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The legality of the re-packaging and re-labelling of parallel imports of medicines
date: 2021-06-17

[Editor's note] The European Court of Justice issued two preliminary rulings on the dispute, Relates to exhaustion of trademark rights in the internal market of the European Community, Legitimacy of repackaging in parallel import of drugs, As well as related evidence and liability for compensation and other aspects, It has an important guiding and forecasting function for similar disputes after that. Therefore, Although the controversy in this case is relatively old, Here we summarize the key rulings in the case, We hope it will be helpful for Chinese customers and partners to understand relevant EU regulations and practices.   

[background]   

Boeheringer Ingelheim KG And several other drug makers (Hereinafter referred to as "producer" ) Sue Swingward Ltd and Dowelhurst Ltd (Hereinafter referred to as "Parallel importer" ) , It is believed that the latter imports drugs made by the former into the UK in parallel (Hereinafter referred to as "Drug involved" ) In the process, The act of repackaging and relabeling drugs violates the registered trademark rights of the former.   Parallel importers purchase the manufacturer's drugs in question from the EC market, By adding a description label, Substitution of packaging, Or change the original packaging of commodities by adding information and description pages in the original packaging, It was then imported and sold in the UK market.    "Treaty Establishing the European Community" The first 28 Article provision, Quantitative restrictions on imports or measures of equivalent effect between member States are prohibited. but, The treaty 30 Article also provides that, For the purpose of protecting the rights of industry and commerce, Member states have the right to take measures to prohibit or restrict imports, However, such measures shall not lead to discrimination or disguised restrictions on trade activities between member States.    "Directive of the First Council of the European Union on the harmonization of trademark legislation in the Member States (The first 89/104/EEC No) " (Hereinafter referred to as "European Union regulation 89/104/EEC Number instruction" ) The first 7 Article about "Exhaustion of trademark rights" Stipulation of, After the trademark owner or a person authorized by him has placed the goods with the trademark right on the Community market for the first time, There is no right to prohibit others from reselling the goods, However, if the nature of the commodity is changed or damaged in the process of resale, The trademark owner shall have the right to prohibit resale.   Based on the above provisions, The manufacturer sued in the High Court of Justice in England and Wales. The Court of Admissibility requested the European Court of Justice to make a preliminary decision on the relevant issues in the case. The European Court of Justice subsequently ruled No C-143/00 Preliminary determination: The trademark owner may, in accordance with his trademark rights, prohibit the parallel importer from repackaging the drug, However, the market among member states shall not be artificially divided; If there is an objective necessity to repackage the drug, The parallel importer notifies the manufacturer in advance about the repacking, Parallel importers should be allowed to repackage them to the extent necessary. The accepting court shall rely on the above preliminary conclusion, The case was decided in favour of the manufacturer.   The decision was then appealed to the Court of Appeal, The appellate court found new facts beyond those found by the court of first instance. Therefore, The court of appeal decided to stay the case, Again to the European Court of Justice, Whether the new findings affect the No C-143/00 Issue a ruling on the preliminary conclusion of the ruling and other relevant issues.   

[conclusion]   

The European Court of Justice first reiterated, The core function of a trademark is to guarantee the origin of the goods or services bearing the mark, The third party repackages the relevant goods without the permission of the trademark owner, May damage trademark above "Guaranteed source function" .   The European Court of Justice in No C-143/00 Determined in the ruling, The act of repackaging a pharmaceutical product bearing a trademark, It may damage the above core functions of the trademark, Therefore, There is no need to consider the actual consequences of the parallel importer's repackaging.   but, The European Court of Justice made it clear in its decision, Repackaging conforms to the following five conditions, The trademark owner has no right to prohibit:    (1) The trademark owner shall prohibit the re-sale of the repackaged goods in accordance with his trademark right, May lead to artificial segmentation of member markets;    (2) To gain access to target import markets, The parallel importers are objectively requested to make necessary modifications to the original packing of the goods, And the repackaging does not affect the original condition of the packaged goods;    (3) New packaging details repackaging party and manufacturer information;    (4) The appearance of the new package will not damage the reputation of the original commodity trademark and trademark owner, That is, the appearance of the new packing shall not be defective, Poor quality or untidy, etc; and,    (5) The parallel importer informs the trademark owner in advance of the repackaging of the goods, And in accordance with the trademark owner requirements, Provide samples of repackaging.   1. "repackage" Concept of  In this case, The parallel importers altered the original packaging of the drugs in question in a variety of ways: Only a new label indicating the necessary information for parallel importation should be affixed to the original package; unpacking, Use the new packing designed by the parallel importer, But it still shows the manufacturer's logo; and, Remove original packaging and manufacturer's trademark, Only the manufacturer's trademark is displayed on the inner package, And so on. Therefore, The court of Appeal asked for clarification "repackage (repackaging) " Concept of, In order to determine the extent of the obligation of the parallel importer to notify the trademark owner in advance of the repackaging.   For that matter, European court of justice ruling, Re-label the outer package of the drug with the label attached, It is consistent with the effect of changing the outer packaging of the drug, May damage the original attached trademark "Source of guarantee" function. In this case, There is no need to analyse in detail the real consequences of the specific changes adopted by parallel importers. The trademark owner has the right to prohibit parallel importers from pasting new labels, Change the packaging box and other ways to change the original goods, After outer packaging, parallel import to other member countries' markets, Unless the repackaging act complies with No C-143/00 All five conditions required in the award.   2. A change to the original packing of the goods, Be limited to "necessary" Within the scope  One of the conditions that allows parallel importers to import goods into the markets of other member States with modifications to the original packaging is, Changes to the original packaging, Must be "necessary" cause. If the importing member state has specific legal requirements for the outer packaging of the goods to be imported, Commodities that do not meet the requirements may not be sold in the market of that country, Parallel importers are required to be able to enter the market, The act of modifying the part of the original package that does not meet the legal requirements of the importing country, Should be considered "necessary" modify.   3. Any modification of the original package of a commodity shall not damage the reputation of the trademark of the commodity  The European Court of Justice in No C-143/00 It has been made clear in the ruling, Parallel importer's modification of the original packing, The trademark of the commodity and the reputation of the trademark owner shall not be damaged, At the same time, enumerate several situations that may cause damage: The new packing of the goods is defective, Poor quality or dirty and untidy.   In this decision, At the request of the appellate court, The European Court of Justice further clarified this claim, The above list of possible causes of damage, Is to illustrate, Incomplete enumeration. For none of the above, But the appearance of the new package or label, Design or use, etc, It may damage the reliability and high quality of the product itself, Or the good impression of the goods in the relevant public groups, It also belongs to the behavior that destroys the value and reputation of the commodity trademark.   Whether the reputation of the trademark is infringed in the specific case, It is up to the receiving court to submit evidence based on the facts of the case, Take into account whether the parallel importers exist in the following situations, Make a judgment:    (1) No trade mark is shown on the new package (debranding (de-branding) ) ;    (2) Use the parallel importer's own logo on the new packaging, decoration, pattern, Or use the same style on different products (Brand generalization (co-branding) ) ;    (3) The new pasted label blocks all or part of the trademark owner's trademark;    (4) The ownership relationship of the disputed trademark is not stated on the new label; or,    (5) The name of the parallel importer appears on the outer package in capital letters, And so on.   4. Burden of proof  In order to defend against the trademark owner exercising the trademark right to prohibit parallel imports, The parallel importer shall ensure that the repackaging of the commodity meets five conditions, And bear the corresponding burden of proof.   but, European court of justice, for "Repacking shall not affect the original nature of the goods to be packed" , and "The repackaging of the appearance shall not damage the reputation of the trademark or the trademark owner" Two conditions, The parallel importer only has to provide prima facie evidence reasonably presuming that the prohibition does not exist. If the trademark owner disagrees with the conclusion of the parallel importer, Evidence shall be provided, Specify the fact that the nature of the goods is affected and the reputation of the trademark and the right holder is damaged.   5. Before the parallel importer repackages the goods, The consequences of not informing the trademark owner in advance  Before making necessary changes to the packaging of parallel imported goods, The parallel importer is obliged to notify the trademark owner of the repackaging, And according to the latter, Provide samples of the new packing, otherwise, The trademark owner has the right to prohibit the parallel import.   As to, Liability of parallel importers for breach of notification obligation, European court of justice ruling, Due to "European Union regulation 89/104/EEC Number instruction" No specific penalties are specified, The competent authorities of the member States should examine all the facts of the specific case, Decide to take appropriate action, Effective and deterrent penalties, To ensure that the objectives of the EU directive are achieved.   

[comment]   

The case has been the subject of two preliminary rulings by the European Court of Justice, Clarified the European Community unified internal market background, Justification by parallel importers for importing into the markets of other Member States medicines purchased and repackaged from the markets of one Member State, Related burden of proof and penalties and other aspects of the problem.   In principle, The drug trademark owner shall have the right to prohibit the parallel importer from changing or changing the original package of the drug without permission in the process of parallel import. but, The parallel importer can provide evidence to prove that the drug was carried out "repackage" Acts in accordance with certain conditions, It can be contested. parallel-importer "repackage" Acting without justification, It may bear the compensation liability arising from the infringement of the trademark rights of goods.   

author: Liu Dan, Esabarry Legal Counsel  source: Esabaril (ELZABURU) Intellectual property rights