New England Biolabs Inc v Commissioner of Patents

the statutory scheme 6 In order to deal with the application, it is desirable to say something about the relevant parts of the 1990 Act and the Regulations. 7 Chapter 10 of the 1990 Act deals with amendments. The drafting of Chapter 10 leaves considerable detail to be dealt with by Regulations, in the way that I shall describe shortly. Part 2 of Chapter 10 is concerned with amendments of patent requests, specifications and other filed documents in various circumstances. It specifies several ways in which amendments may be made as follows: · Section 104 deals with amendments by the Commissioner pursuant to a request made by an applicant for a patent or by a patentee. · Section 105 empowers the Court to direct amendment in the course of any relevant proceedings in relation to a patent. Relevant proceedings are defined in Schedule 1 to the 1990 Act as proceedings for infringement or revocation or in which the validity of a patent is in dispute. · Sections 106, 107 and 108 empower the Commissioner to direct the filing of a statement of proposed amendments for the purpose of removing grounds of invalidity. Section 106 applies where the patent has been granted, s 107 applies where a complete patent application has been made and s 108 applies where a patentee of a petty patent has applied for an extension of the term of the petty patent. In each case, the Commissioner must be satisfied that grounds of invalidity or objection to grant could be removed by appropriate amendments. 8 Chapter 10 of the Regulations specifies and prescribes the details that are left by s 104 to the Regulations. The Regulations draw a distinction between the grant by the Commissioner of leave to amend, on the one hand, and the allowance of an amendment, on the other. They treat the granting of leave to amend by the Commissioner as a juridical act distinct from and anterior to that of the allowance of an amendment by the Commissioner. The present proceeding is concerned only with the act of granting leave to amend under the Regulations, as distinct from the act of allowing an amendment under s 104. 9 Section 104 does not itself draw that distinction as such, although the terminology found in s 104 includes both "leave to amend" and "allowance of amendment". Thus, ss 104(1) and (2) refer to a request for leave to amend and ss 104(3), (4), (5) and (6) then refer to the allowing or allowance of an amendment. 10 Section 104(1) provides that an applicant for a patent may, in accordance with the Regulations, ask the Commissioner for leave to amend a complete specification for any purpose. Under s 104(2), when an applicant asks for leave to amend a complete specification, the Commissioner must consider and deal with the request in accordance with the Regulations. 11 Under s 104(3) the Commissioner may allow an amendment subject to conditions. Under s 104(4) any person may, in accordance with the Regulations, oppose allowing an amendment. Section 104(5) prohibits the Commissioner from allowing an amendment that is not allowable under s 102. Section 104(6) provides that on the allowance of an amendment, the amendment is to be taken to have been made. Section 104(7) then allows an appeal to the Federal Court against the decision of the Commissioner allowing, or refusing to allow, a requested amendment. 12 Thus, s 104 does not expressly speak in terms the Commissioner granting leave to amend, but only in terms of the Commissioner allowing an amendment. The distinction in s 104 between asking for leave to amend and allowing an amendment appears to me to be no more than a recognition of the two aspects of the process involved, looked at from the point of view of an applicant, on the one hand, and the Commissioner, on the other. That is to say, amendment is effected pursuant to s 104 by an applicant asking for leave to amend and the Commissioner allowing the amendment. The section does not contemplate the grant of leave to amend as a juridical act distinct from and anterior to the allowance of an amendment. 13 The Regulations, however, adopt a different scheme. They identify five separate stages in the procedure to effect an amendment pursuant to s 104 as follows:

STAGE 1: THE MAKING OF THE REQUEST 14 The first stage, under r 10.1, consists of the filing by an applicant of a request for leave to amend in the approved form, together with a statement of the proposed amendments. Upon receipt of a request for leave to amend, the Commissioner may require the applicant to file a statement of the reasons for the request being made and any evidence in support of the request as provided in r 10.1(3).

STAGE 2: the making of a report by the commissioner 15 The second stage, under r 10.2, consists of consideration by the Commissioner of the proposed amendments and reporting by the Commissioner on three matters: · whether the request for leave to amend and the proposed amendments comply with r 10.1 and Schedule 3 (that is, whether they have been made in the appropriate form and have complied with former requirements); · whether any proposed amendment is not allowable under s 102; · whether the proposed amendments are not allowable under r 10.3 or, if made, would not otherwise be allowable under the Act or the Regulations.

The Regulations do not enumerate the considerations that must be taken into account by the Commissioner in determining whether the proposed amendments if made "would not otherwise be allowable under the Act or these Regulations". I have set out in Appendix 1 to these reasons a table, prepared by counsel for the Commissioner, indicating the provisions of the 1990 Act and the Regulations that might result in an amendment not being allowable. 16 As part of the reporting process, under r 10.2(6)(a), the Commissioner must provide a copy of the request for leave to amend and a statement of the proposed amendments to any person who has opposed the grant of the patent under s 59. The opponent is entitled to file comments on the request and statement - r 10.2(7). The applicant may contest the report in writing - r 10.2(3).

STAGE 3: THE DETERMINATION BY THE COMMISSIONER OF THE REQUEST BY EITHER REFUSING LEAVE PURSUANT TO REGULATION 10.4 OR GRANTING LEAVE PURSUANT TO REGULATION 10.5 17 The Commissioner must refuse to grant leave to amend if, inter alia, she reasonably believes that a proposed amendment is not allowable. The Regulations expressly refer to certain considerations that are not to prompt refusal. Under r 10.4, the Commissioner must refuse the request for leave to amend if she reasonably believes that a proposed amendment is not allowable other than for the reasons mentioned in r 10.3(4). That regulation provides that the Commissioner is not to allow an amendment if she has not yet provided an opportunity to be heard to a person to whom the Commissioner has given a copy of the request for leave to amend and a statement of the proposed amendments in the context of a patent application in relation to a micro-organism. The Regulations do not enumerate the considerations that might ground a reasonable belief that a proposed amendment is not allowable. 18 Under r 10.5(1) the Commissioner must grant leave to amend if the report made under r 10.2(1) is not an adverse report.

STAGE 4: The opposition process, which is provided for if the Commissioner determines to grant leave to amend. 19 If the Commissioner determines to grant leave, a notice of the grant of leave must be published in the official journal and an opposition process commences. This stage is expressly regulated by Chapter 5 of the Regulations, which governs oppositions, including oppositions under s 104(4). Regulation 5.3(4), contained in Chapter 5, provides that a person must not oppose the allowance of a proposed amendment of a complete specification, except on the grounds that the amendment is not allowable under s 102 of the Act.

stage 5: The determination to allow or refuse amendments following opposition. 20 The Commissioner must determine whether to allow or refuse the amendments. Regulation 10.4 obliges the Commissioner to refuse the request for leave to amend where the Commissioner believes that a proposed amendment is not allowable. However, under r 10.5(1) the Commissioner must grant leave to amend a complete specification if the report on the proposed amendments under r 10.2 "is not an adverse report". Regulation 10.5(2) then provides that if the Commissioner grants leave to amend she must publish a notice of that fact, where: (a) the patent request and complete specification to which the leave to amend relates have been accepted under s 49 or s 50; and (b) the proposed amendments are in respect of the complete specification.

Regulation 10.5(3) authorises any person to oppose allowance of an amendment if a notice is published under r 10.5(2). 21 Regulation 10.6 deals with the time "for allowance of amendments". Thus if the Commissioner grants leave to amend and r 10.5(2) does not apply, the Commissioner must allow the proposed amendment immediately. If r 10.5(2) applies to a proposed amendment, no person opposes the allowance of the proposed amendment and the Commissioner is satisfied that no relevant proceedings are pending, the Commissioner must allow the proposed amendment at the end of time for bringing in opposition proceedings. Finally, if r 10.5(2) applies, a person opposes the allowance of the proposed amendment, the opposition is decided against the opponent and the Commissioner is satisfied that no relevant proceedings are pending, the Commissioner must allow the proposed amendment immediately after the opposition is fully determined. 22 Under s 104(3), the Commissioner may impose conditions on the allowance of an amendment. Section 104(7) provides for an appeal to the Federal Court from an allowance decision of the Commissioner. There is no provision for an appeal from a decision granting leave to amend or a reporting decision. 23 Thus, the Regulations clearly draw a distinction between the granting of leave to amend on the one hand and the allowing of an amendment on the other hand. The two steps occur at different times. A patent applicant may ask for leave to amend and the Commissioner must either allow the amendment or not allow the amendment. However, before deciding whether to allow an amendment, any person who wants it must be given the opportunity of opposing the allowance of the amendment. In so far as the Regulations contemplate an anterior grant of leave to amend before opposition proceedings are commenced, they must be taken to be doing no more than specifying the procedure that leads to any person being afforded the opportunity to oppose the amendment. That procedure, however, permits the Commissioner to refuse leave to amend whether or not the amendment is opposed. 24 The Regulations specify a process for working out either the allowance or non allowance of an amendment, following a request for leave to amend. The grant of leave to amend contemplated by Regulation 10.5 is not the response to the request for leave to amend pursuant to s 104(1). Section 104(2) requires the Commissioner to deal with the request for leave to amend in accordance with the Regulations. The ultimate allowance of amendments is dealt with by Regulation 10.6, which specifies the time when the Commissioner must allow an amendment if it is to be allowed. However, that point is never reached if Regulation 10.4 applies and the Commissioner is obliged to refuse a request for leave to amend.

THE DECISION UNDER REVIEW 25 On 19 June 2000, Roche lodged with the Commissioner a request for leave to amend the complete specification of the Patent Application. Attached to the request was a statement of proposed amendments. The proposed amendments were substantially identical to those proposed in the statement of 17 May 2000 (see paragraph [4] above). On 20 June 2000, pursuant to r 10.2(6), the Commissioner's delegate informed NEB of Roche's request and invited comments on the proposed amendments within two months from that date. 26 On 21 August 2000, NEB delivered to the Commissioner's delegate detailed comments on the proposed amendments, concluding that the Commissioner should not exercise her discretion to grant Roche leave to amend as requested. In the comments, NEB asserted that Roche, in order to advance its central assertion that the Patent Application related to a patentable invention, had made a number of representations that Roche knew to be false and misleading. NEB asserted that such "inequitable conduct" was such as to disentitle Roche to the favourable exercise of the Commissioner's discretion to grant leave to amend as requested. NEB contended that to grant leave to amend in the face of such "inequitable conduct", would be "to reward deliberate deception and mock the manifest intention"of the 1990 Act. 27 On 18 September 2000, the Commissioner's delegate wrote to NEB saying that he had "decided to grant the applicants leave to amend their patent". The delegate said that, in so deciding, NEB's comments of 21 August 2000 had been taken into account. However, the delegate said that NEB's comments went "to the equity of allowing the amendments" and that such equity was not within the administrative power of the Commissioner. He said that NEB's comments were beyond the scope of s 102 of the 1990 Act and, therefore, could not be used as the basis of adverse report. The delegate concluded by saying that, as there was no adverse report, the Commissioner must allow Roche leave to amend. 28 On 19 September 2000, the Commissioner's delegate wrote to Roche enclosing a copy of the comments filed by NEB and the delegate's response to those comments. Roche was invited to respond with any comments of its own within one month from 19 September 2000. The delegate said that, while he considered that no lawful ground of objection applies to the request to amend, further consideration of the request would be deferred until Roche responded to NEB's comments or did not respond within the time given. 29 Apparently there was no response from Roche and on 25 October 2000, the Commissioner's office wrote to Roche advising Roche that the Commissioner's delegate considered that: · Roche's request for leave to amend "is as prescribed"; and · leave had been granted in accordance with r 10.5 to amend the complete specification of the Patent Application.

On 27 October 2000, the delegate also wrote to NEB saying that Roche had made no response to NEB's comments and that on 20 October 2000 the Commissioner's delegate had granted leave to amend. Both letters indicated that the proposed amendments would be advertised on 9 November 2000.

THIS PROCEEDING 30 By its application, NEB asks the Court to review: · the decision of the Commissioner made on or about 20 October 2000 reporting that the amendments filed with Roche's request for leave to amend on 20 June 2000 were allowable under the 1990 Act ("the first decision"); · the decision of the Commissioner made on 20 October 2000 that Roche be granted leave to amend the Patent Application ("the second decision"); · the conduct of the Commissioner engaged in for the purpose of making the second decision.

31 The proceeding was commenced by application filed by NEB on 22 November 2000. In the first instance, NEB relied on grounds related to the failure by the Commissioner's delegate to have regard to what it characterised as the "inequitable conduct" of Roche. During the course of final addresses, after the evidence was complete, I raised the question of whether a report had been prepared that satisfied the requirements of r 10.2(1). The hearing was adjourned to enable the parties to consider that question. As a consequence, an internal document ("the Document") of the Commissioner was tendered and admitted into evidence. A copy of the Document is set out in Appendix 2. At the same time NEB was granted leave to file an amended application. The parties then made further submissions on the new issues. 32 The grounds of the application, as amended, may be summarised as follows: (a) The making of the first decision was an improper exercise of the power conferred by the 1990 Act and the Regulations in that · in making that decision the Commissioner's delegate failed to take a relevant consideration into account, namely, Roche's inequitable conduct. · the exercise of the power by the Commissioner's delegate in making the first decision was so unreasonable that no reasonable person could have so exercised the power, in that it was legally perverse for the delegate, charged with a general duty of protecting the public interest on behalf of the Commissioner, to refuse to consider a factor of such great importance as fraud or inequitable conduct. · in making the first decision the delegate exercised the discretionary powers so conferred in accordance with a rule or policy without regard to the merits of the particular case, as he adhered to a rule that amendments should only be rejected as not allowable if they contravened the provisions of s 102 of the 1990 Act without regard to the merits of the request. (b) The making of the first decision involved an error of law as the delegate misconstrued the requirements of the exercise of the power in that he erroneously considered that Roche's inequitable conduct was an issue that: (i) lay exclusively within the power of a court to determine, and (ii) did not fall to be considered within the scope of the administrative power of the Commissioner. (c) The conduct engaged in by the Commissioner's delegate for the purpose of making the second decision was conduct that rendered the making of that decision an improper exercise of that power in that: · the conduct involved failing to take a relevant consideration into account, namely, Roche's inequitable conduct. · the conduct rendered the exercise of the power so unreasonable that no reasonable person could have so exercised the power, in that it was legally perverse for the delegate, charged with a general duty of protecting the public interest on behalf of the Commissioner, to refuse to consider a factor of such great importance as fraud or inequitable conduct. · the delegate exercised the discretionary power so conferred in accordance with a rule or policy without regard to the merits of the particular case, as he adhered to a rule that amendments should only be rejected as not allowable if they contravened the provisions of s 102 of the 1990 Act without regard to the merits of the request. (d) The conduct engaged in by the Commissioner's delegate for the purpose of making the second decision was conduct which involved an error of law, as the delegate misconstrued the requirements for the exercise of the power conferred in that he erroneously considered that Roche's inequitable conduct was an issue that: (i) lay exclusively within the power of a court to determine, and (ii) did not fall to be considered within the scope of the administrative power of the Commissioner. (e) The second decision was not authorised by the 1990 Act or the Regulations, as the condition precedent for the authorisation of a decision to grant leave to amend was not satisfied, in that there was no valid report on the proposed amendments as was required and upon which a valid exercise of the power conferred by the 1990 Act depended, as the first decision, reporting that the proposed amendments were allowable, did not constitute a valid report. (f) The second decision involved an error of law in that the delegate erroneously considered that the power to grant leave to amend a complete specification can be exercised in circumstances in which: (i) there is no adverse report that the proposed amendments are not allowable, whereas that power can only be exercised in circumstances in which there is a report that is not adverse; (ii) the report required for an exercise of power is not the final report, whereas the report must be a final report which takes into account any comments of an opponent filed and must take into account any matters raised by the applicant for a patent upon the applicant's receipt of such report. 33 The amended application claims the following relief: "(a) A declaration that there was no valid report prepared which satisfied the requirements of regulation 10.2(1) upon which the delegate could rely in granting Roche leave to amend pursuant to regulation 10.5(1)(a). (b) A declaration that the decision of the Commissioner made on 20 October 2000 granting Roche leave to amend Australian Patent Application No. 632857 was null and void and of no effect. (c) In the alternative to (a) and/or (b), an order quashing or setting aside the first and second decisions. (d) A declaration that, in making a decision, pursuant to s.104 of the Patents Act 1990 and r 10.2(1) of the Regulations, reporting on whether proposed amendments are not allowable under regulation 10.3 or, if made, would not otherwise be allowable under the Patents Act 1990 or the Regulations the Commissioner is obliged to take into account as a relevant consideration the allegation, if made, that an applicant for a Patent has engaged in inequitable conduct. (e) A declaration that, in making a decision, pursuant to s.104 of the Patents Act 1990 and regulation 10.5(1) of the Regulations, whether to grant leave to amend the Commissioner is obliged to ensure that the report on the proposed amendments under regulation 10.2(1), upon which an exercise of the power conferred by regulation 10.5(1) depends, has taken into account as a relevant consideration the allegation, if made, that an applicant for a Patent has engaged in inequitable conduct. (f) In the alternative to (d) and/or (e), a declaration that regulation 10.2(1) and regulation 10.5(1)(a) of the Patents Regulations 1991 (Cth) are invalid. (g) An order by way of mandamus, directing the Commissioner to determine according to law Roche's request for leave to amend Australian Patent Application No.632857 made on 20 June 2000. (h) Such further or other declarations or relief as to the Court may seem appropriate. (i) Costs."

JURISDICTION 34 NEB relies on three alternative and concurrent sources of jurisdiction to support the proceeding as follows: · the AD(JR) Act on the basis that the decisions impugned are decisions under an enactment; · section 39B(1) of the Judiciary Act, on the basis that a writ of mandamus is sought against the Commissioner as an officer of the Commonwealth; · section 39B(1A) of the Judiciary Act, on the basis that the proceeding involves a matter arising under a law made by the Commonwealth Parliament, namely, the 1990 Act.

35 Under the AD(JR) Act, a reviewable decision is one for which provision is made by or under an enactment. In the present case, there has been no decision under s 104 such as would attract the AD(JR) Act. The question is whether there has yet been a decision under the Regulations. 36 Generally, but not always, a reviewable decision will be a decision that is final or operative and determinative, at least in a practical sense, of the issue of fact falling for consideration. A conclusion reached as a step along the way in the course of reasoning leading to an ultimate decision would not ordinarily amount to a reviewable decision, unless the statute provides the making of a finding or ruling on that point so that the decision, though an intermediate decision, might accurately be described as a decision under an enactment - Australian Broadcasting Tribunal v Bond (1990) 170 CLR 321 at 337. 37 The Commissioner's report pursuant to r 10.2(1) is an intermediate step in a decision-making process. It is a step that the Regulations specifically require the Commissioner to take. It is a step required before granting leave to amend. That is, in turn, a step required prior to the allowance of an amendment. Under s 3(3) of the AD(JR) Act, where provision is made by an enactment for the making of a report or recommendation before a decision is made in the exercise of the power under that enactment or under another law, the making of such a report or recommendation is itself deemed to be the making of a decision for the purposes of the AD(JR) Act. The making of a report under r 10.2(1), therefore, may be a reviewable decision. 38 If there is a reviewable decision, there is no alternative adequate avenue of redress for NEB if there is any substance in its complaints. The Regulations limit the ground of opposition to amendments to those mentioned in s 102. Thus, the conduct of Roche prior to the time of its request for leave to amend could not be raised in opposition proceedings. A fortiori, any appeal to the Federal Court under s 104(7) would not permit a consideration of that conduct. 39 Section 104 contemplates that : · asking the Commissioner for leave to amend, · opposing the allowance of an amendment, and · considering and dealing with the request for leave to amend,

must be in accordance with the Regulations. The decision that the Commissioner makes is to allow or refuse to allow the amendments. In so far as the Regulations merely specify he procedure contemplated by s 104, the grant or refusal of leave is not a decision that can be characterised as final or operative and determinative. It is no more than a step in the process of making a decision whether or not to allow the amendment. 40 Nevertheless, assuming their validity, rr 10.4 and 10.5 require, in effect, that the Commissioner must either refuse a request for leave to amend or grant leave to amend. Doing either may possibly be characterised as a decision under an enactment, namely, the Regulations. Further, as I have said, assuming the validity of the Regulations, the making of the report required by r 10.2(1) may be deemed to be the making of a decision for the purposes of the AD(JR) Act by the operation of s 3(3) of that Act. Having regard to the conclusion I have reached concerning the substantive matters, it is not necessary to decide.

STANDING 41 Roche disputes NEB's standing to bring proceedings on the basis that NEB is not a person whose interests are adversely affected by the relevant decisions and that, accordingly, NEB has no standing under s 37B of the Judiciary Act and is not a person aggrieved by the decisions within the meaning of the AD(JR) Act. Roche's contention is based on the fact that NEB discontinued its appeal and withdrew its appearance in Roche's appeal - see paragraph [3] above. 42 NEB bases its standing on the circumstances that it filed notice of opposition in respect of the Patent Application and prosecuted that opposition to the stage of decision by the Commissioner's delegate. It also relies on the fact that it has undertaken to commence revocation proceedings if a patent is granted. It withdrew its involvement in the appeals only after I determined that the appeal process would not involve a full consideration on the merits of the validity of any prospective patent. 43 Section 104(4) provides that: "(4) The Minister or any other person may, subject to and in accordance with the regulations, oppose allowing an amendment." Regulations 10.2(6) and (7) relevantly provide: "(6) If:

(a) the grant of a standard patent is opposed under section 59 of the [1990] Act …and the applicant or patentee has requested leave to amend the patent request or complete specification concerned, the Commissioner must:

(c) give a copy of the request for leave to amend and the statement of proposed amendments to the opponent …; and

(d) invite that opponent … to comment on the request and statement. (7) The opponent … may file comments within 21 days … of being given the copy of the request for leave to amend and the statement under paragraph (6)(c)." 44 There is no definition of the term "opponent" in Chapter 10 of the Regulations. However, the term is defined for the purposes of Chapter 5 of the Regulations. Chapter 5 applies to an opposition under s 104(4). The definition in Chapter 5 is as follows: "opponent means a person who has filed a notice of opposition." While the definition is not expressed to apply in Chapter 10, I consider that the term opponent should be understood as having the same meaning as in Chapter 5. 45 If the grant of leave to amend as contemplated by the Regulations is a decision, an opponent would clearly have standing to challenge that decision. Roche contends, however, that NEB is no longer an opponent within the meaning of Regulation 10.2(6). Roche contends that the expression "is opposed" in Regulation 10.2(6)(a) should be construed as "is being opposed". NEB's opposition to the Patent Application has been determined by the Commissioner. NEB has withdrawn its appeal from that decision and has withdrawn its appearance in Roche's appeal. Accordingly, so it is said, NEB is no longer an opponent who is entitled to be given a copy of the request for leave to amend and be invited to comment. 46 The function of comments pursuant to r. 10.2(7) is limited. There is no express requirement for the Commissioner to take them into account. However, it is clearly implicit in the scheme of the Regulations that the Commissioner should have regard to an opponent's comments before deciding whether to grant leave or to refuse to grant leave. Even if the Commissioner's function is not to exercise a discretion, the comments could assist the Commissioner in making a determination as to whether there are grounds for refusing to grant leave. 47 I consider that NEB is a person interested in the questions raised in the proceeding. NEB has at all times maintained its objection to any grant pursuant to the Patent Application. It is a person who had filed notice of opposition. It has not ceased to be a person who filed notice of opposition. It may be that the consequence of such a literal interpretation of r 10.2(6) is that where an application for leave to amend is made after grant, a person who had filed notice of opposition, possibly many years before, would still be entitled to be given a copy of this request and to be invited to comment. Such a consequence is consistent with the scheme of the Regulations. A person who opposed a grant of a patent does not necessarily cease to have any interest in the matter simply because the patent has been granted. I am satisfied that NEB has standing to bring this proceeding.

does the commissioner have a discretion? 48 The grounds advanced by NEB for impugning whatever decision has been made by the Commissioner at this stage are that the Commissioner's delegate: (a) inflexibly applied a rule or policy without regard to the merits of the case; (b) failed to take into account relevant considerations, being considerations as to Roche's conduct; (c) made the decision unreasonably in that it was legally perverse to refuse to consider factors of such great importance as Roche's conduct; (d) committed an error of law in misconstruing the requirements for proper exercise of the power in so far as he erroneously considered that Roche's conduct did not fall to be considered within the scope of the Commissioner's administrative (non discretionary) power.

NEB contends that the Commissioner's power in making a report under r 10.2(1) and granting leave to amend under r 10.5(1) is discretionary and is to be exercised in accordance with the common law principles governing the exercise of discretion. That requires attending to the merits of each individual case and taking into account all relevant considerations. In particular, NEB says that, in considering whether to grant leave, the Commissioner is bound, or is at least entitled, to have regard to inequitable conduct of an applicant up to the stage of the request for leave to amend. 49 The Commissioner, on the other hand, takes the position that there is nothing in the Act or the Regulations that imports a discretion on the part of the Commissioner to consider matters other than those specifically referred to in the 1990 Act and the Regulations. Those provisions specify those types of amendments that are allowable and those that are not. Once a report under s 10.2(1) has been made, which is not adverse, the Commissioner must grant leave to amend. If there is no opposition, or if there is and the opposition is determined in favour of the applicant for amendment, then the Commissioner must allow the amendments. 50 The only grounds mentioned in the Regulations for not allowing an amendment are that: · the proposed amendments are not allowable under s 102, unless the amendment is for the purpose of correcting a clerical error or an obvious mistake made in, or in relation to, a complete specification; · the proposed amendments are not allowable under Regulation 10.3; · the proposed amendments would not otherwise be allowable under the Act or the Regulations.

NEB does not contend that any of those grounds arises in the present case. 51 Section 102(1) provides that an amendment of a complete specification is not allowable if, as a result of the amendment, the specification would claim matter not in substance disclosed in the specification as filed. Section 102(2) provides that an amendment of a complete specification is not allowable after acceptance if, as a result of the amendment, a claim of the specification would not in substance fall within the scope of the claims of the specification before amendment or the specification would not comply with s 40. However, under s 102(3), s 102 does not apply to an amendment for the purpose of correcting a clerical error or an obvious mistake made in, or in relation to, a complete specification. 52 A request for leave can be made for any purpose - see s 104(1). Two purposes are specified in s 104(1)(a) and (b). However, the section makes clear that the enumerated purposes are not exhaustive and that an amendment can be made for any other purpose. There is no reason to conclude that the Commissioner has any discretion to refuse leave to amend or not to allow an amendment by reason of the purpose. Rather, the contrary is likely, since s 104(1) renders an applicant or patentee's purpose irrelevant. 53 Regulation 10.1(3) empowers the Commissioner to require an applicant to file a statement of the reasons for the request being made and any evidence in support of the request. However, in my view, the presence of r 10.1(3) does not signify that the Commissioner has any discretion to refuse to grant leave to amend if a report made under r 10.2 is not adverse. Regulation 10.1(3) is related to s 104(5), which prohibits the Commissioner from allowing an amendment that is not allowable under s 102. 54 Regulation 10.1(3) authorises the Commissioner to ascertain whether a request is being made for the purpose of correcting a clerical error or an obvious mistake. If the Commissioner is satisfied that there has been a clerical error or an obvious mistake, the prohibition in s 104(5) does not apply and an amendment may be allowed, even though the result of the amendment would be that the specification will claim matter not in substance disclosed in the specification as filed. The presence of Regulation 10.1(3) is, therefore, not an indication that any discretion resides in the Commissioner to refuse a request for leave to amend. 55 An application under s 104 may be made by an applicant for a patent, prior to grant, or by a patentee after grant. The process contemplated by s 104 and Part 10 of the Regulations is the same in each circumstances. However, that of itself does not suggest that a discretion is attendant upon the Commissioner's power in either circumstance. 56 Section 104(7) provides for an appeal to this Court against a decision of the Commissioner allowing, or refusing to allow certain requested amendments. As indicated above (see paragraph [19]), r 5.3(4) provides that a person may not oppose the amendment of a complete specification except on the ground that the amendment is not allowable under s 102. When s 104(1) is read in the context of s 104(5) and r 5.3(4), such a right of appeal must be taken to be limited to the grounds set out in s 102. As I have already observed, s 104 provides the mechanism for review of the Commissioner's decisions allowing or disallowing amendments. It would be curious if the statutory regime excluded review on the Commissioner's decisions allowing amendments on other grounds. This points to a legislative intent that the Commissioner should not have a discretion to allow or disallow amendments. 57 Section 105 empowers the Court to direct an amendment in the context of relevant proceedings. The Court's power is discretionary except to the extent that, under s 105(4), the Court may not direct an amendment that is not allowable under s 102. On the other hand, the Court must exercise that discretion judicially. In so doing, the Court exercises the judicial power of the Commonwealth and must do so subject to all of the safeguards that apply in relation to the exercise of that power. 58 The position of the Commissioner, as an administrative officer, is in stark contrast. The detailed nature of the regulatory scheme provided for in Chapter 10 of the Regulations indicates an absence of a general discretion such as would permit account to be taken of the conduct of an applicant prior to the making of the request for leave to amend. The process contemplated by the Regulations prior to publishing notice of the grant of leave under r 10.5(2) is not appropriate for an enquiry of the nature suggested by NEB. The Commissioner, or her delegate, is required to make a determination in opposition proceedings, whether under s 60 or under s 104. However, the Commissioner, as an administrative officer, is ill equipped to conduct what could be a wide ranging enquiry involving assessment of credit in order to determine whether conduct of an applicant prior to making a request for leave to amend should in some way disentitle the applicant to leave. 59 Under s 216(1) of the 1990 Act, the Commissioner must not exercise any discretionary power adversely to any person applying for the exercise of that power without first giving that person a reasonable opportunity to be heard. The opportunity afforded by r 10.2(3) to contest in writing would hardly be a reasonable opportunity to be heard. If NEB's contentions were correct, s 216 would apply. That could well entail a much more complicated and extensive enquiry than would be involved at the opposition stage. There is simply no warrant for giving the Regulations such a construction in the light of the presence s 216. The reference in r 10.2(3) to permitting an applicant to contest a report in writing is clearly not intended to be a reference to being given the opportunity to be heard. The Regulations, therefore, do not contemplate that the making of a report involves the exercise of a discretionary power. 60 Regulation 10.2(1)(c) requires the Commissioner to report on whether the proposed amendments would not otherwise be allowable under the Act or the Regulations. The clear intention of r 10.2(1)(c) is to require the Commissioner to embark on the purely administrative task of checking whether there is any provision in the 1990 Act or the Regulations that would impede the proposed amendment. If the Commissioner reports that there is, the applicant for leave must be given the opportunity to contest the report. 61 There is no provision of the 1990 Act or the Regulations that indicates that prior conduct of an applicant for leave to amend would render the amendment not allowable. In particular, for example, there is no provision equivalent to ss 138(3)(d) or (e) of the 1990 Act in relation to the allowability of an amendment. Section 138(3)(d) provides that the Court may revoke a patent on the ground that the patent was obtained by fraud, false suggestion or misrepresentation. Section 138(3)(e) provides that the Court may also revoke a patent on the ground that an amendment of the patent request or the complete specification was made or obtained by fraud, false suggestion or misrepresentation. 62 If the Regulations contemplated that the Commissioner had a discretion not to allow an amendment by reason of the prior conduct of the applicant, one would expect that the Commissioner would be required to report on that conduct so that the applicant for leave could contest the report pursuant to r 10.2(3). However, there is no requirement for any report on any matter except a matter that would have the effect that the proposed amendments are not allowable under the Act or the Regulations. 63 The procedure in r 10.2 gives the applicant a right to contest the report in writing. There is no restriction or limitation as to the grounds upon which an applicant or patentee can contest the report. However, a report is not required to advert to, for example, inequitable conduct on the part of a patent applicant. Thus, if the applicant is correct in its assertion that the Commissioner retains a discretion to refuse leave to amend on the grounds of inequitable conduct, it would be possible for the Commissioner to refuse to exercise her discretion, without adverting to the existence of inequitable conduct. In that situation, NEB would have no means of knowing the reason for the Commissioner's decision. 64 Regulation 10.2(6) provides that if the grant of a standard patent is opposed under s 59 and the applicant has requested leave to amend the complete specification, the Commissioner must give a copy of the request for leave to amend and the statement of proposed amendments to the opponent and invite the opponent to comment on the request and statement. Such a process is not expressly contemplated by s 104. Section 104(2) requires that the Commissioner must consider and deal with the request in accordance with the Regulations. In so far as r 10.2(6) affords the Commissioner a means of obtaining comments prior to advertising the proposed amendments, the provision must be considered as specifying the manner in which the Commissioner must consider and deal with the request for leave to amend. 65 Regulation 10.2 requires that the Commissioner report on whether certain negatives are applicable, namely: · the request and statement of proposed amendments do not comply with the formal requirements of r 10.1; · any proposed amendment is not allowable under s 102; · the proposed amendments are not allowable under r 10.3; · the proposed amendments are not otherwise allowable under the Act or the Regulations.

If the Commissioner reports that the negatives do apply, the report is characterised as an adverse report and, accordingly, r 10.5(1) would not be applicable. 66 Regulations 10.4 and 10.5 must be presumed to cover the field in their effect, although they do not do so in their language. If the Commissioner reports that any of the negatives applies, the Commissioner must make an adverse report. Thus an adverse report signifies that the Commissioner reasonably believes that the proposed amendment is not allowable. As a result, r 10.4(a) must be read as meaning that the report is an adverse report. If r 10.4 is not so read, circumstances could arise that do not fall within either r 10.4 or r 10.5. Theoretically, it would be possible that a report be adverse, but the Commissioner, notwithstanding that fact, not believe that the proposed amendment is not allowable. There is nothing in the 1990 Act or the Regulations to suggest that is intended. 67 All of the considerations outlined above lead to the conclusion that the Commissioner's delegate did not misconceive his function. The Commissioner had no discretion to refuse to grant leave to amend on the basis of the conduct of Roche prior to requesting such leave. The Commissioner had no discretion to decline to allow the amendments requested on the basis of the conduct of Roche prior to making its request for leave to amend. Accordingly, the relevant grounds of review are not made out and declarations (d) and (e) sought by NEB should be refused.

THE STATUS OF THE FIRST AND SECOND DECISIONS 68 Regulation 10.2(1) sets out expressly the matters on which the Commissioner must report. NEB contends that the Commissioner has failed to comply with that regulation and that, accordingly, the Commissioner could not validly grant leave to amend under r 10.5(1)(a). The Commissioner could only grant leave after there had been a valid report that was not "an adverse report" pursuant to r 10.2(1). NEB asserts, therefore, that the purported grant of leave was null and void. 69 In the first instance, counsel for the Commissioner contended that the letter of 25 October 2000, referred to in paragraph [29] above, constituted the report made pursuant to r 10.2(1). Counsel for Roche supported that contention. However, following the admission into evidence of the Document (see paragraph [31] above), the Commissioner now contends that completion of that document satisfied the requirements of r 10.2(1). 70 The printed part of the Document includes a statement to the effect that the proposed amendments are allowable under the Act and the Regulations. Accordingly, the printed form of the Document is apt only where the Commissioner or her delegate so concludes. If a different conclusion were reached by the Commissioner or her delegate, the printed form could not be used without amendment. 71 Some of the blank spaces in the Document have been completed as indicated in Appendix 2. Thus, in the section headed "Allowable Amendments", reference is made to specification and drawings "filed on 19.06.00". The examining delegate of the Commissioner has signed the form, which has been dated "19/10/00". 72 The next two sections of the Document are intended to relate to the stages of granting leave and allowing amendment respectively. The first section has been completed by indicating that there is no mortgagee or exclusive licensee. That section has been signed by the acceptance delegate of the Commissioner and dated "20/10/00". The section dealing with allowance of amendment has not been completed except to the extent of indicating that there is no mortgagee or exclusive licensee. The section at the foot of the Document has been partly completed by referring to the date on which the request was to be advertised and the date on which Roche was advised of that date. 73 Regulation 10.2(1) is mandatory in its terms. It provides as follows: "For the purposes of subsection 104(2) of the Act…, the Commissioner must report on whether:

(a) the request for leave to amend and the statement of proposed amendments do not comply with regulation 10.1… and Schedule 3; and

(b) any proposed amendment of a complete specification is not allowable under section 102 of the Act…; and

(c) the proposed amendments are not allowable under regulation 10.3… or, if made, would not otherwise be allowable under the Act or these Regulations." 74 It is difficult to see how the Document as completed could satisfy the requirement that the Commissioner must report on whether: · documents do not comply, · any proposed amendment of a complete specification is not allowable under s 102, · the proposed amendments are not allowable under regulation 10.3 or would not otherwise be allowable.

Those matters are simply not adverted to in the Document. The Document is not expressed to be a report. It contains no reference to r 10.2(1). It does not say anything about the three matters that are identified in paragraphs (a), (b) and (c) of r 10.2(1). 75 The use of the word "whether" and the negative in each of the three paragraphs is curious. It would have been possible for the regulation to require the Commissioner to report on: · whether or not the documents comply with r 10.1, · whether or not any proposed amendment is allowable under s 102, · whether or not the proposed amendments are allowable under r 10.3 and are otherwise allowable under the Act and the Regulations.

If the Regulations were so structured, there would be no doubt that the Commissioner would be required to express a view about each of those matters. 76 The structure of regulation 10.2(1) might suggest, therefore, that the Commissioner is only required to report if any one of the three requirements is not satisfied. Such a construction may have been open if paragraphs (a), (b) and (c) were separated by the word "or". However, there are several matters that suggest against such a construction. First, paragraphs (a), (b) and (c) are separated by the word "and". I consider that that indicates a positive requirement that the Commissioner report on the three matters, irrespective of whether the report is favourable or unfavourable. 77 Further, the Commissioner must give a copy of each report to the applicant or patentee, as required by r 10.2(2). That indicates that there must be a document capable of being characterised as a "report". In addition, r 10.5(1)(a) assumes that there will be a report under r 10.2(1) in any event. That regulation provides that the Commissioner must grant leave to amend a patent request, complete specification or other filed document: "(a) if the report on the proposed amendments under subregulation 10.2(1) is not an adverse report." (my emphasis) 78 I do not consider that the completion of the Document satisfied the requirement of r 10.2(1), namely, that the Commissioner report whether any of the matters is applicable. Accordingly, there has been a failure to comply with the requirements of r 10.2(1). 79 Even if completion of the Document could constitute reporting by the Commissioner, there has been a failure to comply with the requirements of r 10.2(2) that the Commissioner give a copy of the report to Roche. Roche, of course, makes no complaint about any such failure. Any failure to give a copy to Roche could be waived and would not lead to invalidity. However, the failure to report as required by r 10.2(1) may be in a different category. 80 An act done in breach of a condition regulating the exercise of a statutory power is not necessarily invalid. Whether it is invalid will depend upon whether there can be discerned a legislative purpose to invalidate any act that fails to comply with a condition. The existence of the purpose is ascertained by reference to the language of the statute, its subject matter and objects, and the consequences for the parties of holding void every act done in breach of the condition - Project Blue Sky v Australian Broadcasting Authority (1998) 194 CLR 355 paragraph [91]. 81 NEB suggests that the purpose of reporting is three-fold as follows: (a) to provide a foundation for the exercise of the power to grant leave to amend; (b) to record, for the decision-maker who decides whether or not to grant leave to amend, the basis upon which the decision may be made; (c) to record, for the benefit of the public, that consideration has been given to the separate criteria expressly referred to in the Regulations.

82 NEB argues that the language of r 10.5(1)(a), and the scheme of Chapter 10 generally, confirm that a report is an essential preliminary or a minimum pre-condition to the grant of leave. However, while the language of the Regulations clearly requires that a report be brought into existence, it does not necessarily follow that the creation of a document that satisfies that requirement is an essential preliminary or a pre-condition to the grant of leave. That is the very question in issue. 83 No doubt a report would function as a record of the decision-maker who decides whether or not to grant leave. However, the essence of the requirement to report in r 10.2(1) is to convey whether there is any impediment to allowing the proposed amendments. A record such as the Document is capable of recording the conclusion reached by the Commissioner or her delegate that there is no impediment to the allowing of the amendments proposed by Roche. 84 There is no requirement that any report be made available for the public. There is no requirement that an opponent be furnished with a copy of a report. So long as the Commissioner or her delegate adverts to the relevant questions and is satisfied that the amendments are allowable, there is no public interest in having a report of the nature described in r 10.2(1). 85 Having regard to the conclusion that I have reached concerning the nature of the function performed by the Commissioner in granting leave, as a purely administrative step, I do not consider that any prejudice would flow to any person by reason of the absence of a report that satisfies the requirements of r 10.1(2). To the extent that the grant of leave is justiciable, the only question is whether the Commissioner is satisfied that the amendments are allowable. 86 As I have said (see paragraph [23] above), the regime introduced by the Regulations, in so far as it draws a distinction between the granting of leave to amend and the allowance of an amendment, is not one contemplated by the 1990 Act. It is a distinction introduced simply as a matter of administrative convenience. On the other hand, the language of r 10.2(1) is mandatory. However, it does not follow that the failure to comply with that procedural requirement leads to any invalidity of the decision to grant leave. 87 The Document evidences the fact that the Commissioner's delegate considered Roche's request for leave to amend and was satisfied that the proposed amendments are allowable under the Act and the Regulations. This suggests that, if the delegate had reported as required by r 10.2(1), he would have reported that: · the request for leave to amend and the statement of proposed amendments comply with r 10.1; · the proposed amendment is allowable under s 102; · the proposed amendments are allowable under r 10.3 and are otherwise allowable under the Act and the Regulations.

If the delegate were not satisfied as to those matters, he could not have made the notation in the Document signifying that the amendments are allowable. 88 In the circumstances, I do not consider that the failure to comply with the requirements of r 10.2(1) leads to the invalidity of any decision made under r 10.5 to grant leave to amend the complete specification.

CONCLUSION 89 I consider that, having regard to the conclusions that I have reached, the application should be dismissed with costs. However, I will first give the parties the opportunity of considering my conclusion. If there is any question as to the appropriate orders, I will give the parties the opportunity to make further submissions. I certify that the preceding eighty-nine (89) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Emmett.

Associate: Dated: 27 June 2001 Counsel for the Applicant: Mr B Caine with Ms P Tate

Solicitor for the Applicant: Blake Dawson Waldron

Solicitor for the First Respondent: Australian Government Solicitor

Counsel for the Second Respondent: Dr A Bennett with Mr S Burley

Solicitor for the Second Respondent: Sprusons Solicitors

Date of Hearing: 8 & 10 May 2001. Final submissions received 12 June 2001.

APPENDIX 1

1. Regulation 10.2(1)(c) of the Patents Regulations 1991 ("the Regulations") states: "the proposed amendments are not allowable under regulation 10.3 ("amendments not allowable") or, if made, would not otherwise be allowable under the Act or these Regulations."
2. Some examples of sections of the Patents Act 1991 ("the Act") or Regulations that may affect amendments and may need to be considered by the delegate in examining amendments made under s.104 of the Act are set out below. The sections that the delegate considers will depend on the nature of the amendments sought and the timing of the application to amend. Act/ Description Of Provision Application/example: Regulation s.15 Section 15 states that a patent may only be granted to the categories of persons identified, including persons who are entitled to have the patent assigned to them or who derive title to the invention from the inventor or another person identified in the section. If a patent request is amended to change the identity of the applicant, it will be necessary to ensure that the new applicant falls into one of those categories.

s.24 Section 24 states that certain information must be disregarded in determining whether an invention is novel or involves an inventive step. An opponent may seek to amend its notice of grounds of objection to the grant of a patent to include such information.

s.43 Section 43(1) states that each claim of a specification must have a priority date. Section 43(2) states that the priority date of a claim is the date of filing of a specification, or date determined under the Regulations. If an amendment has the effect of amending the priority date relied on in an application, it will be necessary to consider whether that may affect the claims of novelty, inventive step, etc.

s.59 Section 59 sets out the only grounds for opposition to the grant of a patent. If a statement of grounds of opposition is amended, the amendment should not include any grounds other than those set out in s. 59. The amendment of a statement is also subject to the requirements reg 5.9.

s.71 Section 71 sets out the requirements for an application to extend the term of a patent. An amendment to an extension of the term of the patent needs to be considered to determine whether it complies with the requirements set out in s.71.

s.81 Section 81 sets out the requirements that need to be satisfied for a patent of addition. Amendments to a patent of addition need to be considered carefully to examine whether the requirements of ss.81(1) are satisfied.

s.95 Section 95 sets out the requirements for a patent request relating to a Convention application. Any amendment to such a patent request would have to comply with this section.

s.103 Section 103(1) provides that where a person is registered as the mortgagee or exclusive licensee of a patent, an amendment of the complete specification is not allowable unless the mortgagee or licensee has consented in writing to the amendment.

Section 103(2) sets out various action that can be taken if a mortgagee or licensee unreasonably refuses consent.

s.112 A complete specification relating to a patent must not be amended, except under s.105, while relevant proceedings in relation to the patent are pending.

s.223 Section 223(2) requires that applications for extensions of time be made in accordance with the Regulations.

Reg 3.20(6) The applicant must filed a copy of the specification relating to the patent referred to in paragraph 47(1)(b) of the Act that is (a) certified by the official head of the Patent Office of the prescribed foreign country by which the patent was granted; and (b) otherwise verified to the reasonable satisfaction of the Commissioner before acceptance, unless the applicant makes a request under s.47(2) of the Act. Any amendments to the certification need to follow the same procedure set out in the Regulations.

Reg 5.3A/5.9 These Regulations deal with the form of amending a notice of opposition, or amendment of statement of opponent. While s.104 allows a party to amend "any other filed document", the scope of the ability to amend would be restricted by the Regulations. For instance, an applicant would be prevented by Regulation 5.3A and 5.9 from amending any documents filed by the opponent.

Reg.8.6(2) Requires specification to be certified by the Patent office of the Convention Country in which basic application is made must be filed within period from the day in which the application is made to immediately before acceptance. Any amendments to the certification need to follow the same procedure set out in the Regulations.

Reg. 22.13 Sets out requirements for declarations. Any amendments to a declaration need to follow the same procedure set out in the Regulations.

IPAustralia Patents Act 1990 Patents - Trademarks Designs (S.104 - 'Voluntary') Consideration of a Request to Amend a Patent Request, Complete Specification or other Filed Document

For an application after acceptance or a sealed patent

For applications before acceptance - please use SIDE A

I have considered the request for leave to amend the patent request and/or the complete specification and/or the other document(s) indicated below in the manner prescribed in the Regulations. The proposed amendments indicated below are allowable under the Act and Regulations. 2 filed 19.06.00

Allowable Amendments (Please indicate the date of the amendment no. (or nos.))

Specification - No. Drawings - No. Patent Request - No.

PERP Examining Delegate of Commissioner of Patents Date

Is there a mortgagee or exclusive licensee (s.103). If has consent been given? (s.103)

Note: If the application is in OPPOSITION, leave to amend must NOT be granted prior to the expiration of the period allowable for the opponent to comment on the amendment(s).

PERP Acceptance Delegate of Commissioner of Patents Date

Is there a mortgagee or exclusive licensee (s.103). If has consent been given? (s.103) Yes/No Note: Amendments must NOT be allowed (1) prior to the expiration of the 3 month period from date of advertisement, (2) when under opposition, or (3) if refused in a decision on the opposition.

PERP Acceptance Delegate of Commissioner of Patents Date Patent Administration