Survey Patent Licensing in Medical Biotechnology in Europe

The Centre for Intellectual Property Rights at the University of Leuven (Belgium) has launched the survey "Patent Licensing in Medical Biotechnology in Europe". The invitation for the survey has in particular been sent to professionals dealing with patenting and licensing in medical biotechnology. However, as we recognize that the members of Eurogentest and the affiliated laboratories are also more and more often directly confronted with issues related to patenting and licensing this topic has become highly relevant for Eurogentest Members as well. Therefore, Eurogentest strongly encourages its Members to take part in this survey, so as to ensure that its results will accurately reflect the current situation and the needs of the genetic community. Hereinafter you find more information on the background, purpose, scope, procedures for selection, etc. of the survey.

Introduction

In the US, Australia , and Switzerland , over the last 10 years several surveys have been carried out regarding patenting and licensing practices in the area of genetics. Until now, in Europe no extensive empirical research has been published on licensing practices focusing on this particular field. Moreover, these previous surveys reviewed existing practices and their problems and consequences and did not consider new collaborative licensing strategies to clear third party's patent rights.

The major aim of the present survey is to bridge this gap and to provide an overview of the current licensing practices among various stakeholders in the field of medical biotechnology in Europe and in particular to evaluate their knowledge of, experience with and attitude towards new collaborative licensing models as an instrument to clear third party's patent rights (in particular to safeguard freedom to operate and prevent royalty stacking). The survey focuses on medical biotechnology, as this is an area prone to the emergence of problems with regard to freedom to operate, especially in booming fields such as kit development and pharmacogenomics.

The outcome of the survey is potentially relevant to the current debates and policy reflections on knowledge transfer and patent licensing. Thus, though the survey was neither commissioned nor funded by the European Commission, the Institute for Prospective Technological Studies (IPTS; Joint Research Centre, European Commission), Eurogentest (Network of Excellence Sixth Framework), the European Association for Bioindustries (EuropaBio), the Licensing Executives Society International (LESI) and ProTon-Europe, these organizations strongly encourage all relevant stakeholders to take part in this survey, so as to ensure that its results will accurately reflect the current situation and the needs of all the stakeholders involved, and they look forward to its outcome.

The questionnaire comprises mainly multiple-choice questions, therefore it only takes 10-20 minutes to complete the questionnaire.

Background

Many patent applications have been filed over the last two decades in the area of medical biotechnology. This trend has triggered concern and debate regarding the impact these patents might have on research, further innovation and access to health care services. Moreover, patent rights may become fragmented among various patent owners (so-called 'patent thickets'). In such cases, clearing third party's patent rights in order to safeguard freedom to operate would require many costly licensing negotiations and may lead to the accumulation of royalties (so-called 'royalty stacking') for development and commercialization of downstream innovations.

A report of the US National Research Council of the National Academies showed that there is no patent thicket yet in the US in the area of genetics [1]. In Europe , it has been argued that the more stringent approach of European patent examiners may largely calm down the concerns over patenting [2]. Nevertheless, it has been emphasized that a risk of patent thickets remains in particular in the area of pharmacogenomics and kit development. Therefore, there is a need to assess how practitioners involved in medical biotechnology in Europe (in both public and private entities) clear patent rights today and to what extent they have knowledge on and experience with alternative, collaborative licensing models, which may also be appropriate to safeguard freedom to operate and prevent royalty stacking.

In the US, Australia, and Switzerland, over the last 10 years several surveys have been carried out regarding patenting and licensing practices in the area of genetics [3-6]. Until now, in Europe no extensive empirical research has been published on licensing practices in this field. Moreover, the surveys in the US, Australia and Switzerland reviewed existing practices and their problems and consequences and did not explicitly focus on collaborative licensing strategies to safeguard freedom to operate.

[1] US National Research Council of the National Academies (Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation), Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health , Washington , D.C. : The National Academies Press (2005), available at: http://www.nap.edu/catalog/11487.html (last visited 30/05/07)

[2] Hopkins, M.M., Mahdi, S., Patel, P. and Thomas, S.M., The Patenting of Human DNA: Global Trends in Public and Private Sector Activity (A Report for the European Commission), Brighton, UK : SPRU (2006), available at: http://www.sussex.ac.uk/spru/documents/patgen_finalreport.pdf (last visited 30/05/07)

[3] Walsh, J.P., Arora, A. and Cohen, W.M., Effects of Research Tool Patents and Licensing on Biomedical Innovation (2001), in: Cohen, W.M. and Merrill, S.A. (eds.), Patents in the Knowledge-based Economy , Washington, D.C.: The National Academies Press, pp. 285-340

[4] Walsh, J.P., Cho, M.K. and Cohen, W.M., Patents, Material Transfers and Access to Research Inputs in Biomedical Research (2005), available at: http://tigger.uic.edu/~jwalsh/WalshChoCohenFinal050922.pdf (last visited 30/05/07)

[5] Nicol, D. and Nielsen, J., Patents and Medical Biotechnology: An Empirical Analysis of Issues Facing the Australian Industry , Occasional Paper No. 6 (2003), available at, http://www.ipria.org/publications/pubfliers/BiotechReportFinal.pdf (last visited 30/05/07)

[6] Thumm, N., Research and Patenting in Biotechnology: A Survey in Switzerland , Bern : Swiss Federal Institute of Intellectual Property, Report No. 1 (2003), available at: http://www.ige.ch/E/jurinfo/documents/j10005e.pdf

Purpose of the Survey

This survey seeks to provide an overview of current licensing practices in Europe in the field of medical biotechnology among various stakeholders and in particular to evaluate their knowledge of, experience with and attitude towards new collaborative licensing models. This information will be used to assess whether the current legal arrangements are satisfactory to deal with patent thickets, and if not, to what extent the legal framework will need to be reformed and/or the use of alternative collaborative licensing models further stimulated.

Scope of the survey

Material scope: “medical biotechnology” for the purpose of this questionnaire encompasses pharmaceutical, therapeutic and diagnostic applications as well as research applications. In other words it includes amongst others drug discovery, vaccines, gene therapy, diagnostics, genetic testing, medical devices, genomics, proteomics and pharmacogenomics) .

Geographical scope: addressees of the survey are established in the contracting states of the European Patent Convention ( Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Monaco, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom ).

Selection of Participants

The questionnaires are sent out to professionals who are involved in patenting and licensing in the pharmaceutical and biotechnology industry, universities, public and private sector research institutions, and hospitals. The participants/their organizations are members of Eurogentest, EuropaBio, national biotechnology organizations associated with EuropaBio, the Licensing Executives Society International (LESI), and/or Proton-Europe. They have been selected using standard search engines together with information provided on the websites of Eurogentest, EuropaBio, national biotechnology organizations, LESI and Proton-Europe.

Participants may opt out by simply clicking on the opt-out option in the invitation e-mail.

Institutional Framework and Funding

This survey is carried out by the Centre for Intellectual Property Rights of the University of Leuven (Belgium). It is also carried out in the framework of the Eurogentest Network of Excellence (Sixth Framework of the European Commission). The study is funded by the Research Fund of Flanders (FWO-Vlaanderen).

Confidentiality and Anonymity

All data will be treated as strictly confidential . Electronic identifiers will only be used for administrative purposes, like sending reminders. After completion of the survey all electronic identifiers will be destroyed and anonymity safeguarded.

Follow-up

In addition to this survey, we may be seeking direct input from individuals in 2008. We would be very grateful, if you would be willing to cooperate on future follow-up interviews to the survey. Please send us your personal details. This information will be treated as strictly confidential and will not be used for other purposes than this academic project. The personal details will be kept separate from the responses to the questionnaire.

Communication of Results

The consolidated results will be published in a report, which will be made available on our website and sent by e-mail to all the respondents and other parties interested. The survey is also part of Esther van Zimmeren's doctoral research. Moreover, in order to enable further comparative analysis, this questionnaire will be used for a survey in Australia by the research group headed by Prof. Dr. Dianne Nicol, Centre for Law and Genetics, Law Faculty, University of Tasmania and funded by the Australian Research Council. It is intended that the results and conclusions of this EU-Australian project will be published in a peer reviewed journal.

Contact Details

The Survey Project Team of the Centre for Intellectual Property Rights consists of Prof. Dr. G. Van Overwalle, Prof. Dr. G. Matthijs, E. van Zimmeren LL.M., Dr. B. Verbeure, Dr. N. Berthels and C. Frison. For further information on the design of the survey, the questionnaire, or our research and publications on licensing strategies, please contact the Survey Project Leader, Esther van Zimmeren (email).

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