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Ompaketeringsundantaget - ett tillägg till den varumärkesrättsliga konsumtionen vid parallellimport av läkemedel.

Follin, Niklas LU (2011) JURM01 20102
Department of Law
Abstract (Swedish)
Med utgångspunkt i unionsrättslig praxis syftar arbetet att undersöka ompaketeringsundantagets innebörd och dess tillämpning i svenska domstolar. Inledningsvis ges en allmän beskrivning av parallellimport och läkemedelsmarknaden och därefter undersöks etablerandet av ompaketeringsundantaget och dess innebörd.

EUD har fastställt att även om fördraget inte berör förekomsten av immateriella rättigheter kan utövandet av sådana rättigheter ändå innebära en restriktion i den fria rörligheter för varor och således strida mot unionsrätten. En restriktion av den fria rörligheten kan endast tillåtas i den mån den är motiverad för att skydda äganderättens särskilda föremål. För varumärkesrätten omfattas all användning som kan förvanska... (More)
Med utgångspunkt i unionsrättslig praxis syftar arbetet att undersöka ompaketeringsundantagets innebörd och dess tillämpning i svenska domstolar. Inledningsvis ges en allmän beskrivning av parallellimport och läkemedelsmarknaden och därefter undersöks etablerandet av ompaketeringsundantaget och dess innebörd.

EUD har fastställt att även om fördraget inte berör förekomsten av immateriella rättigheter kan utövandet av sådana rättigheter ändå innebära en restriktion i den fria rörligheter för varor och således strida mot unionsrätten. En restriktion av den fria rörligheten kan endast tillåtas i den mån den är motiverad för att skydda äganderättens särskilda föremål. För varumärkesrätten omfattas all användning som kan förvanska ursprungsgarantin av det särskilda föremålet och kan således hindras med ensamrätten.

All ompaketering kan i princip skada ursprungsgarantin och kan således hindras med stöd i varumärkesrätten. Ompaketeringsundantaget innebär dock att ett sådant hindrande inte är tillåtet under vissa förutsättningar. Ett hindrande av saluföring av ompaketerade varor är otillåtet om:

- Det fastställs att innehavarens användning av varumärkesrätten för att motsätta sig marknadsföring av ompaketerade varor under varumärket bidrar till att på ett konstlat sätt avskärma marknaderna mellan medlemsstaterna.
- Det visas att ompaketeringen inte kan påverka den ursprungliga beskaffenheten hos den vara som förpackningen innehåller.
- Det på den nya förpackningen klart anges vem som har packat om varan och vem som tillverkat den.
- Varans utformning efter ompaketeringen är inte sådan att varumärkets eller dess innehavares anseende kan skadas.
- Och importören på förhand underrättar varumärkesinnehavaren om att den vara som har packats om saluförs och tillhandahåller honom, på begäran, ett prov av den vara som har packats om.

Bevisbördan för att ompaketeringsundantagets kriterier är uppfyllda vilar huvudsakligen på parallellimportören. Om villkoren inte är uppfyllda innebär varje användande av varumärket intrång i ensamrätten.

Ompaketeringsundantaget har inte behandlats i någon större omfattning i svenska domstolar. I de domar som finns tillgängliga framkommer dock att svenska domstolar verkar ha svårt att förstå innebörden av parallellimport och ompaketeringsundantaget och de tenderar till att döma för strikt gentemot parallellimportören. (Less)
Abstract
This essay investigates the trade mark doctrine for parallel importation of repackaged pharmaceuticals established in community law, and how this doctrine is applied in Swedish courts. Initially the author generally describes parallel imports and the pharmaceutical market before investigating the establishment of the doctrine and its meaning.

The ECJ have established that whilst the treaty does not affect the existence of intellectual property rights, the exercise of those rights may nevertheless constitute restrictions of the free movement of goods and can thus be restricted by the prohibitions contained in the treaty. Derogations from the fundamental principle of free movement of goods are justified only to the extent to which such... (More)
This essay investigates the trade mark doctrine for parallel importation of repackaged pharmaceuticals established in community law, and how this doctrine is applied in Swedish courts. Initially the author generally describes parallel imports and the pharmaceutical market before investigating the establishment of the doctrine and its meaning.

The ECJ have established that whilst the treaty does not affect the existence of intellectual property rights, the exercise of those rights may nevertheless constitute restrictions of the free movement of goods and can thus be restricted by the prohibitions contained in the treaty. Derogations from the fundamental principle of free movement of goods are justified only to the extent to which such exceptions are motivated for the purpose of safeguarding the rights which constitute the specific subject-matter of that property. For trade mark rights all uses of the trade mark that could distort the guarantee of origin falls within the specific subject-matter and can thus be prevented by means of trade mark law.

All repackaging of pharmaceuticals could in principle distort the guarantee of origin, and could hence be hindered. The doctrine of repackaging however constitutes an exception in which such prevention is unjustified under certain circumstances. The trade mark owner may not oppose the further marketing of a repackaged pharmaceutical product if:

- It is established that the reliance on trade mark rights by the owner in order to oppose the marketing of repackaged products under that trade mark would contribute to the artificial partitioning of the markets between Member States.
- It is shown that the repackaging cannot affect the original condition of the product inside the packaging.
- It is clearly stated on the new packaging who repackaged the product and the name of the manufacturer.
- The presentation of the repackaged product is not such as to be liable to damage the reputation of the trade mark and of its owner.
- The importer gives notice to the trade mark owner before the repackaged product is put on sale, and, on demand, supplies him with a specimen of the repackaged product.

The burden of proof that these circumstances are fulfilled lies mainly on the parallel importer. If they are not met every use of the trade mark constitutes an infringement of the trade mark right.

The doctrine of repackaging has been applied by Swedish courts only in a couple cases. From the cases that are published it seems like Swedish courts have difficulties understanding the functioning of parallel importation and the doctrine, and they tend to take on a too strict stance toward the importer. (Less)
Please use this url to cite or link to this publication:
author
Follin, Niklas LU
supervisor
organization
alternative title
The Repackaging Doctrine - an Amendment to the Exhaustion of Trade Mark Rights in Parallel Importation of Pharmaceuticals.
course
JURM01 20102
year
type
H3 - Professional qualifications (4 Years - )
subject
keywords
immaterialrätt, varumärkesrätt, förmögenhetsrätt, EU-rätt, parallellimport, läkemedel, fri rörlighet, konsumtion
language
Swedish
additional info
nfollin@hotmail.com
0702-956612
id
1790360
date added to LUP
2011-03-02 15:34:18
date last changed
2011-03-02 15:34:18
@misc{1790360,
  abstract     = {{This essay investigates the trade mark doctrine for parallel importation of repackaged pharmaceuticals established in community law, and how this doctrine is applied in Swedish courts. Initially the author generally describes parallel imports and the pharmaceutical market before investigating the establishment of the doctrine and its meaning.

The ECJ have established that whilst the treaty does not affect the existence of intellectual property rights, the exercise of those rights may nevertheless constitute restrictions of the free movement of goods and can thus be restricted by the prohibitions contained in the treaty. Derogations from the fundamental principle of free movement of goods are justified only to the extent to which such exceptions are motivated for the purpose of safeguarding the rights which constitute the specific subject-matter of that property. For trade mark rights all uses of the trade mark that could distort the guarantee of origin falls within the specific subject-matter and can thus be prevented by means of trade mark law.

All repackaging of pharmaceuticals could in principle distort the guarantee of origin, and could hence be hindered. The doctrine of repackaging however constitutes an exception in which such prevention is unjustified under certain circumstances. The trade mark owner may not oppose the further marketing of a repackaged pharmaceutical product if:

-	It is established that the reliance on trade mark rights by the owner in order to oppose the marketing of repackaged products under that trade mark would contribute to the artificial partitioning of the markets between Member States.
-	It is shown that the repackaging cannot affect the original condition of the product inside the packaging.
-	It is clearly stated on the new packaging who repackaged the product and the name of the manufacturer.
-	The presentation of the repackaged product is not such as to be liable to damage the reputation of the trade mark and of its owner.
-	The importer gives notice to the trade mark owner before the repackaged product is put on sale, and, on demand, supplies him with a specimen of the repackaged product.

The burden of proof that these circumstances are fulfilled lies mainly on the parallel importer. If they are not met every use of the trade mark constitutes an infringement of the trade mark right.

The doctrine of repackaging has been applied by Swedish courts only in a couple cases. From the cases that are published it seems like Swedish courts have difficulties understanding the functioning of parallel importation and the doctrine, and they tend to take on a too strict stance toward the importer.}},
  author       = {{Follin, Niklas}},
  language     = {{swe}},
  note         = {{Student Paper}},
  title        = {{Ompaketeringsundantaget - ett tillägg till den varumärkesrättsliga konsumtionen vid parallellimport av läkemedel.}},
  year         = {{2011}},
}