De Rol van Intellectuele Eigendom in (Precompetitieve) Publiek-Private Samenwerkingen in de Biomedische Sector

The Ph.D. project assesses the role of intellectual property (IP) in (precompetitive) Public-Private Partnerships (PPPs) in the biomedical sector. Biopharmaceutical enterprises face major challenges, such as increased competition, falling research and development (R&D) budgets, increasing regulatory hurdles, accelerating technological complexity, future patent cliffs, and declining number of promising projects in their drug pipelines. Interdisciplinary, translational research for drug development requires collaboration between stakeholders from industry and academia. A shared objective is to translate basic biological research into therapies serving patients. Industry realizes the potential of combining different ideas, skills, and expertise in technologically demanding areas and is increasingly tapping into early-phase research conducted at universities and small- and medium-sized enterprises specializing in biotechnology (biotech SMEs). In addition, sharing knowledge with competitors at the precompetitive—and even at a competitive—stage is increasingly considered to be both relevant and viable. Taking into account the multifaceted partnering model of (precompetitive) PPPs and the heterogeneity of partners—including their often conflicting missions, objectives, and cultures—it is not surprising that IP plays a pivotal role and that IP and trust issues are part of the negotiation process. The general introduction of the Ph.D. project provides an overview of the pharmaceutical market and the strategic redirection of pharmaceutical firms towards collaboration. The general introduction further provides a background on the wider legal framework wherein PPPs operate (e.g. competition law), particularly the various IPRS that come into play when discussing precompetitive PPPs. An overview of what IPRS are is given: the concept of IP, the different forms of IP protection, as well as the rights attached to the IP. In biomedical projects, different types of IP protection can be sought, depending on the intellectual creation. The most common type of IPRs protection for inventions is patents, but also other forms of IP protection are used, such as copyright, sui generis database rights or protection of trade secrets. Part 2 explains the concept of life science R&D precompetitive PPPs. Precompetitive PPPs can help speed up the drug-development process by stimulating competitors to collaborate in the pre-discovery phase. The precompetitive PPP model is situated in the upstream research phase of the drug development cycle, and the characteristics of such model differ from the PPPs situated further in the downstream development process, such as Product Development PPPs and Product Access PPPs. Precompetitive PPPs aim to solve basic research questions and to generate technology platforms, research tools, and predictive models to advance knowledge about disease pathways. Such activities precede the market exploitation phase and offer opportunities to reduce throughput time and risks associated with such predevelopment phases. Part 3 investigates the difference in stakeholders’ motives for participation, their expectations and objectives. It is important to emphasize that the motives for participation and the expectations of different stakeholder groups differ. It was shown that various stakeholders, such as academia and SMEs, are reluctant regarding Intellectual Property Rights (IPRs) in PPPs and that IPRS management could pose a hurdle for participation. The question of IP will likely remain a matter of debate, and the success of PPPs depends on the attitude and expertise of the participants. Instead of considering precompetitive PPPs as collaborative models, wherein exclusive rights are offered at bargain prices, stakeholders need to become aware that the value of precompetitive PPPs lies in the opportunity to scout for and network with the best scientists. Collaboration will be the only way to generate valuable knowledge. In Part 4, an analysis of Intellectual Property (IP) policies deployed within precompetitive biomedical PPPs revealed a variety of practices. IP frameworks differ in terms of openness (access/use) as well as explicitness. Depending on the nature of the research and the feasibility of an appropriation oriented (business) strategy, the type of IP framework or ‘knowledge sharing strategy’ differs. PPPs wherein downstream research results (drugs and diagnostic tests) are the primary focus opt for an IP sharing strategy wherein access to foreground IPRS and freedom-to-operate are permission constrained and preferably negotiated with the consortium partners only (Partnership-focused strategy). PPPs wherein upstream research results (research tools and platform technologies) or poverty-related and neglected diseases (PRNDs) specific downstream products are focused are more likely to adopt an IP framework that allows sharing IPRS with a broad research community (Open Collaboration strategy). Hybrid strategies, with preferred public release of research results unless patenting is necessary to secure market access or to engage the commercial partner towards further investments, become deployed when either model is sufficient to proceed the project. As both models imply benefits and drawbacks, we argue for a contingency perspective rather than a ‘one best way’ of organizing IP within PPPs. A second level of variation pertains to the explicitness or clarity of the IP policies. The majority of the IP policies lacks basic information on IP concepts such as definitions of background IP and foreground IP, and rules on ownership thereof, access thereto and use thereof. Even when knowledge is shared in the broadest possible way, IP, access and user rights need to be addressed explicitly in order to proceed effectively. Transparency and clear guidelines for IP management are crucial for trust creation amongst the partners in the consortium. Part 5 provides an overview of the practice of IP management in precompetitive PPP projects. Six Case Studies were performed at the Innovative Medicines Initiative (IMI), world’s largest biomedical PPP: project outputs and outcomes, with a focus on IP and business opportunities of six consortia were analyzed. It was demonstrated that in early-phase research, patent applications are not the main source of IPRS outcomes. The six Case Studies have revealed that besides foreground IP and business opportunities, many other extremely valuable assets were developed. The consortium partners developed unique scientific and managerial insights. For the pharmaceutical companies to share non-confidential, and more importantly, and new to the sector, confidential data with consortium partners, which are considered future competitors, valuable tools were developed to guarantee interoperability between partners. They established experiences in knowledge transfer, construed databases, adopted diverse templates, knowledge sharing mechanisms, trust-based agreements and models, applicable bilaterally, within and between consortia as a whole. Such assets offer an enormous potential for new consortia, for the IMI itself, as well as for regulatory, clinical and healthcare practices in general aimed at accelerating the delivery of improved therapy to society. The mindset within the consortia reflects an open attitude towards sharing between profit and non-profit institutes to speed up innovation and eventually market access. Inter-IMI project collaborations having certain degrees of synergy create opportunities for future value creation and have the potential to extend IMI’s projects deliverables. To maximize IMI’s long term impact and treasure those valuable results, time has come to design means for optimal exploitation of the different types of assets, and to guarantee the sustainability of research tools and databases generated. To conclude, a general discussion and recommendations for sustainable precompetitive PPPs are provided in Part 6 of the Ph.D. project. It is recommended for biomedical (precompetitive) PPPs to optimize their functioning to 1) foster IP as a tool for collaboration in PPPs, not as the centerpiece of the partnership, 2) consider precompetitive PPPs as a scouting platform for future collaborations, 3) provide clear and transparent guidelines for managing IP, 4) assure (wide dissemination of) best practices, 5) conduct more research in PPP performance evaluation, 6) consider a stage-gate process, 7) implement the honest broker model, 8) anticipate a sustainability plan, 9) provide an overview of the PPP landscape, 10) set up PPPs for unmet medical needs, and 11) exchange information on the legal framework to ease global research demand.status: publishe