Select Committee on Science and Technology Fourth Report

CHAPTER 8: Commercial applications

8.1 If the full benefits of advances in understanding genetics (through the operation of genetic databases and otherwise) are to be realised, private sector resources will need to be mobilised through commercial development of new discoveries. In this Chapter, we discuss the ownership of genetic data and then turn to intellectual property rights and patenting.

Ownership of data

8.2 In its written evidence, the MRC indicated that UK law on ownership of samples of human tissue was unclear (p 63). This point was also made by Baroness O'Neill, who noted the distinction between 'ownership' and 'lawful possession' (Q 323). Sir George Radda felt it was more useful to consider the holder of genetic information as a data custodian rather than an owner (Q 72), a view supported by Professor Chadwick (Q 284).

8.3 In a helpful note (P 11), the Department of Health differentiated between:

(a)  health data (being the content of a health record) - which were not owned; and

(b)  the media on which such data were held (both written and electronic) - which could be owned.

The Department also noted that there was intellectual property in making additions to a health record (for example, by the attending physician) which may or may not be assigned to the employing organisation. Where the data recorded about an individual were confidential to that individual (as would almost always be the case with health records), rights in common law applied, although they were not absolute and could be overruled in the public interest.

8.4 The MRC draft guidelines on Human tissue and biological samples for use in research highlighted the need for secure and responsible custodianship of samples and associated data, and recommended that in most instances the formal responsibility for custodianship should rest with institutions and not individual researchers (p 63).

8.5 Professor Chadwick agreed that, while the concept of ownership of tissue samples or data derived from them is not particularly helpful, a number of parties nonetheless have an interest or can be regarded as 'stakeholders' in these data - the individual themselves, the researchers, and so forth (QQ 285-287).

8.6 In supplementary memoranda[62], representatives of the pharmaceutical companies took a somewhat different view of ownership from that of other witnesses. Dr Cheeseman of AstraZeneca noted that the important point was neither ownership nor custody but an agreement between the company (or other research institution) and the individual about how the sample could be used. Issues of ownership were matters of law and contract, and depended on the rules of the relevant jurisdictions. His company preferred ownership status to custodial status. Consequently, participants in research ceded their ownership of samples and data derived therefrom to the company, according to the consents obtained (QQ 247 & 250(a)).

8.7 For GlaxoSmithKline, Dr Roses noted that the complex issue of ownership of samples was secondary to the ability to undertake genetic research and to use any intellectual property arising from the discovery in the development and delivery of medicines free from encumbrance. Some sections of the MRC guidelines might be incompatible with this requirement. He noted that authorisation for such research was typically obtained through the individual informed consents provided with the samples (Q 250(a)).

8.8 Dr Power also took the view that, when individuals participating in Pfizer's trials donated samples for genetic research, they were considered to be owned by the company which thus had the right to use the samples within the constraints imposed - for example, by the company itself, by independent Ethics Committees and by any limitations in the individual consent obtained. Dr Power noted that participants could withdraw consent prior to anonymisation and, in this event, the samples would be destroyed (Q 250(a)).

8.9 The FSS also had a distinctive view. It saw ownership as vested in the particular police force which provided the sample (QQ 152-159).

Intellectual property


8.10 Together with a number of other witnesses, Oxagen Ltd, in its written evidence, highlighted the importance of public-private partnership in research involving human genetic databases. In their agreements with academics and clinicians, the biological samples were in the ownership (custodianship) of the collaborating institution where the samples were collected, and hence remained in the public domain, while Oxagen Ltd sought to retain the Intellectual Property Rights (IPR) in discoveries made through the use of the samples (p 71).

8.11 Sir John Pattison, Sir George Radda and Dr Dexter all stressed the importance of industry in exploiting the benefits of genetic research (QQ 5, 8, 102 & 103). An important role for industry was also envisaged in the proposed UK Biomedical Population Collection, although not in funding the core data collection for the study (p 63).

8.12 We heard in written evidence from AstraZeneca (p 11) and in supplementary evidence from Pfizer and GlaxoSmithKline (Q 250(b)) that they contributed to the SNP Consortium, a research collaboration between industry (originally ten pharmaceutical companies), the MRC and The Wellcome Trust. The consortium contracted with academic institutions to perform the work that was being placed in the public domain with results freely available to all (pp 63 & 99).

8.13 In recognition of the importance of genetic/genomic research performed in animal models, GlaxoSmithKline was also providing part of the funding for the Mouse Sequencing Consortium, a public-private research partnership aiming to sequence the mouse genome and place it in the public domain. Through this initiative, important pre-competitive research data were entering the public domain much faster than would have been possible through publicly funded efforts alone (Q 250(b) & (d)).


8.14 In their written submissions, the Sanger Centre (p 88) and Dr Graham Cameron and Professor Michael Ashburner (p 110) emphasised the necessity of keeping the primary human genome sequence freely accessible in the public domain. Without this, modern biological research would be impossible. This was also the position of the MRC and The Wellcome Trust in their written submissions (pp 68 & 105) and was strongly reinforced in the Nature publication of the draft human genome by the International Human Genome Sequencing Consortium[63].

8.15 Professor Chadwick noted the provision in the European Convention on Biomedicine and Human Rights that the human genome should not give rise to financial gain. However, some genetics research - drawing in part on human genome data - was likely to be highly profitable. In recognition of the concern that people could have about their genetic information being exploited for profit, the Human Genome Organisation (HUGO) Ethics Committee proposed[64] that 1-3 per cent of the net profit from exploiting genetic research should be returned to health care infrastructure or health endeavours (QQ 288-293).

8.16 Supplementary evidence from the pharmaceutical companies also dealt with questions of intellectual property. Dr Cheeseman indicated that AstraZeneca collaborated extensively with universities and hospitals in genetic research. The apportionment of IPR between the company and a university was subject to negotiation on a case-by-case basis - generally in proportion to the relative contributions of the respective parties to the research effort in terms of know-how, resources, finance, and exposure to risk (Q 250(c)).

8.17 GlaxoSmithKline had initiated a number of international genetic studies to identify susceptibility genes for common diseases, in collaboration with clinical sites, genome screening centres and academic epidemiology centres (based in the US). Ownership of any intellectual property resided with the party that made the invention. Where this was a university epidemiology centre, Dr Roses noted that his company had exclusive rights to license that intellectual property, with the licence fee shared among the collaborators (Q 250(c)).

8.18 Dr Power stated that Pfizer collaborated extensively with universities and commercial companies. In general, commercial rights (where they related to their own products) were retained, otherwise intellectual property was retained by the universities - although research licences allowed continued research by both parties (Q 248).


8.19 In the recent publication of the draft human genome by a for-profit company, Celera Genomics[65], certain restrictions were placed on access to the raw data[66]. In contrast, the publicly funded effort to sequence the human genome[67] was predicated on the fact that the basic genetic information[68] should be freely available in the public domain (see paragraph 8.14 above).

8.20 The position taken by the publicly funded consortium was that patenting should be based on original discoveries derived from the use of genetic information, in order to develop understanding of gene or cell function or to make new pharmaceutical or other products. There was wide support for this view among our witnesses - including Dr Dexter (Q 102) and the Sanger Centre (p 88).

8.21 Dr Cheeseman explained that material that was the subject of a patent application was published 18 months after filing, so the information was available for use in making new inventions. All patent applications had to satisfy the basic tests for patentability, including being strictly new, not obvious over what was already known and having some commercial/industrial use. Discoveries were not patentable in themselves - something "new and unexpected" had to be added. Dr Cheeseman noted that patents did not give the holder any ownership of the invention - rather, they prevented unauthorised commercial use of the patented invention (Q 250(c)).

8.22 Dr Roses stated that GlaxoSmithKline fully supported the European Directive on the Legal Protection of Biotechnological Inventions[69] and the ability to patent inventions based on isolated DNA sequences, provided that the usual conditions for patentability were met. Published patent applications were recognised as a valuable source of technical information for making further inventions and discoveries. Without the patent system, this information would not be readily available to the public - and research, if conducted at all, would be carried out under great secrecy. Dr Roses asserted that patent law permitted non-commercial research on patented subject matter, so pure research by academic institutions was not affected by the existence of patents. Even in relation to commercial research, it would often be possible to negotiate a license under the patent - or challenge its validity. Third parties could also obtain dependent patents to patent (and then licence) an improvement of a previously patented invention or a new use for an already patented gene. This was frequently encountered with pharmaceuticals and was in principle no different in the genetics field (Q 250(c)).

8.23 A commentary in Nature[70], by Professor Martin Bobrow of Cambridge University and Dr Sandy Thomas of the Nuffield Council on Bioethics, noted the difficulties surrounding the award of patents concerning genetic discoveries, and the tendency to extend the patentability of biotechnology to inventions for which thresholds of novelty, inventiveness and utility had been lowered. They identified a failure of policy in this area. While legal challenges to patents were available, this route was often rejected by the private sector in favour of individual licensing deals which were often quicker and cheaper to achieve.

8.24 Dr Power indicated in supplementary evidence that Pfizer pursued patent rights for inventions having the highest value for drug discovery, for example, biological function of proteins, screening reagents (such as novel enzymes and receptors) and biomarkers identified from outcome studies and toxicological prediction (Q 250(c)).

8.25 In written evidence, the Sanger Centre took the view that the patenting of genes was reasonable where a significant function had been directly established. However, the patent should cover only the application of that function and natural extensions, as opposed to patents which covered all possible but not yet envisaged and speculative uses of a gene (p 88).

8.26 As far as secondary use of data was concerned, scientists at the Sanger Centre believed that work that contained a creative element could be rewarded - for example, information derived from analysis and annotation that combined information from multiple sources. This could allow recovery of the costs of forming the data collection. However, the rights should not be extended over others who reached similar conclusions independently. In most cases, the most effective way to disseminate results of publicly or charitably funded research was to write off the cost of producing the data and place the resulting database in the public domain (p 88).


8.27 In common with most of our witnesses, we do not regard ownership of biological samples as a particularly useful concept with respect to human genetic databases. We prefer the notion of partnership between participants and researchers, for medical advance and the benefit of others, including future generations.

8.28 Much of the research that we discussed in earlier Chapters is of a basic nature funded in large measure from public funds with some commendable support from the private sector (e.g. the SNP Consortium). The results of that research are freely available to all.

8.29 Building on these basic data to develop the hoped-for new treatments will require substantial investment of risk capital. The private sector will make that investment only if it has the degree of protection afforded by patenting of inventions and discoveries in order to turn them into products. The protection given, however, should not be such as to stifle research progress. In our view, patenting in the field of genetics is, in principle, no different from that in other fields.

8.30 We strongly endorse the position taken by the International Human Genome Sequencing Consortium, the Sanger Centre, The Wellcome Trust and others that insists that the primary genetic sequence data should be freely available in the public domain. Patenting of intellectual property should be based on innovations and original discovery from the use of genetic information, in order to develop understanding of gene or cell function or to make new pharmaceutical or other products. We recommend that the Government should press, both within Europe and more widely, for patent rights over genes to continue to be granted only where a significant gene function has been established, and to ensure that the patent should cover only that function and direct extensions of it. Possible but not yet envisaged and speculative uses of a gene should not be patentable.

8.31 As we have found during the course of our Inquiry, a distinctive feature of genetics is the rapid pace of change. For the future, we recommend that the Government should monitor closely patenting practices in the field of genetics and take steps as necessary to ensure that the proper balance is maintained between protecting inventors' interests, facilitating commercial development of ideas and allowing research to flourish.

62   Relevant parts of which are, for convenience, reproduced as QQ 250(a)-(d) on PP 54-57. Back

63   International Human Genome Sequencing Consortium. "Initial sequencing and analysis of the human genome." Nature 2001; 409: 860-921. Back

64   In its Statement on Benefit Sharing, 9 April 2000. Back

65   J Craig Venter et al. "The sequence of the human genome." Science 2001; 291: 1304-1351. Back

66   Marshall E. "Celera and Science spell out data access provisions." Science 2001; 291: 1191. Back

67   International Human Genome Sequencing Consortium. "Initial sequencing and analysis of the human genome." Nature 2001; 409: 860-921. Back

68   Including SNP data, as noted by Dr Cameron and Professor Ashburner (p 110). Back

69   98/44/EC. Back

70   "Patents in a genetic age." Nature 2001; 409:763-764. Back

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