Spirit Pharmaceuticals Pty Limited v Euroceltique S.A

[2013] APO 16

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Spirit Pharmaceuticals Pty Limited v Euroceltique S.A. [2013] APO 16

Patent Application:                   2002300863

Title:Controlled Release Formulation

Patent Applicant:  Euroceltique S.A.

Opponent:  Spirit Pharmaceuticals Pty Ltd

Delegate:  Dr S.D.Barker

Decision Date:  11 February 2013

Hearing Date:  Written submissions filed on 25 January 2013 and 1 February 2013

Catchwords:  PATENTS – direction to extend the time for filing amendments after an opposition – applicant withdrew previous amendments and filed new amendment – direction made

Representation:  Patent applicant:  Spruson & Ferguson

Opponent:Ashurst

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application:                   2002300863

Title:Controlled Release Formulation

Patent Applicant:  Euroceltique S.A.

Date of Decision:  11 February 2013

DECISION

Euroceltique have until 8 October 2012 to propose amendments.

Costs associated with this hearing awarded against Spirit Pharmaceuticals Pty Limited.

REASONS FOR DECISION

Background

The present matter is somewhat unusual. Patent application 2002300863 in the name of Euroceltique S.A. was opposed by Sandoz Pty Ltd. On 12 November 2009 I issued a decision in the matter ([2009] APO 21), finding that claims 1 and 18 to 20 lack inventive step, and that claim 17 is not clear. The decision states in the penultimate paragraph:

"It is appropriate to allow Euroceltique 60 days to propose amendments."

On 2 December 2009 the opponent brought an appeal in the Federal Court (designated NSD 1385/2009), and on 3 December 2009 the patent applicant brought an appeal in the Federal Court (designated 1384/2009). 

On 11 January 2010 amendments were filed, and the Federal Court appeals were stood over pending consideration of amendments.  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. 

On 5 October 2012 the applicant advised the Commissioner that it withdrew the amendments dated 11 January 2010, and that it wished to file a further amendment.  This amendment is outside the 60 days allowed for amendments, so the applicant requested that the time for proposing amendments be extended.  On 12 October 2012 I asked the parties whether there was any reason why I should not extend the time for proposing amendments until 8 October 2012 (being the date that the amendments were filed with IP Australia).  Spirit indicated that it wished to be heard on the matter of the time for proposing amendments, and a hearing was held by way of written submissions.

Consideration

Where an opposition to the grant of a patent is successful, it is common for the applicant to be allowed a period of time to propose amendments.  The opposition proceedings remain in existence until a final determination is made, and the opportunity to propose amendments is a direction for the conduct of the remainder of the opposition proceedings.  Consequently the period can be altered by a direction under regulation 5.10.  Sub-regulation 5.10(5) says the Commissioner must not give a direction unless reasonably satisfied that it is appropriate, so in the present case I must decide whether it is appropriate in the circumstances to alter the time for filing amendments.

The applicant states that it withdrew the previous amendments and filed new amendments in an attempt to resolve all remaining grounds of opposition.  The amendments were filed immediately after the previous amendments were withdrawn. 

Spirit has not argued that the new amendments would not be allowable, or that they would not overcome the deficiencies found in the opposition.  Rather, they submit that there has not been a proper explanation of why the new amendments were not proposed earlier.  The history of this matter shows that this is not a case where the applicant has been sitting on its hands.  The applicant responded to the opposition decision by both amendment and appeal.  However, the original amendments were themselves subject to opposition.  The applicant indicates that it has proposed the new amendments due to the approaching expiry of the term of the patent:

"In particular, it is desirable that the matter be decided before the expiry of the 20 year term of a patent that may be granted on the application.  This term expires on 9 May 2014."

Spirit also refers to the costs of its opposition to the previous amendments.  Those costs are a separate matter, and I do not consider they are relevant to the decision I have to make.

In summary, the opposition decision stated that there was patentable subject matter, and that it was appropriate to allow amendment.  It is not suggested that the amendments are not a reasonable attempt to define that patentable subject matter.  The applicant originally adopted a different strategy for dealing with the issues in the opposition decision, but has now proposed the current set of amendments.  There seems a realistic possibility that the present amendments may resolve the opposition (the applicant has indicated that they intend to withdraw the appeal against the original decision, but has not yet done so).  Overall I am satisfied that the time for proposing amendments should be extended to 8 October 2012.  Those amendments have been filed within time, and will now be considered by an Examiner.

Spirit's objection to extending the time for proposing amendments was not well taken.  It is appropriate for the costs associated with this hearing to be awarded against Spirit.

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. 

Dr S.D.Barker
Delegate of the Commissioner of Patents