Genetics Institute Inc v Kirin-Amgen Inc

REASONS FOR JUDGMENT 1 This is an application for leave to appeal against a decision of Justice Heerey upholding a decision of the Commissioner of Patents to dismiss the applicant's opposition to the grant of a patent to Kirin-Amgen Inc. Leave to appeal to the Full Federal Court is required by subs 158(2) of the Patents Act 1990 (Cth) ("the Patents Act"), which provides as follows. "Except with the leave of the Federal Court, an appeal does not lie to the Full Court of the Federal Court against a judgment or order of a single judge of the Federal Court in the exercise of its jurisdiction to hear and determine appeals from decisions or directions of the Commissioner." 2 Two broad questions have been identified by the parties for determination by the Court. Firstly, what are the principles to be applied by the Court in determining whether leave to appeal should be granted under subs 158(2)? And second, should leave to appeal be granted on the basis of those principles? The principles to be applied in determining the application for leave to appeal 3 The Patents Act enables two levels of appeal in patent matters, progressing through either of two possible lines depending on where the matter originates. The first line of appeal is for matters originating with a court other than the Federal Court. In those matters, an appeal lies to the Federal Court and then, but only with "special leave", to the High Court. The second line of appeal is for matters originating with the Commissioner of Patents. In those matters, an appeal lies to the Federal Court and then, but only with "leave", to the Full Federal Court. In both cases the second level of appeal is permitted by s 158, which provides as follows. "(1) An appeal lies to the Federal Court against a judgment or order of: (a) another prescribed court exercising jurisdiction under this Act; or (b) any other court in proceedings under subsection 120(1) or section 128. (2) Except with the leave of the Federal Court, an appeal does not lie to the Full Court of the Federal Court against a judgment or order of a single judge of the Federal Court in the exercise of its jurisdiction to hear and determine appeals from decisions or directions of the Commissioner. (3) With the special leave of the High Court, an appeal lies to the High Court against a judgment or order referred to in subsection (1). (4) Except as otherwise provided by this section, an appeal does not lie against a judgment or order referred to in subsection (1)." [Emphasis added.] 4 The respondent contends that the requirement for leave to appeal to the Full Federal Court under subs 158(2), and the requirement for special leave to appeal to the High Court under subs 158(3), are analogous. Its argument can be summarised as follows. · The lines of appeal permitted by the Patents Act are analogous because they both envisage two levels of appeal, albeit through different courts. · In particular, the final appeal against a judgment or order of the Commissioner of Patents, which by subs 158(2) lies to the Full Federal Court with leave of that Court, is analogous to the final appeal against a judgment or order of a court other than the Federal Court, which by subs 158(3) lies to the High Court with special leave of that Court. Analogous principles should therefore be applied in determining applications for leave to appeal and special leave to appeal made under those provisions. · Moreover, the principles to be applied in determining an application for leave to appeal under subs 158(2) should be similar to the principles applied by the High Court in determining applications for special leave to appeal under the Judiciary Act 1903 (Cth) ("Judiciary Act"), on the ground that the accepted justifications for the special leave test apply equally to appeals to the Full Federal Court under subs 158(2). · This construction of subs 158(2) is not denied by the legislature's use of the term "leave" rather than "special leave" in that provision, which merely reflects the conventional usage of "leave" in respect of the Federal Court and "special leave" in respect of the High Court. Put differently, "leave" and "special leave" are merely the terms recognised in respect of the Federal Court and High Court respectively for "permission of the Court", and do not denote the particular tests adopted by those Courts in determining whether such permission should be granted. 5 The applicant opposes the construction of subs 158(2) contended for by the respondent, arguing that the terms "leave to appeal" and "special leave to appeal" denote, and were intended by the legislature to denote, different tests for the granting of leave under subs 158(2) and subs 158(3) respectively. According to the applicant, "special leave" under subs 158(3) requires satisfaction of the test set out in s 35A of the Judiciary Act (as applied by the High Court), whilst "leave" under subs 158(2) requires satisfaction of one of the less stringent tests for leave applied by the Federal Court. In the applicant's submission, if the legislature intended the special leave test to apply to applications for leave brought under subs 158(2), it would have used clear language to express that intention. 6 In their respective submissions the parties examined whether "special leave" and "leave" are generic terms or whether they denote different tests for the granting of leave by a court. 7 The term "special leave" describes the test for permission to appeal to the High Court under subs 35(2) and subs 35AA(2) of the Judiciary Act which is more stringent than the alternative test for "leave". The coexistence of the tests for "leave" and "special leave" within High Court procedure - both of which were recognised by the Judiciary Act at the date of its enactment in 1903 (see subs 35(1) of Act No 6, 1903) - makes it clear that neither term is truly a generic expression for permission of that Court. Thus in Morris v The Queen (1987) 163 CLR 454 at 475, Dawson J said: "All too often in applications before this Court insufficient attention is given to the distinction between leave to appeal and special leave to appeal. Leave to appeal may be given where an applicant makes out a prima facie case of error. That is not enough to attract special leave to appeal, which should only be given where, in addition, there is some special feature of the case which warrants the attention of this Court. It would be wrong to attempt to formulate rules which would confine the exercise of the jurisdiction to grant special leave. It remains a discretionary jurisdiction. Sufficient has, however, been established in the decided cases to provide a clear guide to those occasions when it is appropriate to grant special leave and those when it is not." 8 We would make two points about his Honour's observations. First, the requirement for permission of the High Court is in practice usually a requirement for "special leave" with the result that that term is often used synonymously with permission of the Court. Hence the confusion between the tests of special leave and leave alluded to by Dawson J. The second point, emphasised by Dawson J, is that the fact that "special leave" denotes a particular test for the granting of leave by the High Court deprives neither that test of its discretionary nature nor (it follows) the High Court of its discretion in determining whether special leave is appropriate in a particular case. 9 The situation in respect of the Federal Court is different. "Special leave" has no place in the lexicon of Federal Court procedure, where permission of the Court is denoted generically by the term "leave". 10 Applications for leave to appeal to the Full Federal Court have been determined by reference to different principles, depending on the nature and terms of the legislative provision requiring leave. In some cases the fact of the requirement for leave has been interpreted by the Court as indicating a need for some important question of principle to be involved (see for example Ozberk & Ors v Minister for Immigration and Multicultural Affairs (Full Federal Court, unreported, 13 July 1998); Kraft General Foods Incorporated v Gaines Pet Foods Corporation (Lockhart J, unreported, 8 September 1995)). In other cases, the legislature's choice of the word "leave" in place of "special leave" has been seen as reflecting an intention that some lesser test than the test for special leave be applied (see for example The Sports Cafe v Registrar of Trade Marks (1998) AIPC ¶91-409; Lombardo v Federal Commissioner of Taxation (1979) 45 FLR 253). 11 In 1984 subs 24(1A) of the Federal Court of Australia Act 1976 (Cth) was enacted, requiring leave of the Full Federal Court to appeal against an interlocutory decision of a single judge of the Court. This requirement for leave to appeal to the Full Court under subs 24(1A) has not been construed by the Court as a requirement that a particular test be satisfied. Rather, in interpreting subs 24(1A) the Court has emphasised: the discretionary nature of its jurisdiction to grant leave to appeal under that provision; the inappropriateness of formulating rigid rules that could restrain the exercise of that discretion beyond the extent required to give effect to any clear legislative policy underlying the requirement for leave; and the importance of dealing with each application for leave brought under subs 24(1A) in accordance with its own special circumstances (see for example National Mutual Holdings v Sentry Corporation (1988) 83 ALR 434 at 440-441; Decor Corporation v Dart Industries (1991) 23 IPR 1 ("Decor Corporation")). In Decor Corporation, the Full Court considered the extent to which the principles applied by the Full Court of the Supreme Court of Victoria in Niemann v Electronic Industries [1978] VR 431 ("Niemann") in respect of the similarly worded par 40(1)(b) of the Supreme Court Act 1958 (Vic) were applicable to applications for leave made under subs 24(1A). In Niemann, the Supreme Court had held that leave to appeal from an interlocutory order should only be granted where the order was clearly wrong (at 440 per Murphy J), or at least attended with sufficient doubt to warrant its being reconsidered on appeal (at 433 per McInerney J), and substantial injustice would be done by leaving the decision unreversed (at 434 per McInerney J and at 440 per Murphy J). The Court had also held that leave would be granted more readily if the effect of the order was to change substantive rights or terminate the action, so that substantial injustice would be effected if the order was wrong (at 441 per Murphy J). In considering the relevance of these principles for applications for leave brought under subs 24(1A), the Full Court said in Decor Corporation: "In our opinion, the major considerations to be derived from Niemann do provide an appropriate litmus test for the general run of cases in which leave to appeal from an interlocutory decision is sought. If differently constituted courts are to give consistent rulings, it is necessary that they be guided by relevant principles. There is a considerable body of authority which supports the approach taken in Niemann. But we do not understand the judges who decided Niemann to have laid down any rigid rules that might destroy a court's discretion in all cases but those falling within them. That, so far as this court is concerned, would be contrary to the unqualified terms of s 24(1A) of the Federal Court of Australia Act 1976 (Cth) which confer on the court an unfettered discretion. … [T]he principles discussed in Niemann … provide general guidance which a court should normally accept. However, there will continue to be cases raising special considerations, and the court should not regard its hands as tied in any case beyond this, that by s 24(1A) the legislature has evinced a policy against the bringing of interlocutory appeals except where the court, acting judicially, finds reason to grant leave." [At 3-4, with emphasis added.] 12 The emphasis in these passages is also consistent with the approach of the High Court of Australia to the various legislative provisions requiring special leave to appeal (see for example Fredericks v May (1973) 47 ALJR 362 at 364; Adam P Brown Male Fashions Pty v Philip Morris Inc (1981) 148 CLR 170 at 177; Morris v The Queen (1987) 163 CLR 454 at 475, extracted above). 13 The Federal Court's jurisdiction to grant leave is a discretionary jurisdiction the exercise of which will only be constrained by express legislative provision. In the case of the jurisdiction conferred by subs 158(2) no such provision exists, and we do not accept the contention of the applicant that the reference in that provision to "leave" was intended to entrench a particular test to be applied by the Court when determining applications made under it. In the context of Federal Court procedure, the term "leave" is used synonymously with "permission", with the result that no conclusions can be drawn from the legislature's use of that word in subs 158(2) regarding the principles to be applied by the Court in determining whether an application under subs 158(2) should be granted. 14 The various statements of this Court against the laying down of rigid rules that would restrict its discretion in determining applications for leave under subs 24(1A) are particularly apposite in the present context given the diversity of cases to which subs 158(2) will potentially apply. Those cases will include all matters originating from a decision or order of the Commissioner of Patents, and not just those involving a pre-grant opposition proceeding commenced under subs 60(4) of the Patents Act or subs 60(5) of the Patents Act 1952 (Cth). Indeed, even cases commenced under those provisions may require different treatment depending, for example, on whether or not opposition to the patent was upheld by the Commissioner and/or the single judge. 15 Some general observations may nevertheless be made as to the circumstances in which it will be appropriate to grant an application for leave to appeal to the Full Federal Court under subs 158(2) against a single judge's decision rejecting a pre-grant opposition. 16 An appeal to the Full Federal Court against a decision of a single judge to reject a pre-grant opposition will follow a full hearing of the opposition before the Commissioner of Patents and an appeal by way of re-hearing before the single judge. Where an opponent to a patent has had the benefit of two hearings and has been unsuccessful in both, we think there should be limited scope for a further appeal, particularly where the matters primarily in issue are essentially questions of fact. Only in exceptional cases would it be right to grant an applicant what would effectively amount to a further consideration of factual issues. This is particularly so given that an unsuccessful opponent of a patent will still be able to institute revocation proceedings under s 138 of the Patents Act, with the result that a refusal to grant leave to appeal under subs 158(2) will not be finally determinative of the opponent's rights. In such circumstances it is unlikely that substantial injustice will be caused by the refusal of leave. 17 During the hearing there was some discussion as to the possibility of the owner of a patent the grant of which was unsuccessfully opposed, defending a revocation proceeding instituted by the pre-grant opponent by raising an issue estoppel in respect of the findings of fact of the single judge. In the present case, however, the respondent has conceded that no issue estoppel would apply to the findings of fact of Heerey J in any revocation proceeding instituted by the applicant in respect of the patent. In any event, the difference between the issue determined by his Honour in the pre-grant opposition proceeding, and the issue that would arise for determination in any revocation proceeding instituted by the applicant, is in our view sufficient to preclude the operation of issue estoppel principles in that second proceeding. The overriding issue in the pre-grant opposition proceeding before Heerey J was whether it was practically certain that the patent to be granted on the specification would have been invalid on the ground that the content of the specification was not in accordance with the requirements of s 40 of the Patents Act 1952 (Cth) (Genetics Institute Inc v Kirin-Amgen Inc (No 3) (1998) 156 ALR 30 at 39-41). Even if revocation of the patent was subsequently sought by the applicant on the virtually identical ground of non-compliance with subs 40(2) or subs 40(3) of the current Act (see par 138(3)(f) of the Act), the issue for determination by the judge hearing that revocation application would be whether the patent should be revoked for the specification's non-compliance with subs 40(2) or subs 40(3). The decision of Heerey J that it was not practically certain that the patent should be so revoked would be inconclusive of this issue. Accordingly, there would be no scope for the operation of an issue estoppel in relation to the decision of Heerey J in any post-grant revocation proceeding instituted by the applicant in respect of the current patent. 18 We note in this context that the applicant in the present case contends that neither the hearing before the Commissioner of Patents nor the hearing before Heerey J can properly be considered to have been a full hearing on the facts because, in the former case, a hearing before a commissioner is not akin to a hearing before a court and, in the latter case, the respondent failed to adduce the evidence considered by the Commissioner in the hearing before Heerey J. We are not persuaded by this argument. 19 As the parties in the present case accepted, the purpose of pre-grant opposition proceedings is to provide a swift and economical means of settling disputes that would otherwise need to be dealt with by the courts in more expensive and time consuming post-grant litigation; that is, to decrease the occasion for costly revocation proceedings by ensuring that bad patents do not proceed to grant. This purpose is reflected in the explanation by the Minister for Science for the Federal Government's policy decision to retain pre-grant opposition proceedings in Australia, despite the recommendation of the 1984 Industrial Property Advisory Committee Report Patents, Innovation and Competition in Australia ("IPAC Report") that they be abolished (recommendation 29). "Pre-grant opposition provides a relatively inexpensive mechanism for resolving third party disputes as to validity. Opposition procedures will be made more stringent in order to expedite the determination of oppositions." [(1986) 56 No 47 Official Journal of Patents, Trade Marks and Designs 1475.] 20 The Patents Act implemented the Minister's response to the IPAC Report (Explanatory Memorandum to the Patents Bill 1989 (Cth), clause 2). 21 A second aspect of the purpose of pre-grant opposition proceedings concerns their potential use to delay improperly the grant of a patent. The potential for such use was the reason for the IPAC Report's recommendation that proceedings of that nature be abolished. In its response to that recommendation (extracted above), the Minister implicitly acknowledged the validity of IPAC's concern by proposing to make the appellate process in opposition procedures more stringent in the new Patents Act. It is therefore appropriate that any interpretation of subs 158(2) in respect of pre-grant opposition proceedings take account of the policy considerations to which we have referred. 22 In our view, the statutory context of subs 158(2) as it applies in pre-grant opposition proceedings, and the nature of those proceedings, are such as to require a relatively stringent filter for appeals to the Full Federal Court against a decision of a single judge made under subs 60(4) (or subs 60(5) of the Patents Act 1952 (Cth)). We agree, in this regard, with the comments of the Court of Appeal in England in Imperial Chemical Industries Limited (Haggis') Application [1975] RPC 403 concerning the broadly corresponding provision in the Patents Act 1949 (UK) (which allows an appeal on grounds of error of law or excess of jurisdiction). "It is immediately apparent that, where there is an application under this paragraph to this court for leave, the court has a discretion to give or refuse leave, and so can, if it thinks fit, refuse leave notwithstanding that the applicant for leave asserts that the Tribunal has erred in law. … We would, however, add that, in our judgment, the fact that section 87(1)(aa) [requiring leave of the Court or Tribunal to appeal in pre-grant opposition proceedings] permits an appeal on a point of law only, and only with leave, makes it clear that the mere demonstration of the possibility of some error in law in a decision of the Tribunal cannot entitle the would-be appellant as of right to leave to appeal. In every case the Tribunal or this court, when asked for leave, must consider whether the point is one of sufficient importance to merit being made the subject-matter of an appeal. In this connection it should, we think, be borne in mind that … the [pre-grant opposition] procedure under section 14 is designed to prevent registration of patents which would be certain to be revoked, if granted. It is a procedure designed to act as a sieve at comparatively little expense to the parties. It is not intended to provide a method of finally determining rights the determination of which merits a full-scale trial with oral evidence. Accordingly, it is a jurisdiction which should be exercised only in clear cases. If any bona fide conflict of fact or expert opinion is involved, a grant should not be refused unless and until that conflict has been resolved in the opponent's favour. Just as the jurisdiction under section 14 is to be exercised with care, so also, in our opinion, the discretion under section 87(1)(aa) in relation to an appeal from a decision under section 14 should be exercised with care. An applicant who has successfully fought off opposition under section 14 should not be at the risk of an expensive appeal unless something serious has gone wrong or a point of general public importance is involved. The opponent, after all, can have another chance in a revocation action." [At 417-419, with emphasis added.] 23 We consider that the Full Federal Court should also exercise its discretion to grant leave to appeal under subs 158(2) against a decision of a single judge of the Federal Court refusing to grant relief in a pre-grant opposition proceeding with care. Leaving aside applications for leave on a question of pure law in the context of essentially undisputed facts, and subject always to considerations of fairness and the interests of justice raised by a particular case, we think the contextual and policy matters to which we have referred will ordinarily require that leave to appeal against a decision rejecting a pre-grant opposition only be granted where the applicant has demonstrated a clear prima facie case of error in the decision appealed from, such that the likely effect of that decision would be to allow an invalid patent to proceed to grant. Whether leave to appeal should be granted 24 At the hearing, the applicant developed the grounds set out in its proposed Notice of Appeal in terms of seven substantial issues of mixed fact and law that it said were raised by the decision of Heerey J. We will deal with those issues in turn in order to determine whether a case of clear prima facie error has been made out. 25 Issue 1: Does the disclosure of a genomic DNA sequence in a patent entitle the patentee to make a claim for all DNA sequences of all species, regardless of whether the means of producing those sequences has also been disclosed? This issue was described by the applicant during the proceeding as perhaps the broadest and most fundamental issue raised. In our view, however, it does not arise from the decision of Heerey J. The reason is that it presupposes a finding that his Honour did not make; namely, that the respondent's disclosure of a particular DNA sequence in the specification legitimated a claim for DNA sequences of other species that were not disclosed. On the contrary, his Honour found that the DNA sequences that were claimed by the respondent were disclosed in the specification. His Honour said: "Genetics' primary case - fair basing Genetics argued that the claims are 'avariciously' broad because they purport to include human EPO cDNA which is not disclosed by the specification. It was said that the invention only disclosed: (i) the isolation from a genomic library of the gene that encodes human EPO; and (ii) the isolation from a cDNA library of the gene that encodes monkey EPO and the subsequent expression of these proteins in host cells. There was said to be no relevant disclosure of the isolation of the gene that encodes human EPO by the use of a cDNA library. Conclusion on Genetics' primary case I accept Amgen's argument that the object of the invention was to produce biologically active EPO in sufficient quantities for therapeutic use. The problem was that no one knew the sequence of the DNA encoding for EPO. Once the sequence was disclosed in the specification, the skilled addressee could use that sequence to produce EPO with existing technology. That sequence is disclosed in Table VI [of the specification]." [At 41, with emphasis added.] 26 His Honour's finding that the sequence of the DNA encoding for EPO (which could be used by the skilled addressee to produce EPO with existing technology) was disclosed in the specification means that what the applicant described as a "fundamental" issue does not arise in the manner contended by it. 27 Issues 2 & 3: Does the concept of enabling disclosure apply in relation to the test of sufficiency? What is the nature of the relationship between the sufficiency and fair basis tests? Again, in our view these issues do not arise from his Honour's decision, and by raising them the applicant appears to be inviting the Court to revisit his Honour's findings of fact. Relevantly, those findings are that the specification discloses to the skilled addressee the sequence of DNA encoding for EPO, and that each of the claims in the specification is sufficiently clear to the skilled addressee so as to constitute a clear and precise definition of the relevant monopoly within the meaning of the test set out in CCOM Pty Ltd v Jiejing Pty Ltd (1994) 122 ALR 417 at 432-437. The applicant also argued, in respect of these issues, that Heerey J incorrectly applied the principles of Biogen Inc v Medeva plc [1997] RPC 1 ("Biogen"). That misapplication was said to arise from his Honour's alleged "implicit finding" that Biogen stands for the proposition that the disclosure of one or two of a number of products claimed in a specification will constitute sufficient disclosure of all of those products. In our view no such finding was made by his Honour. Moreover, we are not persuaded that Biogen, which was distinguished by Heerey J on the facts, was misapplied. 28 Issue 4: Does disclosure in a patent of a term understood according to its secondary meaning entitle the patentee to maintain a claim based on that term's primary meaning? Once more this issue presupposes a finding of fact that was not made by Heerey J - namely, that "cDNA" has a primary meaning ("a physical entity") and other secondary meanings (including "information") - and invites a review by the Full Court of his Honour's finding to the contrary. What his Honour found, rejecting the applicant's contention that "cDNA" means, and only means, a physical entity, was that the question of the meaning of "cDNA" is irrelevant, the real question being "whether, given the information in the specification, and regardless of what label is put on that information, the skilled addressee could produce the invention claimed" (at 48, with emphasis added). His Honour said: "There was considerable evidence and argument as to the meaning which the expression 'cDNA' would convey to a skilled addressee at the priority date. The Genetics case was that the expression meant, and meant only, a physical entity, that is to say a DNA molecule that is the product of a laboratory process in which mRNA is copied into DNA using the enzyme reverse transcriptase… Amgen did not dispute that 'cDNA' could bear the meaning contended by Genetics. However, Amgen argued that the expression could, according to context, also bear several secondary meanings including not only DNA molecules but also information - in this case the protein coding sequence of EPO. … On the evidence, I do not think Genetics has made out its case on this issue. More fundamentally however, the question of meaning was approached by both sides as though a finding as to which meaning 'cDNA' bore would resolve a legal issue. In a forensic context, a dispute as to the meaning of words frequently has such a consequence… I am not persuaded that the present case is of that character. While the term 'cDNA' appears on a few occasions in the Amgen patent, including in the claims, it does not do so in any context where it could be said the skilled addressee would or would not be able to work the invention, depending on the meaning 'cDNA' conveyed. In other words, this is not a case where the specification says 'take cDNA and do such and such with it' and the court is asked to find that 'cDNA' would convey to a skilled addressee meaning X and that, given that meaning, the addressee could not produce something answering the description of the claims. Rather, I think the question is whether, given the information in the specification, and regardless of what label is put on that information, the skilled addressee could produce the invention claimed." [At 47-48, with emphasis added.] 29 In conclusion, therefore, we do not think that the issue whether disclosure in a patent of a term understood according to its secondary meaning entitles the patentee to maintain a claim based on that term's primary meaning arises from Heerey J's reasons for judgment. 30 During the hearing the applicant for leave further contended that if its submission regarding Heerey J's finding as to the primary meaning of "cDNA" was correct, the entire fair basis analysis undertaken by his Honour must fail on the ground that such analysis can only be supported if one accepts that what is disclosed in the specification is the information conveyed by the cDNA, and not cDNA as a product. As we do not accept the applicant's submission in relation to the meaning of "cDNA" it is unnecessary for us to consider this point further. 31 Issue 5: Did his Honour err in defining the test for clarity of claims regarding the analogues of the sequences disclosed in the specification as being whether the analogues could be produced rather than whether, once produced, the analogues could be identified as such? The question of clarity in respect of the analogue claims was dealt with by his Honour in the following short passage. "Genetics also complained of lack of clarity in claims 33 and 34 which were as follows: '33. A DNA sequence coding for a polypeptide analog of naturally-occurring erythropoietin.' … However the evidence establishes that a skilled addressee could routinely have made substitutions to the amino acid sequences and thereby obtained EPO analogues or variants…" [At 48-49.] 32 Once again, we do not accept the applicant's characterisation of his Honour's findings in respect of this issue. In our view it is clear from both this passage and his Honour's approach to the question of clarity of claims generally that the test applied by his Honour was whether a skilled addressee could knowingly produce the analogues. Accordingly, we do not accept the applicant's submission on this point on the ground that the issue raised by it does not arise from his Honour's reasons for judgment. 33 Issue 6: Did his Honour err in finding that claim 1 was a product limited by result claim and not a product by process claim? Claim 1 is expressed in the following terms. "A purified and isolated polypeptide having the primary structural conformation and one or more of the biological properties of naturally-occurring erythropoietin and characterised by being the product of procaryotic or eucaryotic expression of an exogenous DNA sequence." 34 Again, we think the applicant has not accurately represented his Honour's finding on this point, which was that no lack of clarity existed in respect of claim 1. In reaching this finding his Honour considered the clarity of the three main integers of claim 1 noting, in respect of the last of those integers (commencing with the words "and characterised by"), that no question of clarity arose with the result that that integer did not need to be considered in determining whether claim 1 as a whole was sufficiently clear. The applicant has, in our view incorrectly, interpreted this finding as a finding that claim 1 as a whole is a "product limited by result" claim. His Honour said: "Genetics argued that a number of the claims lacked clarity. It was said that the use of the term 'primary structural conformation' was not clear. I accept the contention of counsel for Amgen that the term 'primary structural conformation' is clear and means 'amino acid sequence'… The skilled addressee would understand the term 'primary structural conformation' to mean the amino acid sequences of human EPO and monkey EPO disclosed in [the specification's] tables… The skilled addressee would further have understood claim 1 … to include amino acid sequences of EPO of additional species which could be obtained by using a probe based on the nucleotide sequences disclosed in the tables… In addition to having an amino acid sequence of naturally occurring EPO, a polypeptide of claim 1 must also have one or more of the biological properties of EPO... A skilled addressee would have been able to determine whether a polypeptide had such a property using standard tests for EPO activity… The additional and last integer of the claim, that is, 'characterised by being the product of procaryotic or eucaryotic expression of an exogenous DNA sequence' is a description of the physical characteristics of the polypeptides of the claim. This may be referred to as a 'limitation by result'… Thus the claim is not a process claim." [At 48, with emphasis added.] 35 Issue 7: The role of the court assessor. The applicant argued that by having what it said must have been "lengthy discussions" with the court assessor after the close of submissions, Heerey J appears to have acted either improperly or in breach of principles of natural justice so as to warrant that the invention be denied a patent or that a re-hearing be granted. Significantly, the applicant did not refer to anything in his Honour's reasons for judgment in support of this argument. 36 We reject the applicant's contention. The fact that it can be inferred that his Honour had discussions with the assessor provides insufficient support for the conclusion that the role performed by the assessor was anything other than the role his Honour intended that he perform at the time of his appointment under s 217 of the Patents Act. That intention is clear from the following passages of his Honour's published reasons for appointing the assessor (see Genetics Institute Inc v Kirin-Amgen Inc (No 2) (1997) 149 ALR 247 at 250-251). "There is no question of an assessor [appointed under s 217] 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. [In Re JRL; Ex parte CJL (1986) 161 CLR 342] the High Court set aside an order of the Family Court because a court counsellor had approached a judge of the court in the judge's private chambers… Features of JRL included the following: (i) the intervention of the counsellor was a partisan one, made with a view to influencing the conduct and outcome of the litigation…; (ii) the intervention was not authorized by the applicable legislation…; (iii) the counsellor … was a potential witness. None of these features appears in the present case or might reasonably be anticipated. I do not see the appointment of an assessor as being inconsistent with any principle emerging from JRL. It should be particularly noted that Mason J cited with approval the well known decision in R v Magistrates' Court at Lilydale; Ex parte Ciccone [1973] VR 122. In that case McInerney J said (at 127): 'The sound instinct of the legal profession - judges and practitioners alike - has always been that, save in the most exceptional cases, there should be no communication or association between the judge and one of the parties (or the legal advisers or witnesses of such a party), otherwise than in the presence of or with the previous knowledge and consent of the other party. Once the case is under way, or about to get under way, the judicial officer keeps aloof from the parties (and from their legal advisers and witnesses) and neither he nor they should so act as to expose the judicial officer to a suspicion of having had communications with one party behind the back of or without the previous knowledge and consent of the other party. For if something is done which affords a reasonable basis for such suspicion, confidence in the impartiality of the judicial officer is undermined.' Mason J then conintued (at CLR 351…): 'This proscription does not, of course, debar a judge hearing a case from consulting with other judges of his court who have no interest in the matter or with court personnel whose function is to aid him in carrying out his judicial responsibilities. The same standard is applied in the Code of Judicial Conduct for United States Judges, approved by the Judicial Conference of the United States…' An assessor appointed under s 217 is in my opinion to be included in the category of court personnel referred to by his Honour. How the assessor appointed under s 217 performs his or her role in the actual conduct of this case will of course be governed by law, including the rules of natural justice. It is not appropriate at this early stage to lay down any detailed prescription. Suffice to say that the practical experience of Beecham shows how an appointment can work well and be of great assistance to a trial judge, without infringing natural justice." 37 We have quoted extensively from his Honour's reasons for appointing the assessor to show that the questions of the role of the assessor, and of the potential impact of that role on the parties' rights of natural justice and his Honour's obligations to perform his judicial functions fairly and independently, were considered and addressed by his Honour before the commencement of the trial. Against this background we are not persuaded that any aspect of his Honour's conduct with respect to the assessor provides a basis for leave to appeal. 38 In these circumstances, we are not persuaded that a clear prima facie case of error has been shown such that the likely effect of the decision of Heerey J would be to allow an invalid patent to proceed to grant. Our conclusions in this regard are not intended to fetter or influence any subsequent revocation proceeding that the applicant may institute, in which the Court will have to consider the matter afresh in the light of the evidence and submissions then before it. We are also of the view that considerations of fairness and justice between the parties point against the granting of leave to appeal to the Full Court and the further hearing and delay in the grant of the patent that such an appeal would entail. In all the circumstances, we consider that leave to appeal should be refused, with costs.