Impact of gene patents on novel genetic therapies

20.66 Patent laws and practices may have an impact on the development and provision of other forms of healthcare, including novel therapies such as gene therapy, the use of stem cells and the production of therapeutic proteins. However, as these therapies remain largely experimental, gene patents have as yet had little practical impact.[110]

20.67 Any treatment based on gene therapy will require the use of a gene carrier or ‘vector’ and a genetic sequence. Patents on the use of vectors may constrain the development of gene therapy in Australia. Further, if the gene is patented, treatment for gene therapy may depend, at least in part, on the availability of a licence from the patent holder.

20.68 Gene patents may also affect the use of therapeutic proteins in healthcare.[111] Patents over therapeutic proteins generally assert rights over the genetic sequence as well as the protein itself because the genetic sequence is crucial to the production of the protein.[112]

20.69 Gene patents may also be relevant to the use of stem cells in medical treatment (see Chapter 15). The Ontario Government report, Genetics, Testing & Gene Patenting: Charting New Territory in Healthcare, has commented that ‘the patenting of stem cells may well mean that exclusive royalty fees will have to be paid in the future for replacement organs and tissues, developed in this manner, raising significant implications for publicly funded healthcare systems’.[113]

20.70 While patent rights are essential in encouraging investment in the development of novel genetic therapies, the RCPA submitted that the ‘broad scope of many patents on genetic material’ is likely to discourage such investment.[114]

20.71 Dr McBratney and others submitted that patenting these kinds of therapeutics raises the same kind of issues as the patenting of drugs or medical methods generally and should be treated no differently.[115] The Department of Industry, Tourism and Resources observed that restricting gene patenting would be likely to have a negative impact on capital inflows into Australia, which may deny the community the benefit of new gene based therapies.[116] Similarly, GlaxoSmithKline referred to the major investment needed to develop new treatments based on genetics and emphasised that patents are no less essential to the development of these forms of treatment than they are in relation to pharmaceutical development.[117]

[110] As at June 2004, the Gene and Related Therapies Research Advisory Panel (GTRAP) of the National Health and Medical Research Council had approved 14 gene therapy studies: National Health and Medical Research Council, Australian Gene Therapy Studies Approved by GTRAP, < nhmrc> at 16 June 2004. The possible therapeutic uses of stem cells are discussed in Ch 15.

[111] Drugs based on proteins produced by the body include beta interferon and Epo (erythropoietin). Beta interferon is used to treat multiple sclerosis. Epo is used as a treatment for persons with certain types of anaemia.

[112] Nuffield Council on Bioethics, The Ethics of Patenting DNA (2002), 63.

[113] Ontario Ministry of Health and Long-Term Care, Genetics, Testing & Gene Patenting: Charting New Territory in Healthcare: Report to the Provinces and Territories (2002), 39.

[114] Royal College of Pathologists of Australasia, Submission P26, 1 October 2003.

[115] A McBratney and others, Submission P47, 22 October 2003.

[116] Department of Industry Tourism and Resources, Submission P36, 13 October 2003.

[117] GlaxoSmithKline, Submission P33, 10 October 2003.