Should Research Tools Be Patentable? Troubles & Chances of Patenting Research Tools in Biotechnology and Nanotechnology

Abstract

Biotechnology is the key technology of the 21st century. Nanotechnology is about to follow, but has not met the expectations yet. However, expectations are high of finding better treatments to common diseases.Research tools, on one hand, are the fundamental toolkit to develop diagnostics and pharmaceuticals. Patents, on the other hand, are powerful instruments for protection. They offer an exclusive right, which is the entitlement to the fruit of mental labour and knowledge. Patents, moreover, stimulate innovation and investments as well as they may offer benefits and compensation to its owner. But, patents are accompanied by fragmentation, blocking patents, thickets, exclusive/expensive licensing, bioprivatisation and the Tragedy of the Anticommons. As biotechnology and nanotechnology are very complex areas, scientists need access to several resources. Therefore, patents on (upstream) research tools can slow down research and development and thus, indirectly harm public health.There are two famous examples that clearly show the risks of research tool patents: Myriad and its patents on the BRCA genes including their mutations; Chiron/Roche with their patents on genomes/tests of the Hepatitis C and Aids virus. Those cases may or may not seem to be solved by today, but there are more (new) patent files regarding patents on genes that may cause the same problems: new cancer genes CHEK, BMP7 - osteogenesis/bone growth, CDKN2A - tumour elimination/already owned by 9 different owners, PIK3R5 - against diabetes, LEPR - obeseness or the patent on the honey bee allergen.Therefore, the concerning question raised within this thesis is, whether research tool patents cause negative impacts and if so, what can be done to overcome them. What are the legal risks and opportunities of patenting research tools in bio- and nanotechnology? By evaluating this question I will, finally, give an answer on whether research tools should be patentable. What solutions are most promising to alleviate negative impacts?But, how shall the question best be evaluated? The thesis will evaluate the influence of research tool patents, particularly on the example of DNA patents. I will also look into the area of nanotechnology to see if research tool patents cause similar problems there. The thesis, moreover, contains an interesting and fascinating collection of (very new) inventions in bio- and nanotechnology that have been patented or are still under examination of the EPO. In its main Chapter this thesis subsequently explores the answer on whether research tools shall be patentable. Chapter 6 aims at providing a guideline on how to deal with the negative impacts of research tool patents by developing and discussing several ideas on possible solutions and offering recommendations. It concludes that compulsory licensing combined with voluntary licensing and/or expansive research exemptions offer the most promising approaches. Furthermore, Chapter 6 proposes a couple of terms & conditions for a possible compulsory license and tries to find a definition of 'research tools' that may be used for legislation.