02.08.2010
10.24 Gene patents raise complex scientific and legal issues, whose resolution may require expert advice and assistance. This section addresses the role of experts in providing advice to judges hearing gene patent matters.
10.25 Section 217 of the Patents Act enables Australian judges to have access to expert assistance in patent proceedings in appropriate cases. The provision states: ‘A prescribed court may, if it thinks fit, call in the aid of an assessor to assist it in the hearing and trial or determination of any proceedings under this Act’.[35]
10.26 The term ‘assessor’ is not defined the Patents Act. The role of an assessor was considered by the ALRC in its report, Managing Justice: A Review of the Federal Civil Justice System (ALRC 89).[36] An assessor is an expert available for a judge to consult if the judge requires assistance in understanding the effect or meaning of expert evidence.[37]
10.27 Heerey J considered the benefits of an assessor in Genetic Institute Inc v Kirin-Amgen Inc (No 2).[38] That case involved complex and contested issues of molecular biology and, between them, the parties intended to call 15 scientific experts from various disciplines.[39] Heerey J held that, in such a case, a non-expert judge would be aided by expert assistance, such as that provided by an assessor, and thus perform the judicial task better.[40]
10.28 However, concerns have been expressed about assessors exercising too much influence over a judge, and about the procedural fairness of contact between judges and experts in chambers.[41] These matters may be appropriately addressed by a clear and detailed prescription of an assessor’s functions.[42] Heerey J explained it in these terms:
There is no question of an assessor giving any judgment or making any order (even by consent) or otherwise exercising any judicial functions. An assessor is to assist the judge, both in hearing and trial and/or in determination of any proceeding. The judgment in the case, the exercise of the judicial power, remains that of the judge. In exercising judicial power, a judge is routinely assisted by persons who are not judges: counsel, solicitors, witnesses, the judge’s associate and secretary and other court staff.[43]
10.29 Despite the potential benefits, the appointment of assessors in Australian patent cases is rare. Although the power to appoint assessors had been included in Australian patents legislation since 1903,[44] it has been considered and invoked in a very small number of cases to date.[45]
10.30 Different regimes for the appointment and use of experts by a court exist under the Federal Court Rules[46] and comparable provisions in the rules of state and territory Supreme Courts.[47] For example, under the Federal Court Rules,‘expert assistants’ may assist a judge of the Federal Court on ‘any issue of fact or opinion’ identified by the Court or a judge (other than an issue involving a question of law).[48] The appointment of an expert assistant requires the consent of both parties, and any assistance provided by the expert must be reduced to writing and made available to both parties.[49]
Submissions and consultations
10.31 DP 68 proposed that courts exercising jurisdiction under the Patents Act should continue to develop procedures and arrangements to allow judges to benefit from the advice of assessors or scientific advisers in litigation involving patents over genetic materials and technologies.[50]
10.32 A range of submissions supported this proposal.[51] Submissions considered that assessors could help judges in examining and determining issues in litigation involving genetic technologies. Submissions also commented that such experts could be a valuable resource for judges. For example, the Centre for Law and Genetics submitted: ‘judges are more likely to be able to give a reasoned and informed judgment if properly advised on the technical matters inherent in litigation involving gene and biotechnology patents’.[52]
10.33 A few submissions voiced reservations about assessors or scientific advisers being appointed too readily, particularly given that the views of these experts may not be subject to examination by the parties.[53] GlaxoSmithKline was concerned that scientific advisers may ‘de facto … become arbiters of fact’ because ‘a non-technically qualified judge may find it difficult to come to a finding of fact which is inconsistent with the views expressed by the assessor or adviser’.[54] GlaxoSmithKline submitted that the role of scientific advisers should be carefully limited to assisting a judge ‘to understand the issues and evidence before him’.
ALRC’s views
10.34 In ALRC 89, the ALRC noted the value of assessors in patent cases, given the novel and technical issues frequently raised.[55] The ALRC recommended that: ‘The Federal Court should continue to develop appropriate procedures and arrangements, in consultation with legal and professional user groups, to allow judges to benefit from expert assistance in understanding the effect or meaning of expert evidence’.[56] The ACIP FMS Report also encouraged the use of ‘court-appointed experts to assist courts, particularly with technical aspects of patent cases’.[57]
10.35 In its response to the ALRC’s recommendation, the Australian Government indicated that this was a matter for the Federal Court.[58] The Government noted that the Federal Court Rules had been amended to provide for the appointment of a Court expert assistant, and that the Court had advised it would continue to consult with the legal profession and user groups on issues concerning expert evidence.[59] The Government’s response did not make specific reference to the use of assessors pursuant to s 217 of the Patents Act.
10.36 In a paper delivered in 2002 about techniques used by the Federal Court to address issues posed by expert evidence, Justice Heerey commented that:
Today the complexity of science expands at an exponential rate … Looking back to the 1960s, a decade when many of today’s judges commenced their professional careers, there are many fields of science which were not merely less complicated than today; they simply did not exist … [Further,] scientific issues about which eminent scientists themselves have doubt, fall to be decided by judges who, in common law countries at any rate, usually do not have much in the way of formal scientific education.[60]
10.37 Some Australian judges have specialist scientific training, or a familiarity with scientific matters as a result of their professional or personal interests. However, many judges could benefit, in appropriate cases, from the additional assistance that an assessor may provide in interpreting and understanding scientific evidence. The pace of scientific change is rapid, and expert evidence may be complicated and voluminous. Even those judges who have specialist training in a relevant discipline are unlikely to have the detailed knowledge of an assessor or scientific adviser in the specific field to which the case relates.
10.38 The ALRC considers that the use of an assessor may be particularly beneficial in gene patent litigation, which may involve novel issues and complex scientific and technical evidence. The ALRC recognises the concerns that have been identified about the use of assessors, including issues relating to the appropriate role of an assessor in patent proceedings, the costs involved, and potential conflicts of interest.[61] However, the ALRC considers that such issues are capable of being addressed on a case-by-case basis with appropriate cooperation between the court and the parties to the proceedings.[62] One example of such cooperation is the practice of appointing assessors from a joint list presented by the parties—which allows for greater confidence in the expertise and impartiality of the assessor.
Recommendation 10–2 Courts exercising jurisdiction under the Patents Act should continue to develop procedures and arrangements to allow judges to benefit from the advice of assessors or scientific advisors in litigation involving patents over genetic materials and technologies.
[35]Patents Act 1990 (Cth) s 217. A ‘prescribed court’ is defined to mean the Federal Court, the Supreme Court of a State and the Supreme Court of each of the Australian Capital Territory, the Northern Territory and Norfolk Island: Patents Act 1990 (Cth) sch 1. State and territory Supreme Courts may also be empowered to appoint an assessor in any type of proceedings: see, eg, Supreme Courts Act 1995 (Qld) s 255(2); Supreme Court Act 1935 (SA) s 71; Supreme Court Act 1935 (WA) s 56; Supreme Court Rules 1970 (NSW) Pt 39, r 7; Queensland Government, Submission P103, 22 April 2004; Attorney-General for South Australia, Submission P115, 3 May 2004.
[36] Australian Law Reform Commission, Managing Justice: A Review of the Federal Judicial System, ALRC 89 (2000). See also P Heerey, ‘Expert Evidence in Intellectual Property Cases’ (1998) 9 Australian Intellectual Property Journal 92.
[37] Australian Law Reform Commission, Managing Justice: A Review of the Federal Judicial System, ALRC 89 (2000), [7.150].
[38]Genetic Institute Inc v Kirin-Amgen Inc (No 2) (1997) 149 ALR 247.
[39] Ibid, 251.
[40] Ibid, 251–252.
[41] Australian Law Reform Commission, Managing Justice: A Review of the Federal Judicial System, ALRC 89 (2000), [7.153]–[7.155].
[42]Genetic Institute Inc v Kirin-Amgen Inc (No 2) (1997) 149 ALR 247, 251; Genetics Institute Inc v Kirin-Amgen Inc (1999) 92 FCR 106, 117–118; Beecham Group Ltd v Bristol-Myers Company [1980] 1 NZLR 185, 190.
[43]Genetic Institute Inc v Kirin-Amgen Inc (No 2) (1997) 149 ALR 247, 250.
[44]Patents Act 1903 (Cth) s 86(8). See also Australian Law Reform Commission, The Judicial Power of the Commonwealth: A Review of the Judiciary Act 1903 and Related Legislation, ALRC 92 (2001), [7.149].
[45]Adhesives Pty Ltd v Aktieselskabet Dansk Gaerings-Industri (1935) 55 CLR 523 (assessor appointed by consent); Genetic Institute Inc v Kirin-Amgen Inc (No 2) (1997) 149 ALR 247 (assessor appointed by court order, upheld on appeal: Genetics Institute Inc v Kirin-Amgen Inc (1999) 92 FCR 106); F Hoffman-La Roche AG v New England Biolabs Inc (1999) 47 IPR 105 (appointment of assessor deferred until later stage of proceedings). In addition, Branson J commented on the role of assessors in patent proceedings in a case arising under the Evidence Act 1995 (Cth): EI DuPont de Nemours & Co v Imperial Chemical Industries plc (2002) 54 IPR 304.
[46]Federal Court Rules 1979 (Cth) O 34B. ‘Expert’ is defined in r 2(3) as a ‘person who has specialised knowledge based on the person’s training, study or experience’.
[47] See, eg, Supreme Court Rules 1970 (NSW) Pt 39, rr 1–6; Rules of the Supreme Court 1987 (SA) rr 82.01–82.07; Rules of the Supreme Court 1971 (WA) O 40. See also Queensland Government, Submission P103, 22 April 2004.
[48]Federal Court Rules 1979 (Cth) O 34B r 2(1).
[49] Ibid O 34B r 3.
[50] Australian Law Reform Commission, Gene Patenting and Human Health, DP 68 (2004), Proposal 10–2.
[51] Walter and Eliza Hall Institute of Medical Research, Submission P71, 13 April 2004; Human Genetics Society of Australasia, Submission P76, 16 April 2004; Commonwealth Department of Health and Ageing, Submission P79, 16 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 Victoria, Submission P101, 20 April 2004; Centre for Law and Genetics, Submission P104, 22 April 2004.
[52] Centre for Law and Genetics, Submission P104, 22 April 2004. See also Walter and Eliza Hall Institute of Medical Research, Submission P71, 13 April 2004; Human Genetics Society of Australasia, Submission P76, 16 April 2004.
[53] Human Genetics Society of Australasia, Submission P76, 16 April 2004; GlaxoSmithKline, Submission P85, 16 April 2004; F B Rice & Co, Submission P84, 16 April 2004.
[54] GlaxoSmithKline, Submission P85, 16 April 2004.
[55] Australian Law Reform Commission, Managing Justice: A Review of the Federal Judicial System, ALRC 89 (2000), [7.148].
[56] Ibid, rec 85.
[57] Advisory Council on Intellectual Property, Should the Jurisdiction of the Federal Magistrates Service be Extended to Include Patent, Trade Mark, and Design Matters? (2003), rec 2.2.
[58] Australian Government, Government Response to Recommendations of Australian Law Reform Commission Report Managing Justice: A Review of the Federal Civil Justice System (2003), 39.
[59] Ibid, 39. The Australian Government has not yet published its response to the ACIP FMS Report.
[60] P Heerey, ‘Expert Evidence: The Australian Experience’ (Paper presented at World Intellectual Property Organization Asia–Pacific Colloquium, New Delhi, 6 February 2002).
[61] Similar concerns were expressed at a round table conducted by ACIP in connection with the ACIP FMS Report: Advisory Council on Intellectual Property, Should the Jurisdiction of the Federal Magistrates Service be Extended to Include Patent, Trade Mark, and Design Matters? (2003), 26.
[62] See, eg, the orders made by Emmett J in a case relating to identification of an assessor at a time when a party was still in the process of retaining expert witnesses: F Hoffman-La Roche AG v New England Biolabs Inc (1999) 47 IPR 105, 107.