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

Författare

Timo Minssen

Summary, in English

“The implications and applications of biotechnology continue to be at the centre of public debate. In the light of rapid scientific advances and novel insights, the multi-faceted discussions are particularly fierce with regard to patents on DNA–related technology. In the often very emotionally-led debate basically two directly conflicting schools of thoughts can be identified. Some people believe for multiple reasons that DNA, and in particular human DNA, is much more than a mere chemical structure. They believe that any form of patenting DNA, or of the natural processes it is involved in, is utterly wrong, since any DNA and the information it contains is the embodiment of the code of life and should be regarded part of the common heritage of mankind. Some patent opponents go even further and argue for a prohibition of patents on proteins. Others, and in particular the life science industry, assert that DNA and proteins are simply chemical compounds, albeit complex ones. Thus they claim that it should be principally possible to grant various types of patents directed to isolated DNA sequences and proteins. In the past, U.S. and European patent authorities have basically followed this line of thinking. Thus, the grant of patents on DNA- and protein- related technology had become routine.

While it almost seems impossible to reconcile these fundamentally diverging views, the purpose of this thesis is related to a third area of debate. It focuses on the fierce discussions among those who principally support patents on DNA -related technology over particular threshold-requirements for receiving such patents, the appropriate scope/form of its protection, and its exclusionary effects.

This study scrutinizes one crucial aspect pertaining to the latter debate. More specifically, it 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.”

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