摘要 : While there are only a small number of new molecular entities (NME) and novelbiologics annually approved by the United States (US) Food and Drug Administration(FDA) for pharmaceutical industry manufacture and distribution (Cohen,2... 展开 While there are only a small number of new molecular entities (NME) and novelbiologics annually approved by the United States (US) Food and Drug Administration(FDA) for pharmaceutical industry manufacture and distribution (Cohen,2005; Bouley, 2008),1 there are exponentially greater numbers of improvementpatents2 covering variations in existing pharmaceuticals (also referred to as‘incrementally modified drugs’, or IMDs) and manufacturing processes and, infewer cases, ‘new use’ patent applications for secondary therapeutic indicationsthat are filed with the US Patent and Trademark Office (USPTO) (Richardson,2006). In the case of new use patents, major pharmaceutical companies haveemployed life-cycle total product strategies to extend pre-existing drugs into newtreatments, cures and preventions for diseases and illnesses, therefore preservingthe market value of some successful pharmaceutical brands beyond their normal1In 2007, the US FDA approved only 19 new drugs, 17 of them created with novel chemicalingredients, and two with biologic, gene-based ingredients (Blum, 2008). Moreover, over the previousthree years (2005–2007), the FDA approved just 61 new molecular entities and novel biologicsas compared to 60 FDA approvals in 1996 alone (Bouley, 2008).2Teska (2008) describes improvement patents as inventors adding something to an existing patent;incorporating new technology into an existing product; or finding a new use for an existing product.Therefore, Teska (2008) includes ‘new use’ patents as a subset of an ‘improvement patent’.International Journal of Innovation ManagementVol. 16, No. 4 (August 2012) 1250016 (17 pages)© Imperial College PressDOI: 10.1142/S13639196110036591250016-1patent life (Grau and Serbedzjia, 2005; Richardson, 2006).3 This pharmaceuticaltechnology strategy is referred to variously as ‘drug repositioning’, ‘drug re-profiling’,or ‘drug repurposing’ (and hereafter referred to as drug repurposing). 收起