Patent Policy in Genomics and Human Genetics: A Public Policy in... · 11 FEBRUARY 2015 Dr Katerina...

SAD CASES IN THE CORONERS’ COURTS . 3

in association with the Centre for Socio-Legal Studies and Wolfson College, University of Oxford

Patent Policy in

Genomics and Human

Genetics: A Public

Health PerspectiveREPORT OF A CONFERENCE AT THE UNIVERSITY OF OXFORD

11 FEBRUARY 2015

Dr Katerina Sideri

The Foundation for Law, Justice and Society

ContemporaryIssues

Report

www.fljs.org

FLJ+S Sideri Report.qxp_Layout 1 01/05/2015 16:35 Page 3

4 . SAD CASES IN THE CORONERS’ COURTS


The findings of this report are solely those of the author and do not necessarily representthe view of all participants involved.

© The Foundation for Law, Justice and Society 2015


SAD CASES IN THE CORONERS’ COURTS . 1PATENT POLICY IN GENOMICS AND HUMAN GENETICS . 1

The patentability of DNA sequences has stirred a debate on both sides of the Atlantic, and

views are mixed with regard to the impact of patents on research and development (R&D)

and the degree to which they bring benefit to present and future patients of public health

systems. One aspect of the problem concerns the licensing of technologies generated by

universities and other public institutions to private companies. For instance, in the UK the

100,000 Genomes Project, which aspires to put to commercial use whole genome

sequences, raises important questions: How should we think about licensing, so that

commercialization brings benefit to present and future patients by guaranteed access to

diagnostic services in the National Health Service? Even if we allow commercialization of

research funded by public money, how can we ensure that society gets back its fair share?

Another important aspect of the problem concerns the viability of models of open data

and open source licensing. In the past, on certain occasions governments have forced

companies to share intellectual property (IP) rights in the public interest, and nowadays

various public–private partnerships have been created to address the same need. We need

to ask: How successful are public–private partnerships operating in the spirit of open

science, advancing sharing and collaboration? Is the open source model of licensing a

viable tool?

Executive Summary


2 . SAD CASES IN THE CORONERS’ COURTS2 . PATENT POLICY IN GENOMICS AND HUMAN GENETICS

A workshop held at Wolfson College, Oxford on 11

February 2015 brought together policymakers and

academic experts in the field of genetics and

bioethics to discuss the governance of biomedical

patents in the public interest. The workshop

considered the broader context of DNA

patentability, but the focus was on the post-

(patent) grant stage. The aim was to propose

policies that can accommodate both public health

needs and the policy drive towards

competitiveness in local and global markets.

The workshop reflected on the following questions:1. Patents on DNA Sequences in Europe and

the USA;2. Biomarker Patenting, Monopolies, and

Public Health;3. The 100,000 Genomes Project and IP

Licensing;4. University Licensing;5. Collaborative R&D, Open Science, and Open

Source.

Introduction



Dr Julian Cockbain explained that the UnitedStates Patent and Trademark Office (USPTO) in2014 rejected a patent application by thepharmaceutical company Novobiotic for anantibiotic compound called teixobactin, on thebasis that it is not patent-eligible subject matter.Teixobactin was discovered using a new methodof culturing bacteria in soil, allowing researchers togrow previously unculturable bacteria thatproduce the antibiotic. The USPTO decided thatthe compound and methods of treatmentinvolving the compound were not different from anaturally occurring product. The decision clearlyfollows the spirit of AMP v. Myriad (in that thecombination of the natural with the conventionalwas not deemed to confer patent-eligibility in theabsence of an inventive concept), Mayo v.Prometheus, and Alice v. CLS (simply combining theexcluded natural component with a conventionalcomponent would eviscerate the exclusion of thenatural, making patent-eligibility dependent onthe patent attorney’s drafting skill). Dr Cockbainexplained that Article 5 of the EuropeanCommission’s Biotech Directive states that elementsisolated from the human body are patent-eligibleeven if they are identical to the elements as theyexisted in the body. This means the teixobactinclaims mentioned earlier are acceptable, and theEuropean Patent Office (EPO) practice follows thisapproach. Europe should learn from the USjurisprudence on the question of patent eligibility,and the distinction between the natural andtechnical in biotech needs to be revisited.

Professor Ingrid Schneider focused in herpresentation on stem cells and the democraticshaping of patent law, arguing that the patentsystem is striking in how closed it remains, and it isonly those involved in the practice of law (judges,attorneys, applicants, examiners) who interpret,redefine, and reconstitute the meaning of the law.She expressed concern that the EPO’s GrantingPractice is to allow patents on methods and

products derived from human embryonic stem cell(hESC) lines which were filed after 10 January 2008.According to the Technical Board of Appeals T 1441/13, hESC patents can once again be granted,despite the Court of Justice of the European Union(CJEU) judgment C-34/10 (Bruestle v. Greenpeace)which refused such patents on the grounds that theyinvolve the destruction of the embryo, which thecourt found to be immoral. Specifically, the TechnicalBoard of Appeals decided to allow patents onmethods and products derived from hESC lines, aslong as these are based upon the derivation methoddisclosed by Chung et al. in ‘Human Embryonic StemCells Lines Generated without Embryo Destruction’,Cell Stem Cell 2(2) 2008: 113–17. This article claims tohave allowed for the first time the provision of hESCcultures (cell lines) without destroying a humanembryo in any production step. Has Chung’s methodindeed changed the field of human embryonic stemcell research? This is debatable, as the existence ofthe cell line in question (No. 5 in Chung et al. 2008) iscontested, as it is not registered in any internationalstem cell registry. The method has no real-worldapplicability with respect to transfer of the remaining,biopsied embryo to a woman’s uterus. The methodapplied in practice — taking a blastomere from ahuman embryo without destroying it — could causeharm to the embryo, without any indication andmedical benefit for the embryo itself (Recital 42 of Dir.98/44 does not apply). Therefore, the EPO appears to beusing this method as a legal construct without sufficienttechnical basis, and no stem cell lines produced by thismethod are currently used in hESC research.

Professor Schneider concluded her presentation bynoting that patent attorneys, patent examiners, andboards of appeal undermine legislatively fixedexclusions from patentability. Decisions onpatentability of hESC for patents (applied for after 10January 2008) at the EPO are not documented in itsGuidelines for Examination. The problem of lack ofaccountability to the EU legislator needs to beaddressed.

Session I: Patenting DNA Sequences andStem Cells. Law and Politics inComparative Perspective


4 . SAD CASES IN THE CORONERS’ COURTS4 . PATENT POLICY IN GENOMICS AND HUMAN GENETICS

Session II: Biomarker Patenting,Monopolies, and Public Health

Dr Michael Hopkins opened his presentation byoutlining the different innovation pathways in thehealth sector, such as the development ofpharmaceuticals, which currently relies on themaximization of profit through intellectualproperty rights. However, as Dr Hopkins explained,the NHS in the UK presents a different model, onewhich facilitates innovation in the public sectorwithout industry involvement or patents, eventhough such innovation may remain hidden, or gounmeasured. Policymakers rarely acknowledge thedifferent characteristics of diverse innovationpathways, and mistakenly seek to apply uniformpolicies to the industry and public health sector. Animportant first step in addressing this problem is tomeasure how much innovation is produced in thepublic health sector.

In the ensuing discussion, the idea was raised thatDNA patents are in fact ‘a phantom menace’, in thatfew public sector labs report actually withdrawinga service due to IP (4% in the EU vs. 25% in the US).Hospital staff are hostile to industry attempts touse IP (especially on genes), and there is a lack ofDepartment of Health/NHS guidance on in-licensing IP.

Dr Hopkins concluded his presentation withquestions for future research: How do diagnosticpatent owners utilize European IP? What is theconsequence of biomarker IP not being upheld? Isthere sufficient motivation for industry to developevidence for biomarker validation/utility in the UKmarket? (or will government fund it?) On balance,which innovation pathways does the de facto UKpolicy environment favour?

Dr Stuart Hogarth discussed the Human Papillomavirus genetic test (HPV, a viral model of cancer). Henoted the uneasy relationship between the HPVtest and the Papanicolaou (Pap) smear test and theaggressive business tactics employed by Digene(the only manufacturer of the test in the US with

Food and Drug Administration [FDA] approval) in itsattempts to replace Pap smear testing in certaingroups of the population. The idea of introducing co-testing has also been discussed in the UK. In 2011 theNational Institute for Health and Care Excellence(NICE) established a Diagnostics Advisory Committee,which begun evaluation of genomic diagnostics toguide adjuvant chemotherapy in early breast cancermanagement. There were three commercial tests —Mammostrat, Mammaprint, OncotypeDX (costing£2580) — and one in-house NHS test, IHC4 (costing£150). The NICE draft decision was to recommendOncotype DX, based on a narrowing of thepopulation for which the test would be used, but theDirectly Commissioned Services Committee (DCSC)ultimately decided to ratify the recommendation ofthe Clinical Priorities Advisory Group (CPAG) to notcurrently commission OncotypeDX on the groundsthat ‘the cost of the test to NHS England is significant,even when the additional savings in chemotherapycosts are factored in.’

Although co-testing was not endorsed by the DCSC,it is worth explaining the reasons why NICE initiallyrecommended Oncotype DX for certain groups of thepopulation and not the cheaper alternative, IHC4. Thekey advantage which OncotypeDX enjoys over IHC4concerns the supporting evidence for the efficacy ofeach test. The IHC4 has been in development for arelatively short time, and although NICE deems itpromising, it lacks the cumulative weight of evidencefrom multiple studies which support use ofOncotypeDX. What this suggests is that in the era ofproprietary combinations of biomarkers, significantfirst-mover advantage is gained by building a clinicalevidence base at an early stage. The two leading tests— Mammaprint and OncotypeDX — are nowbenefiting from large publicly funded trials to testtheir utility (MINDAct and TailorRx respectively). Thisis set to change with the launch in the UK of theOPTIMA trial, a study which may give IHC4 the chanceto prove its worth against its commercialcounterparts.



Professor Sigrid Sterckx detailed in her presentationthe Health and Social Care Act 2012 in the UK, whichgives the power to the Health and Social CareInformation Centre to collect, collate, and provideaccess to the medical information for all patientstreated by the NHS in England, whether in hospitalsor by general practitioners (GPs). Leaving asidequestions with respect to informed consent, adifferent set of questions concern thecommercialization process and the ways theInformation Centre would be used as a source ofprofit by the UK government. The Information Centrereassures people that it will not make a profit fromproviding data to other organizations, but will onlycharge an access fee to cover its costs. However,according to Professor Sterckx, this means thatcommercial companies have access to assets theyhave not themselves bought/created, effectivelyreceiving a quasi-free commercial boost by the UKgovernment. To put NHS databases at the disposal ofindustry, without requiring a ‘kick-back’ to helpenhance the service that the NHS provides, isinappropriate at best.

Professor Sterckx suggested that some form ofbenefit-sharing is needed, with benefit effectivelypassing back to UK citizens whose data will be usedto commercial advantage; the mere fact that newdrugs might reach the market is not sufficient. Onepossible improvement would be for the companiesseeking access to be required to provide the NHSwith reduced access costs for the resulting drugs orother health-related products.

Dr Mark Bale explained that the UK 100,000Genomes Project is a hybrid research/service projectaiming at developing key elements of UK researchand clinical infrastructure to sequence 100,000genomes by 2017, focusing on cancer, rare diseases,and infectious diseases. Genomics England was setup by the Department of Health to deliver theproject, which raises a number of challengesconcerning patents, copyright and database rights,and licensing strategies.

Dr Bale explained that the Ethics Working Groupestablished by the Chief Medical Officerrecommended the adoption of a balanced approachto IP to ensure that any commercialization is in thepublic interest and brings benefits to the NHS. Oneaspect of the problem concerns future lincensingstrategies. In this respect there is a need to reachagreement on IP across the Department of Health,Genomics England, NHS England, NHS GenomicMedicine Centres, universities, and commercial users.A good starting point is the OECD Guidelines for theLicensing of Genetic Inventions published in 2006which state that ‘Licensing practices should seek tostrike a balance between the delivery of newproducts and services, healthcare needs, andeconomic returns’. Beyond the 100,000 GenomesProject there remain some challenges to theappropriate licensing of diagnostic patents for NHSlaboratory use, such as a lack of awareness ofexisting IP rights by NHS diagnostic labs. TheDepartment of Health is still exploring practicalapproaches that respect IP rights while striking theright balance regarding the diagnostic uses ofgenomics with the growth of a vibrant genomicsindustry in the UK.

PATENT POLICY IN GENOMICS AND HUMAN GENETICS . 5

Session III: The 100,000 Genomes Projectand IP Licensing



Dr Harry Thangaraj outlined the current picture ofuniversity licensing of patents, explaining that 57percent of the research origin of biopharmaceuticalpatents can be found in universities and 6 percent inindustry–academia collaborations (data published in2009 in Nature Biotechnology). Dr Thangarajdiscussed the non-profit organization UniversitiesAllied for Essential Medicines (UAEM), established aspart of a global movement of university students topromote socially responsible licensing (SRL).According to UAEM, academic licensing contractscan be structured in a flexible manner to improveaccess to essential technologies for the poor indeveloping countries. Before licensing academicinventions, consideration should be given to marketsegmentation, tiered or differential pricing(territorial), field of use (suited for platformtechnologies), humanitarian use, reservation ofrights, and inserting a non-assert clause (not to seekto enforce patents or other intellectual propertyrights in certain countries).

Nowadays, various funders (Wellcome, Gates etc.)make funding conditional on the mandatorydevelopment of fair access policies, and, in certaincases, on early release of data. However, access toessential medicines, particularly antiretrovirals(ARVs), has been a long and difficult battle, whichhas only partly been won. Dr Thangaraj concludedwith the recommendation that funders of publicresearch should insist on social responsibility, andthat responsible licensing policies for all diseases,rather than a selection of diseases, should beconsidered.

Dr Adam Stoten introduced Isis Innovation, theUniversity of Oxford's technology transfer company,which translates research into innovation and impactthrough technology transfer. Impact is an

increasingly important factor in the UK government’smechanism for assessing University performance(REF) and subsequent allocation of block fundingfrom Research Councils UK. Impact accounts for 20percent of the evaluation of research under the REF2014, and is defined as ‘an effect on, change orbenefit to the economy, society, culture, publicpolicy or services, health, the environment or qualityof life, beyond academia.’ It is also of increasingimportance to other funders of academic research,such as charities and the European Commission. Thefocus on wider impact differentiates universitiesfrom commercial technology developers, who bynecessity must prioritize financial return for theirshareholders.

Dr Stoten emphasized the importance attached tothe delivery of technologies at affordable cost and insuitable quantity to developing countries and leastdeveloped countries (LDCs), and acknowledged thata high level of social responsibility is appropriategiven the fact that the majority of funding comesfrom public sources. He also highlighted thecommercial pressures on technology developers,and argued that suitable private partners are difficultto find for most early stage university technologies.Oxford’s access to medicines policy follows theresponsible licensing model as explained by HarryThangaraj. However, one size does not fit all — eachlicensing opportunity needs to be consideredseparately and within its particular context. Theterms of a licence cannot be so restrictive thatcompanies will not sign up, since if there is nocommercial partner and ultimately no productensues, then no one will benefit, so a balance needsto be found, for which the early appraisal of the likelyapplications of a new technology and the pathwayto its commercialization is essential.

6 . PATENT POLICY IN GENOMICS AND HUMAN GENETICS

Session IV: University Licensing



Dr Javier Lezaun began his presentation byasking: Why does a pharma company decide tocreate a public resource, employing open sourceideas and models? Looking in particular intoantimalaria drug discovery, and noting thatmarket mechanisms have failed to incentivize theproduction of drugs, Dr Lezaun explained thatGlaxoSmithKline (GSK) used phenotypic (whole-cell) screening to create a compound library (twomillion compounds) at Tres Cantos Malaria(TCAMs) Drug Performance Unit (DPU). Realizingthat there was need for new and structurallydifferent drugs, but there was a lack of validatedtargets (functional information about the naturallyexisting cellular or molecular structure involved inthe pathology of interest), the company decidedto make the data public, but stipulated that, inexchange for their openness, users of itscompound library should also share data. GSK’sown lawyers revealed to Dr Lezaun, in the courseof various interviews conducted at TCAMs DPU,that they opposed the opening up of a proprietarydatabase on the grounds that it may jeopardizethe company’s intellectual property. Importantly,the release of data by TCAMs redefined the pre-competitive space, as chemical space became‘public’, constraining the breadth of patent claimsthat could be pursued by other actors. This in turnforced IP lawyers to change their focus, since theycould only pursue market exclusivity for anyeventual treatment that might emerge from thisresearch.

Dr Lezaun continued his presentation bypresenting the details of the Open Access MalariaBox (MMV) a not for profit partnership based onthe idea of reciprocity, and Open Source malariadrug discovery led by Matthew Todd’s laboratoryat the University of Sidney. In the latter case, bymeans of crowdsourcing the evaluation ofcompounds, the hope is to advance faster science(up to Phase I), raising a number of questions, suchas how to ensure some form of market exclusivity

and therefore financial reward in an open sourceproject. Julian Cockbain intervened to point out thatorphan drug protection may serve as a model ofprotection, as it states that for any drug designatedfor a rare disease or condition, the statute providesfor seven years of marketing exclusivity.

Dr Wen Hwa Lee introduced the StructuralGenomics Consortium (SGC) at the University ofOxford, explaining that it was established in 2004,with members drawn from three governmentagencies, the Wellcome Trust, and ten leadingpharma companies. The SGC is involved in more than550 international collaborations, an example beingthe SGC–CHDI alliance, to rapidly discover anddevelop drugs that delay or slow Huntington’sdisease. The SGC advocates a new model forbiomedical research based on open innovation drugdiscovery (patent-free). Funding sources are $100mfunding from global pharma and $200m from publicsources and foundations. The SGC has contributed15 percent of all human protein structures in thepublic domain, and produced 776 peer-reviewedarticles (20% of which in high-impact journals).

Focusing on the crisis in drug discovery, Dr Leeexplained why neither academia nor pharmasoffered innovative solutions, in an example of thephenomenon dubbed the Harlow–Knapp effect. Thevast majority of the cancer research conducted onkinases, the class of proteins implicated in severalcancers, covers only between forty and fifty types,which represents less than 10 percent of the totalnumber. In the pharma industry, similar gaps can beobserved: patents cover only 10 percent of kinasetypes. As a result, despite massive investment,insufficient novel medicines are being delivered, andover 90 percent of early activity is destined forfailure, since no single organization has the range ofcapabilities necessary to deliver success. The currentmodel requires the patenting of early-stage research,and the resultant secrecy prevents collaboration,resulting in unneccessary duplication of research

Session V: Open Science and Open Source



licensing models. Questioning whether synbioproducts are best characterized as drugs (discretetechnologies) or as something more akin to mobilephones or microprocessors (complex technologies),or even as hybrids comprising characteristics ofboth, he reviewed the implications of suchcategorizations for IP policy and business models.Synbio is a complex technology; hence, thesmartphone comparison is a useful one, since itillustrates the complex patent issues that are likely toemerge in the future. Assessing the alternatives,Professor Dutfield questioned whether openinnovation provides a real opportunity for a betterbalance between IP and the public domain, arguingthat how we address this question depends largelyon our categorizations of synbio, as a hybridcomprising characteristics of diverse technologies, atthe intersection between true engineering systemsand biology.

and suboptimal use of public (and industrial)resources. The solution can only be open innovation.The pre-competitive space requires redefinition toinclude research tools and basic knowledge (forexample, on the structure of novel proteins) andthen the proprietary phase will include drugdiscovery and development, facilitated by access toincreased amounts of information in the publicdomain. This approach is endorsed in economicanalysis produced in 2014 by the New York Academyof Sciences, which focused on opportunities toaccelerate R&D for Alzheimer’s disease. Dr Leeconcluded that translational research in a pre-competitive commons through public–privatepartnerships will bring the best possibility of success.

Professor Graham Dutfield discussed themanagement of intellectual property in theemerging technologies of synthetic biology andassessed the recent ascendance of open source-type




1. Patents may protect technologies, but productsof nature fall outside the realm of patent protection.Europe should learn from the current turn in the USjurisprudence on the question of patentability ofproducts of nature, which reflects the concern thatthe drafting skills of patent attorneys rendermeaningless the distinction between the naturaland the technical in patent law.

2. The European Patent Office (EPO) GrantingPractice is to allow patents on methods andproducts derived from human embryonic stemcell lines which were filed after January 2008 if theinvention uses the derivation method disclosed byChung et al. in 2008, which for the first time hasallowed the provision of hES cultures (cell lines)without destroying a human embryo in anyproduction step. However, the grounds of thisdecision should be scrutinized, and the problem oflack of accountability of an administrative agencysuch as the EPO to the EU legislator needs to beaddressed.

3. Public institutions such as the NHS participate in‘hidden’ innovation, which escapes measures ofquantity and impact applied to the private sector.We need to understand better the amount andquality of this type of innovation and devisepolicies that accommodate the characteristics ofdifferent innovation paths, both public andprivate.

4. Human Papillomavirus testing illustrates recentattempts by private companies to monopolize themarket for genetic testing. In the UK, a decisionwas made on whether to endorse co-testing withthe Pap smear test or not, and whether proprietarytechnology should be used instead of muchcheaper tests developed in-house by the NHS. Inthese cases, policymakers should take intoaccount that significant first-mover advantage isgained by building a clinical evidence base at anearly stage.

5. The Health and Social Care Act 2012 in the UKallows the Health and Social Care Information Centre(HSCIC) to collect and share confidential informationfrom medical records. The subsequent Care Act 2014means that the public’s data can only be shared andanalysed when there is a clear healthcare benefit.Beyond well-rehearsed arguments with respect toinformed consent, the lack of public trust resultingfrom the commercialization of personal informationneeds to be addressed. In this respect, the idea ofreciprocal benefit-sharing becomes salient: if apublic resource such as the databases held by theNational Health Service are shared with industry, areciprocal benefit must be secured to enhance thehealthcare services that the NHS provides.

6. The 100,000 Genomes Project requires theadoption of a balanced approach to IP to ensure thatany commercialization is in the public interest andbrings benefits to the NHS. OECD guidelines for thelicensing of genetic inventions may serve as a usefulmodel.

7. University technology transfer offices shoulddetermine the correct balance between commercialconsiderations and the translation of technologies toproducts that serve the needs of the public. On theassumption that social impact should be of primaryimportance, academic licensing contracts should bestructured in a flexible manner to improve access toimportant technologies.

8. Given the current drive to translate universityresearch into valuable commercial products, it isargued that public institutions lead privatecompanies in the discovery of novel drug targets.The question is whether there is value in filing forpatents in early research, or whether to adopt openaccess policies. Given the declining levels of pharmainnovation, serious consideration should be given tothe adoption of open science and open sourceinitiatives that redefine the pre-competitive (toolsand basic knowledge) and competitive

Key Findings



space/proprietary (drug discovery and development)phases, facilitated by access to increased amount ofinformation in the public domain. The managementof intellectual property in synthetic biology andother emerging technologies and the ascendancy of

open source licensing models present interestingquestions for the best way to incentivize futureinnovation, and should be subject to furtherresearch.


Dr Mark Bale, Deputy Director, Health Science andBioethics Division, Department of Health, UK

Dr Julian Cockbain, Consultant, European patentattorney, independent researcher

Professor Graham Dutfield, Professor ofInternational Governance, University of Leeds

Dr Stuart Hogarth, Senior Research Fellow, King'sCollege London, University of London

Dr Michael Hopkins, Senior Lecturer, Science PolicyResearch Unit, University of Sussex

Dr Wen Hwa Lee, Strategic Alliances ProgrammeDirector, Disease Foundations Network StructuralGenomics Consortium (SGC), University of Oxford

Dr Javier Lezaun, James Martin Lecturer in Scienceand Technology Governance, and Deputy Director ofthe Institute for Science, Innovation and Society,Oxford Martin School, University of Oxford

Prof Ingrid Schneider, University of Hamburg,Germany, and Member, European CommissionExpert Group on the development and implicationsof patent law in the field of biotechnology andgenetic engineering

Dr Katerina Sideri, Agricultural University of Athens,Greece

Professor Sigrid Sterckx, Professor of Ethics, GhentUniversity and Vrije Universiteit Brussels; member,Belgian Advisory Committee on Bioethics

Dr Adam Stoten, Head of Technology Transfer, LifeSciences, Isis Innovation, University of Oxford

Dr Harry Thangaraj, Director, Access toPharmaceuticals Project, St George’s UniversityLondon


Participants



The Foundation The mission of the Foundation is to study, reflect on,and promote an understanding of the role that lawplays in society. This is achieved by identifying andanalysing issues of contemporary interest andimportance. In doing so, it draws on the work ofscholars and researchers, and aims to make its workeasily accessible to practitioners and professionals,whether in government, business, or the law.

Dr Katerina Sideri is affiliated with the AgriculturalUniversity of Athens, Greece. In the past she wasassociate research fellow at the Centre for Socio-LegalStudies, University of Oxford, lectured on IP law at theUniversity of Exeter, and earned her PhD in law at theLondon School of Economics. Her latest publication isBioproperty, Biomedicine and Deliberative Governance:Patents as Discourse on Life (Ashgate, 2014).

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