Zentaris Aktiengesellschaft - [2002] APO 41

OFFICIAL NOTICE
DECISION OF A DEPUTY COMMISSIONER OF PATENTS
Patent: No. 671881 in the name of Zentaris Aktiengesellschaft

Title: Novel Process for the Preparation of Lyophilised Peptides

Action: Request under s.70 for an extension of the term of the patent, and objections thereto by the Commissioner's delegate.

Decision: Issued: 21 October 2002 .
Abstract

Patent relates to a lyophilisate of a polypeptide, characterised by a method of making the lyophilisate. Objection that a pharmaceutical substance per se was not in substance within the scope of the claims, on the basis that the claims were directed to a product by process. Following further information, application to extend the term accepted on the basis of the omnibus claim.
·The morphology of a polypeptide is often a critical factor in the biochemical activity of the polypeptide – such that a different morphology might result in a different 'pharmaceutical substance';
·The evidence indicated that the lyophilisation process involved in the invention resulted in a polypeptide with altered morphology. Having regard to the date of the patent, it was reasonable to expect the morphologically different polypeptide to be defined by its method of production, rather than by 3-D characterisation;
·The substance as described was consistent with the substance on the ARTG;
·The critical method step described in the specification was to dissolve the polypeptide in a 30% acetic acid solution. In the absence of this step, it could not be reasonably concluded that the morphological characteristic of the peptide would be the same. However, this step was not present in any of Claims 1 to 4, and thus it was not possible to conclude that the substance was in substance within the scope of any of these claims;
·However, it was found that the substance was in substance within the scope of the omnibus claim (claim 5).
·Observations concerning extension of term proceedings in situations where the claims relied upon are clearly prima facie invalid.

PATENTS ACT 1990
DECISION OF A DEPUTY COMMISSIONER OF PATENTS
Re:Patent No. 671881 in the name of Zentaris Aktiengesellschaft, Request under s.70 for an extension of the term of the patent, and objections thereto by the Commissioner' delegate.

BACKGROUND

Patent 671881 was applied for on 17 Feb 1994, claiming a priority date of 19 Feb 1993, and was subsequently granted. On 29 March 2001 the patentee (then Asta Medica Aktiengesellschaft) applied for an extension of the term of the patent. If the extension is granted, I understand the term will be extended from 17 Feb 2014 to 22 Feb 2016.
Three reports have issued from the Commissioner's delegate. The substance of those reports is that the specification does not include a claim to a pharmaceutical substance per se; that the claims relied upon are claims to a product by process. The attorney has argued that the claims do provide a proper basis, as the only way to properly characterise the pharmaceutical substance is by its method of preparation.
The matter was set for hearing on…

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

AGLC: Zentaris Aktiengesellschaft [2002] APO 41
Case: [2002] APO 41
Decision Date: 21 October 2002

CaseChat Overview and Summary

The case involves Zentaris Aktiengesellschaft, the owner of Patent No. 671881, which pertains to a novel process for the preparation of lyophilised peptides. The dispute centres on the Commissioner's delegate's objections to the patent term extension request under section 70 of the Patents Act 1990. The central legal issues revolve around whether the pharmaceutical substance claimed in the patent is indeed within the scope of the claims, and if the substance falls within the definition of a pharmaceutical substance per se.

The court examined the specification, which describes a process involving the dissolution of cetrorelix in 30% acetic acid, followed by lyophilisation. The critical aspect of the process is the use of a 30% acetic acid solution, which results in a polypeptide with altered morphology. The court concluded that the morphology of the polypeptide is a critical factor in its biochemical activity, thus making the lyophilised form of cetrorelix a different pharmaceutical substance. The court found that the claims 1 to 4 did not fairly encompass the critical method steps necessary to produce the altered morphology, thus the substance was not within the scope of these claims. However, the omnibus claim (claim 5) was found to sufficiently cover the lyophilised form of cetrorelix. The court also noted that the substance on the Australian Register of Therapeutic Goods (ARTG) aligns with the substance described in the patent specification.

The Deputy Commissioner of Patents ultimately accepted the application for the extension of the term of the patent, based on the omnibus claim. The decision was grounded on the reasoning that the altered morphology of cetrorelix, resulting from the patented process, was a new pharmaceutical substance that could only be properly characterised by its method of production. The presence of other potentially defective claims did not bar the granting of the patent term extension, as long as the omnibus claim was valid and supported the extension.

Orders