Intellectual Property (IP) and Commercialisation

The definition of Intellectual Property (IP) includes patents, trademarks, designs, copyright (new software, protocols, questionnaires etc) and research tools (data analysis, assays, biomarkers etc).

For the commercialisation plan, it is expected that you have an idea of market size and competition and product pricing. During the project it is expected that you will expand on the commercialisation plan, identifying and mitigating risks and barriers to allow for successful adoption into the NHS and beyond.

The commercial strategy should also consider the regulatory pathway, implementation into clinical practice and health economic assessment.

Further considerations:

• Thought should be given to any potential arising IP
• IP not owned by the applicants should be evaluated in terms of any future third-party licensing arrangements
• Freedom to Operate searches should always be carried out. These can be in-house with support of eg organisation support functions (R&I departments, TTO) or through professional bodies (eg Patent agents). Important to state who carried searches out and what was revealed
• An overview of competitive technologies and market changes should be maintained to ensure your technology remains innovative
• There should be a clear route to market for the technology
• Consideration should be given to outputs and impact on patients and NHS or what impacts the research is seeking to achieve
• Consideration should be given to the dissemination of results from the research and how this may influence future licensing deals, sales or own business development

WPX Intellectual Property and Commercialisation  | Months 0-36 | Cost £xK | Lead: XXX

The background Intellectual Property (IP) covering the product and usage is owned by xxx and is in the form of patents, copyright and know how. In house Freedom to Operate (FtO) search conducted indicated no FtO issues.

IP due diligence will be carried out by the IPMG to identify and monitor the status of any related patents, technologies etc to be able to assess any future FtO issues. A formal FtO search will be carried out as part of the commercialisation strategy.

The project will call on the use of the background IP to progress to a commercial product. Any arising IP will be actively managed through the IPMG to ensure that the technology and commercial exploitation are adequately protected. A decision will be made by the IPMG and NIHR on how best to protect any arising IP

The best routes to market, the primary market will be adoption into the NHS, will be identified and a draft commercial plan completed by the end of the first year of the project. The route to market will be finalised in quarter three of the third year.

Worldwide marketing will run in parallel, but behind NHS adoption, with (eg) UK, EU and US markets being targeted.

The roadmap will include a commercial rollout to xxxx stakeholders in the private healthcare sector including yyyyyyyy and partnership exploration to increase commercial success in this sector.

The product has a unique value proposition ……………………….

A full health economic package will be included in the commercial strategy supported by XXX with support for pricing in the NHS and overall cost-effectiveness of the product.

We will seek to license the technology to a commercial partner(s) for scale-up production and distribution.

Deliverables
D1 IP review
D2 Formal Freedom to Operate search
D3 Draft commercial plan
D4 Full commercialisation strategy plan

Milestone
M1 Completion of Freedom to Operate search by month xx
M2 Draft commercial plan by month xx
M3 Full commercialisation plan to include NHS adoption, health economic assessment and FtO search by month xx