Euroceltique S.A.
[2013] APO 30
•9 May 2013
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Euroceltique S.A. [2013] APO 30
Patent Application: 2002300863
Title:Controlled Release Formulation
Patent Applicant: Euroceltique S.A.
Deputy Commissioner: Philip Spann
Decision Date: 9 May 2013
Hearing Date: 29 April 2012
Catchwords: PATENT – Section 104 – Request to amend – whether section 112A applies – transitional provisions – meaning of “if the Commissioner had not dealt with the request” – whether the request should be refused – amendment refused.
Representation: Patent applicant: R Grant, Patent Attorney, Spruson & Ferguson.
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2002300863
Title:Controlled Release Formulation
Patent Applicant: Euroceltique S.A.
Date of Decision: 9 May 2013
DECISION
The request to amend the complete specification filed on 8 October 2012 is refused.
REASONS FOR DECISION
Background
The current Patent application 2002300863 in the name of Euroceltique S.A. (Euroceltique) has been accepted but was subsequently opposed by Sandoz Pty Ltd (Sandoz). On 12 November 2009 a delegate of the Commissioner issued a decision (the opposition decision) in the matter (Euroceltique S.A. v Sandoz Pty Ltd [2009] APO 21). He found that claims 1 and 18 to 20 lack inventive step, and that claim 17 is not clear. However, finding that the application contained patentable subject matter, the delegate allowed Euroceltique the opportunity to propose amendments overcoming the successful grounds of opposition.
Both parties appealed that decision in the Federal Court (NSD 1384/2009 and NSD 1385/2009), and on 11 January 2010 Euroceltique filed a request to amend the complete specification under section 104 of the Act. In consequence of this, on 28 January 2010, Justice Bennett stood over both appeals “pending the outcome of the application dated 11 January 2010 to the Commissioner of Patents”
On 26 March 2010 an Examiner granted leave to amend. The amendments were advertised, and oppositions were commenced by Sandoz Pty Ltd and by Spirit Pharmaceuticals Pty Limited (Spirit). Those oppositions progressed through the filing of evidence in support and in answer but on 8 October 2012 Euroceltique informed the Commissioner that it wished to withdraw the opposed request to amend. At the same time it filed a new request which it says brings the claims into conformity with claims 2 to 16 of the accepted application and that “These claims were found by the Delegate of the Commissioner of Patents to have no valid ground of opposition raised against them”. (The applicant also stated that it proposed to withdraw its appeal however in the event this does not appear to have occurred).
The delegate wrote to the parties concerning the withdrawal and also sought comment on a proposal to vary his direction for the filing of amendments in response to the opposition decision. That is, to extend the period for filing amendments to 8 October 2012. Spirit objected to this but on 11 February 2012 the delegate decided (Spirit Pharmaceuticals Pty Limited v Euroceltique S.A. [2013] APO 16) that the period for filing amendments arising from the opposition decision be extended to encompass the new request to amend.
The delegate also included in his decision the following footnote:
“On 15 April 2013 amendments to the Patents Act come into force. One of those amendments is the introduction of section 112A, which says that the Commissioner must not amend a complete specification relating to an application if an appeal is proceeding and has not been finally determined, withdrawn or otherwise disposed of. The transitional arrangements state that this provision applies in relation to requests for amendment made before the commencement date, if the Commissioner has not dealt with the request on or before the commencement date. Due to the need to advertise the amendment, it will not have been finally dealt with before the commencement date. Consequently, the appeals may become an impediment to the allowance of the amendment. The parties to the appeals should take this into account.”
Euroceltique’s attorney filed submissions on 27 March 2013 refuting the application of section 112A. Nevertheless on 15 April the delegate indicated that he intended to refuse the amendment request following the Commissioner’s practice for non-allowable amendments of patents under section 112. The delegate provided Euroceltique the opportunity to be heard before taking that step and consequently it requested to be heard and filed further written submissions on 30 April 2013.
The applicant submission is that the amendments should not be refused and the Commissioner should continue to deal with the request for amendment. The submissions include the following summary of Euroceltique’s position:
“1) We contend that the transition provisions of the Raising the Bar Act apply so as to allow the Commissioner to rule on the present request for amendment, since the request had been "dealt with" prior to the commencement date of 15 April 2013;
2) Several indications point to the fact that the new provisions of the Patents Act introduced by the Raising the Bar Act were not intended to apply to cases such as the present one; and
3) If, despite 1) and 2), the request for amendment is considered not to have been "dealt with" by the Commissioner before the commencement date, we submit that the delay in doing so was undue (the request for amendment having being filed on 5 October 2012, i.e. more than 6 months prior to the commencement date) and the Applicant should not be penalised by such delays by the Commissioner.”
I will deal with the submissions in more detail below. However, it appears that fundamentally I must consider, a) whether section 112A applies to the current request to amend and b) if so, whether I should refuse it.
Does section 112A apply?
Section 112A of the Act came into effect on 15 April 2013 by virtue of the commencement of Schedule 3 Item 10 of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (the Raising the Bar Act). It provides:
112A Decisions on appeal
A complete specification relating to a patent application must not be amended, except under section 105, if:
(a)an appeal against a decision or direction of the Commissioner has been made to the Federal Court in relation to the specification; and
(b)the appeal, and any proceedings resulting from it, have not been finally determined, withdrawn or otherwise disposed of.
10.Section 105 of the Act as amended on the same date (Schedule 3 Items 6, 7, 8 and 9), permits the Court in an appeal to order amendment of a complete specification in relation to a patent application in a similar way as it can in relevant proceedings for a patent. Applications under section 105 are governed by Federal Court Rule 34.41. The Explanatory Memorandum for Item 6 indicates:
“This item amends the Patents Act to provide that a court may consider and decide on amendments to a patent application during an appeal from a decision of the Commissioner.
Currently, during an appeal from a decision of the Commissioner the Court must confine itself to the same subject matter as considered by the Commissioner.101 This
means that where an applicant has amended their specification subsequent to the Commissioner's decision, the Court cannot consider the amended specification, even where the amendments may overcome the grounds on which the decision is being appealed.This adds complexity to the appeals process and to resolution of opposed patent applications.
The item addresses this problem by giving a court power to consider and decide upon
any amendments proposed by the applicant while an appeal is on foot. These
amendments would be considered under the existing provisions under which courts
may direct amendments.102….
101 New England Biolabs Inc v F Hoffmann-La Roche AG [2004] FCAFC 213
102 Section 105, Patents Act”11.The application provision in Item 32(5) of Schedule 3 is that:
“The amendments made by items 6, 7, 8 and 9 of this Schedule apply in relation to appeals to the Federal Court:
(a)made on or after the day this Schedule commences; and
(b)made before that day, if the appeal had not been finally determined, withdrawn or otherwise disposed of.”
and the Explanatory Memorandum relevantly states:
“Sub-item (5): Items 6, 7, 8, and 9 relate to giving the court the discretionary power to direct amendment of a patent application during an appeal from a decision of the Commissioner. The changes should apply to:
· appeals made on or after the day of commencement; and
· appeals made before commencement, but not determined, dismissed or disposed of at commencement.”
12.Returning to section 112A, the Explanatory Memorandum indicates that:
“This item is consequential upon item 6 above, which gives a court the discretion to consider and decide on amendments to a patent application during an appeal from a decision of the Commissioner.
The item specifies that only the Court can deal with amendments to an application during an appeal to the Court against a decision of the Commissioner relating to that application. This is similar to an existing prohibition, where there are court proceedings in respect of a granted patent.103 The intention is to avoid having the same issues dealt with by different decision makers.
103 Section 112, Patents Act”
13.The application of section 112A is governed by item 32(1) of Schedule 3:
The amendments made by items 1 and 10 of this Schedule apply in relation to:
(a)requests for amendments made on or after the day this Schedule commences; and
(b)requests for amendments made before that day, if the Commissioner had not dealt with the request on or before that day.
14.In relation to the application provisions for Schedule 3 the Explanatory Memorandum indicates generally at that:
“The principles underpinning the application provisions are that the changes should:
· take effect as soon as possible, to quickly bring about a better balance and operation to the intellectual property system; and
· not unduly prejudice users of the system, particularly with respect to not affecting rights granted prior to implementation of the changes, or making decisions of the Commissioner or Registrar made prior to the changes incorrect.”
and more specifically for Sub-item (1):
“Items 1 and 10 relate to amendments to patent applications during an appeal to the court. The amendments prohibit the Commissioner from dealing with amendments while court proceedings are afoot. The changes should apply to:
· requests to amend made on or after the day of commencement; and
· requests to amend made before commencement, if the Commissioner has not dealt with the request on or before that day.”
15.It is important to note that section 112A concerns requests to amend filed under subsection 104(1) of the Act. Subsection 104(2) indicates that where a request is made “the Commissioner must consider and deal with the request in accordance with the regulations”. The Full Court in New England Biolabs Inc v F Hoffmann-La Roche AG [2004] FCAFC 213 in considering this scheme stated:
“12.As can be seen from s 104(2) and (3) the Commissioner is required to consider and deal with the request in accordance with the regulations and she may allow the amendment with conditions, but subject to the regulations. How the Commissioner must consider and deal with the application and her power to allow an amendment sought under s 104(1) is regulated by regulations 10.1 to 10.6.”
(Note that subsection 104(3) permitted the Commissioner to allow an amendment subject to conditions but was repealed by Schedule 8 of the US Free Trade Agreement Implementation Act 2004)
16.Consequently it can be seen that Chapter 10 of the Patents Regulations sets out as a whole how the Commissioner is to “deal” with a request to amend and dealing with the request includes, as appropriate, examination of the request (10.2), refusing requests to amend (10.4), granting of leave to amend and advertisement (10.5) and allowing the amendments (10.6).
17.In its submissions (including its earlier submissions of 27 March 2013) Euroceltique argues that Item 32(1) of Schedule 3 should not be read to apply where the Commissioner had not “finally” dealt with the amendment (suggesting that the delegate had impermissibly read in the word “finally”) and that, as the amendments had “been dealt with (albeit not finally) by the commencement date”, then the provisions of section 112A did not apply. It follows that it is the applicant’s submission that “dealt with” includes any dealing with the amendments, including any consideration of the amendment by the delegate that occurred before 15 April.
18.In my view it is not necessary to read any additional words into Item 32(1) nor are the words unclear in the context of the Act. I consider that the words “dealt with” in Item 32(1) of Schedule 3 have a clear connection with the requirement for the Commissioner to “deal with” the request under subsection 104(2). As I have found above, Chapter 10 of the Regulations sets out how the Commissioner is to “deal” with requests to amend. “dealt” is simply the past tense of “deal” (Macquarie dictionary) so, accordingly, I consider that on the plain meaning the Commissioner has not dealt with an amendment if the Commissioner has started but not completed the processing of the amendments as required by all relevant provisions of Chapter 10 of the Regulations. In this case, she is still “dealing” with the amendment as required by the Regulations.
19.Were there any doubt about the construction I have adopted and its effect in this matter, the relevant parts of the Explanatory Memorandum cited above make it clear that:
· the introduction of section 112A is consequential to the additional powers granted to the Court by the amendment of section 105;
· the Court should have the power to deal with amendments for complete applications where an appeal is before the Court, including appeals filed before commencement of schedule 3 of the Raising the Bar Act; and
· it is not intended that the Commissioner deal with amendments if the Court has the power to deal with those amendments under section 105.
20.Consequently, the construction I have adopted appears entirely consistent with the policy intent reflected in the Explanatory Memorandum. If the Commissioner had “dealt” with the amendment before commencement, that is, completed all the steps required by Chapter 10, then there would be no possibility of conflict with the jurisdiction of the Court. Conversely, under the applicant’s construction, the Commissioner, having not disposed of the request will be required to continue to process the amendments, and potentially allow amendments, at a time that the Court is considering an appeal and clearly has jurisdiction to deal with amendments under section 105. I do not see any support for this outcome in the Explanatory Memorandum, even for a transitional case.
21.There are also other difficulties with the applicant’s construction. For example, if any part of “dealing” with a request was intended to exclude the operation of section 112A then it would be pointless for the application provision to refer to “requests for amendments made before that day”. All would have been “dealt with” to some extent on the applicant’s interpretation. If “dealt with” means more than that but not all steps required by Chapter 10 then the legislation gives no indication of what is encompassed. Consequently the applicant’s construction leads to ambiguity that otherwise does not arise.
22.Euroceltique’s submissions concerning undue prejudice similarly do not advance its case on construction. While the Explanatory Memorandum indicates that the principles underpinning the application provisions in Schedule 3 Item 32 include that the changes should not unduly prejudice users of the system, this was clearly balanced against an intention that the changes take effect as quickly as possible and related particularly to not affecting rights granted prior to implementation. Here, while it is difficult to find that the construction I have adopted in any way results in undue prejudice in relation to a pre-existing right, it is nevertheless clear that the intent of the legislation is to provide the Court with sole jurisdiction in relation to amendments where an appeal has been filed and regardless of whether the appeal was filed before, on, or after 15 April 2013.
23.I conclude that for Item 32(1) of Schedule 3, the request for amendment was made before commencement of the Schedule on 15 April 2013 but that the Commissioner had not dealt with that request on or before that date. Consequently section 112A applies to the present application. Since an appeal of the opposition decision has been filed and has not been “finally determined, withdrawn or otherwise disposed of”, the complete specification must not be amended.
Should the application be refused?
24.Regulation 10.4 requires that a request to amend be refused in certain circumstances. The regulation, as it applies to the current request, states (my emphasis):
The Commissioner must refuse the request for leave to amend, if:
(a)he or she reasonably believes that a proposed amendment is not allowable, other than for the reasons mentioned in subregulation 10.3 (4); or
(b)the applicant or patentee has not complied with a request of the Commissioner under subregulation 10.1 (3); or
(c)in the case of a proposed amendment of a complete specification relating to a patent -- the patentee has not complied with a request of the Commissioner under subregulation 10.1 (4).
25.Regulation 10.6 provides for the allowance of amendments and subsection 104(6) provides that on allowance of an amendment, the amendment is taken to be made. It follows that an amendment that must not be made because of sections 112 and 112A also must not be allowed and is therefore “not allowable”. It is the same as certain other amendments which under Section 102 of the Act and Chapter 10 of the Regulations are not allowable.
26.Consequently I find that, because section 112A applies, the amendments are not allowable and I am required under regulation 10.4 to refuse the request to amend. No discretionary considerations are admitted.
Conclusion
27.I have found that because the Commissioner had not dealt with the current requested amendments before 15 April 2013, section 112A of the Act applies. Consequently, the amendments are not allowable and the request must be refused as required by Regulation 10.4.
Philip Spann
Deputy Commissioner of Patents
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