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Abstract
Manufacturers of medicinal products are legally obliged to obtain regulatory approval for their product before marketing of that product may begin. However, where different salts, esters, ethers, isomers, complexes or derivatives of a brand (on-patent) drug are made by a generic company, and these differ significantly in properties with regard to safety and/or efficacy when compared to the patented drug, additional clinical data demonstrating the safety and/or efficacy of that generic drug must be submitted by the generic company to the marketing authority. Providing this additional data often requires the generic manufacturer to produce and use the brand drug, and where this is covered by a valid, in force, UK patent that patent may be infringed by that manufacture and use. Many European countries, including the UK, have a statutory experimental use exemption, which, depending on the type of experiments conducted, may mean that obtaining the additional data referred to above may not be considered as an infringing act.