TaylorWessingJust this week, GlaxoSmithKline announced an open innovation alliance with the new Francis Crick Institute to explore new avenues of medical research and drug discovery across a broad range of diseases. In today’s blog, Amanda Rowell, Taylor Wessing, takes a look at open innovation and some of the ways it is being adopted in the life sciences sector.

Companies were once reliant on developing strong in-house research and development capabilities in order to generate innovation and fill their product pipelines. Increasingly, larger companies and big Pharma are looking to build their pipelines by looking outside their organisation for other opportunities to pursue. This is consistent with the growing movement of “open innovation” to find solutions to problems.

What is “Open Innovation?”

Open innovation is a business paradigm that the in-flow and out-flow of research is not confined by organisational boundaries.

The benefit of adopting such a model is that it increases the pool of possible research opportunities, and draws on a wider range of skills and experiences than possible when limiting R&D to within organisational boundaries. It also allows smaller organisations to find ways of exploiting and commercialising their research output in another setting.

In many respects, this has been an approach in the life sciences sector for some time. Establishing joint ventures and collaborations between industry and academia have existed for some time and have yielded successful products. However, technology has changed how potential collaborators can be identified meaning the net can be cast far wider than ever before. The mobility of our modern day work force also means that inventors may be less likely to remain working in one organisation for their research career or may be more interested in collaborating with an organisation outside the traditional framework of a standard employment contract. The role of venture capital in funding smaller organisations has meant there is also growth in R&D output outside of the traditional larger players in the sector.

Innovative Medicines Initiative

The Innovative Medicines Initiative (IMI) is a partnership between the European Commission and the European pharmaceutical industry (represented by EFPIA, the European Federation of Pharmaceutical Industries and Associations) and is a form of brokerage service bespoke to the pharma sector. The IMI was established in 2008, with the aim of improving the efficiency and effectiveness of the drug development process with a focus on areas of unmet need. Unlike collaborations where one partner funds the other(s), the IMI provides financial support to enable the participation of academia, SMEs and non-governmental organisations in projects. Participating EFPIA members receive no financial support, but contribute “in kind” to projects through researcher time and the use of facilities. Between 2007 and 2013, the IMI saw the investment of nearly €2 billion in a variety of areas such as antimicrobial resistance, neurological diseases and diabetes. The budget for 2014 to 2024 is now €3.3 billion, half of which is from Horizon 2020, the EU’s framework programme for research and innovation.

As a first step, the IMI engages with stakeholders to determine upcoming priorities for investment. The IMI then advertises the particular problems and calls for submissions. From these submissions, a team is assembled to take the project forward. The IMI has guidelines in place regarding the ownership and licensing of IP developed by project participants. The general approach is that project participants retain ownership of their background IP and the IP generated by them in the project, subject to the grant of cross-licences to the other participants to use such IP rights in connection with the project or for research purposes. Alternatively, ownership and licensing can be determined on a project-by-project basis. This allows a degree of flexibility and as the IMI funds the participation of academia or NGOs (rather than the larger commercial participants), in principle this places such organisations in a stronger position to exploit their IP than if the commercial partner was funding their research in the area. The model grant agreement also sets out that beneficiaries of IMI funding are obliged to disseminate their results and ensure open access to peer-reviewed publications that publish the results.

In a recent example, the IMI has responded to the Ebola crisis by establishing eight projects directed at the development of a vaccine, vaccine manufacture and improved rapid diagnostic tests. The projects have a combined budget of €215 million and have brought together over 40 partners from the pharmaceutical & diagnostics industries, academia, small biotech companies and non-governmental organisations from Europe, Africa and the United States. The call for proposals was made in November 2014 and the selected projects launched two months later, demonstrating that the IMI is able to fast track proposals where needed and attract a range of participants from different geographies and areas of expertise.

The full version of this article is available from Synapse, Taylor Wessing. If you have any questions on this article please get in touch with the team.