Les Laboratoires Servier v Apotex Pty Ltd - [2008] APO 11

ABSTRACTS OF DECISIONS

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Application : No. 2001276418 in the name of Les Laboratoires Servier

Title: A crystalline form of perindopril tert-butylamine salt

Action: Request under Regulation 5.5(1) by Les Laboratoires Servier for a dismissal of an opposition made under Section 104(4) by Apotex Pty Ltd

Decision: Issued 11 April 2008 .
Abstract

Opposition dismissed.

Some general principles that flow through to the dismissal of patent oppositions from recent changes to Section 31A of the Federal Court Rules and subsequent Federal Court decisions are discussed. Notably, an opposition need not be “clearly untenable” or “manifestly groundless” in order for it to be dismissed. An opposition may be dismissed if it is considered to have no reasonable prospects of success.

The claims as accepted defined a new polymorph of perindopril tert-butylamine salt which was characterised by X-ray crystallography. Uses of the compound in pharmaceutical formulations and methods were also defined. The proposed amendments sought to include claims to the compound and methods with the further characteristic that the polymorph was in the form of “individual needles”. The opponent opposed the amendments under section 104 and addressed all grounds of opposition available under section 102. The applicant requested dismissal of the opposition on the basis that it was manifestly groundless and could not possibly succeed.

A consideration of the case set out by the opponent shows that it has no reasonable prospects of success. The opponent has not established that there is a real issue to be determined, or the issues identified are in respect to matters that do not arise as a result of the amendments and would not be sustainable in an opposition under section 104. On that basis the opposition is dismissed.

Costs awarded against the opponent Apotex.

PATENTS ACT 1990

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Re:Patent Application No. 2001276418 by Les Laboratoires Servier and a request under Regulation 5.5(1) by Les Laboratoires Servier for a dismissal of an opposition made under Section 104(4) by Apotex Pty Ltd.

BACKGROUND

Patent application 2001276418 in the name of Les Laboratoires Servier (the Applicant) was advertised accepted on 6 July 2005. A notice of opposition to the grant of the patent was filed by Lupin Ltd on 28 October 2005, but the opposition was withdrawn on 5 February 2007 following settlement by the parties. Before the application could proceed to grant a further notice of opposition was filed on 9 March 2007 by GenRx Pty Ltd (who subsequently changed their name to Apotex Pty Ltd). An application under section 223 to extend the time in which to file the notice was required, which the applicant opposed. The opposition was heard on 26 July 2007 and a decision refusing the extension of time was issued on 4 September 2007. This decision was appealed to the Administrative Appeals Tribunal who recently issued a decision affirming the Commissioner’s decision.

An associated divisional Innovation Patent, 2006101079, has also been the…

Grounds of appeal

[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.

[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.

[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.

Consideration

[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.

[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.

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Details

Case: [2008] APO 11
Decision Date: 11 April 2008

CaseChat Overview and Summary

Les Laboratoires Servier applied to a delegate of the Commissioner of Patents for the dismissal of an opposition made by Apotex Pty Ltd against the grant of patent application 2001276418. The application related to a crystalline form of perindopril tert-butylamine salt and the Commissioner dismissed the opposition. The Commissioner found that the opposition raised no reasonable prospects of success on any of the grounds available under section 102 of the Patents Act 1990. The Commissioner found that the amendment to include claims to the compound and methods in the form of "individual needles" was in substance disclosed in the specification as filed and that the proposed use claims were within the scope of the accepted claims. The Commissioner also found that the amended claims defined the invention fully and in a clear manner. The Commissioner awarded costs against Apotex.

Orders