Existing patents and patent applications

15.27 Patent applications claiming animal and human stem cells and stem cell technologies have been filed in Australia and other jurisdictions.[38] A 2002 report of the European Group on Ethics in Science and New Technologies (EU Stem Cell Report) indicated that, by May 2002, over 2,000 patent applications involving human and animal stem cells had been filed worldwide, one quarter of which related to embryonic stem cells.[39] Approximately one third of all stem cell patent applications have been granted.[40]

15.28 The types of products and processes claimed in patent applications include stem cells, stem cell lines, and differentiated and genetically modified stem cells. They also include processes for: the creation of embryos by somatic cell nuclear transfer and parthenogenesis; isolating and culturing stem cells; inducing stem cells to differentiate; and genetically modifying stem cells for particular applications.[41]

15.29 A number of granted stem cell patents have been identified as particularly significant because of the scope of the patent claims and the specific stem cell technologies covered by the patents. These include certain patents over human and primate embryonic stem cell technology held by the Wisconsin Alumni Research Foundation (WARF).[42] These patents are often referred to as the ‘Thomson patents’, after Dr James Thomson who led the team that first reported the isolation and differentiation of human embryonic stem cells.[43] The Thomson patents cover methods for isolating embryonic stem cells[44] and for transplanting them into human beings.[45] One of the Thomson patents also claims unmodified human embryonic stem cell lines per se, regardless of their ‘creator’.[46]

15.30 In Australia, stem cell patents have been granted to a number of companies, including BresaGen Limited, Geron Corporation, and ES Cell International Pte Ltd.[47] A preliminary search of IP Australia’s online patents databases also revealed pending applications claiming inventions involving human embryonic stem cells, or processes involving such cells.[48]

15.31 Patents have also been granted over adult stem cell lines. For example, Johns Hopkins University holds a patent on the processes for isolating adult bone marrow stem cells;[49] and MorphoGen Pharmaceuticals Inc has obtained a patent claiming ‘purified pluripotent mesenchymal stem cells’ obtained from cultured muscle cells.[50]

[38] As of February 2000, IP Australia had granted four patents for cloning processes applicable to non-human mammals and ‘routinely grants patents for both human and animal cell lines’ that satisfy the statutory requirements for patentability: IP Australia, Submission to House of Representative Standing Committee on Legal and Constitutional Affairs Inquiry into the Scientific, Ethical and Regulatory Aspects of Human Cloning and Stem Cell Research, Commonwealth of Australia, <www.aph.gov.au/house/ committee/laca/humancloning/sub274.pdf> at 16 June 2004.

[39]European Group on Ethics in Science and New Technologies, Ethical Aspects of Patenting Inventions Involving Human Stem Cells: Opinion to the European Commission (2002), 11. This figure does not make any adjustment for patent applications that may be filed in a number of jurisdictions but relate to the same invention.

[40]Ibid, 11. For a survey of United States patents covering embryonic stem cells, see G McGee and E Banger, ‘Ethical Issues in the Patenting and Control of Stem Cell Research’ in D Magnus, A Caplan and G McGee (eds), Who Owns Life? (2002), 243.

[41]European Group on Ethics in Science and New Technologies, Ethical Aspects of Patenting Inventions Involving Human Stem Cells: Opinion to the European Commission (2002), 11–12.

[42] WARF is an intellectual property holding entity established by the University of Wisconsin.

[43]J Thomson and others, ‘Embryonic Stem Cell Lines Derived from Human Blastocysts’ (1998) 282 Science 1145.

[44] US Pat No 5,843,780 and 6,200,806.

[45] US Pat No 6,280,718.

[46] US Pat No 6,200,806.

[47] See, eg, AU Pat No 755176; AU Pat No 751321; and AU Pat No 764684.

[48] See, eg, AU App No 2002322379 filed by Geron Corporation; AU App No 2002334378 filed by Reliance Life Sciences Pvt Ltd; and AU App No 2002340638 filed by ES Cell International Pte Ltd.

[49] US Pat No 5,130,144.

[50] US Pat No 5,827,735.