Source: https://www.alrc.gov.au/publication/genes-and-ingenuity-gene-patenting-and-human-health-alrc-report-99/28-copyright-and-databases/genetic-databases/
Timestamp: 2019-10-16 14:58:33
Document Index: 243884317

Matched Legal Cases: ['sui generis', 'sui generis', 'art 6', 'art 7', 'art 7', 'art 7', 'art 10', 'art 11', 'art 3', 'arts 6', 'art 6', 'art 12']

Genetic databases | ALRC
Home / Publications / Genes and Ingenuity: Gene patenting and human health (ALRC Report 99) / 28. Copyright and Databases / Genetic databases
28.25 Genetic databases may hold compilations of the sequences of the human genome or other genomes—including whole genomes, single genes and gene fragments, such as single nucleotide polymorphisms (SNPs) and expressed sequence tags (ESTs)—or information about the biochemical pathways related to the expression of genes.[36]
28.26 In recent years, there has been a proliferation of both public and private databases created for use in scientific research. They have become essential for research biologists because:
First, the increasing rate of discovery and the increasingly varied publication options make it difficult for scientists to keep abreast of new knowledge. Second, most of the new scientific data, such as [a] nucleic acid sequence, is no longer being published by conventional means, such as in scholarly journals. Third, an electronic cataloguing of the sequence information within a database facilitates the emerging need for computational analysis of genetic information.[37]
28.27 Publicly available databases have been established by international collaborations including the International Human Genome Sequencing Consortium; the SNP Consortium; and the International HapMap Project. These databases make genomic information widely and rapidly available for use in genetic research.
28.28 Several international statements have recognised the benefits of placing primary genetic information in the public domain. For example, the Bermuda Principles state that primary genomic sequences should be in the public domain; primary genomic sequences should be rapidly released; and the Human Genome Organisation (HUGO) should be advised of large-scale sequencing of particular regions of the genome.[38] These principles have encouraged the producers of large-scale DNA sequencing collections to release their data immediately for free and unrestricted use by the scientific community. The HUGO Ethics Committee’s Statement on Human Genomic Databases also declared that primary genomic sequences should be rapidly placed in the public domain.[39]
28.29 Private genetic databases have also been established, and access to these databases is generally subject to a fee. The attraction of private databases lies in the additional information that they contain; that is, the annotations that have been added to the sequence information.
28.30 The Australian Genomic Information Centre operates the Australian National Genomic Information Service (ANGIS), which provides internet-based access to various publicly available nucleotide, protein, structure and reference databases, and other services.[40] Access to ANGIS is based on payment of an annual fee. Academic pricing is available to universities and non-government not-for-profit organisations. Government pricing is available to federally and state funded organisations and institutions.[41]
28.31 In February 2004, a workshop of the Organisation for Economic Co-operation and Development (OECD) Working Party on Biotechnology concluded that the OECD should develop principles of best practice for the management and governance of human genetic research databases.[42]
28.32 In Australia, copyright may subsist in a database of factual information. In Desktop Marketing Systems Pty Ltd v Telstra Corporation Ltd, the Full Federal Court held that, for the purposes of copyright, originality can flow purely from the ‘sweat of the brow’ involved in obtaining and compiling factual information, even if there is no creativity involved in its selection or arrangement.[43]
28.33 In that case, the Court held that copyright subsists in Telstra’s telephone directory, as an original literary work. Lindgren J stated that a factual compilation would be original if the compiler has exercised sufficient labour and expense in collecting, verifying, recording and assembling the information.[44] Sackville J stated that a factual compilation would be original if the compiler has undertaken substantial labour or incurred substantial expense in collecting the information recorded in the compilation.[45] The High Court refused special leave to appeal against this decision.[46] The Attorney-General’s Department submitted that:
The consequence of the decision in Desktop Marketing v Telstra is that raw data, including raw data that may only be represented in one particular way, will be subject to protection under the Copyright Act 1968, at least where substantial independent skill, labour and effort have been used to compile the data. This would cover most, if not all, databases in existence in Australia.[47]
28.34 Therefore, in Australia, copyright may subsist in a database of factual information on the basis of the ‘sweat of the brow’ involved in obtaining and compiling the information, as well as the selection and arrangement of the information. In addition, copyright may subsist in the individual items contained within the database.
Contract and other protection
28.35 Online database owners often use technological protection measures (TPMs) to restrict or control access to, or copying of, the contents of their databases. The Copyright Act defines a TPM as a device or product, or a component incorporated into a process, that is designed, in the ordinary course of its operation, to prevent or inhibit the infringement of copyright in a work by ensuring that access to the work is only available by use of an access code or process with the copyright owner’s authority; or through a copyright control mechanism.[48]
28.36 TPMs may include encryption, password protection, or ‘read only’ technology.[49] Database owners may permit access on contractual terms, for example through a written licence agreement or a ‘click-through’ agreement on the website.[50]
28.37 The Copyright Act does not currently prohibit the use of a circumvention device or service[51] to avoid the effect of a TPM. Accordingly, a researcher could use a circumvention device to avoid an access or copy control measure for fair dealing purposes, but would remain subject to liability for any infringement involved in thus gaining access. However, while it may not be unlawful for an individual to use a circumvention device to access and reproduce copyright works for this purpose, it may be difficult to obtain such a device within Australia. Section 116A of the Copyright Act prohibits the making, importing, selling, distribution and promotion of such devices and services, subject to certain ‘permitted purposes’.[52] These permitted purposes do not include fair dealing.
28.38 In addition, while the use of circumvention measures is not currently prohibited, database owners could insert conditions into licence agreements that require users to agree not to use such measures for fair dealing purposes.[53]
28.39 The United States has rejected the ‘sweat of the brow’ approach to originality in copyright law. Copyright is extended only to those factual compilations that display a degree of creativity, and can therefore be considered intellectual creations.[54] In addition, or as an alternative, copyright database owners tend to protect their investment through other measures including TPMs and licensing arrangements.[55] Several bills have been introduced into the United States Congress to create a form of sui generis protection for databases or collections of information; however none of these has been passed.[56]
28.40 The United States distinguishes between access control and copy control measures in relation to TPMs. The Digital Millennium Copyright Act 1998 (US) (DMCA) prohibits commercial dealings in circumvention devices or services, and the use of these measures to circumvent an access control measure, subject to limited exceptions. The prohibition does not extend to the circumventionof copy control measures. The DMCA contains an administrative rule-making procedure whereby the Library of Congress must conduct a three yearly review as to whether copyright users are, or are likely to be, adversely affected in their ability to make non-infringing uses of a particular class of copyright works due to these anti-circumvention provisions.[57]
28.41 The application of the DMCA has been criticised on various grounds: including concerns that it may impair the fair use doctrine under United States law; enclose the public domain through ‘digital lock-up’; skew the balance that copyright policy has traditionally aimed to achieve between private rights and the public interest; have a chilling effect on scientific research; and be unworkable due to its complex maze of prohibitions and exemptions.[58] Elouise Dellit and Dr Christopher Kendall have commented that if a researcher cannot gain access to a copyright work due to the operation of a TPM, he or she is not in a position to copy parts of the work for fair use purposes.[59]
28.42 The European Parliament and Council’s Directive on the Legal Protection of Databases (EU Database Directive) deals with copyright protection for databases that, by virtue of the selection or arrangements of their contents, constitute the author’s own intellectual creation.[60] It also provides for a sui generis database right that applies to databases for which the owner has made a substantial investment in obtaining, verifying or presenting the contents.[61]
28.43 The EU Database Directive permits three different sets of rights in relation to a database. First, copyright may subsist in the structure of the information in a database; that is, the selection and arrangement of the database. Second, copyright may subsist in the individual items constituting the database contents. Third, the database right may protect the contents of the database.[62]
28.44 The EU Database Directive prohibits the unauthorised extraction[63] or re-utilisation[64] of the whole or a substantial part of the database contents, whether evaluated quantitatively or qualitatively.[65] The term of protection is 15 years, which may be extended by a substantial change—in qualitative or quantitative terms—to the database contents.[66] The European Union may conclude agreements to extend the database right to databases made in third countries.[67] It appears that protection will be offered only on the basis of reciprocity; that is, where the third country offers protection comparable to the database right.[68]
28.45 In 2001, the European Parliament and Council adopted a Directive on the Harmonisation of Certain Aspects of Copyright and Related Rights in the Information Society (EU Copyright Directive). The EU Copyright Directive has limited the scope of fair dealing for research purposes. The Directive permits member States to provide exceptions and limitations to the right of reproduction and communication for the purpose of illustration for teaching or scientific research of a non-commercial nature; or for the purpose of research or private study by individual members of the public at dedicated terminals in public libraries, educational establishments and other specified organisations.[69]
28.46 Article 6 of the EU Copyright Directive prohibits the use of, and commercial dealings in, circumvention measures to avoid TPMs, subject to specified exceptions.[70] Member States must promote the use of voluntary agreements to accommodate certain exceptions to copyright infringement and, where necessary, take measures to ensure that beneficiaries of those exceptions can benefit from them. However, the Directive appears to provide that online contracts may prevail over the copyright exceptions.[71]
28.47 The European Commission must report on the operation of the EU Copyright Directive every three years. The report must examine whether art 6 confers a sufficient level of protection and whether acts that are permitted by law are being adversely affected by the use of TPMs.[72]
[36] E Baba, ‘From Conflict to Confluence: Protection of Databases Containing Genetic Information’ (2003) 30 Syracuse Journal of International Law and Commerce 121, 128–132.
[37] Ibid, 127.
[38] The Bermuda Principles were established in 1996 at an International Strategy Meeting on Human Genome Sequencing, and endorsed in Bermuda the following year: Wellcome Trust, Genome Data Release, <www.wellcome.ac.uk/en/1/awtvispoldat.html> at 16 June 2004; Wellcome Trust, Summary of Principles Agreed at the International Strategy Meeting on Human Genome Sequencing, University College London, <www.gene.ucl.ac.uk/hugo/bermuda.htm> at 16 June 2004.
[39] HUGO Ethics Committee, Statement on Human Genomic Databases (2002).
[40] Australian Genomic Information Service, About ANGIS, <www.angis.org.au/new/about/index.html> at 16 June 2004.
[41] Australian Genomic Information Service, Subscription and Costs, <www.angis.org.au/new/about/ subscription.html> at 16 June 2004.
[42] Organisation for Economic Co-operation and Development, Main Points from the OECD Workshop on Human Genetic Research Databases–Issues of Privacy and Security, <www.oecd.org> at 16 June 2004.
[43]Desktop Marketing Systems Pty Ltd v Telstra Corporation Ltd (2002) 192 ALR 433. See also J Lahore, Copyright and Designs: Looseleaf Service (1996), [10,065], [10,115].
[44]Desktop Marketing Systems Pty Ltd v Telstra Corporation Ltd (2002) 192 ALR 433, 474.
[45] Ibid, 532–533.
[46]Desktop Marketing Systems Pty Ltd v Telstra Corporation Ltd (Unreported, High Court of Australia, Hayne and Callinan JJ, 20 June 2003).
[47] Attorney-General’s Department, Submission P61, 11 November 2003.
[48]Copyright Act 1968 (Cth) s 10(1). See also Kabushiki Kaisha Sony Computer Entertainment v Stevens (2003) 200 ALR 96.
[49] E Dellit and C Kendall, ‘Technological Protection Measures and Fair Dealing: Maintaining the Balance between Copyright Protection and the Right to Access Information’ (2003) 4 Digital Technology Law Journal 1, 17.
[50] Royal Society, Keeping Science Open: The Effects of Intellectual Property Policy on the Conduct of Science (2003), 24.
[51] The Copyright Act defines a ‘circumvention device’ as a device that has only a limited commercially significant purpose or use, or no such purpose or use, other than the circumvention, or facilitating the circumvention, of a TPM. A ‘circumvention service’ is a service, the performance of which has only a limited commercially significant purpose, or no such purpose or use, other than the circumvention, or facilitating the circumvention, of a TPM: Copyright Act 1968 (Cth) s 10(1).
[52] Ibid s 116A.
[53] Phillips Fox, Digital Agenda Review Report and Recommendations (2004), [13.27].
[54] M Davison, The Legal Protection of Databases (2003), 15. See Feist Publications Inc v Rural Telephone Service 499 US 340 (1991).
[55] Attorney-General’s Department, Submission P61, 11 November 2003.
[56] M Davison, The Legal Protection of Databases (2003), 213.
[57]Digital Millennium Copyright Act 1998 (US); 17 USC s 1201. See also E Dellit and C Kendall, ‘Technological Protection Measures and Fair Dealing: Maintaining the Balance between Copyright Protection and the Right to Access Information’ (2003) 4 Digital Technology Law Journal 1, 26–27. In 2002, two bills were introduced into Congress to permit the circumvention of technological protection measures for fair use purposes: Digital Media Consumers’ Rights Bill 2002 (US) and Digital Choice and Freedom Bill 2002 (US): J Cunard, K Hill and C Barlas, Current Developments in the Field of Digital Rights Management (2003) World Intellectual Property Organization, 64–65.
[58] See I Kerr, A Maurushat and C Tacit, Technical Protection Measures: Part II The Legal Protection of TPMs (paper prepared for the Copyright Policy Branch of the Department of Canadian Heritage) (2002) Nelligan O’Brien Payne, 55.
[59] E Dellit and C Kendall, ‘Technological Protection Measures and Fair Dealing: Maintaining the Balance between Copyright Protection and the Right to Access Information’ (2003) 4 Digital Technology Law Journal 1, 27.
[60]Directive 96/9/EC of the European Parliament and of the Council on the Legal Protection of Databases, (entered into force on 11 March 1996), Ch II. The European Commission is currently reviewing the operation of the EU Database Directive.
[61] Ibid, Ch III.
[62] M Davison, The Legal Protection of Databases (2003), 50–51.
[63] ‘Extraction’ is defined as the permanent or temporary transfer of all or a substantial part of the contents of a database to another medium by any means or in any form: Directive 96/9/EC of the European Parliament and of the Council on the Legal Protection of Databases, (entered into force on 11 March 1996), art 7(2)(a).
[64] ‘Re-utilisation’ is defined as any form of making available to the public all or a substantial part of the contents of a database by the distribution of copies, by renting, or by online or other forms of transmission: Ibid, art 7(2)(b).
[65] Ibid, art 7(1).
[66] Ibid, art 10.
[67] Ibid, art 11(3).
[68] Ibid, recital 56.
[69]Directive 2001/29/EC of the European Parliament and of the Council on the Harmonisation of Certain Aspects of Copyright and Related Rights in the Information Society, (entered into force on 22 May 2001), art 3(a), (n).
[70] Ibid, arts 6(1), (2).
[71] Ibid, art 6(4). See generally, Copyright Law Review Committee, Copyright and Contract (2002), 210, 215–216.
[72]Directive 2001/29/EC of the European Parliament and of the Council on the Harmonisation of Certain Aspects of Copyright and Related Rights in the Information Society, (entered into force on 22 May 2001), art 12.