Divestment of mature pharmaceutical products in the EU – implications for parallel imports

| December 8, 2016

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In the forty-three years since the UK acceded to the European Union, a large body of case law has developed in the Court of Justice of the EU and national courts dealing with parallel trade of pharmaceuticals within the EU. A recent decision in the English Courts, Flynn Pharma v Drugsrus Limited and Tenolol Limited [2015] EWHC 2759 (Ch), has added to that body of case law. It considers parallel imports in an commercially important context: the divestment in one member state of the EU by a research-based pharmaceutical company of its rights in a mature, off-patent, branded pharmaceutical product. The divesting company retained the rights to the product elsewhere in the EU, and continued to market the product there. The acquirer of the rights in the UK did not manufacture the product itself. Instead, it sourced its supplies for the UK market from the divesting party. A third party also began to import the products of the divesting party into the UK. The imported products were therefore identical to the products of the UK acquirer. Nevertheless, the acquiring party successfully blocked the parallel imports, on the basis of a trademark infringement claim at the High Court. Due to the nature of the particular drug in question, the case involved an unusual combination of regulatory and pricing/reimbursement issues which make it of particular interest.

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Medicines Australia

Medicines Australia represents the discovery-driven pharmaceutical industry in Australia. Our member companies supply 86 per cent of the medicines that are available to Australian patients through the Pharmaceutical Benefits Scheme as well as providing a range of other medicines and vaccines to the Australian community. Those medicines keep Australians out of hospitals, prevent disease and play a pivotal role in ensuring a productive and healthy community.

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