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This paper was originally submitted to the American Intellectual Property Law Association (AIPLA) ahead of its 2021 Annual Meeting and was the subject of a presentation at a plenary session there on 28 October 2021. The author, Andrew Bentham, is a partner in the Biotechnology and Life Sciences group of J A Kemp LLP (Cambridge, UK). If you wish to discuss any of the issues covered in the paper, please feel free to contact Andy direct.