REPURPOSING PHARMACEUTICALS: DOES UNITED STATES INTELLECTUAL PROPERTY LAW AND REGULATORY POLICY ASSIGN SUFFICIENT VALUE TO NEW USE PATENTS

摘要

While there are only a small number of new molecular entities (NME) and novelnbiologics annually approved by the United States (US) Food and Drug Administrationn(FDA) for pharmaceutical industry manufacture and distribution (Cohen,n2005; Bouley, 2008),1 there are exponentially greater numbers of improvementnpatents2 covering variations in existing pharmaceuticals (also referred to asn‘incrementally modified drugs’, or IMDs) and manufacturing processes and, innfewer cases, ‘new use’ patent applications for secondary therapeutic indicationsnthat are filed with the US Patent and Trademark Office (USPTO) (Richardson,n2006). In the case of new use patents, major pharmaceutical companies havenemployed life-cycle total product strategies to extend pre-existing drugs into newntreatments, cures and preventions for diseases and illnesses, therefore preservingnthe market value of some successful pharmaceutical brands beyond their normaln1In 2007, the US FDA approved only 19 new drugs, 17 of them created with novel chemicalningredients, and two with biologic, gene-based ingredients (Blum, 2008). Moreover, over the previousnthree years (2005–2007), the FDA approved just 61 new molecular entities and novel biologicsnas compared to 60 FDA approvals in 1996 alone (Bouley, 2008).n2Teska (2008) describes improvement patents as inventors adding something to an existing patent;nincorporating new technology into an existing product; or finding a new use for an existing product.nTherefore, Teska (2008) includes ‘new use’ patents as a subset of an ‘improvement patent’.nInternational Journal of Innovation ManagementnVol. 16, No. 4 (August 2012) 1250016 (17 pages)n© Imperial College PressnDOI: 10.1142/S1363919611003659n1250016-1npatent life (Grau and Serbedzjia, 2005; Richardson, 2006).3 This pharmaceuticalntechnology strategy is referred to variously as ‘drug repositioning’, ‘drug re-profiling’,nor ‘drug repurposing’ (and hereafter referred to as drug repurposing).