@article{24931,
      author = {Boscheck, Ralf.},
      url = {http://tind.wipo.int/record/24931},
      title = {Constraining Drug Supply Product Positioning, Patent  Protection and Regulatory Standards.},
      abstract = {On both sides of the Atlantic, fast growing drug  expenditures and an apparent slow–down in the  introduction of new pharmaceutical compounds and generics  had rekindled antitrust concerns. Yet while the EU  Commission was entering largely uncharted territory, US  authorities seemed guided by relevant legislation and case  law that has no equivalent in Europe. Still, the US  experience so far also shows that public outcries over  high–profi le cases are no substitute for a dispassionate  assessment of conflicting incentives, inconsistent  regulatory standards and essential welfare trade–offs. In  fact, it suggests the need to reconsider fundamental policy  options and to establish efficient rules so as to ensure a  competitive supply of innovative drugs. Contemplating the  US experience, this article is organised in five parts. By  way of introduction, Part I links US healthcare  expenditures, drug research costs and elements of drug  regulation and reimbursement to identify four corporate  imperatives for product positioning and life–cycle  management. Part II focuses on the economics of innovation  and intellectual property rights and the need to challenge  patents. Part III outlines the structure of the  Hatch–Waxman Act, intended to speed up generic  substitution, and discusses the evolution of US court  decisions on patent settlements in the wake of it. Part IV  offers some considerations for modifying the application of  Hatch–Waxman rules as well as the processes for  contesting patents and pharmaceutical product markets. Part  V sums up and links back to the current EU initiative},
      recid = {24931},
      pages = {1 volume ([13] pages) ;},
}