In the debate about counterfeiting and public health there is a tendency to conflate three distinct issues: first, counterfeit goods that infringe trademarks; second, medicines suspected of infringing patents; and, third, falsified medicines which contain the wrong or insufficient active ingredients. Counterfeiting is a term with a very specific meaning in intellectual property law. It describes the theft of brand owners’ intellectual property, namely a trademark violation.2 This very specific meaning of the term is set out in the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), which defines counterfeiting as use of a trademark or mark similar to a trademark without the permission of the rights holder. Specifically, the TRIPS Agreement defines ‘counterfeit goods’ in footnote 14 of Article 51 as: In the context of pharmaceutical products, the World Health Organization (WHO) uses a similar definition to describe a counterfeit medicine as one that is ‘deliberately and fraudulently mislabelled with respect to identity and/or source.’ Particular countries also define in different ways what is to be understood by counterfeiting. In the United States, it is directly related to trademark violations.5 Other countries focus instead on the active pharmaceutical ingredients (APIs) contained in medicinal products.
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