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OPEN BIOBANKS Reframing Intellectual Property Rights in Biobanking

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OPEN BIOBANKS Reframing Intellectual Property Rights in Biobanking ADVERTIMENT. Lʼaccés als continguts dʼaquesta tesi queda condicionat a lʼacceptació de les condicions dʼús establertes per la següent llicència Creative Commons: http://cat.creativecommons.org/?page_id=184 ADVERTENCIA. El acceso a los contenidos de esta tesis queda condicionado a la aceptación de las condiciones de uso establecidas por la siguiente licencia Creative Commons: http://es.creativecommons.org/blog/licencias/ WARNING. The access to the contents of this doctoral thesis it is limited to the acceptance of the use conditions set by the following Creative Commons license: https://creativecommons.org/licenses/?lang=en OPEN BIOBANKS Reframing intellectual property rights in biobanking DOCTORAL DISSERTATION in Private Law by Jurate Breimelyte Supervisor Dr. Susana Navas Navarro Full Professor of Private Law Departamento de Derecho Privado Facultad de Derecho Universidad Autónoma de Barcelona 2018 ABSTRACT This thesis faced the challenge of answering the question if intellectual property rights that are created by the biobanks can be managed more openly to ensure the equitable distribution of knowledge and improvements of the genetic research. The proposal is made to encourage the biobanks to use more broadly open licenses in their copyrighted works, databases and patented inventions. To ease the transfer of knowledge between biobanks and ensure that the genetic research is improving, the reflection to apply open licenses is made. The thesis describes the open sharing model and supports the possibilities to use IP rights in a non-restricting way. The thesis also proposes to use broad informed consent in the biobanks’ activities. Broad informed consent would ensure the right balance between individual rights and biobanks’ need to share collected information, especially, because there are incentives to treat human genetics as a common good. Open consent can be used in the biobank’s activities to ensure that the tissues are not left unutilised. Such form of consent can assure the maximum value of the collected biological tissues. If collected samples are not restricted to the one-time or one-research use, we can expect that other studies perform research on the same samples and the broader scientific information is presented. Keywords: open biobanks; intellectual property rights; open licenses; broad informed consent. RESUMEN Esta tesis se enfrentó al reto de resolver la cuestión sobre si los derechos de propiedad intelectual creados por los biobancos pueden gestionarse más abiertamente para garantizar la distribución equitativa del conocimiento y las mejoras de la investigación genética. Se propone fomentar que los biobancos usen licencias más abiertas en sus obras protegidas por derechos de autor, bases de datos e inventos patentados. Para facilitar la transferencia de conocimiento entre biobancos y garantizar que la investigación genética mejore, se realiza una reflexión sobre la aplicación de licencias abiertas. La tesis describe III el modelo de intercambio colectivo y apoya la posibilidad de usar derechos de propiedad intelectual de forma no restrictiva. La tesis también propone el uso del consentimiento informado amplio en las actividades de los biobancos. Un consentimiento informado amplio garantizaría el equilibrio adecuado entre los derechos individuales y el derecho de los biobancos de compartir la información recogida, especialmente, porque existen incentivos para tratar la genética humana como patrimonio común. El consentimiento abierto puede usarse en las actividades del biobanco para garantizar que los tejidos no permanecen sin uso. Este tipo de consentimiento puede asegurar el máximo valor de los tejidos biológicos recogidos. Si las muestras recogidas no están restringidas a un solo uso o a una sola investigación, podemos esperar que otros estudios lleven a cabo investigaciones sobre las mismas muestras y se presente información científica más amplia y relevante. Palabras clave: biobancos abiertos, derechos de propiedad intelectual, licencias abiertas, consentimiento informado “amplio”. IV Table of Contents ABBREVIATIONS AND ACRONYMS.............................................................................9 INTRODUCTION..............................................................................................................13 I. Intangible assets in biobanking (or where is the problem?)............................................13 II. Defining relevance and framework...............................................................................19 CHAPTER I.......................................................................................................................21 FROM BIOBANKING TO BIG DATA.............................................................................21 I. Definition of a biobank...................................................................................................21 II. Types of biobanks..........................................................................................................26 1. Public v. private..............................................................................................................26 2. Large-scale biobanks v. small-scale biobanks................................................................33 3. “Closed” biobanks v. “open” biobanks..........................................................................36 III. Information stored in biobanks.....................................................................................42 1. Generalities.....................................................................................................................42 2. Digitalization of the content...........................................................................................43 2.1. From samples to data...................................................................................................43 2.2. Data storage: from cloud computing to synthetic DNA..............................................49 CHAPTER II......................................................................................................................52 INTELLECTUAL PROPERTY RIGHTS IN BIOBANKING. CURRENT LEGAL STATUS..............................................................................................................................52 I. Overview of biobanks regulations..................................................................................52 1. International legal instruments.......................................................................................52 2. National legislation.........................................................................................................54 II. IPR regulation in biobanks............................................................................................56 CHAPTER III.....................................................................................................................59 COPYRIGHT AND DATABASES IN BIOBANKS.........................................................59 I. Copyright of the genomic data........................................................................................59 1. Fixation requirement......................................................................................................60 2. Originality requirement..................................................................................................62 II. Scientific publications and authorship...........................................................................67 III. Database rights v. “sweat of the brow” doctrine..........................................................69 1. Should biobanks fall under the sui generis exceptions?.................................................72 V 2. Is a spin-off doctrine applicable to biobanks?................................................................75 3. EU database right v. US copyright.................................................................................78 4. Negative aspects of database protection in biobanks.....................................................81 CHAPTER IV.....................................................................................................................86 THE ROLE OF GENE PATENTING IN BIOBANKS......................................................86 I. Patentable subject matter................................................................................................88 II. Patenting of a gene. US and European practices...........................................................91 1. US case law....................................................................................................................91 2. Regulation in Europe......................................................................................................95 III. Can biobanks patent genes?.......................................................................................103 1. The participant’s right to samples.................................................................................103 2. Biobank’s and researcher’s intellectual rights..............................................................111 IV. The influence of gene patenting to innovation...........................................................116 1. Hamper of future research............................................................................................116 1.1. Changing the overall concept of genetic research.....................................................117 1.2. Broad patent monopoly.............................................................................................117
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