ANTECEDENTES

Act n° 429 on Processing of Personal Data of July 1, 2000 Health Act n°913 of 13 July 2010

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Chapter 4: IPRs in biobanking: Risks and opportunities for

translational research

This chapter is based on:

Verlinden M, Minssen T, Huys H IPRs in biobanking: Risks and opportunities for translational research. Intellect Property Q. 2015 [Accepted for publication]

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1 Introduction88

The worldwide focus on biobanks has increased considerably due to several reasons. Large-scale, interoperable biobanks make it possible for researchers with different backgrounds and scientific expertise to analyse large and diverse collections of biospecimen, as well as genetic, clinical, health and other personal data of the donor. Those analyses could allow them to identify novel biomarkers or to validate the clinical significance of genomic mutations. After discovering – for example – a certain gene that could correlate with the severity of a given disease or condition, researchers can use HBM to test new drug candidates that target this mutation(21).

Thus biobanks can provide a crucial platform for international and interdisciplinary cooperation. They can act “as key drivers for next generation biomarker (diagnostics) research and drug discovery”(21). Since size and quality really matters in this field, translational research increasingly requires cooperation between top quality biobanks in different countries. There has been a gradual shift from traditional closed innovation systems to more “open” and “transparent” innovation models. At the same time there were rapid technological advances and bio-pharmaceutical innovation gaps. These factors have highlighted the increasing importance of an effective establishment, governance and use of large-scale longitudinal biobanks(129). Biobanks, and in particular public biobanks, are often constructed to operate for several decennia and to be used by numerous research projects. They could potentially be used by a great variety of stakeholders with different objectives. Such stakeholders could be private companies, university researchers, bio hackers, research foundations, patient groups, governmental bodies or "hybrid" consortia in the framework of Private Public Partnerships (PPPs). This great variety of stakeholders and the increasing significance of biobanking require substantial investments in the creation, organization and maintenance of the HBM and data stored in biobanks.

This raises important organizational, regulatory and ethical questions for any type of biobank. It also raises legal questions such as how to deal with intellectual property rights (‘IPRs’) that could arise out of the creation or later use of the collected HBM and data. This is a complicated question that often involves both IPRs and contractual rules and interests. As a starting point, the IPR legislation identifies (amongst other) the subject matter and the beneficiaries of the protection. In patent law, only subject matter that is not considered as pure discoveries is patentable. The (exclusive) rights arising under IPR can then in principle be transferred by a contract. Research collaborations between stakeholders often would involve such technology- or information transfer.

It is therefore also a specific issue under which conditions a biobank could or should become (co)owner of IPRs resulting from the use of the HBM and data which it provided, selected and possibly processed for the specific research (so-called downstream IPRs). This entails investigating how to reach a balance between the exclusive nature of IPRs to exclude others from using protected material without consent of the owner, and the requirement of funding agencies to share as widely as possible

88 _{This Chapter was written together with prof. dr. Timo Minssen (University of Copenhagen) and prof. dr. Isabelle} Huys (KU Leuven)

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(with minimal restrictions) the data which result from research on the basis of HBM and associated data.

Another issue concerns the modalities and conditions for use of the data derived from the biobank. It pertains to the choice between an “open” and “closed” collaboration model or a combination thereof. Even though there are built-in tensions between the rules of IPR and the norms underpinning the principles of “openness” and “data sharing”, it is important to bear in mind that IPRs do not imply the establishment of closed collaboration models. Instead, right holders could use the IPRs provided to them to find the right balance. This balance lies somewhere in what has been described as “the spectrum between free use of knowledge by anyone for any purpose and exclusive use by one entity for its own use”(130). The mere acquisition of IPR does not necessarily imply any specific modalities for rights administration and user-generated solutions. Instead it necessitates to make decisions and agreements about the way IPRs are/can be used, and to be aware of the consequences of the different choices(129).

Developing biomedical treatments or diagnostics can be very costly and industry involvement is thus often essential. Therefore, an appropriate balance in the user modalities of IPRs appears particularly important within the area of translational medicine. In order to obtain the necessary knowledge to develop new drugs (or new uses of existing/approved drugs), access to large-scale biobanks is crucial. For this reason (international) cooperation between different institutions is needed. The industry has realized that the development of truly innovative biologics and “cutting edge” personalized therapies is complex and difficult to achieve within the traditional “closed innovation” model. New strategic partnerships with competitors, smaller specialized biotech companies or with governmental institutions through Public Private Partnerships (PPPs) are often necessary to develop breakthrough- drugs. This has encouraged several innovator companies to support the current shift towards more transparency in the pharmaceutical sector. In addition to regulatory responses and initiatives from authorities89, the drug industry has initiated their own transparency projects. These include biobank- initiatives with a various level of transparency.90 However, due to the immense risks and costs associated with pharmaceutical R&D and clinical trials, the industry and investors would – at least at some stage – presumably require a certain type of exclusivity. This could e.g. be achieved through IPRS and licenses, regulatory exclusivities or trade secrets. Therefore, determining the right balance between openness and exclusivity is particularly decisive but also difficult here.

So far only a limited number of studies have delivered in-depth insights in strategies and policy choices with regard to IPRs in biobanking. The inherent complexity involving many areas of expertise and stakeholders, probably explains why. Previous studies focused on the potential negative impacts and risks of IPRs in the context of biobanking(131). Only a few projects highlighted the opportunities and potential benefits of user-generated solutions and proper governance of IPRs in

89 _{This shift has not only resulted in data disclosure provisions in the new European regulations on clinical trials} but also to – arguably rather cautious - transparency initiatives by the FDA and the EMA.

90_{See e.g. Astra Zeneca’s transparency program at: http://www.astrazeneca-us.com/responsibility/corporate-}

Page | 117 biobanking(112,132).Moreover, there seems to be a far too narrow understanding of the concept of IPRs in the academic debates on biobanking. After all, IPRs are not only about the protection of private interests. The underlying rationales of intellectual property intend in fact to stimulate innovation and to promote technology transfer under fair conditions. The debate on IPRs and biobanking is furthermore often narrowed down to patent rights, while several other types of IPRs could be relevant for biobanking. Another misconception is that “IP might not be so relevant for biobanks” and would only constitute a hurdle for access to biobanks.

Against this background, the paper aims to provide an overview and analysis of the most relevant IPRs in biobanking. It further discusses the risks and opportunities associated with the identified IPRs for an effective use of biobanks in translational research and innovation. In pursuing this goal it will often be necessary to distinguish between different types of biobanks. Different types of biobanks exist, depending on their design and purpose, as well as on the perspectives of multiple stakeholders. We decided to focus on biobanks collecting human samples.91 We therefore define for the purpose of this paper “a biobank” as “an organized collection of human biological materials and associated information stored for one or more research purposes”(26).92

To achieve our objectives, we first identify the types of IPRs that we consider as most relevant in relation to ‘access to biobanks’. We also briefly describe the basic requirements and rationales for receiving IP protection. We then define potential right holders and ownership options, and explain the legal effects of the protection granted.

Section 2 specifies potential challenges in finding a balance between an open and a close

collaboration model. We elaborate on possible tensions between the exclusive nature of IPRs and obligations posed by funding agencies and “open innovation” partnerships to share the results from research on and with biobank material and data. Moreover, we discuss how rights of donors or patients may influence the possibility to obtain IPRs on technologies developed with biobank material and data.

Taken into account the above, section 3 will analyse and discuss potential strategies and options to stimulate the exchange of HBM, data and research results. It will also look into the question of how to address, govern and manage IPRs directed to biobank material and data. We investigate in more detail if, and under which conditions, a biobank could/should become co-owner of upstream and downstream IPRs.

This will ultimately allow us to draw conclusions in section 4.

91 _{These can be distinguished by various categories depending on purpose and design. They include i.a.} population-based biobanks, disease-oriented biobanks, case control biobanks, tissue biobanks and biobanks for clinical trials. These basic categories can be divided into specific sub-groups, such as stem cell biobanks, tumour biobanks or cord-blood banks.

92 _{Note that collections of non-human material, such as plant, animal, microbe, environmental, may also be} described as biobanks but this is less relevant for the purposes of this paper. For a more detailed and generally applicable definition of biobanks cf. (6).

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