Accommodating new technologies
3.11 The patent system is over 400 years old. It has accommodated the arrival of many new technologies including: inventions associated with mechanics in the industrial revolution; electricity and electronics; industrial and chemical materials; food production and agriculture; scientific instruments and devices; transportation and energy; warfare; medical devices and pharmaceutical products; computing and information technology; and business methods. In the past 20 years, inventions in the field of biotechnology have become a new focus of the patent system, particularly in relation to genetic materials and technologies.
3.12 Each new field of technology has brought with it new challenges for the patent system, as those responsible for processing patent applications seek to assess the novelty, inventiveness and usefulness of each new claimed invention, in the light of what has gone before. These challenges have been felt in the area of gene patents, where the difficulty of the examiners’ task has been compounded by the newness of the claims, the increasing pace of technological change, the global nature of scientific inquiry, the highly specialised nature of genetic science and technology, and the sheer volume of inventions. Once patent examiners have become familiar with genetics, they will, no doubt, be met with a new range of challenges from emerging disciplines such as bioinformatics, pharmacogenomics, proteomics and nanotechnology.
A chronology of genetic technologies and patents
3.13 In 1953, the foundation for modern genetics was laid when the scientific journal, Nature, published Watson and Crick’s hypothesis about the double helix structure of DNA. Their article suggested a mechanism by which genetic material could be stored, transferred and copied.
3.14 Twenty years later, Cohen, Boyer and Chang developed a technique that allowed sections of DNA to be transferred from one life form into another, thereby producing the first ‘recombinant organism’. This advance was significant because, for the first time, scientists could artificially introduce genetic traits into other species.
3.15 Commercialisation of genetic technology followed soon after when, in 1976, Boyer and Swanson established the first known biotechnology company, Genentech Inc, in Berkeley, California. In 1977, Genentech reported the production of the first human protein manufactured in a bacterium. The technology demonstrated that molecules could be produced in large quantities in bacterial vectors and then administered to patients, raising hopes that recombinant technology could aid the treatment of human disease.
3.16 A second crucial breakthrough in genetic science occurred in 1977 when Sanger identified a method for reading DNA sequences. Scientists could now read the genetic code, and so gain an understanding of genetic mutations that cause human disease as well as the functional and evolutionary relationships between genes. The Sanger methodology remains the basis of modern gene sequencing.
3.17 A third major innovation in genetics was the development of PCR. Developed in the 1980s by Mullis and others at Cetus Corporation, PCR provided a quick and easy method for selective amplification of DNA fragments, removing the need for cloning in micro-organisms. Amplifications that previously took weeks could now be done in a matter of hours. After patenting the process, Cetus sold the patent to Hoffman-La Roche Inc (Roche). Roche now holds more than 130 patents in the United States related to the PCR process. The process has become the foundation for almost all genetic laboratory work, making access to the patented technology crucial.
3.18 While genetic technology was progressing apace, legislatures, courts and regulators were also forced to address issues arising from the commercialisation of genetic inventions. The controversial decision in Diamond v Chakrabarty, handed down by the United States Supreme Court in 1980, allowed a patent to be granted for a recombinant bacterium, thus determining that life forms are patentable subject matter under United States law. In the same year, the United States Congress passed the Bayh-Dole Act, providing that intellectual property rights arising from publicly funded research vest in the organisations that carry out the research. The underlying policy of the legislation was to encourage innovation and exploitation by allowing universities to patent inventions flowing from their research. In 1982, the United States Food and Drug Administration (FDA) approved the first recombinant DNA drug for market, demonstrating that government agencies had accepted some genetically manipulated products as safe for medical use.
3.19 The biotechnology industry expanded rapidly during the 1980s. In 1985, the FDA gave approval for the first drug to be both manufactured and marketed by a biotechnology company. Sequencing methods improved with the introduction in 1986 of the automated DNA fluorescence sequencer developed by the Californian Institute of Technology and Applied Biosystems Inc. In 1988, the United States Patent and Trademark Office granted the first United States patent over an entire animal, the ‘Harvard Mouse’. This move provoked widespread concern about the ethics of patenting higher life forms. Genetically altered mice (and other animals) are valuable research tools for both industry and academic researchers, principally because they serve as animal models of human disease.
3.20 The role of patent law in facilitating innovation in the field of genetics continued to excite controversy in the 1990s. One issue of contention was the level of usefulness or utility that needed to be demonstrated to support a claim over a genetic invention. In 1991, the United States National Institutes of Health (NIH) filed patent applications on approximately 2,700 ESTs. The applications included not only claims over the ESTs, but also over their full-length gene sequences and derivative proteins. These claims were controversial because the functions of these sequences were unknown at the time of filing. The NIH eventually abandoned the applications.
3.21 Another issue for patent law has been the breadth of claims made in applications for patents over genetic inventions. An example is the patent issued in 1993 to Australian scientist Dr Malcolm Simons, over ‘the use of non-coding DNA for genetic analysis’, and the grant five years later of a further patent to cover the use of non-coding DNA for the purposes of gene mapping. An Australian company, Genetic Technologies Limited, now holds these patents.
3.22 The commencement of the Human Genome Project in 1990 was an indication of the thriving state of genetic research. A new era of genomics was entered in February 2001, with the publication by the Human Genome Project and the Celera Genomics Group of the working draft of the human genome sequence. Final sequencing of the human genome was completed in April 2003. The vast amount of information released during the course of the Project will be a spur to further research and innovation, and may bring with it a new array of problems for gene patenting.
 The protein produced was somatostatin, a hormone that inhibits the secretion of human growth hormone.
 Gilbert and Maxam also created a sequencing method at this time, based upon the ‘cleavage method’.
 The PCR process is described in Australian Law Reform Commission and Australian Health Ethics Committee, Essentially Yours: The Protection of Human Genetic Information in Australia, ALRC 96 (2003), [10.2].
 Roche Molecular Diagnostics, PCR Information for Journalists, <www.roche-diagnostics.com/ba_rmd/ pcr_jounalists.html> at 16 June 2004.
Diamond v Chakrabarty 447 US 303 (1980).
 Previously, the United States government retained title to such intellectual property. This meant that universities and researchers had little incentive to commercialise their inventions.
 See D Mowery and others, ‘The Growth of Patenting and Licensing by US Universities: An Assessment of the Effects of the Bayh–Dole Act of 1980’ (2001) 30 Research Policy 99, 103.
 The drug was a recombinant human insulin, produced by Genentech and licensed to Eli Lilly & Co.
 This was Genentech’s protropin, a treatment for child growth hormone deficiency.
 The ‘Harvard Mouse’ was genetically engineered to be highly susceptible to breast cancer.
 See, eg, Greenpeace, Supreme Court of Canada Rejects Patent for Mouse, 5 December 2002, <www.greenpeace.ca/e/campaign/gmo/depth/highlights> at 16 June 2004.
 Mice and other animals may be genetically engineered by adding a foreign gene to their cells (a ‘transgenic mouse’), or deleting or making inactive a specific gene in their cells (a ‘knockout mouse’).
 M Holman and S Munzer, ‘Intellectual Property Rights in Genes and Gene Fragments: A Registration Solution for Expressed Sequence Tags’ (2000) 85 Iowa Law Review 735, 750.
 Intron Sequence Analysis Method for Detection of Adjacent and Remote Locus Alleles as Haplotypes: US Pat No 5,192,659. See also US Pat No 5,612,179 and 5,789,568.
 Genomic Mapping Method by Direct Haplotyping Using Intron Sequence Analysis: US Pat No 5,851,762.
 Patents have also been granted in Australia in relation to non-coding DNA: see, eg, Intron Sequence Analysis Method for Detection of Adjacent and Remote Locus Alleles as Haplotypes AU67519; Genomic Mapping by Direct Haplotyping Using Intron Sequence Analysis AU647806; Intron Sequence Analysis Method for Detection of Adjacent and Remote Locus Alleles as Haplotypes AU654111.
 See K Davies, Cracking the Genome: Inside the Race to Unlock Human DNA (2001), 3.
 The draft was published in special issues of Science (16 February 2001) and Nature (15 February 2001).
 National Human Genome Research Institute, Home Page, <www.nhgri.nih.gov> at 16 June 2004.
 See F Collins and others, ‘A Vision for the Future of Genomics Research: A Blueprint for the Genomic Era’ (2003) 422 Nature 835.