FOURTEEN QUESTIONS FOR THE ECJ FROM PHARMA REPACKAGING CASE

Yesterday saw the latest development in the protracted and keenly fought group of cases that goes under the handy banner of Boehringer Ingelheim v Swingward. This was the setting out by Lord Justice Jacob (for the Court of Appeal) of the questions which are to be referred to the European Court of Justice relating to the legitimacy of reboxing and overstickering pharmaceutical products that are bought in one EU country and then imported into another in which the language, or market preferences, are different. The package for the ECJ includes five questions on repackaging, five on overstickering and a further four on the requirement of the parallel importer to give notice to the trade mark proprietor (the original pharmaceutical manufacturer) before doing either of those things.

The questions are as follows:

(1) Reboxed products: Where a parallel importer markets in one Member State a pharmaceutical product imported from another Member State in its original internal packaging but with a new exterior carton printed in the language of the Member State of importation (a “reboxed” product): (a) does the importer bear the burden of proving that the new packaging complies with each of the conditions set out in Joined Cases C-427/93, C-429/93 and C-436/93 Bristol-Myers Squibb v Paranova or does the trade mark proprietor bear the burden of proving that those conditions have not been complied with or does the burden of proof vary from condition to condition, and if so how? (b) does the first condition set out in Bristol-Myers Squibb v Paranova as interpreted in Case C-379/97 Upjohn v Paranova and Case C-143/00 Boehringer v Swingward, namely that it must be shown that it is necessary to repackage the product in order that effective market access is not hindered, apply merely to the fact of reboxing (as held by the EFTA Court in Case E-3/02 Paranova Inc v Merck & Co Inc) or does it also apply to the precise manner and style of the reboxing carried out by the parallel importer, and if so how? (c) is the fourth condition set out in Bristol-Myers Squibb v Paranova, namely that the presentation of the repackaged product is not such as to be liable to damage the reputation of the trade mark or its owner, only infringed if the packaging is defective, of poor quality or untidy or does it extend to anything which damages the reputation of the trade mark? (d) if the answer to question 1(c) is that the fourth condition is infringed by anything which damages the reputation of the trade mark and if either (i) the trade mark is not affixed to the new exterior carton (“de-branding”) or (ii) the parallel importer applies either his own logo or a house-style or get-up or a get-up used for a number of different products to the new exterior carton (“co-branding”) must such forms of box design be regarded as damaging to the reputation of the trade mark or is that a question of fact for the national court? (e) if the answer to question 1(d) is that it is a question of fact, on whom does the burden of proof lie?

(2) Overstickered products: Where a parallel importer markets in one Member State a pharmaceutical product imported from another Member State in its original internal and external packaging to which the parallel importer has applied an additional external label printed in the language of the Member State of importation (an “overstickered” product): (a) do the five conditions set out in Bristol-Myers Squibb v Paranova apply at all? (b) if the answer is question 2(a) is yes, does the importer bear the burden of proving that the overstickered packaging complies with each of the conditions set out in Bristol-Myers Squibb v Paranova or does the trade mark proprietor bear the burden of proving that those conditions have not been complied with or does the burden of proof vary from condition to condition? (c) if the answer to question 2(a) is yes, does the first condition set out in Bristol-Myers Squibb v Paranova as interpreted in Upjohn v Paranova and Boehringer v Swingward, namely that it must be shown that it is necessary to repackage the product in order that effective market access is not hindered, apply merely to the fact of overstickering or does it also apply to the precise manner and style of overstickering adopted by the parallel importer? (d) if the answer to question 2(a) is yes, is the fourth condition set out in Bristol-Myers Squibb v Paranova, namely that the presentation of the repackaged product is not such as to be liable to damage the reputation of the trade mark or its owner, only infringed if the packaging is defective, of poor quality or untidy or does it extend to anything which damages the reputation of the trade mark? (e) if the answer to question 2(a) is yes and the answer to question 2(d) is that the fourth condition is infringed by anything which damages the reputation of the trade mark, is it damaging to the reputation of a trade mark for this purpose if either (i) the additional label is positioned so as wholly or partially to obscure one of the proprietor’s trade marks or (ii) the additional label fails to state that the trade mark in question is a trade mark owned by the proprietor or (iii) the name of the parallel importer is printed in capital letters?

(3) Notice: Where a parallel importer has failed to give notice in respect of a repackaged product as required by the fifth condition of Bristol-Myers Squibb v Paranova, and accordingly has infringed the proprietor’s trade mark(s) for that reason only: (a) is every subsequent act of importation of that product an infringement or does the importer only infringe until such time as the proprietor has become aware of the product and the applicable notice period has expired? (b) is the proprietor entitled to claim financial remedies (i.e. damages for infringement or the handing over of all profits made by infringement) by reason of the importer’s acts of infringement on the same basis as if the goods had been spurious? (c) is the granting of financial remedies to the proprietor in respect of such acts of infringement by the importer subject to the principle of proportionality? (d) if not, upon what basis should such compensation be assessed given that the products in question were placed on the market within the EEA by the proprietor or with his consent?

The IPKat wonders whether the ECJ will answer all these questions, or whether it will just shrug its shoulders and say that the answer to them is somehow implicit in its earlier ruling and that the Court of Appeal should be able to work them out for themselves.

Court of Appeal’s earlier judgment of 5 March 2004 here; IPKat blog on it here
European Court of Justice’s earlier ruling here