Patent management was discussed in particular with representatives of the IMIDIA project. As part of the IMIDIA project, a patented cell line from an SME was introduced into the consortium as a base pi (Table 2). The patented cell line remained the property of the SME „Endocells SARL“. Databases were developed in the six projects analysed. Databases combine non-confidential and confidential records of public and private partners, resulting in datasets that, due to their size, allow for new ideas and approaches. Each party remains the owner of the data provided. Database producers, usually one or two members of the consortium, have a sui generis right to the database.19 Access rights to the database may vary. In some cases, all project participants can freely access the database, while in other projects, only certain WP members can access and use the database. As regards access rights for third parties, no detailed regulations have yet been defined for the selected projects. All project partners must sign a consortium agreement defining the rights and obligations of the participants and addressing issues such as governance, accountability and intellectual property rights.

The agreement must be adapted to the needs of each project. A model prepared by EFPIA shows what a consortium agreement could look like. Consortia can also use alternative models if they wish. Do you need more information on the preparation and signing of grant agreements? Watch this Horizon 2020 webinar for the coordinators of the successful proposals. Finally, experts rank applications by score, and the IMI Board approves the results of the evaluation. The applicant consortium that submitted the best placed application will then be invited to move to Level 2. A consortium of EFPIA companies and, in some cases, associated IMI partners agrees on the need to work with other stakeholders on a particular issue. These questions need to be aligned with IMI`s objectives and IMI`s strategic research agenda.

Topic ideas can come from EFPIA companies or associated partners or from proposals from external organisations. The consortium agreement governs the relationship between the project partners. It has been signed by all partners and deals with issues such as project management, accountability and intellectual property. There is no fixed model for the consortium agreement, as it would have to be tailored to the needs of each project. A model prepared by EFPIA shows what a consortium agreement could look like. However, consortia can use alternative models if they wish. The thematic text is drafted by the EFPIA/Associated Partner Consortium and, after extensive discussions with the European Commission and consultations with various groups (including the IMI Scientific Committee and the State Representatives Group), the text of the call for tenders will be sent to the IMI Management Board for approval. The pi framework provided by IMI is considered by respondents to be appropriate for selected IMI projects. The project agreement template has been tested as transparent and tailor-made adaptations to the needs of the consortium are possible. IMI has already made reasonable efforts to explain ip42, which was made public in 2007. In 2008, the IPR Helpdesk issued an explanatory note,43 In 2009, the IMI EO issued a clarification,44 and in 2010 there was an additional guidance note on intellectual property.45 One recommendation that emerged from this case study was to harmonize this set of documents into a revised intellectual property directive, in which the concepts, rules and differences between fp7 rules and Horizon 2020 rules were explained.

illustrated with relevant and case-related examples.46 This is what happened when IMI 2 was introduced. In addition, the available strategy papers contain limited information on data management and sample sharing, which needs to be further developed. There are also biotechnological SMEs that aim to bring medicines to market. These SMEs face a difficult position in the context of IMI projects, as they may compete with efpia member companies involved in the respective projects. It could be argued that competition stimulates innovation and stimulates the advancement of projects. These SMEs in the biotechnology sector may see participation in large IMI consortia as an opportunity to apply, acquire or obtain brand recognition, or to be acquired by a large pharmaceutical company, e.B. deCODE Genetics, Inc. (Icelandic: Islensk erfdagreining, based in Reykjavik), which has joined the NEWMEDS consortium as a biotechnology SME. In December 2012, deCODE Genetics was acquired by Amgen. Nevertheless, before joining the consortium, biotech SMEs should be fully aware of their position within the consortium, their strengths and weaknesses, as well as the disadvantages and advantages of participation, in order to be able to adapt their strategy accordingly.

Once the Board has given its green light, the call for proposals will be published on the IMI website and on the funding and tendering portal. All interested parties from academia, small and medium-sized enterprises (SMEs), medium-sized enterprises, patient organisations, regulators, health technology assessment bodies, etc. are invited to form consortia and submit a brief proposal via the funding and tendering portal in response to the call. At this stage, applicants generally should not include EFPIA companies or partners associated with I in their consortium. As a general rule, the deadline for submission is approximately three months after the start of the call. IMI INVESTIGATED consortia have invested in the standardization and harmonization of protocols and agreements to facilitate communication, increase trust and improve efficiency, reproducibility, transferability and validation potential between partners. For example, the principles of material and data flows were developed by IMIDIA and SUMMIT to address the sharing of intellectual property within the consortium and between different consortia (Fig. 3).

These consortia agreed on a Memorandum of Understanding to improve knowledge transfer and reduce duplication. The MoU was also later signed by DIRECT, another diabetes-specific research project at IMI. .