Sunesis Pharmaceuticals, Inc. and Millennium Pharmaceuticals, Inc.  APO 34 (30 May 2013)
Two recent decisions of a Delegate of the Commissioner of Patents have focussed attention on transitional provisions in the Intellectual Property Laws Amendment (Raising the Bar) Act 2012. In each case the outcome has been unfavourable to the applicant.
- In the first decision, Euroceltique S.A. has been denied permission to amend its patent application while an appeal of an earlier opposition to the Federal Court remains pending, as a result of the operation of new section 112A of the Patents Act 1990.
- In the second decision, a request by joint applicants Sunesis Pharmaceuticals, Inc. and Millennium Pharmaceuticals, Inc. for an extension of time to file a request for examination under the former law, predating the Raising the Bar reforms, has been refused.
The most important of these transitional provisions cover the substantive changes to the standards required of a valid patent, including the tests for inventive step, utility, and the level of disclosure required in order to support the full scope of protection claimed by an application or patent. For these types of reforms introduced by the Raising the Bar Act, the new standards may apply to applications filed before 15 April 2013, but only if a request for examination is not filed until after that date.
However, other amendments made by the Raising the Bar Act have alternative transitional provisions and, in particular, some had immediate effect from 15 April 2013 even in respect of matters already in-progress.
In the short time since commencement of the Raising the Bar reforms, the Patent Office has already had reason to consider the effect of each of these types of transitional provision.
New Section 112A – Amendments While Decisions on AppealOne line of reform introduced by the Raising the Bar Act was to bring the administrative powers of the Commissioner of Patents into alignment with the judicial powers of the Federal Court in relation to a number of procedures, including those for amending applications and patents. The idea behind a number of the changes was to streamline administrative and judicial processes, and avoid duplication of effort and responsibility. In short, once a matter is before the Federal Court, then the court should have the power to direct proceedings, and should not have to deal with parallel processes taking place within the Patent Office.
Appeals from opposition decisions could become particularly unwieldy, because the court was confined to reviewing the same claims considered by the Commissioner during the opposition, even if the applicant made subsequent amendments through the Patent Office procedures.
One of the new provisions giving effect to this streamlining is section 112A, which states that:
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.
Section 105 gives the Court the power to direct the Commissioner to amend a patent of application, and new subsection 105(1A) mirrors the prohibition in section 112A:
If an appeal is made to the Federal Court against a decision or direction of the Commissioner in relation to a patent application, the Federal Court may, on the application of the applicant for the patent, by order direct the amendment of the patent request or the complete specification in the manner specified in the order.
Opposition and Amendment RequestsEuroceltique S.A. is the applicant in respect of Australian patent application no. 2002300863, which was opposed by Sandoz Pty Ltd. A decision in the opposition was issued in November 2009, finding a number (but not all) of Euroceltique’s claims to be unpatentable. Both parties appealed to the Federal Court, but Euroceltique subsequently applied independently to the Patent Office, requesting to amend the application under section 104 (which was permissible at the time). The court suspended the appeal proceedings, pending the outcome of the amendment request.
The amendment request was initially granted, but the amendments were opposed (by Sandoz Pty Ltd and by Spirit Pharmaceuticals Pty Ltd). This ultimately led to Euroceltique withdrawing its initial amendment request, and filing a new request in October 2012.
Impending Effects of Raising the BarThe problem with this further request, however, was the looming commencement of the Raising the Bar reforms, and most particularly of section 112A. In granting Euroceltique the opportunity to file its revised amendment request, the Commissioner’s delegate noted that:
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. (Emphasis added.)
Since the Federal Court appeals were still pending in 15 April 2013, the delegate indicated his intention to refuse the amendment request, though not before giving the applicant the opportunity to be heard.
Arguments and OutcomeAt the hearing, Euroceltique argued firstly that its request to amend had been ‘dealt with’ by the Commissioner prior to 15 April 2013 (even though the amendment process had not been completed), and secondly that it would be unduly prejudiced by the refusal of its request (which would then require that it make the same request before the court).
The delegate was not persuaded by either of these arguments, finding 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’ (at ); and
- ‘…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.’
Raising the Bar Means No Going Back!As I have written previously, the impending commencement of the Raising the Bar reforms had a significant impact on applicant behaviour in the weeks and months prior to 15 April 2013. I recently noted the large increase in new filings in the month prior, while one of my Watermark colleagues obtained data from IP Australia showing substantial growth in voluntary examination requests from February 2013, culminating in over 22,000 requests filed during the month prior to 15 April!
With all of this intensive activity, it is not at all surprising that some applicants, for one reason or another, missed the boat!
Missing the BoatSunesis Pharmaceuticals, Inc. and Millennium Pharmaceuticals, Inc. are the joint applicants of Australian patent application no. 2010303567. It had been their intention to file a request for examination prior to 15 April 2013, in order to obtain the benefit of the less stringent validity requirements under the prior provisions. However, as a result of what might be termed an ‘unfortunate series of events’ (see paragraphs  to  of the Patent Office decision for details) the request was not filed in time.
The applicants therefore sought an extension of time under section 223(2) of the Patents Act, contending that ‘because of … an error or omission by the person concerned or by his or her agent or attorney … a relevant act that [was] required to be done within a certain time’ was not done, and extension of the time to request examination should be available.
Reasoning and OutcomeThe outcome in this case turned on the meaning of ‘relevant act’, and of ‘required to be done within a certain time’.
The delegate found that:
- ‘…when considered in the scope, context and purpose of the Patents Act, the power conferred by section 223 is specific rather than general and is necessarily restricted to requirements, and the extending of time limits, that are expressed in the provisions of that Act’ (at ); and
- ‘…while the present circumstances might well reflect the loss of a potential benefit as a result of an error or omission, it is not a matter that can, or is intended to be, remedied by section 223 because there is no relevant requirement or time period’ (at ).
The extension request was therefore refused.
ConclusionParties involved in opposition proceedings (or, indeed, any other matters before the Patent Office which may be subject to a Federal Court appeal) should be aware that the new provisions of section 112A and subsection 105(1A) are now in-force, and apply in all cases where amendment procedures had not been finalised prior to 15 April 2013.
For new matters, the provisions should not create any significant problems. The period during which an appeal may be filed is generally 21 days from the date of the Patent Office decision, whereas the Office normally allows a longer period (typically 60 days) to make any amendments necessary to overcome adverse findings. It will therefore usually be clear well in advance of the amendment deadline whether an application to amend should be filed with the Office, under section 104, or in the course of an appeal proceeding, under section 105.
In this context, I think that Euroceltique was rather hard done by, in that an amendment under section 105 was not available before 15 April 2013, while the incomplete amendment made legitimately under section 104 was refused after 15 April 2013. Nonetheless, this does appear to be the intended and actual effect of the transitional provisions of the Raising the Bar Act.
As for the failed attempt to extend the examination request ‘deadline’ set by the Raising the Bar Act, the outcome is not at all surprising. However, I doubt that we have heard the last of this issue, because it seems almost certain that with tens of thousands of additional examination requests filed in the period leading up to commencement of the reforms, there must be other cases in which requests have been inadvertently delayed. There may yet be further attempts to backdate late-filed examination requests to a date prior to 15 April 2013.
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