8.1 The Australian patent system is administered by the Patent Office of IP Australia. This chapter provides an overview of certain aspects of IP Australia’s practices and addresses concerns about the examination of applications for gene patents. It considers the resources available to IP Australia; the expertise of, and training provided to, Australian patent examiners; and the assistance available to patent examiners in applying Australian patent law to gene patent applications.

8.2 DP 68 outlined the general concerns voiced in submissions and consultations about IP Australia’s capacity to scrutinise gene patent applications.[1] The ALRC believes that these concerns do not warrant fundamental changes to the functions performed by IP Australia. Rather, these concerns may be addressed by specific recommendations with respect to: (a) the training of patent examiners; (b) the development of examination guidelines for genetic inventions; and (c) the standard of proof to be applied by patent examiners when assessing whether the requirements for patentability have been satisfied at the examination stage.

8.3 Benchmarking activities conducted by IP Australia and recent academic studies indicate that IP Australia’s practices are comparable to those of other major patent offices. IP Australia noted that a comparison with the United Kingdom Patent Office suggests that similar patentability outcomes were reached by the two patent offices when examining the same patent applications.[2] A 2003 study by Professor Andrew Christie and Melanie Howlett compared the approaches adopted by the United States Patent and Trademark Office (USPTO), the European Patent Office (EPO), the Japanese Patent Office (JPO) and IP Australia in examining a series of hypothetical claims for partial DNA sequences (or expressed sequence tags).[3] They found that while each patent office adopted its own approach to interpreting and applying the requirements for patentability, the end result of the examination of such claims was the same for all the offices.[4]

8.4 The issues raised about IP Australia’s practices are not unique to Australia. Internationally, questions have been raised about the capacity of patent offices to assess applications for gene patents effectively and to process such applications efficiently.[5] It has been suggested that patent offices may lack the resources or expertise to deal with the volume and nature of patent applications filed in this area. The reforms recommended in this chapter are intended to assist IP Australia in adapting its current practices to the challenges posed by inventions involving genetic materials and technologies, and to enhance mechanisms already adopted by IP Australia to address these issues.

[1] Australian Law Reform Commission, Gene Patenting and Human Health, DP 68 (2004), [8.8]–[8.17].

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

[3] M Howlett and A Christie, An Analysis of the Approaches of the Trilateral and Australian Patent Offices to Patenting Partial DNA Sequences (ESTs) (2003). The hypothetical claims were taken from a similar comparative study conducted by the Trilateral Offices—that is, the USPTO, EPO and JPO.

[4] Ibid, 25–28.

[5] See, eg, United States Federal Trade Commission, To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy (2003), Ch 5; United States National Research Council, A Patent System for the 21st Century (Prepublication Copy) (2004), 84–87. The USPTO has introduced a Strategic Planin response to concerns about its capacity to process pending applications efficiently and accurately: United States Patent and Trademark Office, 21st Century Strategic Plan, <> at 16 June 2004. See also B Lehman, Making the World Safe for Biotech Patents (2002) International Intellectual Property Institute Discussion Paper, 26 June 2002; T Hsieh, J Hack and L Galvin, United States: Thinking Small: The Patent Office Grapples with Nanotechnology, Mondaq, <> at 16 June 2004.