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About

Editor-in-Chief,   Anatole Krattiger

Editorial Board

Concept Foundation

PIPRA

Fiocruz, Brazil

bioDevelopments-   Institute

CHAPTER NO. 17.11   IP Management in the National Health Service in England
Editor's Summary, Implications and Best Practices

Krattiger A, RT Mahoney, L Nelsen, JA Thomson, AB Bennett, K Satyanarayana, GD Graff, C Fernandez and SP Kowalski. 2007. Editor’s Summary, Implications and Best Practices (Chapter 17.11). From the online version of Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices. MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. Available online at www.ipHandbook.org.

© 2007. A Krattiger et al. Sharing the Art of IP Management: Photocopying and distribution through the Internet for noncommercial purposes is permitted and encouraged.

Editor's Summary

This chapter explains how intellectual property arising from within the National Health Service (NHS) in England is managed within the context of the U.K.’s framework for managing intellectual property from public-sector organizations.

In the U.K. universities have had the freedom and responsibility of owning and commercializing intellectual property arising from their research since 1985, and all other public research entities have had similar rights and requirements since 2000. The core principles of the U.K. national policy include

  • ownership by the organization that (employed the researchers who) conducted the research
  • income retained by the organization and not reclaimed by the research sponsor
  • inventors have a share in royalty income generated or equity in companies founded
  • provision of assistance to set up commercialization offices and develop IP management capacity.

The NHS in England is the health care provider for the residents of England, but it also conducts some internal R&D as well as funds some external R&D, primarily at universities. Intellectual property arises from all of these activities, and thus, the IP management framework for the NHS has to account for the full range of such possibilities. Also important is the fact that the NHS is made up of over 600 individual “trusts”, semi-independent organizations that each has its own management and internal policy. Any exercise of ownership and commercialization would thus in principle be carried out by one of the individual trusts, as it is the legal entity that could hold title to a piece of property.

The IP policy for the NHS was developed in the late 1990s via a series of policy documents, culminating in a highly legalistic Framework and Guidance document in 2002 that encompassed the full range of possible IP outputs from the NHS. Interestingly, the statutory basis of commercializing intellectual property in the NHS is to make income available for the provision of health services (as opposed to creating or aligning incentives in order simply to drive the development of innovations.)

Main elements of the NHS Framework and Guidance include

  • Sharing income with inventors (rather than the usual practice of sharing surpluses with other NHS organizations)
  • Ownership by the trust of intellectual property over inventions “reasonably expected” to result from an employee’s duties
  • IP conditions incorporated into employment contracts and handbooks
  • Terms and procedures to clarify ownership of intellectual property arising in joint work with other research organizations
  • Terms to set up, participate in, and invest in companies to generate income
  • Terms to be used in license agreements, including terms for access by patients in developing countries and terms for preferential sales to other NHS organizations.

The management system set up to handle intellectual property for the more than 600 trusts that make up NHS was organized as a network of nine “hubs”, nine regionally centralized technology commercialization offices corresponding to the nine regional governments in England. Each hub is thus responsible for an average of 60 to 70 trusts within its region. Start up funding for the hubs came from both the national and the regional governments and the hubs typically charge a fee to those trusts they serve. The services they provide include IP training, technology evaluation, IP protection, development, commercialization, and company start ups. Managers and employees from all nine hubs come together for bi-monthly meetings.

The progress to date is illustrated by the very rapid increase in new invention disclosures made to the hubs, with an important stimulus being the publicity and enthusiasm generated by regional and national innovation competitions. Licenses and companies are resulting, and income is beginning to be generated. The scope of new technologies reflects the range of sources from which it arises within the NHS: medical devices are about half of the total and IT and training technologies another third; biotechnologies, pharmaceutical, and diagnostics make up about 16%. About one third arise from joint work with universities.

Finally, the chapter considers how the English model might be applied in developing countries. In particular having core principles laid out in national policy helps create common ways of dealing with intellectual property. Efficiency can be gained with a division of labor: scientists and physicians do not need to become experts in intellectual property, while IP professionals can identify and handle commercial opportunities, becoming the product champions for the researchers. Finally, IP offices need to be of appropriate scale, neither too centralized nor too isolated, and of critical mass to provide sufficient quality of services.

Key Implications and Best Practices

Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.

For Government Policymakers

  • Create the environment so that government, employers, employees and citizens understand the potential importance of innovation to your economy.
  • Ensure that there is an infrastructure, such as an Institute of Innovation funded by a government department, to support innovation from whatever source it arises.
  • Establish within this infrastructure an advisory service that would oversee and monitor the commitment of public sector research organizations and would be the focus for industry.
  • It is important to understand the full spectrum of IP opportunities and how public sector institutions can use intellectual property to advance their missions.
  • Support for training of key people in IP management in universities, hospitals and research centers (in collaboration with international expertise) should be prioritized and made available.
  • Create a fund dedicated to the development of innovations capable of being commercialized, whose uses can include the protection of a potential innovation, its market assessment and its proof of concept.
  • An IP office similar to that of a National Health Service (NHS) hub, dealing with a number of organizations, has many advantages. It could attract, or have access to, the necessary level of expertise, much of it from outside the country, to draw up the agreements that protect the interests researchers, the developing country, and collaborators or investors in the technology.

For Senior Management (university president, R&D manager, etc)

  • An IP office needs to be of sufficient scale so that it offers the experience and expertise required to deal with complex, and often unanticipated, issues.
  • Ensure that the institutional IP policy articulates the management of intellectual property generated by employees, either by themselves or with external collaborators, particularly with regard to the ownership and apportionment of said intellectual property.
  • Employee employment agreements should include provisions for intellectual property of all kinds arising from their work and from their work with external collaborators.
  • An employee handbook should stipulate responsibilities to the organization and the share of the distribution of financial benefits with respect to intellectual property associated with potentially important advances.
  • Set up an Institute of Innovation, possibly externally advised and partly staffed initially by international experts, that can assess, protect and commercialize technologies where appropriate Ensure that commercialization staff are trained to a high standard, utilizing international expertise where appropriate.
  • Encourage participation of researchers in the commercial development of their technologies as they emerge, with career recognition as appropriate.

For Scientists

  • Notify your technology transfer or licensing office as soon as it appears that a collaboration agreement between your programs and an external organization might arise.
  • Your contribution towards best practices in IP management in your institution will, not focus on how to draft and negotiate a license agreement, but rather on proper recordation of results, avoidance of disclosure and recognition of valuable outputs and findings.

For Technology Transfer Officers

  • Within the context of a collaborative research project, the agreement should clearly state the background IP position of both organizations before any work begins. In addition, the agreement should address ownership and commercialization of new knowledge that arises from the joint research program.
  • Recognize the importance of gaining the confidence of the employees of your organization with regards to IP management and patenting.
  • Do not work in isolation. Develop a global network of contacts capable of providing advice and expertise on a wide range of issues. Formalize advice with international expertise in particular for complex subjects like agriculture and medicine and intellectual property.

Krattiger A, RT Mahoney, L Nelsen, JA Thomson, AB Bennett, K Satyanarayana, GD Graff, C Fernandez and SP Kowalski. 2007. Editor’s Summary, Implications and Best Practices (Chapter 17.11). From the online version of Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices. MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. Available online at www.ipHandbook.org.

© 2007. A Krattiger et al. Sharing the Art of IP Management: Photocopying and distribution through the Internet for noncommercial purposes is permitted and encouraged.