Assessing the Inventiveness of Bio-Pharmaceuticals under European and US Patent Law: A comparative study with special emphasis on DNA- & protein-related inventions

Publikation: Bog/antologi/afhandling/rapportDoktordisputatsForskning

This study investigates how the European and US patent systems interpret and apply the so called "inventive step" (Europe) or "non-obviousness" requirement (U.S.) vis-à-vis bio-pharmaceutical technology with a special emphasis on DNA-and protein related inventions. In addition to evaluating the de lata situation through analysis of recent case law and regulations, this study also discusses the impact of the inventive step/non-obviousness requirement on biomedical innovation. In that regard particular attention is given to the continuing debates over a variety of significant issues, such as the appropriated scope of protection to be conferred to patents, the "obvious to try" issue and hindsight problems, but also pharmaceutical life cycle strategies and the notion of a so called “innovation gap” in the pharmaceutical sector. Recognizing that the gravity of potential and actual problems associated with DNA- and protein related patents is often difficult to assess and depends on a variety of “pre-grant“ and “post-grant” factors that fall outside the scope of the analysis, this study highlights the importance of a properly balanced and stringent application of the inventive step/non-obviousness requirement in order to achieve well defined “high quality” patents that may either forestall problems or at least provide a sound basis for more comprehensive solution models.”

ForlagIneko /Intellecta AB
Antal sider430
ISBN (Trykt)978-91-628-7735-4
StatusUdgivet - 2012

ID: 41326262