Qualifications, training and assistance

8.19 IP Australia has a number of examination sections, each of which specialises in different areas of technology.[24] A report on the Australian biotechnology industry published in 2001 noted that biotechnology inventions are assessed by examiners with particular expertise and training in the field, in accordance with the practices of patent offices in other jurisdictions.[25] However, IP Australia informed the ALRC that ‘while there is a degree of specialisation within each field, IP Australia examiners are expected to assess a greater range of technologies than may be the case in the larger offices such as the USPTO and EPO’.[26] IP Australia has provided the ALRC with further information about qualification requirements and training programs for Australian patent examiners.[27]

Qualifications

8.20 To be eligible for a position as a patent examiner, an applicant must hold a university degree in science or engineering. Examiners who assess applications for genetic materials and technologies must have qualifications in the field of biochemistry. Although experience in a relevant industrial field is not mandatory, it is now common for newly recruited examiners to have considerable industrial experience, as well as graduate or postgraduate qualifications. IP Australia also uses its recruitment process strategically and ‘particularly seeks to recruit staff with demonstrated expertise in emerging technologies’.[28]

8.21 IP Australia trains new recruits to allow them to perform the various functions required of a patent examiner. Supervising and senior examiners conduct this training, which covers Australian patent law and practice. It includes a formal assessment regime, as well as practical training and supervision. The purpose of this training is to enable new examiners to reach the required competency standard to exercise the ‘acceptance delegation’.[29] Acceptance delegation refers to the Commissioner of Patents’ ability under the Patents Act to delegate his or her power to examine and, if appropriate, accept patent applications.[30] Examiners must demonstrate an ‘appropriate level and quality of work output and have the experience, knowledge and judgement to be able to reliably exercise the delegation’.[31] Typically, examiners reach this level of competence after approximately 30 months of service with IP Australia.

Training

8.22 IP Australia has a continuing professional development program for patent examiners. The program aims to develop examiners’ skills in patent law, examination and searching practices, and knowledge in relevant technological fields. The majority of resources allocated to IP Australia’s professional development program are directed to improving examiners’ understanding in relevant technological fields.[32] The program includes: supporting examiners in postgraduate studies; internal and external training programs conducted by industry specialists or tertiary institutions; participation in conferences and seminars; visits to relevant industries; and placements in patent attorney firms.

8.23 Each examination section within IP Australia also has access to relevant on-line resources, text books and key scientific journals—such as Nature and Science—to allow examiners ‘to keep abreast of the latest scientific developments and for researching issues for particular examination cases’.[33]

Assistance

8.24 Currently, patent examiners may refer any issues or problems to senior or supervising examiners within their section. IP Australia’s Patent Manual of Practice and Procedure (the Manual) indicates that an examiner should raise any concerns he or she may have about mastering the technical and legal aspects of an application with a senior examiner.[34] IP Australia has adopted policies that require patent applications for certain types of technologies to be referred to a supervising examiner automatically; for example, patent applications that may claim human beings or the biological processes for their generation.[35] In addition, examiners faced with new issues may consult other examiners with relevant expertise to obtain assistance on an informal basis.[36]

8.25 A more formalised system for review of particular types of patent applications has been adopted by the USPTO. The USPTO has announced that it will expand its practice of ‘second-pair-of-eyes’ review to cover fields such as biotechnology, semiconductors and software.[37] A report of the United States Federal Trade Commission in 2003 endorsed such initiatives[38] and commented that they ‘can significantly help improve the quality of patent application review’.[39]

8.26 To date, there is limited precedent for providing patent examiners with access to outside scientific or technical expertise.[40] A recent report of the Royal Society recommended that patent examiners in the United Kingdom should consult experts to ensure that their understanding of relevant areas of science is extremely high,[41] so that examiners are able to apply the same demanding standards in both developing and established areas of science.[42] The USPTO has engaged an in-house business practice specialist to act as a resource on industry practices, terminology and standards for patent examiners assessing applications for business systems. However, IP Australia indicated in its submission that an equivalent position ‘would not be feasible … due to the much smaller scale of operations’ in Australia.[43]

Submissions and consultations

Qualifications and training

8.27 During the Inquiry, concerns were raised about patent examiners’ expertise and the need for continuing training to allow patent examiners to keep abreast of technological developments in relevant fields. Some submissions considered that the expertise of patent examiners in any rapidly developing area of science might be an issue because the quality of patent examination is limited by the level of technical skill of an examiner.[44] Other submissions commented that this might be a particular issue for patent applications relating to genetic materials and technologies, and stem cell technologies, because the assessment of such applications might require a greater understanding of the relevant scientific background than in other areas of technology.[45] Variations in the level of skill of Australian patent examiners were noted in consultations.[46] A small number of submissions indicated that the expertise of patent examiners is not currently a concern, but is a matter that warrants further review.[47]

8.28 To ensure the ongoing competence of Australian patent examiners in assessing patent applications, DP 68 proposed that IP Australia should continue to enhance its efforts to provide examiners with continuing education in areas of technology relevant to their particular specialty.[48]

8.29 A majority of submissions supported this proposal.[49] Some submissions indicated that providing continuing education to patent examiners is vital ‘given the rapid growth in the scope and complexity of gene technology’[50] and the concomitant difficulties for examiners in finding and managing all relevant information.[51] Others considered that enhancing IP Australia’s current education programs would help to ensure that, when determining whether to grant a patent, examiners strike an appropriate balance between ‘providing an incentive to innovate and ensuring that the results of such innovation are readily … available’.[52] Dr Amanda McBratney and others suggested that there should be regular ‘auditing and updating of examiner skills’.

Examiners should be involved in a process of ongoing education so that they are as up to date in the relevant technological areas as possible. Continuing education should be mandatory—not only course work, but attendance at conferences (as this is where the most up to date information is discussed).[53]

Expert assistance

8.30 At an early stage of the Inquiry, a number submissions and consultations indicated that expert advice should be available to patent examiners in assessing patent applications, whether involving genetic materials and technologies or new technologies generally.[54] However, differing views were expressed about the composition of any expert panel, the types of issues on which expert advice should be provided, and the function of an expert advisory panel.[55]

8.31 DP 68 proposed that the Patents Act be amended to authorise IP Australia to establish panels of legal and scientific experts to advise patent examiners in assessing patent applications, as circumstances may require.[56] A number of submissions supported this proposal as a means of improving patent examination practices.[57] For example, the Department of Health and Ageing submitted:

The provision of expert advice through panels of experts would enable the consideration of complex issues beyond that which is realistically achievable by individual examiners.[58]

8.32 However, other submissions expressed a range of concerns about the establishment of an expert panel. Comments suggested that the use of expert panels would increase the costs of examining patent applications and delay the grant of patents.[59] A few submissions observed that a panel of experts would introduce additional decisions in respect of which a patent applicant may seek administrative or judicial review.[60] Those decisions include: an examiner’s decision as to whether an application should be referred to the panel; the advice provided by the panel in relation to a particular application; and the decision of an examiner about whether or not to adopt the panel’s advice. Further, an obligation to accord procedural fairness may require that an applicant be notified of, and be given the opportunity to make submissions in relation to, each of these decisions.[61] Submissions also indicated that procedural fairness would require that an applicant be provided with copies of relevant information relied upon by the patent examiner, as well as any written advice of the panel.[62]

8.33 Submissions also raised concerns about the operation of the panel.[63] Some questioned whether patent examiners are equipped to decide whether to rely on advice provided by an expert panel.[64] Others indicated that members of the panel might be too highly skilled to be capable of assessing applications according to the relevant legal standard—that is, from the perspective of ‘a person skilled in the relevant art’.[65]

8.34 The composition of an expert panel was also seen as problematic, particularly if the pool from which experts are selected is limited to those within Australia.[66] Submissions considered that actual and potential conflicts of interest might be a significant issue.[67] Further, IP Australia commented that, given the breadth of issues that may arise, it might be difficult to maintain a panel with sufficient breadth of expertise to allow useful advice to be obtained relatively quickly.[68]

8.35 In its submission to the Inquiry, IP Australia considered alternative means of addressing concerns about the level of expertise of patent examiners, based on models provided by the USPTO. IP Australia indicated that it could provide a ‘second level of review in genetic technologies by increasing the role of senior and supervising examiners in checking the work of examiners’—similar to the ‘second-pair-of-eyes’ review instituted by the USPTO. However, as discussed above, IP Australia considered that introducing an industry expert to act as a resource for Australian patent examiners assessing gene patent applications was not feasible.[69]

ALRC’s views

8.36 New developments in human genetics require an increasingly detailed grasp of the scientific context to distinguish potentially novel developments from what has come before. It is important that IP Australia has in place mechanisms to ensure that patent examiners have sufficient expertise in the areas of technology in which they may be required to assess applications.

8.37 DP 68 proposed that one way to achieve this is by introducing a panel of scientific and technical experts to assist examiners in assessing patent applications in appropriate circumstances. However, submissions and consultations raised a number of concerns about the effectiveness of this approach. In particular, the introduction of an expert panel may provide a number of additional decisions in respect of which a patent applicant may seek administrative or judicial review during the examination process. This could increase both the time and cost of examination, which the ALRC considers to be undesirable.[70]

8.38 It is particularly important that patent examiners have access to training and professional education to allow them to continue to develop knowledge and skills in relevant areas of technology. IP Australia employs a comparatively small number of patent examiners, and these examiners assess patent applications in a broad range of technological fields. To maintain high quality in the examination of patent applications, particularly in the genetics field, examiners should participate regularly in education and training programs that highlight new directions in genetic research and assist examiners in understanding the practical implications of these developments.

8.39 IP Australia currently operates a professional development program for patent examiners, and has implemented mechanisms to assess the suitability of such programs in light of technological developments. Submissions and consultations did not identify specific inadequacies in the current training of Australian patent examiners. However, the ALRC believes that IP Australia should review the subject matter and structure of its education and training programs regularly to so that examiners remain up to date with new developments. Regular reviews will also highlight areas in which additional education or training programs, or strategic recruitment by IP Australia, may be required.

8.40 IP Australia has some mechanisms in place to resolve difficult issues that may arise during the assessment of a particular patent application—for example, referral of particular matters to supervising or senior examiners. Regular audits of IP Australia’s education and training programs, and the organisation’s needs, will allow IP Australia to identify whether additional mechanisms are required—such as systematic review by senior examiners of patent examiners’ work in particular areas of technology.

8.41 The need for appropriate education and training is not unique to inventions involving genetic materials and technologies.[71] It will also be an important issue in connection with new technologies that emerge in the future.

Recommendation 8–1 To ensure the ongoing competence of Australian patent examiners in examining patent applications, IP Australia should enhance its efforts to provide examiners with education and training in areas of technology relevant to their particular specialty. IP Australia should review and update its education and training programs regularly so that new developments can be incorporated as required.

[24] IP Australia, Submission P56, 4 November 2003.

[25] Biotechnology Australia, Freehills and Ernst & Young, Australian Biotechnology Report (2001).

[26] IP Australia, Submission P56, 4 November 2003. See also Western Australian Department of Health and others (healthcare issues), Consultation, Perth, 17 September 2003; Western Australian Department of Health and others (legal issues), Consultation, Perth, 17 September 2003.

[27] IP Australia, Submission P56, 4 November 2003; IP Australia, Submission P86, 16 April 2004.

[28] IP Australia, Submission P86, 16 April 2004.

[29] IP Australia, Submission P56, 4 November 2003.

[30] Subject to certain formalities, the Commissioner may delegate powers and functions conferred upon him or her under the Patents Act or any other Act: Patents Act 1990 (Cth) s 209. Other powers of the Commissioner of Patents may also be delegated to more senior examiners, for example, the power to hear and determine oppositions and re-examinations.

[31] IP Australia, Submission P56, 4 November 2003.

[32] IP Australia, Submission P86, 16 April 2004.

[33] Ibid.

[34] IP Australia, Patent Manual of Practice and Procedure Volume 2: National (2002), [12.1(f)].

[35] Ibid, [8.5]. The exclusion from patentability of inventions claiming human beings or the biological processes for their generation is discussed in Ch 7 and 15.

[36] IP Australia, Submission P86, 16 April 2004.

[37] United States Patent and Trademark Office, 21st Century Strategic Plan, <www.uspto.gov/web/ offices/com/strat21/index.htm> at 16 June 2004; United States Patent and Trademark Office, Patent Quality Improvement: Expansion of the Second-Pair-of-Eyes Review, <www.uspto.gov/web/offices/ com/strat21/action/q3p17a.htm> at 16 June 2004.

[38] United States Federal Trade Commission, To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy (2003), rec 5(c).

[39] Ibid, Ch 6, 20.

[40] For example, in Singapore, legislation grants the Registrar of Patents the discretion to appoint a scientific adviser from a panel of advisers established under the Act to assist the court and the Registrar of Patents: Patents Act 1995 Chapter 221 (Singapore) s 90. Creation of an independent ethical advisory body as part of the Australian patent system is considered in Ch 7.

[41] Royal Society, Keeping Science Open: The Effects of Intellectual Property Policy on the Conduct of Science (2003), [3.28].

[42] Ibid.

[43] IP Australia, Submission P86, 16 April 2004.

[44] Royal College of Pathologists of Australasia, Submission P26, 1 October 2003; A McBratney and others, Submission P47, 22 October 2003; AusBiotech Ltd, Submission P58, 7 November 2003; Western Australian Department of Health and others (healthcare issues), Consultation, Perth, 17 September 2003.

[45] South Australian Government, Submission P51, 30 October 2003; BresaGen Limited, Consultation, Adelaide, 15 September 2003.

[46] National Stem Cell Centre, Consultation, Melbourne, 4 September 2003; Institute of Patent and Trade Mark Attorneys of Australia, Consultation, Melbourne, 5 September 2003; BresaGen Limited, Consultation, Adelaide, 15 September 2003.

[47] Cancer Council Australia, Submission P25, 30 September 2003; Cancer Council Tasmania, Submission P40, 29 September 2003; Cancer Council South Australia, Submission P41, 9 October 2003. See also New South Wales Genetics Service, Consultation, Sydney, 9 September 2003.

[48] Australian Law Reform Commission, Gene Patenting and Human Health, DP 68 (2004), Proposal 8–1.

[49] Caroline Chisholm Centre for Health Ethics Inc, Submission P69, 2 April 2004; Walter and Eliza Hall Institute of Medical Research, Submission P71, 13 April 2004; South Australian Department of Human Services, Submission P74, 15 April 2004; Medicines Australia, Submission P75, 15 April 2004; Australian Centre for Intellectual Property in Agriculture, Submission P81, 16 April 2004; Royal College of Pathologists of Australasia, Submission P82, 16 April 2004; IP Australia, Submission P86, 16 April 2004; Cancer Council Australia, Submission P96, 19 April 2004; Cancer Council New South Wales, Submission P99, 20 April 2004; Cancer Council Victoria, Submission P101, 20 April 2004; Queensland Government, Submission P103, 22 April 2004; Centre for Law and Genetics, Submission P104, 22 April 2004; National Health and Medical Research Council, Submission P107, 19 April 2004; G Suthers, Submission P116, 4 May 2004.

[50] Commonwealth Department of Health and Ageing, Submission P79, 16 April 2004. See also Human Genetics Society of Australasia, Submission P76, 16 April 2004; Sydney IVF Limited, Submission P98, 19 April 2004; New South Wales Health Department, Submission P112, 30 April 2004.

[51] Department of Health Western Australia, Submission P89, 16 April 2004; Genetic Support Council WA (Inc), Submission P119, 13 May 2004.

[52] Ministry for Science and Medical Research New South Wales, Submission P109, 28 April 2004. See also Medicines Australia, Submission P75, 15 April 2004; Department of Human Services Victoria, Submission P111, 30 April 2004.

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

[54] Ibid; Department of Health Western Australia, Submission P53, 3 November 2003; Commonwealth Department of Health and Ageing, Submission P65, 28 January 2004; Consumers’ Health Forum of Australia, Consultation, Canberra, 23 September 2003.

[55] Chapter 7 considers the potential role of ethicists in advising patent examiners.

[56] Australian Law Reform Commission, Gene Patenting and Human Health, DP 68 (2004), Proposals 8–2 and 8–3.

[57] Royal College of Pathologists of Australasia, Submission P82, 16 April 2004; Western Australian Department of Industry and Resources, Submission P90, 16 April 2004; Cancer Council Victoria, Submission P101, 20 April 2004; National Health and Medical Research Council, Submission P107, 19 April 2004; Department of Human Services Victoria, Submission P111, 30 April 2004; New South Wales Health Department, Submission P112, 30 April 2004; G Suthers, Submission P116, 4 May 2004; Genetic Support Council WA (Inc), Submission P119, 13 May 2004.

[58] Commonwealth Department of Health and Ageing, Submission P79, 16 April 2004.

[59] IP Australia, Submission P86, 16 April 2004; Intellectual Property Research Institute of Australia, Submission P88, 16 April 2004; Centre for Law and Genetics, Submission P104, 22 April 2004; South Australian Government, Submission P51, 30 October 2003.

[60] IP Australia, Submission P86, 16 April 2004; Intellectual Property Research Institute of Australia, Submission P88, 16 April 2004; A Bennett, Consultation, Sydney, 15 March 2004.

[61] IP Australia, Submission P86, 16 April 2004; Intellectual Property Research Institute of Australia, Submission P88, 16 April 2004; Unisearch, Consultation, Sydney, 15 March 2004.

[62] IP Australia, Submission P86, 16 April 2004; Intellectual Property Research Institute of Australia, Submission P88, 16 April 2004.

[63] Walter and Eliza Hall Institute of Medical Research, Submission P71, 13 April 2004; Institute of Patent and Trade Mark Attorneys of Australia, Submission P106, 27 April 2004; J McKeough, Consultation, Sydney, 23 March 2004; A Bennett, Consultation, Sydney, 15 March 2004.

[64] Institute of Patent and Trade Mark Attorneys of Australia, Submission P106, 27 April 2004; A Bennett, Consultation, Sydney, 15 March 2004.

[65] IP Australia, Submission P86, 16 April 2004; Intellectual Property Research Institute of Australia, Submission P88, 16 April 2004. See Patents Act 1990 (Cth) s 7(2). A person skilled in the relevant art is a ‘skilled but non-inventive worker in the relevant field of technology’: IP Australia, Patent Manual of Practice and Procedure Volume 2: National (2002), [4.2.4.2].

[66] Walter and Eliza Hall Institute of Medical Research, Submission P71, 13 April 2004; Sydney IVF Limited, Submission P98, 19 April 2004; J McKeough, Consultation, Sydney, 23 March 2004.

[67] Human Genetics Society of Australasia, Submission P76, 16 April 2004; IP Australia, Submission P86, 16 April 2004; Cancer Council Victoria, Submission P101, 20 April 2004; Institute of Patent and Trade Mark Attorneys of Australia, Submission P106, 27 April 2004; IP Australia, Consultation, Canberra, 24 September 2003; Unisearch, Consultation, Sydney, 15 March 2004; J McKeough, Consultation, Sydney, 23 March 2004; Walter and Eliza Hall Institute of Medical Research, Consultation, Melbourne, 1 April 2004.

[68] IP Australia, Submission P86, 16 April 2004. See also Sydney IVF Limited, Submission P98, 19 April 2004.

[69] IP Australia, Submission P86, 16 April 2004.

[70] A similar conclusion was reached by the United States National Research Council: United States National Research Council, A Patent System for the 21st Century (Prepublication Copy) (2004), 74.

[71] A 2003 report of the Advisory Council on Intellectual Property (ACIP) on patenting business systems noted similar concerns about the expertise of examiners. ACIP recommended that IP Australia enhance its business training for patent examiners: Advisory Council on Intellectual Property, Report on a Review of the Patenting of Business Systems (2003), rec 4.