8.42 As discussed in Chapter 16, the Australian biotechnology industry is still in the early stages of development. One consequence of this is that there has been limited judicial consideration of how patent law applies to biotechnological inventions. Little specific guidance is available to patent examiners in assessing whether a particular biotechnological or genetic invention satisfies the requirements for patentability. Dr Dianne Nicol and Jane Nielsen have suggested that ‘the absence of judicial guidance in this area is problematic’.
8.43 IP Australia has developed the Manual to assist Australian patent examiners in applying the Patents Act and Patents Regulations 1991 (Cth) (Patents Regulations). The Manual is intended as a reference guide for examiners on all aspects of patent practice, including: search and examination procedures; interpretation and application of the requirements of patentability under Australia law and relevant procedural provisions of the Patents Act; and practice and procedures in connection with patent applications filed under the PCT. The Manual does not, however, contain a section that specifically considers issues that may arise in applying each of the requirements of patentability to inventions involving genetic materials and technologies.
8.44 To date, the only specific guidance that IP Australia has developed on the patentability of biological inventions is the user guide entitled Australian Patents for: Microoganisms; Cell Lines; Hybridomas; Related Biological Materials and their Use; and Genetically Manipulated Organisms. However, this guide is directed primarily to potential patent applicants, rather than patent examiners, and focuses on the way in which the disclosure requirements might be satisfied in relation to biological inventions.
8.45 Other jurisdictions, particularly the United States and Europe, have more highly-developed case law on patents over biotechnological inventions generally, and inventions involving genetic materials and technologies in particular. In addition, patent offices in some jurisdictions have released specific guidelines outlining the way in which patent law might apply to biotechnological or genetic inventions.
8.46 In September 2002, the United Kingdom Patent Office released its Examination Guidelines for Patent Applications Relating to Biotechnology Inventions in the UK Patent Office (UK Biotech Examination Guidelines), which supplement the Manual of Patent Practice developed by the United Kingdom Patent Office for general use by patent examiners. The introduction to the UK Biotech Examination Guidelines states that applying the basic patentability requirements to biotechnological inventions can ‘place considerable demands on the judgment of the examiner’. To assist United Kingdom patent examiners in assessing such applications, the Guidelines set out relevant case law in this area, and also indicate how patentability requirements should be applied to biotechnological inventions, subject to further guidance from the courts and the Boards of Appeal of the EPO.
8.47 The United States has not issued specific guidelines for examiners about the application of United States patent law to biotechnological or genetic inventions. United States case law in this area is, however, considerably more developed than in other jurisdictions. In addition, the USPTO has provided guidance about its approach to gene patent applications in connection with its implementation of new guidelines for examination of patent applications under the utility and written description requirements for patentability in United States law. While these guidelines apply to all relevant technologies, the USPTO has indicated that the impetus for their adoption was to assist patent examiners in reviewing ‘biological patent applications’.
8.48 In Japan, the JPO has published implementing guidelines for inventions in specific fields, including genetic engineering, as well as model examination reports for certain types of genetic inventions, including applications claiming DNA fragments (or expressed sequence tags) and single nucleotide polymorphisms.
8.49 In Canada, reports by both the Ontario Government and the Canadian Biotechnology Advisory Committee (CBAC) have proposed that the Canadian Intellectual Property Office develop new patent office guidelines, procedures and training manuals relating to gene patents. In addition to assisting patent examiners, CBAC considered that such guidelines would be useful for smaller biotechnology companies who are inexperienced in the patent process.
Submissions and consultations
8.50 DP 68 proposed that IP Australia should develop examination guidelines, consistent with the Patents Act, Patents Regulations and existing case law, to explain how the criteria for patentability apply to inventions involving genetic materials and technologies. A wide range of submissions and consultations supported this proposal.
8.51 Some submissions considered that the adoption of examination guidelines for genetic inventions would assist in improving IP Australia’s examination practices and ensuring that the criteria for patentability are correctly applied—particularly in determining the permissible scope of patent claims. Other submissions indicated that guidelines would help potential patent applicants understand the process by which applications are considered and examined by the Patent Office.
8.52 A few submissions commented on the processes for developing the examination guidelines. The National Health and Medical Research Council suggested that there should be ‘extensive consultation’ in the formulation of the guidelines. The Genetic Support Council WA (Inc) considered that the guidelines needed to ‘include consumer input’. The Caroline Chisholm Centre for Health Ethics suggested that IP Australia should review the guidelines regularly—‘every three years or so’—to keep them ‘current, appropriate and identify any unanticipated areas needing reform’.
8.53 A few concerns were expressed about the effect of adopting examination guidelines for biotechnological inventions alone. The Garvan Institute of Medical Research suggested that, while the proposed guidelines may increase the predictability and transparency of the Patent Office’s decisions in relation to gene patent applications, they may also discourage overseas companies from applying for Australian patents. Similarly, Unisearch Ltd suggested that patent examiners’ reliance on the guidelines might, over time, result in a more rigid application of the patentability criteria. ACIPA submitted that administrative guidelines should be supported by legislative reform of the patentability criteria.
8.54 IP Australia has published general guidelines to assist patent examiners in applying Australian patent law to particular inventions and a users’ guide on patent applications for biological material. However, the ALRC considers that additional guidelines would be desirable to assist patent examiners in applying general patent law principles to biotechnological inventions. Currently, Australian patent examiners have little relevant case law to assist them in determining how the general requirements for patentability in s 18 of the Patents Act apply to a specific genetic invention.
8.55 The examination guidelines should outline IP Australia’s general approach to genetic inventions, and the considerations it regards as relevant in applying the requirements for patentability to gene patent applications, particularly where analogies must be drawn with other technologies on the basis of established case law. The guidelines must be consistent with the Patents Act, the Patents Regulations and existing case law. While the final interpretation of the Act and the Regulations lies with the courts—which may ultimately reject an interpretation of patent law that has been adopted by IP Australia—the ALRC considers that a clear explanation of IP Australia’s approach in assessing gene patent applications would be useful. This approach is consistent with the practices of other Australian regulatory agencies, which have developed guidelines to assist in understanding the application of relevant legislation to specific circumstances.
8.56 The proposed examination guidelines will make IP Australia’s assessment of applications for gene patents more transparent. It will also assist applicants and their legal advisers in assessing the likely availability of patent protection for a particular genetic invention, and in drafting patent claims appropriately. To this end, the guidelines should be in a form that is comprehensible to both patent examiners and patent applicants. The UK Biotech Examination Guidelines are a worthwhile model. However, the ALRC agrees with IP Australia’s suggestion that the proposed guidelines could be included as a separate section in the Manual in order to maintain all instructions on patent examination practices in a single source.
8.57 IP Australia is clearly the most appropriate body to formulate specific guidelines relating to the assessment of patent applications for biotechnological inventions. It should, however, engage relevant stakeholders and other interested parties in consultations before adopting any guidelines in final form. In addition, IP Australia should review the guidelines periodically to ensure that case law and other relevant matters are incorporated.
Recommendation 8–2 IP Australia should develop examination guidelines, consistent with the Patents Act 1990 (Cth) (Patents Act),the Patents Regulations 1991 (Cth) and existing case law, to explain how the criteria for patentability apply to inventions involving genetic materials and technologies.
 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, 20.
 Ibid, 20.
 IP Australia, Patent Manual Practice and Procedure Volume 1: International (2003); IP Australia, Patent Manual of Practice and Procedure Volume 2: National (2002); IP Australia, Patent Manual of Practice and Procedure Volume 3: Oppositions, Courts, Extensions & Disputes (2002).
 There are isolated references to genetic materials in the Manual, as well as a chapter setting out the principles and procedures relevant to the deposit of micro-organisms and other life forms: IP Australia, Patent Manual of Practice and Procedure Volume 2: National (2002), [8.4.2], Ch 6.
 IP Australia, Australian Patents for: Microorganisms; Cell Lines; Hybridomas; Related Biological Materials and their Use; & Genetically Manipulated Organisms, <www.ipaustralia.gov.au/pdfs/ patents/specific/biotech.pdf> at 16 June 2004.
 The fair basis and sufficiency requirements for patentability under Australian law are discussed in Ch 6.
 United Kingdom Patent Office, Examination Guidelines for Patent Applications Relating to Biotechnological Inventions in the UK Patent Office (November 2003), <www.patent.gov.uk/patent/ reference/index> at 16 June 2004.
 Ibid, .
 Ibid, .
 See, eg, University of Rochester v G D Searle & Co Inc (2004) 69 USPQ 2d 1886; Enzo Biochem Inc v Gen-Probe Inc 285 F 3d 1013 (Fed Cir, 2002); Regents of the University of California v Eli Lilly & Co 119 F 3d 1559 (Fed Cir, 1997); Re Dueul 51 F 3d 1552 (Fed Cir, 1995); Re Bell 991 F 2d 781 (Fed Cir, 1993).
 United States Patent and Trademark Office, ‘Guidelines for Examination of Patent Applications under the 35 USC 112, “Written Description” Requirement’ (2001) 66 FR 1099; United States Patent and Trademark Office, ‘Utility Examination Guidelines’ (2001) 66 FR 1092. These guidelines have now been incorporated into the United States Patent and Trademark Office, Manual of Patent Examining Procedure (8th Edition) (2003), , –.
 United States Patent and Trademark Office, ‘Request for Comments on Interim Examination Guidelines for Examination of Patent Applications under the 35 USC 112 para 1 “Written Description” Requirement’ (1998) 63 FR 32639. As a result of certain comments that the USPTO received on the interim written description guidelines, the agency determined that a review of the utility examination guidelines was also required: United States Patent and Trademark Office, ‘Revised Utility Examination Guidelines: Request for Comments’ (1999) 64 FR 71440.
 Japan Patent Office, Implementing Guidelines for Inventions in Specific Fields: Biological Inventions, <www.jpo.go.jp/tetuzuki_e/t_tokkyo_e/txt/bio-e-m.txt> at 16 June 2004.
 Japan Patent Office, Examples of Examinations on the Inventions Related to Genes (DNA Fragments, Full-length cDNAs, and Single Nucleotide Polymorphisms) (Abridged Translation), <www.jpo.go.jp/ tetuzuki_e/t_tokkyo_e/dnas.htm> at 16 June 2004.
 Ontario Ministry of Health and Long-Term Care, Genetics, Testing & Gene Patenting: Charting New Territory in Healthcare: Report to the Provinces and Territories (2002), rec 13(b); Canadian Biotechnology Advisory Committee, Patenting of Higher Life Forms and Related Issues: Report to the Government of Canada Biotechnology Ministerial Coordinating Committee (2002), rec 10.
 Canadian Biotechnology Advisory Committee, Patenting of Higher Life Forms and Related Issues: Report to the Government of Canada Biotechnology Ministerial Coordinating Committee (2002), 21. An update of the Canadian Manual of Patent Office Practice is scheduled for completion by September 2004: Canadian Intellectual Property Office, Information about the Manual of Patent Office Practice, <http://strategis.ic.gc.ca/sc_mrksv/cipo/patents/mopop/mopop-e.html> at 16 June 2004.
 Australian Law Reform Commission, Gene Patenting and Human Health, DP 68 (2004), Proposal 8–4.
 Walter and Eliza Hall Institute of Medical Research, Submission P71, 13 April 2004; South Australian Department of Human Services, Submission P74, 15 April 2004; Royal College of Pathologists of Australasia, Submission P82, 16 April 2004; IP Australia, Submission P86, 16 April 2004; Department of Health Western Australia, Submission P89, 16 April 2004; Cancer Council Australia, Submission P96, 19 April 2004; Cancer Council Victoria, Submission P101, 20 April 2004; National Health and Medical Research Council, Submission P107, 19 April 2004; G Suthers, Submission P116, 4 May 2004; J McKeough, Consultation, Sydney, 23 March 2004; Garvan Institute of Medical Research, Consultation, Sydney, 17 March 2004.
 Medicines Australia, Submission P75, 15 April 2004; Commonwealth Department of Health and Ageing, Submission P79, 16 April 2004; Department of Human Services Victoria, Submission P111, 30 April 2004; Centre for Law and Genetics, Submission P104, 22 April 2004.
 Queensland Government, Submission P103, 22 April 2004. See also A McBratney and others, Submission P47, 22 October 2003; Human Genetics Society of Australasia, Submission P76, 16 April 2004; Sydney IVF Limited, Submission P98, 19 April 2004.
 National Health and Medical Research Council, Submission P107, 19 April 2004.
 Genetic Support Council WA (Inc), Submission P119, 13 May 2004.
 Caroline Chisholm Centre for Health Ethics Inc, Submission P69, 2 April 2004. See also J McKeough, Consultation, Sydney, 23 March 2004.
 Garvan Institute of Medical Research, Consultation, Sydney, 17 March 2004.
 Unisearch, Consultation, Sydney, 15 March 2004.
 Australian Centre for Intellectual Property in Agriculture, Submission P81, 16 April 2004.
 Nicol and Nielsen have also proposed biotechnology-specific guidelines for assessing the ‘description criteria’ (that is, the sufficiency and fair basis requirements for patentability): 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, 258.
 See, eg, Australian Competition and Consumer Commission, Telecommunications Competition Notice Guidelines (2004), developed pursuant to s 151AP of the Trade Practices Act 1974 (Cth).
 IP Australia, Submission P86, 16 April 2004.