Trademark rights are exhausted once goods have been put on the mar-ket in the European Economie Area34 under a trademark by the trade-mark owner or with its consent.35 Trademark owners may want to act against parallel trade from outside the EU, but also against parallel trade inside the internai market, because it disturbs their distribution and marketing strategy for specifie markets. While this interest in the main-tenance of exclusive marketing networks must be balanced against free-dom of competition and the free circulation of goods and services in the internai market, it is important that no exhaustion occurs when the trademark owner has legitimate reasons to oppose further commercial-ization of the goods especially where the condition of the goods is changed or impaired after the goods have been put on the market.36 With regard to the pharmaceutical industry, the regula tory requirements of packaging/labelling to be fulfilled before putting products on the market in an EU member state are of particular interest in this context.
There is extensive case law on the question to what extent pharmaceuti-cal products may be overstickered, repackaged or relabelled in accord-ance with these regulatory requirements.37
34 European Economie Arca: Austria, Belgium, Bulgaria, Czech Republic, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, ltaly, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom.
35 Article 7(1) EU Trademark Directive 2008/95/EC; Article 13(1) EU Community Trademark Regulation.
36 Article 7(2) EU Trademark Directive 2008/95/EC; Article 13(2) EU Community Trademark Regulation.
37 CJEU, 23 May 1978, Case C-102/77, Hoffman-La Roche v. Centrafarm; CJEU, 3 December 1981, Case C-1/81, Pfizer !ne v. Eurim-Pharm GmbH; CJEU, 11
J uly 1996, joined Cases C-427 /93, C-429/93 and C-436/93, BMS v. Paranova;
CJEU, 12 October 1999, Case C-379/97, Upjohn v. Paranova; CJEU, 23 April
140 Matthijs Mareil/Martin Senftleben/Manon Rieger-Jansen
The main question in those cases is whether and on which conditions the repackaging gives the trademark owner a legitimate reason to op-pose further commercialisation of the goods. The CJEU provided guid-ance on these questions in severa! landmark cases, in particular BMS/
Paranova,38 Boehringer lngelheim/Swingward & Dowelhurst.39
In short these judgments stipulate that the trademark owner can oppose the repackaging and relabeling of pharmaceutical product unless five cu-mulative conditions are met.40 The burden of proof does not lie with the proprietor, but with the parallel trader. The trader also has to prove that the trademark owner gave permission for the parallel trade of each sin-gle product, if such is the case. The cumulative conditions read as fol-lows:
1. opposing the repackaging and relabeling of pharmaceutical products would contribute to artificial partitioning of the markets between the member states, in particular where repackaging 1 relabeling is necessary to market the product;
2. no adverse effect on the original condition of the products and its proper instructions;
3. the manufacturer and importer of the goods can be identified
de arly;
4. the presentation of the goods may not be damaging to the repute of the trademark and its proprietor;
S. the parallel trader informs the trademark proprietor before the goods are put for sale on the market.4'
2002, Case C-443/99, Merck, Sharp & Dohme GmbH v. Paranova Pharmazeutika Handels GmbH; CJEU, 26 April2007, Case C-348/04, Boehringer lngelheim KG and Others v. Swingward Ltd and Others; CJEU, 22 December 2008, Case C-276/05, The Wellcome Foundation v. Paranova; CJEU, 28 July 2011, joined Cases C-400/09 and C-207 /10, Orifarm AIS and others and Paranova Danmark AIS and Paranova Pack AIS v. Merk Sharp & Dorme.
38 CJEU, 11 July 1996, joined Cases C-427/93, C-429/93 and C-436/93, BMS v.
Paranova.
39 CJEU, 26 April 2007, Case C-348/04, Boehringer lngelheim v. Swingward &
Dowelhurst.
40 These conditions have been developed in CJEU, 11 July 1996, joined Cases C-427 /93, C-429/93 and C-436/93, BMS v. Paranova, para. 79.
41 Ibid.
Trademark Enforcement Issues in the Pharmaceutical Industry 141
Moreover, the new Directive on Falsified Medicines42 contains provi-sions on the obligation for manufacturers to provide medicinal prod-ucts43 with safety features in the near future. The new Directive would oblige manufacturers repackaging and thereby removing completely or partly, or covering these safety features, to verify whether the medicinal product is authentic and whether there has not been tampered with it.
Furthermore, if the safety feature will be replaced, the replacement should be equivalent with regard to the possibility to verify the authen-ticity and identity of the product. Thus, repackaging of medicinal prod-ucts seems to become even more regulated and thus more complicated in the near future.
III. Conclusion
In sum, trademark owners in the pharmaceutical sector have various in-struments at their disposai to prevent counterfeit drugs from entering the EU territory. Moreover, they can rely on established CJEU case law that regulates the repackaging and resale of pharmaceutical products that have been marketed by them directly or under their control in the European Economie Area. With new legislative initiatives in both areas - a proposed new Customs Regulation and initiatives for a new Direc-tive on Falsified Medicines -the position of the owners of pharmaceu-tical trademarks may further be strengthened in the near future.
Irrespective of the additional challenges arising from the need for regu-latory approval besicles trademark registration requirements, !rade-marks will thus continue to play a central role in the pharmaceutical sec-tor. They serve as relia ble identifiers of commercial source and constitute important business assets after the expiry of patent rights. The described enforcement measures can be employed to safeguard these trademark functions.
42 Directive 2001/83/EU amended by Directive 2011/62/EU, see also note 21.
43 Not ali medicinal products will have to provided with the safety feature, in principle the prescription medicinal products and non-prescription medicinal products which are often falsified or with which falsification would lead to serious problems.
inlt'l!tt:lual fJ~!i:ojil'rfJ'- po~~npri1''!t'' in telle~: tuclit' p@opriété intelle©tuelle -intelle<f)tual p@operty
Livres parus dans la collection Books published in the series
Vol. 1 (20 1 0):
Sport et propriété intellectuelle 1 Spo,-t and Intellectual Property ISBN: 978-3-7255-6005-9
Vol. 2 (20 1 0):
La résolution des litiges de propriété intellectuelle 1 Resolution of Intellectual Property Disputes ISBN: 978-3-7255-6154-4
Vol. 3 (2011):
Marques notoires et de haute renommée 1 Wèll-Known and Famous Trademarks ISBN: 978-3-7255-6389-0
Vol. 4 (20 12):
La propriété intellectuelle dans l'industrie pharmaceutique 1 Intellectual Property in the Phannaceutical Industry
ISBN: 978-3-7255-6654-9