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9. Ownership and valorisation of research results

9. Ownership and valorisation of research results

 

9.1 Introduction


Academic research is aimed at creating new knowledge, which can manifest itself in many ways, ranging from technological inventions and new methods, to social scientific insights. New knowledge is the basis for future research, education and responding to societal challenges such as the optimizing of healthcare. Specific laws and regulations are applicable to the ownership and commercial use of knowledge. Clear agreements about the availability and use of new knowledge are therefore of vital importance in enabling the UMCs to perform their principal tasks.

The AMC and the VUmc have adapted the NFU guideline 'Naar een goede waarde' and have a separate set of IP regulations that are applicable to any person involved in research within the UMCs: for VUmc Regeling Kennis, Intellectueel Eigendom en Participatie  and for AMC (Remuneration and incentive system). This chapter sets out general principles on intellectual property and the treatment of research findings. Please check your local intranet site for more information.

Innovation Exchange Amsterdam (IXA, previously  Technology Transfer Office TTO) is the central point of contact for UMC inventors/ researchers who have questions regarding any aspect of economic valorization as well as for industry representatives and entrepreneurs who are interested in particular UMC technologies or in collaboration in general. Please check the  IXA website  for more information. IXA  helps researchers to protect and exploit IP. Its services cover activities ranging from handling confidential disclosure agreements and material transfer agreements, the patenting of inventions, the management of IP, and negotiating research and licensing contracts with industry, to creating start-up companies based on UMC technologies.

9.2 Ownership of research results and IP rights


9.2.1 Ownership of knowledge


Under Dutch law and internal regulations, all research results - including without limitation data, computer software, apps, computer databases, prototype devices, and biological materials (cell lines, plasmids, etc.) - developed by a UMC employee in the course of his/her employment are the property of the UMC. In addition, the UMC owns any IP rights in respect of the foregoing.
According to the Dutch Patent Act 1995, all inventions made by employees of universities and research institutes are owned by the employer, regardless of whether the invention is in a different field or made outside office hours. If an inventor works for multiple employers, it may be the case that the invention is jointly owned. In any case, partial employment of a UMC employee with another legal entity does not preclude ownership by the UMC, unless the UMC has specifically agreed otherwise with that other legal entity.
Employees are obliged in such cases to inform their employer of a potential invention at the earliest possible stage. The UMC also has the ownership rights to knowledge generated by academic staff working on projects with third parties. Clauses on IP rights and the use of IP are often an important element in contracts with external parties (see Chapter 8).

Individuals may have an association with the UMC other than being an employee, for example visiting academics and students (hereinafter 'academic visitors'). These academic visitors are required to transfer to the UMC any IP they create in the course of their activities as though they were UMC employees.

If research is subject to a contract with a third party, the parties can make specific arrangements about the ownership of IP (see Chapter 8).

Laboratory notebooks are essential in order to demonstrate how the invention came about (see Chapter 6). The UMC also needs to be prepared to have the research audited for quality assurance. All data should therefore be stored appropriately and be accessible to internal or external auditors. When a staff member leaves his/her employment at the UMC, the laboratory notebooks should be handed over to the head of department. In the case of a project that is externally funded, it can be agreed contractually that a copy of the data and the results is to be transferred to the funding party.



9.2.2  Human material


Following the donation of human material, the person donating his/her bodily material is no longer the legal owner: through the donation, the ownership is transferred to the UMC, which can use the material for scientific research in a certain field. Patients or healthy volunteers thus renounce their power of decision and potential financial revenues resulting from the research performed with their material. A certain say regarding their material is retained, however, such as the right to have the material destroyed if so wished, and the possibility for the donor to indicate that he/she does not want to be informed about individual research findings (right to 'not know'; however, this right can be overruled if the donor or a relative is at serious risk).

The primary use of human material at the UMC is scientific research, but it may also be transferred to third parties, provided that it is used in accordance with the objectives for which it was originally donated. For the transfer of human material to a third party, as a rule the UMC and the third party must have agreed on a collaborative project for which the transfer is required. Before any transfer can take place, a collaborative research agreement between the UMC and the recipient should be signed. The agreement should stipulate, for example, the subject of the collaboration and which party will own the results yielded by the collaborative project, and safeguard UMC's rights to use the human material for further research purposes. Obviously, all arrangements with third parties should be in accordance with applicable legislation on the use of human material, informed consent, privacy regulations, etc. Databases that contain data related to human material are also covered by the Copyright Act and/or Database Act.

9.3 Protection of knowledge


It is essential to protect potential research results through the proper legal means (e.g. a patent) in order for new UMC technology to eventually benefit the patient. Due to the high costs associated with the development and marketing of, for example, a new drug or medical device, companies will only make such large investment if a temporary monopoly position through a patent can be obtained. Technologies that are not protected by a patent will therefore not be commercialized and consequently not reach the market or become available to patients. The way in which this knowledge will be protected, for example by applying for a patent or confidentiality agreement, depends on the nature of the knowledge or invention.

Premature disclosure of knowledge in the form of articles and publications, presentations at public events such as conferences, but also in discussions with non-employees in which the confidentiality is not safeguarded in advance in writing, seriously endangers the possibility of knowledge protection in the form of a patent. Prior to any disclosure it is therefore obligatory to verify whether it is wise to protect the knowledge. Once a patent has been applied for - which in most cases can be done within a period of a few weeks - the protected knowledge can be published in whatever form preferred.

Further details on the use of human material in research and the specific rules and regulations that apply are presented in Chapter 3.

9.4 Patentable Inventions


In the course of his/her work, a researcher is confronted with various types of IP rights, for example patent rights, copyrights, rights in designs, database rights and trademarks. This chapter covers patentable inventions in general. More information can be found for VUmc in the Regeling Kennis, Intellectueel Eigendom en Participatie , and for the AMC  in the 'Renumeration and incentive system'.
 
A patent is a form of IP. It consists of a set of exclusive rights granted by a sovereign state to an applicant for a limited period of time in exchange for the public disclosure of an invention. It is important to realize that a patent right is not a right that allows the applicant to perform the invention, but a right to prevent a third party from copying or using the invention without permission or from bringing the invention to the market (i.e. it provides monopoly rights). The period of protection afforded by a patent is generally 20 years.

As mentioned, bringing a new invention to the market is a costly and risky process, and companies will only be prepared to make the necessary investments if they are confident that they will be able to prevent others from copying the innovation and competing against them. A patent allows a company the time to recoup the costs associated with the design, development and marketing of the innovation (return on investment). Therefore, as an inventor interested in seeing your innovation become a product in the market, it is essential that it is properly protected. A successfully filed patent can represent a great financial and social value if there is a market for the product it describes. Thus, even if you are not interested in bringing an innovation to the market yourself, you should think of seeking protection for the benefit of patients and society in general and to capture the value the innovation may represent.
Patentable inventions include new processes, products, apparatuses, compositions of matter, and living organisms, or improvements to existing technology in those categories.

A process is a method of producing a useful result. A process can be an improvement on an existing system, a combination of old systems in a novel manner or a new use of a known process. A machine is an apparatus that performs a function and produces a definite result or effect. It can range from a simple device to a complicated combination of many parts. A manufacture is an article that is produced and has usefulness. Compositions of matter include chemical compounds, mixtures such as drugs and, more recently, living matter.

Abstract ideas, principles, and phenomena of nature cannot be patented.

What are the criteria for a valid patent? In Europe, as well as in most other territories outside Europe, patentability is determined by: 1) novelty, 2) industrial applicability and 3) inventive step:

  1. Novelty: an invention is novel if nothing identical previously existed. How does your invention differ from what already exists?
  2. Industrial applicability: an invention is useful if it produces an effect, if the effect is the one claimed and if the effect is desired by society, at least in principle. This criterion is considered met if an invention has at least one possible industrial use.
  3. Inventive step: namely the degree to which an invention differs from the totality of previous knowledge, and the degree to which an invention could not have been anticipated from that knowledge. At the time it was conceived, why might your invention not have been obvious to people reasonably skilled in the field? Are there ways in which it might be an evolutionary step? What is the difference between the proposed invention and what previously existed?

9.5 Valorization of research results


Intellectual property may lead to new products or processes for which a licence can be granted to a company or institution. In some cases, further development of the IP through a limited spin-off company can be the preferred route. The choice between external licensing or setting up a spin-off company is determined by the question which of these routes to exploitation offers the best chance of a successful market introduction. IXA will assist researchers to ensure that the UMC's academic and commercial interests are safeguarded. Its staff has the knowledge and expertise to select the appropriate way for knowledge transfer and can help researchers to take the necessary formal steps.

If a company is interested in obtaining the right to use (license) certain UMC intellectual property, IXA will conduct negotiations regarding the conditions and a licensing agreement will be drawn up. In the process, certainty is provided that the knowledge can continue to be used for the UMC's own research and teaching. The licensing agreement will also contain a compensation arrangement. This may take the form of payments linked to concluding the agreement, achieving particular development objectives, income generated from sales of sub-licences, or a combination of these.

New entities such as foundations and companies that involve UMC knowledge, staff or resources can only be founded with the explicit approval of the executive board. It is not permitted in the context of subsidy applications or the acquisition of other resources to make any proposals or commitments relating to jointly (or otherwise) founding a new entity, without the abovementioned approval. If employees or others consider setting up a new company that will involve staff and knowledge or other IP of the UMC, approval has to be given in advance, both by the department concerned and by the executive board. If there is an intention to establish a spin-off company to commercially exploit UMC intellectual property, the executive board will make the final decision.

Revenues may be generated by licensing rights to results to market parties, or through the founding of a spin-off company that is based on the underlying technology. Taking into account the NFU guidelines and the UMC conflict of interest guidelines (see Chapter 12), such revenues will be divided according to the remuneration and incentive system set out in the Regeling Kennis, Intellectueel Eigendom en Participatie of your UMC.


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