© Springer Science+Business Media Dordrecht 2015Deborah Mascalzoni (ed.)Ethics, Law and Governance of BiobankingThe International Library of Ethics, Law and Technology1410.1007/978-94-017-9573-9_4
Intellectual Property and Biobanks
University of Exeter, Exeter, UK
Biobanks are a new form of research infrastructure, which enable exciting new ways of conducting research, made possible by advances in genomic sciences. The purpose of biobanks is to allow groundbreaking research in genomics, in the hope that this research will ultimately benefit patients. In this chapter, it is argued that, having regard to this purpose, biobanks should develop IP policies which aim to maximise patient benefit.
Any consideration of intellectual property (IP) rights in the context of biomedicine, and genomics more specifically, arouses strong feelings. On the one side, there are those who laud IP as incentivising innovation and leading to the development of innovative new treatments for disease. In contrast, others claim that IP rights cause blocks to innovation and prevent legitimate academic and scientific research, to the detriment of patients.
The justifications for the grant of IP rights over intangible property tend to fall into one of two general categories. The first is related to natural right to the products of labour; for example, copyright is frequently justified as recognition of an author’s natural rights over the products of their creative endeavour (Drahos 1999). The other major justification is instrumental; that IP induces or encourages desirable activities (Machlup and Penrose 1950). The patent system is most commonly justified on the basis that it provides inventors with an incentive to invest in the research and development of new products, or an incentive to disclose technical information to the public which would otherwise remain secret.1 Under this second justification, IP rights are not solely about benefit for individuals; instead, they serve the purpose of providing a sufficient reward for creators of IP, in order that they develop innovations which have a socially useful purpose. In the biomedical sciences, the incentives tend to be provided by patents, although copyright may also play a role.
Although there have been many considerations of IP in biomedicine, IP in the context of biobanks is less discussed, perhaps largely because biobanks are a relatively new type of research infrastructure, and translational outcomes are still on the horizon. A biobank is a research infrastructure or resource, which is built up from many individual parts, to be used for research. It is therefore intended, and likely, that a biobank will be used by others to develop useful innovations.
There two key issues which will be considered in the following chapter. The first key issue is that of the subsistence of IP rights: can a biobank be the subject of IP, and how may research done on the biobank be the subject of IP? The second key issue is the question of how a biobank may manage its IP policy to shape the translational outcomes which arise from research.
2 What IP Arises from a Biobank?
The first relevant question to consider in relation to IP and biobanks is the ways in which IP might arise. Below, I consider the question of whether there is IP in the biobank itself, and if so, what purpose it might serve. Secondly, I consider the more important question of the IP that arises in innovations developed through research on the biobank.2
It is worth noting at this point that information per se cannot be owned.3 As a result, an individual genetic profile in a biobank is not the subject of IP rights.
2.1 Is the Biobank Itself IP?
A biobank is a compilation of information. IP rights can arise in compilations in two areas; through copyright, and the database right.
A biobank may be the subject of copyright protection as a database (Harris and Rosenfield 2005). Under UK copyright law, a database is protected as a literary work.4 A database is defined very broadly as a collection of independent works, data or other materials which are arranged in a systematic or methodical way, and which are individually accessible by electronic or other means.5 The database will only be protected if it is the author’s own intellectual creation, by reason of the selection or arrangement of the contents of the database.6 It seems reasonable that the far from routine skill and knowledge required to select the appropriate participants for a biobank, and then arrange the material within the biobank, would satisfy this requirement.
Copyright in a literary work arises automatically, without application or registration, and subsists for the life of the author plus 70 years. When the database is created in the course of employment by an employee, provided there is no agreement to the contrary, the copyright will vest in the employer.7 Copyright provides for a number of exclusive rights which vest in the owner, such as the right of reproduction and the right of distribution. Infringement occurs if the defendant carries out an activity which falls within the copyright owner’s substantial control, the defendant’s work was derived from the copyright work and the act was carried out in relation to a substantial part of the original work.8 In the case of a biobank, copying of a substantial part of the database without the authorisation of the copyright holder would amount to infringement.
The second type of IP right that may arise in a biobank is the database right. This is a sui generis right which was introduced in Europe to protect the work involved in creating a database. The database right is a property right that subsists in a ‘database’ which is defined as a collection of independent works, data or other materials that are arranged in a systematic or methodical way, and are individually accessible by electronic or other means.9 The right arises if there has been a substantial investment of financial, human or technical resources, and the investment may be substantial in terms of quality, quantity or a combination of both. The creation of a biobank would quite clearly satisfy these requirements. The database right vests in the maker of a database. The maker is the person who takes the initiative in obtaining, verifying or presenting the contents of a database, and who assumes the risk of investing in that obtaining, verification or presentation. In the case of biobanks, it is likely that there would be joint making, as the responsibilities for these actions would be split among a number of parties such as funders who take financial responsibility and multiple institutions such as universities and hospitals. Where an employee makes a database in the course of employment, the employer is regarded as the maker of the database.10
The database right is infringed where a person, without the consent of the owner of the right, extracts or re-utilizes all of, or a substantial part of, the contents of the database. The fact that material is only transferred to another medium after critical examination does not preclude a finding of extraction.11 ‘Substantial’ means substantial in terms of quantity or quality or a combination of both, and this is assessed by reference to the investment in the creation of the database and the prejudice caused to that investment by the act of extracting or re-utilising that part.12 It is arguable that the unauthorised use of the database for the purposes of research would be an infringement of the database right. The remedies which are provided for infringement of the database right are the same as for copyright in the UK. Copyright and the database right may coexist.
IP might also arise in other aspects of a biobank. For example, software, manuals or standard operating procedures all could be the subject of copyright. These aspects of the biobank could therefore be protected from unauthorised copying, and could also be licensed commercially, or placed in the public domain.
These IP rights are likely to be relevant in the following ways. Firstly, the holder of copyright, or a database right can prevent unauthorised copying. Therefore, if there is unauthorised access and copying of the biobank information, copyright may provide a basis to prevent further copying or use of the information or recover damages for the unauthorised copying. It is worth noting that an unauthorised use that harms an individual participant, for example theft of data on an individual, is unlikely to constitute copying or extraction of a substantial part so in such a case neither copyright nor the database right would provide a remedy. Secondly, IP is often regarded as useful for the raising of funds; investors are said to be reluctant to deal with a party that does not hold IP. Therefore, a biobank may be in a stronger bargaining position with a potential investor if it can point to specific IP rights in the biobank. The final area in which the ownership of the copyright or the database right in the biobank is likely to be significant is in the case of the bankruptcy, dissolution or other ending of the biobank (Vorhaus and Moore 2009). In such a case, the IP is an asset, which can be sold or otherwise transferred.
Despite these three functions, the significance of the subsistence of IP in the biobank itself is not high. Biobanks exist in order to provide access to their information to researchers, not to protect it from being copied. Provided that the security of the biobank is good, and access is provided under the terms of a well drafted contract, copyright protection is only likely to be of use in rare cases when there is some sort of unauthorised access. Should there be any problems with a researcher who has gained access under a contract, the contract is likely to provide a much better scheme for relief than copyright law.
2.2 Can IP Arise from Research Done on the Biobank?
When research gives rise to an innovation, then that invention could potentially be patentable. A patent is a limited monopoly that is granted in return for the disclosure of technical information. In contrast to copyright and the database right, patents are only granted after the applicant satisfies the requirements of registration.
In order for an innovation to be patentable, it must satisfy a number of criteria. Patents are available for inventions in the form of products, such as chemicals or useful objects, and also processes, or methods. The invention must be novel, that is, not previously made available to the public anywhere in the world, prior to the date of filing.13 It must be non-obvious, or inventive.14 It must also be susceptible of industrial application, or useful in some way; inventions which have a clear role in treating disease are susceptible of industrial application.15 Genetic inventions, such as the isolation of a gene encoding for a particular protein, where the physiological role of that protein is unknown, which are ‘useless for any known purpose’ do not fulfil this requirement.16
Inventions in patents must also be sufficiently described, in order to enable that invention to be performed. The applicant must disclose the invention in a manner that is clear and complete enough for it to be performed without undue burden by the person skilled in the art using his or her common general knowledge to supplement the information contained in the specification.17 This requirement reflects the general principle that a patent monopoly is only awarded provided that the inventor makes the invention available to the public.
In Europe, patents are only available for inventions, and not for discoveries.18 Patents reward a technical contribution, and not the mere discovery of an existing law of nature. A distinction is drawn between naturally occurring substances and the products and processes which result from the human effort involved in isolating those substances from their natural environment. The case law is clear that not only the process for isolation, but also the product per se, where it is new in the absolute sense of having no previously recognized existence, are both patentable.19 In relation to biotechnological inventions, the limits of the prohibition on the patenting of discoveries are further elaborated by the terms of the Biotechnology Directive,20 which provides in art 5(1) that ‘the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions’. Article 5(2) provides, however, that ‘[a]n element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element’. However, patents may be awarded in relation to the technical manifestation of a discovery. In this way, a genetic diagnostic test which is the technical embodiment of the discovery of the relationship between a gene and a disease is patentable, while the mere relationship between the gene and the disease, in the abstract, is not.
Ownership of a patent is key, as the patent owner is able to exploit and control the use of the patent, make decisions about the assignment, licensing and mortgage of the patent and sue for infringement.21 The first owner of a patent is usually the person who is entitled to grant. In most cases, this will be the inventor(s) of the patent.22 There are two cases where an employer is entitled to grant of the patent. The first of these is where inventions are made by employees during the course of normal and specifically assigned duties, where the invention was made in circumstances where an invention might reasonably have been expected to arise from the carrying-out of those duties.23 The second case is where an employee’s position and status within an organisation is such that they will be taken to be under a ‘special obligation to further the interests of the employer’s undertaking’.24 In the case of biomedical inventions, in the vast majority of cases, the employer will own the patent in question, as in most of these cases, employees are employed to invent.
In relation to inventions which are created by parties who have accessed a biobank, the patent is likely to be owned by the employer of the inventor. In the absence of an agreement with the inventor, the biobank itself will not be an inventor, nor will it have any entitlement to the patent. A biobank could however, as a term of the access agreement, provide that it was entitled to own any patent arising from the biobank information.
The way in which the law allocates ownership of inventions prioritises certain types of contribution over others. It is extremely unlikely that participants would provide the inventive contribution required to be recognised as inventors under English law.25 The supply of crucial starting materials, in this case the genetic material necessary to conduct the study, is not sufficient to establish an inventive contribution sufficient to be an inventor on the patent.26 Thus, the ‘inventive’ contribution to a patent is deemed to be the most important, and the contribution of material which is necessary to the invention, but which is considered to be routine, is not allocated any benefit. This may be contested as unfair, or unreasonable. Indeed, many commentators in this field consider that traditional IP models do not adequately or appropriately recognise the contribution of participants in genomic research (Dickenson 2008, p. 531; Merz et al. 2002).
Although the legal allocation of ownership of a patent may fail to appropriately recognise the role of participants in a study, it is also arguable that participant ownership of patents on inventions arising from biobanks is inappropriate. Whilst participants in a particular biobank may contribute to the development of an innovation, modern genomics research relies on the contribution of many thousands of participants, in many studies (Wang et al. 2005