Exploiting patents over stem cell technologies

15.68 In addition to concerns about the patentability of inventions involving stem cell technologies, other issues have been raised about stem cell patents. These focus on the impact of stem cell patents on access to, and the licensing of, stem cell lines and stem cell technologies. The balance of this chapter examines these issues, including those in relation to broad claims in stem cell patents; the licensing practices of stem cell patent holders; and access to, and the commercialisation of, stem cell technologies.

Broad stem cell patents

15.69 Various reports and academic commentators have identified broad claims in stem cell patents as a concern because such patents could have adverse effects on further innovation.^[115] For example, the EU Stem Cell Report noted that stem cell patents may cover important research tools and recommended that stem cell patents should be granted only where ‘the patent claim refers to a specific and sufficiently accurately described stem cell line and its industrial application’.^[116] Similarly, in its submission to this Inquiry, the Nuffield Council on Bioethics stated that ‘the granting of over-generous patents with broad claims … should be discouraged’ to minimise restrictions on stem cell research.^[117]

15.70 Some commentators have suggested that the majority of human embryonic stem cell research could fall within the scope of the claims of the Thomson patents.^[118] However, despite the broad foundational stem cell patents owned by entities such as WARF and Geron Corporation, other biotechnology companies have derived stem cell lines that may fall outside the scope of these patents. For example, BresaGen Limited, an Australian biotechnology company with facilities in Georgia, USA, has developed four pluripotent embryonic stem cell lines derived from embryos at a later stage of embryonic development than that claimed in the Thomson patents.^[119]

15.71 Broad claims are characteristic of patents granted early in the development of a new technological field, like stem cell science. However, the prior art against which any subsequent patent applications may be assessed is likely to significantly limit the scope of the claims in any stem cell patents that may be granted in the future.^[120] Further, broad claims may not be objectionable if access to stem cell technologies covered by such claims is not unduly restricted.

Licensing stem cell patents

15.72 It has also been suggested that stem cell patents may impede further research and innovation in relation to stem cell technologies, particularly if stem cell patent holders license such patents exclusively, or only on restricted terms.^[121] These concerns are similar to those addressed elsewhere in this Report about the licensing and exploitation of gene patents.^[122]

15.73 Currently, the extent to which access to stem cell technologies is being restricted is unclear. Licences over stem cell patents and other collaborative arrangements relating to the development of stem cell technologies have been reported in connection with Australian commercial entities, including BresaGen, ES Cell International, and Stem Cell Sciences.^[123]

15.74 Concerns about the licensing of stem cell patents have been particularly acute in the United States. This is largely the result of a government policy relating to funding embryonic stem cell research.^[124] On 9 August 2001, President George W Bush announced that human embryonic stem cell research using federal funds could be conducted only on existing stem cell lines.^[125] This policy sought to balance the potentially valuable therapies that stem cell research may produce against concerns in some sections of United States society that research involving human embryos should not be permitted.

15.75 President Bush indicated that there were then more than 60 ‘genetically diverse stem cell lines’ in existence, which had been created from embryos that had already been destroyed.^[126] However, concerns have now been raised that an insufficient number of human embryonic stem cell lines are available^[127] and that there are deficiencies in existing cell lines.^[128] Further, many of these human embryonic stem cell lines are covered by patents.^[129] It has been suggested that President Bush’s policy has rendered existing embryonic stem cell lines (and patents over such cell lines) more significant.^[130] Professor Rebecca Eisenberg has been reported as saying: ‘what constrains the monopoly power of a patent holder is the prospect of new technology being developed that will make it unnecessary to deal with them … [the] President’s decision limits that threat’.^[131]

15.76 The United States National Institutes of Health (NIH) and private institutions in the United States have endeavoured to facilitate access to human embryonic stem cell lines. The NIH maintains a registry of all stem cell lines that fall within the ambit of President Bush’s policy.^[132] Further, it has entered into agreements with a number of entities to ensure access to proprietary embryonic stem cell lines—including those covered by the Thomson patents—for researchers funded by the NIH.^[133] Privately funded research centres in the United States have also begun to make embryonic stem cell lines available to researchers. For example, in April 2004, the newly established Harvard Stem Cell Institute indicated that it would make 17 new human embryonic stem cell lines available for free to qualified researchers.^[134]

Stem cell banks

15.77 Other overseas initiatives have also been implemented to facilitate access to existing and newly created stem cell lines. In the United Kingdom, the National Institute for Biological Standards and Controls has established the world’s first stem cell bank (UK Stem Cell Bank). The UK Stem Cell Bank opened in May 2004 and plans to supply stem cell lines of all types for use in research in the United Kingdom and other countries, as well as for direct use in the production of human therapeutic products.^[135] A code of practice for the UK Stem Cell Bank is expected to be available in late 2004, regulating the use of stem cell lines in the bank. Terms and conditions about related intellectual property issues are also being developed.

15.78 The establishment of a stem cell bank has also been considered in a number of other jurisdictions. For example, the EU Stem Cell Report proposed the creation of an EU registry of unmodified human stem cell lines, which would include both embryonic stem cells and embryonic germ cells.^[136] In January 2003, the United Kingdom Medical Research Council convened the International Stem Cell Forum for the discussion of international policy issues relating to stem cells.^[137] One of the projects under consideration by the Forum relates to potential collaboration between countries in connection with stem cell banks.

15.79 In Australia, the Research Involving Human Embryos Act and the Prohibition of Human Cloning Act provide for independent reviews of the operation of this legislation, which will include consideration of the applicability of establishing ‘a National Stem Cell Bank’.^[138] The reviews are to be conducted as soon as possible after 19 December 2004 and reports are to be submitted to the Council of Australian Governments and both Houses of Parliament upon completion.^[139]

Commercialisation of stem cell technologies in Australia

15.80 To date, consideration of issues relating to stem cell technologies in Australia has focused on the circumstances in which stem cell research may be conducted and whether it is appropriate for intellectual property rights to be granted in relation to inventions involving stem cell technologies. Regulation of the way in which stem cell patents might be exploited and commercialised has not been addressed in any detail.

15.81 The Andrews Report recommended that a licensing body be established to regulate any research involving the isolation, use and creation of embryonic stem cell lines.^[140] The Report contemplated that this licensing body should have regard to ‘the potential commercialisation of the products’ of such research and would ‘issue guidelines to other Commonwealth agencies’.^[141] However, the functions of the licensing body contemplated by the Andrews Report were more extensive than those ultimately conferred upon the NHMRC Licensing Committee pursuant to Commonwealth, state and territory legislation.^[142]

15.82 Only limited reforms have been implemented to address specific aspects of the commercialisation of stem cell technologies at this stage. For example, in 2003, the Therapeutic Goods Regulations 1991 (Cth)were amended to include provisions requiring manufacturers of prescription medicines to provide consumers with information about whether medicines have been manufactured or tested using human embryonic stem cells.^[143] In the future, additional regulatory provisions directed specifically to stem cell technologies may have a significant effect on the way in which these technologies are developed and commercialised.^[144]

Submissions and consultations

15.83 DP 68 asked whether specific mechanisms should be established to regulate the exploitation of patented stem cell technologies. DP 68 suggested that these mechanisms might include: establishing an Australian stem cell bank, or collaborative agreements with existing stem cell banks in other countries; conferring responsibility on a specific body to monitor the potential exercise of stem cell patent rights; or requiring the NHMRC and the Australian Research Council (ARC) to develop guidelines for researchers relating to the commercial exploitation of inventions involving stem cell technologies.^[145]

15.84 Submissions generally did not support the implementation of specific mechanisms to regulate the exploitation of stem cell patents, or the commercialisation of stem cell technologies.^[146] A few submissions commented that if mechanisms to regulate the exploitation of stem cell patents were introduced, they should operate independently of the Patents Act.^[147]

15.85 A range of submissions commented on the establishment of a stem cell bank in Australia.^[148] Most of these indicated that further consideration of this issue should await the review scheduled to occur under the Research Involving Human Embryos Act and the Prohibition on Human Cloning Act, which is specifically required to consider the need for ‘a National Stem Cell Bank’.^[149] A few submissions observed, however, that even if a stem cell bank were established, it might not be able to compel access to patented stem cell technologies.^[150] The issue of access could be addressed contractually.^[151] Rimmer suggested that a stem cell bank could play ‘an important role as a fair broker between parties to encourage the sharing and exchange of stem cell lines at reasonable prices’.^[152]

15.86 Only a few submissions expressed support for conferring responsibility on a new or existing body to monitor the potential exercise of stem cell patent rights.^[153] The Centre for Law and Genetics suggested that the proposed Human Genetics Commission of Australia could perform this function.^[154] However, another submission commented that the need for such a body had not been demonstrated.^[155] The NHMRC suggested that there may be practical difficulties in determining the scope of any organisation’s role in this regard, including:

the point at which the ‘potential exercise of patent rights’ would be considered, the criteria that any Committee would use to assess the potential impact of the exercise of patent rights, the means by which the Committee would enforce its decisions and how any decisions would ‘cut across’ general patents law.^[156]

15.87 Some submissions expressed support for the development of guidelines to ensure that the public interest in the commercial exploitation of inventions involving stem cell technologies is balanced with the public interest in dissemination of such technologies.^[157] However, others suggested that separate guidelines relating solely to stem cell technologies were not desirable because balancing these competing public interests is an issue for all patented technologies.^[158] In addition, the Department of Health Western Australia observed that the NHMRC and ARC can only ‘encourage compliance [with such guidelines] through provision of funding for research, but this does not apply to commercial organizations’.^[159]

ALRC’s views

15.88 No firm evidence has been presented to the Inquiry to support the establishment of new mechanisms to regulate the exploitation of patented stem cell technologies. Views expressed in submissions and consultations indicated that existing mechanisms and guidelines would be more appropriate to address any concerns that might arise in this area.

15.89 Recommendations made elsewhere in this Report to facilitate access to genetic materials and technologies could also apply to stem cell technologies. These recommendations include: amendments to the existing Crown use and compulsory licensing regime provisions in the Patents Act to facilitate access to patented technologies in appropriate circumstances; and amendments to the Patents Act to incorporate an experimental use exemption.^[160] The ALRC has also recommended that the NHMRC and ARC review the National Principles of Intellectual Property Management for Publicly Funded Research to ensure that publicly funded research, where commercialised, results in appropriate public benefit.^[161] Issues arising in publicly funded research involving stem cell technologies should be addressed as part of this review.

15.90 The ALRC believes that any assessment of whether a stem cell bank should be established in Australia should be addressed as part of the reviews to be conducted under the Research Involving Human Embryos Act and the Prohibition of Human Cloning Act. The desirability of establishing a stem cell bank in Australia will be affected by a variety of factors. These include the need for controlled conditions that comply with good manufacturing practices to maintain stem cell lines, as well as privacy, ethical and legal considerations. Another important issue will be the existence of patent rights over any stem cell lines included in the bank, or technologies related to those stem cell lines. Patent rights could affect the types of stem cell lines that are deposited and the terms on which such stem cell lines may be accessed. These issues should be specifically addressed when the establishment of a National Stem Cell Bank is considered in the forthcoming reviews.