6.156 Patent law in Australia and in other jurisdictions requires a patent specification to disclose an invention in such a manner as to allow a person skilled in the relevant art to make or carry out the invention. This requirement is intended to ensure that the scope of protection afforded by a patent is commensurate with the technical contribution made by the claimed invention.
Disclosure requirements under Australian law
6.157 Section 40 of the Patents Act sets out the requirement that a patent specification must fully disclose an invention. Section 40(2)(a) provides that a complete specification must ‘describe the invention fully, including the best method known to the applicant for performing the invention’. This is known as the ‘sufficiency’ requirement. Section 40(3) requires the patent claims to be ‘clear and succinct and fairly based on the matter described in the specification’. This is known as the ‘fair basis’ requirement.
6.158 The Federal Court considered the application of s 40 to biotechnology inventions in Genetics Institute v Kirin-Amgen Inc (No 3). The principal claim at issue was for an isolated and purified polypeptide having the primary structural conformation, and one or more of the biological characteristics, of naturally occurring erythropoietin. The patent disclosed specific DNA sequences for human and monkey DNA, but the claims included other mammalian species. Heerey J held that the claims were permissibly wide because they disclosed the coding sequence for erythropoietin, which is a ‘principle capable of general application’. His Honour held that a claim in correspondingly general terms was therefore acceptable.
6.159 It has been suggested that broad claims of the type accepted by Heerey J in Kirin Amgen may no longer satisfy the disclosure requirement given the developments in the field of genetics since that case was decided. There is, however, little other guidance in Australian case law to assist patent examiners in determining how the disclosure requirements should apply to gene patents. IP Australia commented that, although the decision in Kirin-Amgen is consistent with decisions in other areas of technology, the gene technology at issue in the case was relatively straightforward and the case was not required to address ‘many of the more complex and contentious issues that arise in gene technology’.
6.160 IP Australia’s Manual sets out its approach to one particular issue in the application of the disclosure requirements to inventions in the biotechnology field, namely, the question of ‘reach-through claims’. A reach-through claim is one that seeks to claim the right to a future invention on the basis of a currently disclosed invention. In such cases, the Manual explains that:
The specification generally discloses a new peptide or nucleic acid sequence, or a newly discovered link between a peptide or a nucleic acid and a specific disease or medical condition, and then claims compounds that interact with the peptide or nucleic acid and downstream uses of those compounds.
6.161 The Manual states that reach-through claims that seek to cover compounds that interact with a specific peptide or nucleic acid sequence may fail to satisfy the fair basis requirement because they are not claims to the product of the invention, but are merely directed to compounds inherently capable of interaction with the invention. In addition, such claims may fail to satisfy the sufficiency requirement because they provide insufficient information to enable the production of the full range of compounds that potentially fall within the scope of the claims. The Manual suggests, however, that reach-through patent claims to methods of using candidate compounds may not raise the same issues.
Disclosure requirements in the United States
6.162 In the United States, the disclosure requirements are expressed in terms of ‘enablement’ and ‘written description’. Enablement requires a determination of whether a person skilled in the art can make and use the claimed invention without undue experimentation. The written description requirement is satisfied if a patent specification describes the claimed invention in sufficient detail that a person skilled in the art can reasonably conclude that the inventor ‘had possession’ of the claimed invention. Satisfaction of the enablement and written description requirements are closely linked to the utility requirement because the application of an invention claimed in a patent must be described such that a person skilled in the art could make and use the invention themselves on the basis of the patent claims.
6.163 Recent decisions of the Court of Appeals for the Federal Circuit have begun to elucidate principles governing the nature of the disclosure that will be required for particular types of genetic inventions. In 2001, the USPTO introduced new guidelines for the application of the written description requirement by United States patent examiners.
Submissions and consultations
6.164 Several submissions expressed concern about the scope of gene patent claims. Concerns about the breadth of claims in gene patents were primarily directed to the potential adverse impact such claims may have on further research and the development, cost and accessibility of new procedures and products involving genetic materials and technologies.
6.165 DP 68 asked whether the fair basis and sufficiency requirements in s 40 of the Patents Act adequately limit the scope of gene patent claims and, if not, what reforms are required to address deficiencies in the way these requirements are applied.
6.166 A number of submissions considered that the sufficiency and fair basis requirements in s 40 are capable of adequately limiting gene patent claims. Some suggested that there was no evidence of a particular problem. Others commented that broad claims are characteristic of patents relating to all types of new technologies, not only gene patents. A few submissions indicated that the scope of gene patent claims appears to have narrowed in recent times.
6.167 IP Australia did not consider that inventions involving genetic materials and technologies require special treatment under the sufficiency and fair basis requirement. It acknowledged, however, that there may be a lack of understanding about the application of s 40 to genetic inventions. It suggested that this might be a result of the fact that ‘many legal practitioners do not have a genetics or biotechnology background’; a situation which is compounded by the paucity of relevant case law in Australia and overseas.
6.168 However, IP Australia considered that greater certainty in the application of s 40 to gene patents will develop as case law and practice evolves. It suggested that the development of specific examination guidelines relating to biotechnological inventions would ‘improve technical understanding of the interaction between s 40 and gene technology’. Other submissions also supported the development of guidelines in this area. IPTA and AusBiotech Ltd suggested that it is possible to apply precedents developed in relation to chemical and pharmaceutical compounds to inventions involving genetic materials and technologies, by analogy.
6.169 In his submission, Dr John Abbott analysed the scope of claims in a range of Australian patents and patent applications relating to gene-based diagnostic testing of human diseases. The study suggested a wide range in the scope of patent claims, but concluded that existing provisions in the Patents Act—particularly s 40—may provide mechanisms to limit the scope of gene-based diagnostic patents. Abbott considered that the application of the sufficiency and fair basis requirements could be facilitated by accepting ‘a more sophisticated and detailed level of scientific input’—including by ‘changes to the levels of scientific expertise of those involved in the process, as well as [the] evidence provided for their consideration’.
6.170 A small number of submissions commented on the type of information that a patent applicant should be required to adduce to satisfy the disclosure requirements. AusBiotech Ltd considered that ‘the specification must disclose an actual experimental demonstration of at least one biological function of the nucleic acid or corresponding protein’. Similarly, the Australian Health Ministers’ Advisory Council considered that ‘experimental evidence of biological function [should be] disclosed in the patent specification’. The Department of Health Western Australia considered that a patent applicant should be required to support the claims in a patent with ‘proof of concept’ data, at the bare minimum.
6.171 Some submissions considered that the sufficiency and fair basis requirements are not being stringently applied by Australian patent examiners and may require reform. ACIPA stated that ‘the evidence would suggest that patent attorneys are still drafting broad claims in respect of genes and gene sequences, and such claims are being accepted by the Patent Office in large part’. ACIPA questioned the way in which the disclosure requirements have been applied by IP Australia:
It is submitted that genetic materials are presently being patented in a way that fails to recognise the potential additional inventiveness … by granting broad claims which include the additional potential of the sequence and other biological processes associated with that sequence.
6.172 McBratney and others also considered that the fair basis requirement is ‘long overdue for review and reform’, but that the difficulties raised by the requirement are not restricted to inventions involving genetic materials and technologies:
[T]here is great ambiguity as to what experimentation and disclosure is necessary to sufficiently enable Australian and US patents, especially as relating to ‘gene patents’ and more so with potential drug targets and ‘method of treating disease’ patents. The same problem may also be encountered with ‘composition of matter’ patents which claim broad classes of analogue compounds for inhibiting certain targets or proteins. The question is where to draw the line.
6.173 McBratney and others proposed that this issue might be addressed by the development of clear guidelines on sufficiency and fair basis, similar to the USPTO’s Written Description Guidelines.
6.174 While some submissions raised concerns about the scope of gene patent claims, no firm evidence was provided to the Inquiry that the sufficiency and fair basis requirements in s 40 of the Patents Act are not adequate to address them. The ALRC agrees with submissions suggesting that complexities in the way in which these requirements apply to inventions involving genetic materials and technologies are likely to be resolved by the development of further guidance in this area. Pending further judicial consideration of this issue, the ALRC believes that guidelines developed by IP Australia could assist patent examiners and users of the patent system in understanding how the s 40 requirements should apply to patents over genetic materials and technologies (see Recommendation 8–2).
6.175 In Chapter 8, the ALRC recommends that IP Australia should enhance its education and training programs for patent examiners in areas of technology relevant to their particular specialties and that the Commissioner of Patents should be satisfied on the balance of probabilities that each requirement for patentability relevant at the examination stage is made out. These reforms will assist patent examiners in understanding particular issues that may be raised by genetic technologies in the application of the sufficiency and fair basis requirements. It will also raise the standard of proof from the ‘benefit of the doubt’ standard that currently applies to the examination of the fair basis and sufficiency requirements.
 M Howlett and A Christie, An Analysis of the Approaches of the Trilateral and Australian Patent Offices to Patenting Partial DNA Sequences (ESTs) (2003), 22.
 Genetics Institute Inc v Kirin-Amgen Inc (No 3) (1998) 156 ALR 30 (Heerey J). This decision was an appeal from the decision of the Deputy Commissioner of Patents in Kiren-Amgen Inc v Board of Regents of University of Washington (1995) 33 IPR 557 discussed above. An appeal to the Full Federal Court was dismissed: Genetics Institute Inc v Kirin-Amgen Inc (1999) 92 FCR 106.
 Genetics Institute Inc v Kirin-Amgen Inc (No 3) (1998) 156 ALR 30, 46.
 Ibid, 46.
 D Nicol and J Nielsen, Patents and Medical Biotechnology: An Empirical Analysis of Issues Facing the Australian Industry (2003) Centre for Law and Genetics Occasional Paper No 6, 33. See also C Lawson, Submission P67, 4 March 2004.
 IP Australia, Submission P86, 16 April 2004.
 IP Australia, Patent Manual of Practice and Procedure Volume 2: National (2002), [10.10].
 S Kunnin and others, ‘Reach-through Claims in the Age of Biotechnology’ (2002) 51 American University Law Review 609, 618–619.
 IP Australia, Patent Manual of Practice and Procedure Volume 2: National (2002), [10.10.1].
 Ibid, [10.10.3].
 Ibid, [10.10.4]. ‘Reach-through’ compound claims may also fail to satisfy the novelty requirement: IP Australia, Patent Manual of Practice and Procedure Volume 2: National (2002), [10.10.2].
 IP Australia, Patent Manual of Practice and Procedure Volume 2: National (2002), [10.10.5].
 35 USC s 112.
 Re Wands 858 F 2d 731 (Fed Cir, 1988).
 United States Patent and Trademark Office, ‘Guidelines for Examination of Patent Applications under the 35 USC 112, “Written Description” Requirement’ (2001) 66 FR 1099. See also United States Patent and Trademark Office, Manual of Patent Examining Procedure (8th Edition) (2003), –.
 See, eg, University of Rochester v G D Searle & Co Inc (2004) 69 USPQ 2d 1886; Regents of the University of California v Eli Lilly & Co 119 F 3d 1559 (Fed Cir, 1997); Enzo Biochem Inc v Gen-Probe Inc 285 F 3d 1013 (Fed Cir, 2002). See also A Cantor, ‘Using the Written Description and Enablement Requirements to Limit Biotechnology Patents’ (2000) 14 Harvard Journal of Law & Technology 267.
 United States Patent and Trademark Office, ‘Guidelines for Examination of Patent Applications under the 35 USC 112, “Written Description” Requirement’ (2001) 66 FR 1099.
 See, eg, Cancer Council Australia, Submission P25, 30 September 2003; Caroline Chisholm Centre for Health Ethics Inc, Submission P38, 17 October 2003; Australian Health Ministers’ Advisory Council, Submission P49, 23 October 2003; South Australian Government, Submission P51, 30 October 2003; National Health and Medical Research Council, Submission P52, 31 October 2003; Commonwealth Department of Health and Ageing, Submission P65, 28 January 2004.
 Australian Health Ministers’ Advisory Council, Submission P49, 23 October 2003; Commonwealth Department of Health and Ageing, Submission P79, 16 April 2004.
 Australian Law Reform Commission, Gene Patenting and Human Health, DP 68 (2004), Question 6–1.
 F B Rice & Co, Submission P84, 16 April 2004; Queensland Government, Submission P103, 22 April 2004.
 J Abbot, Submission P83, 16 April 2004; GlaxoSmithKline, Submission P85, 16 April 2004; Department of Industry Tourism and Resources, Submission P97, 19 April 2004; Institute of Patent and Trade Mark Attorneys of Australia, Submission P106, 27 April 2004.
 Department of Industry Tourism and Resources, Submission P36, 13 October 2003; Davies Collison Cave, Submission P48, 24 October 2003; IP Australia, Submission P56, 4 November 2003; Department of Health Western Australia, Submission P89, 16 April 2004.
 National Health and Medical Research Council, Submission P52, 31 October 2003; Commonwealth Department of Health and Ageing, Submission P65, 28 January 2004; F B Rice & Co, Submission P84, 16 April 2004.
 IP Australia, Submission P86, 16 April 2004. In contrast, another submission considered that patent examiners lack sufficient expertise to apply the sufficiency and fair basis requirements: Department of Health Western Australia, Submission P89, 16 April 2004.
 IP Australia, Submission P86, 16 April 2004. See also GlaxoSmithKline, Submission P33, 10 October 2003.
 See rec 8–2.
 A McBratney and others, Submission P47, 22 October 2003; Queensland Government, Submission P103, 22 April 2004; Centre for Law and Genetics, Submission P104, 22 April 2004.
 AusBiotech Ltd, Submission P58, 7 November 2003; Institute of Patent and Trade Mark Attorneys of Australia, Submission P106, 27 April 2004.
 J Abbot, Submission P83, 16 April 2004.
 Ibid. Dr Abbott’s comments in this regard were not limited to Australian patent examiners or judges, but included those who present the ‘evidence and analysis’ of a particular case to an examiner or judge (ie, legal practitioners).
 AusBiotech Ltd, Submission P58, 7 November 2003.
 Australian Health Ministers’ Advisory Council, Submission P49, 23 October 2003.
 Department of Health Western Australia, Submission P53, 3 November 2003.
 C Lawson, Submission P67, 4 March 2004; Walter and Eliza Hall Institute of Medical Research, Submission P71, 13 April 2004; S Brown, Submission P78, 16 April 2004; Australian Centre for Intellectual Property in Agriculture, Submission P81, 16 April 2004.
 Australian Centre for Intellectual Property in Agriculture, Submission P12, 29 September 2003. See also R Barnard, Submission P32, 7 October 2003; South Australian Government, Submission P51, 30 October 2003; Commonwealth Department of Health and Ageing, Submission P65, 28 January 2004.
 Australian Centre for Intellectual Property in Agriculture, Submission P12, 29 September 2003. See also C Lawson and C Pickering, ‘Patenting Genetic Material: Failing to Reflect the Value of Variation in DNA, RNA and Amino Acids’ (2000) 11 Australian Intellectual Property Journal 69.
 A McBratney and others, Submission P47, 22 October 2003.
 Ibid. See also United States Patent and Trademark Office, ‘Guidelines for Examination of Patent Applications under the 35 USC 112, “Written Description” Requirement’ (2001) 66 FR 1099.
 See rec 8–1 and 8–2.
 See rec 8–3. See also Commonwealth Department of Health and Ageing, Submission P79, 16 April 2004.