the repackaging? 
(3) Is it only the risk that the consumer or end-user might be misled into assuming that the trade mark proprietor is responsible for the repackaging which is of significance in answering Question 1, or are other considerations regarding the trade mark proprietor also relevant, for example 
(a) that the entity which in fact undertakes the purchasing and repackaging and reaffixes the trade mark proprietor’s trade mark on the product’s packaging thereby potentially infringes independently the trade mark proprietor’s trade mark rights, and that that may be due to factors for which the entity that physically carried out the repackaging is responsible, 
(b) that the repackaging affects the original condition of the product, or 
(c) that the presentation of the repackaged product is of such a kind that it may be assumed to harm the trade mark or its proprietor’s reputation? 
(4) If, in answering Question 3, the Court finds that it is also relevant to take account of the fact that the repackaging company potentially infringes independently the trade mark rights of the trade mark proprietor, the Court is asked to indicate whether it is of significance to this answer that the marketing company and repackaging company of the parallel importer are jointly and severally liable under national law for the infringement of the trade mark proprietor’s trade mark rights. 
(5) Is it of significance in answering Question 1 that the parallel importer which holds the marketing authorisation and has indicated itself as being responsible for repackaging, at the time of the notification of the trade mark proprietor prior to the intended sale of the repackaged medicinal product, belongs to the same group as the company which undertook the repackaging (sister company)? 
(6) Is it of significance in answering Question 1 that the repackaging company is indicated as the manufacturer in the package leaflet?’
What with all these questions, some readers might have been expecting a lengthy set of answers -- but not this Kat. He knew they'd be short and sweet:
"Article 7(2) of First Council Directive 89/104 ... must be interpreted as not allowing the proprietor of a trade mark relating to a pharmaceutical product which is the subject of parallel imports to oppose the further marketing of that product in repackaged form on the sole ground that the new packaging indicates as the repackager not the undertaking which, on instructions, actually repackaged the product and holds an authorisation to do so, but the undertaking which holds the marketing authorisation for the product, on whose instructions the repackaging was carried out, and which assumes liability for the repackaging".
In other words, never mind the technicalities as to whose name appears on the packaging -- look at the reality. The trade mark owner's interest in preserving the integrity of its trade marks is unaffected and the consumer is not threatened or misled,  End of story.

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