Chapter 4 IP law - an analysis of the Enforcement Directive and the Customs Regulation
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IP law and its contribution to combatting counterfeit medicines in the EU is presented in Chapter 4. At first, the legal basis and the form and extent of EU competence in the context of IP related matters are discussed. Thereafter, the main focus revolves around the Enforcement Directive (Directive 2004/48/EC) and the Customs Regulation (Regulation 608/2013) and the relevant provisions that provide tools in the Directive and the Regulation in combatting counterfeiting in the EU. It is emphasized that these two legal instruments address IP law, in general, and not counterfeiting of medicines, in particular. The various measures such as injunctions that empower the enforcement authorities, under specific circumstances to withhold goods at the borders in order to intercept counterfeit products from entering the EU are analysed. The effectiveness of the provisions contained in the two pieces of secondary legislations are examined. An analysis of the shortcomings and possible ways to bridge the gap in the legal framework, in context of IP law, has also been undertaken.

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