Euroceltique S.A. v Sandoz Pty Ltd - [2009] APO 21

ABSTRACTS OF DECISIONS
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 2002300863 in the name of Euroceltique S.A.

Title: Controlled release formulation

Action: Opposition by Sandoz Pty Ltd to the grant of a patent

Decision: Issued 12 November 2009.
Abstract

The specification relates to a sustained release form of the drug tramadol. The invention is defined by reference to dissolution rates of the tramadol, which were found to be logically related to achieving sustained release for a 12 hour dosing. However, any preparation that achieves a 12 hour release would inevitably possess the dissolution profile of the specification.
The opposition succeeds on the grounds of inventive step and clarity.
Inventive step: The problem addressed by the specification is the provision of a sustained release tramadol preparation suitable for 12 hour dosing.
A person faced with the problem of producing a sustained release form of tramadol would have ascertained, understood and regarded as relevant documents that discussed the preparation of sustained release preparations, if those documents referred to tramadol as a suitable active ingredient. From that point it would have been a matter of routine to make adjustment to the preparation to alter the dissolution profile.
EP 147780 refers to tramadol as a drug suitable for incorporation in a sustained release preparation. The inclusion of tramadol in the preparation, and any necessary adjustment to achieve sustained release over 12 hours would have been a matter of routine. Claims 1, 18, 19 and 20 lack inventive step.
DE 3810343 is in German, and does not contain an English language abstract. Where a person has a reason to consider a document could likely be relevant, it is reasonable to expect that they would obtain a translation (which would make the full content of the document understandable). In the present case, a motivation to obtain a translation is not apparent from the face of the document. The declarants did not indicate that they considered the German language document relevant. It has not been established that this document could have been regarded as relevant.
Clarity: The scope of the omnibus claim (claim 17) could not be determined due to inconsistencies in the description.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 2002300863 by Euroceltique S.A., and an opposition by Sandoz Pty Ltd to the grant of a patent

BACKGROUND

Patent application 2002300863 was filed by Euroceltique S.A. on 4 September 2002. The application is a divisional application, being the third generation of divisional applications derived from application 61963/94 (all of the parent cases have lapsed without gaining acceptance). The great-grandparent application claimed priority from four basic documents, the earliest being a German application filed on 10 May 1993.
The present application was advertised accepted on 14 October 2004. A notice of opposition was filed by Hexal Australia Pty Ltd, and the evidence stages were completed on 15 May 2009. Pursuant to regulation 5.3B, the opponent was changed to Sandoz Pty Ltd…

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: [2009] APO 21
Decision Date: 12 November 2009

CaseChat Overview and Summary

The case of Euroceltique S.A. v Sandoz Pty Ltd concerns a patent application for a sustained release formulation of tramadol, a pain relief medication. The application was opposed by Sandoz Pty Ltd on various grounds, including lack of novelty, lack of inventive step, and lack of clarity. The application was ultimately rejected on the grounds of lack of inventive step and lack of clarity. The decision highlights the importance of a clear and specific patent specification, as well as the need for a patent application to demonstrate a clear and substantial inventive step over the prior art. The decision also underscores the importance of a patent specification providing a fair basis for the claims made, and being sufficient to enable the skilled person to reproduce the invention. The case serves as a reminder to patent applicants to ensure that their patent specifications are carefully drafted and sufficiently detailed, in order to avoid potential rejection of their applications.

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