Intellectual Property (IP) Principles and concepts in precompetitive public-private partnerships

Motivation Traditionally, conflicts between public and corporate collaborators concern aspects of confidentiality, publishing, intellectual property rights (IPRs) and ownership 1. Public-private partnerships (PPPs) are knowledge-based relationships; hence the management of intellectual property (IP) is of critical importance. The initial knowledge of each partner brought in the partnership, i.e. the background IP, is a crucial starting point for collaboration. Further, the management of the knowledge created by the partnership throughout the project, i.e. foreground IP, depends on many practical decisions, such as whether or not an idea is protected, where the IP protection is pursued, how exclusive rights are deployed, by whom and for which purpose2. The different expectations of and approach to IP by the various stakeholders must be taken into account. The need is high for stakeholders to work together, get rid of unrealistic, outmoded and conflicting expectations of IP from multiple stakeholders1;3. There is a lot of uncertainty about the approach towards IP management. The optimal model for promoting innovation with respect IPRs of the collaborators has not been defined yet3. In-depth insights in the impact of various IPRs rules applied in PPPs, is urgently needed. The aim of this study is to investigate to what extent IPR rules vary across (precompetitive) PPPs. This study will serve to further explore the impact of the variation of various IPR rules in order to develop best practices for further optimizing collaborative efforts and to engage stakeholders in sharing objectives and develop common approaches to address the aspects of IP 3;4. Research questions 1) To which extent do IPR rules vary across precompetitive PPPs? 2) What is the impact of the variation of IPR rules across precompetitive PPPs? Research methodology Comparative analysis of IPRs documents (IP policies, IP guidelines, IP principles and Grant Agreements/Project Agreements templates) related to precompetitive PPPs. Abstract The pharmaceutical sector faces major challenges in the discovery and development of new drugs and therapies. New approaches and insights with respect to novel or existing compounds are hardly needed. Based on the principle that knowledge development is enhanced through sharing of ideas and resources, R&D projects at the precompetitive level are increasingly conducted in public-private partnerships (PPPs). Such precompetitive PPPs are presented through multifaceted partnering models and reflect heterogeneity of partners with different, often conflicting objectives and cultures. It is not surprising that intellectual property rights (IPRs), so crucial in pharmaceutical R&D, play a pivotal role in safeguarding partner’s interests, and that IPRs and trust issues take a crucial part of the negotiation process 5-12. The open nature of the so-called precompetitive PPPs complicates agreements with respect to IPRs. The empirical study identifies IPRs concepts used in life sciences precompetitive PPPs and explores the variation of those concepts across precompetitive PPPs. IPRs principles, policies, guidelines, grant agreements and project agreements of 19 precompetitive PPPs have been analyzed. Key concepts such as background IPRs, foreground IPRs, (co-)ownership, access rights and IPRs management are compared. Some precompetitive PPPs allow a certain degree of flexibility during negotiations on IPRs whereas others require partners to stick clearly at restrictive contractually defined IPRs. The executive office of a precompetitive PPP can be an intermediary, but in a few cases it has an active role as partner with equal rights in terms of ownership. Ownership of background IPRs remains with the original owner in 8 of the PPPs investigated. The other PPPs did not include specific guidance on the ownership rights to background IPRs. In terms of foreground IPRs, 8 PPPs assign ownership of new inventions to the idea generator(s), 3 PPPs claim foreground ownership and in 1 case, the partners and the PPP are co-owners of foreground IP. The rules on access rights to background IPRs vary between royalty-free access versus access on ‘fair and reasonable conditions’. Access rights to foreground IPRs cover much more possibilities. The IPRs management is heavily context specific; there is no ‘one size fits all’. In precompetitive PPPs, some projects are only focused on training, education and basic information sharing, whereas other projects are aimed at evolving towards a proof-of-concept stage, wherein access to background IPRs and development of foreground IPRs can implicate the progression of the process. Depending on the scope, the objectives and expected outcome of the project, certain project agreements require very clear and upfront specified grant IPRs clauses, whereas other projects may include more general grant IPRs clauses, leaving room for possible IPRs negotiations further in the project development. For precompetitive PPPs acting as information sharing platforms, flexibility in the IPRs policy might be of key importance 12;13. A stepwise approach whereby open source templates guide initial knowledge exchange, followed by a ‘closure’ step after which IPRs could be contractually defined once the project becomes more specific, could increase trust and clear early IPRs issues, offering beneficial solutions for both public and private stakeholders.status: accepte