Hoechst Aktiengesellschaft - [1988] APO 14

In the Matter of the Patents Act 1952 - and - In the Matter of Application No. 41365/85 for a Patent by HOECHST AKTIENGESELLSCHAFT and In the Matter of a Request under Regulation 19D.

DECISION OF A SUPERVISING EXAMINER OF PATENTS:

Background

Patent application No. 41365/85 was lodged on 17 April, 1985 and is based on an application made in the Federal Republic of Germany, thereby acquiring a priority date of 18 April, 1984.

During the course of examination of the application the examiner reported that the statement of claims was ambiguous, in that either there was redundancy within a group thereof or some of the members of the group were of indeterminate scope. The examiner maintained this stance through to the third official report and the attorney for Hoechst, Mr. James Murray, requested that a decision be made on the written record, as provided for by regulation 19D.

The Specification

The specification relates to the use of gonadoliberin or its agonistic analogs in the treatment of climacteric complaints and pathological conditions in which the level of parathyroid hormone is too high.

Gonadoliberin is a decapeptide and is depicted in formula I (below). It is formed in the hypothalamus and brings about the release of follitropin and lutropin in the pituitary.

Glu-His-Trp-Ser-Tyr-Gly-Leu-Arg-Pro-Gly-NH2(I)

The method according to the invention uses lower doses of gonadoliberin than were used in prior treatments; the diagnostic dose of gonadoliberin in such prior treatments was 25-100 ug/adult human on parenteral administration compared to the present method in which, on parenteral administration, only 0.5-5 ug of gonadoliberin is required for a woman of normal weight (i.e. 6 to 60 ug/kg/dose).

The claims, as proposed to be amended, read as follows:

"1. A method of treatment of climacteric complaints and pathological conditions with an elevated level of parathyroid hormone to a patient in need of such treatment by administration of a pharmacologically effective amount of gonadoliberin or its agonists which are at least as active, said effective amount being below the diagnostic dose of gonadoliberin or its agonists that is necessary to release follitropin or lutropin.

2. A method of treatment as claimed in claim 1 by parenteral administration of 0.5 to 5 ug of gonadoliberin per single dose for an adult of normal weight, or the equally active amount of a gonadoliberin agonist.

3. A method of treatment as claimed in claim 1, by administration onto the mucosa of 10 to 20 ug of gonadoliberin per single dose for an adult of normal weight, or the equally active amount of a gonadoliberin agonist.

4. A method of treatment of osteoporosis as claimed in one of claims 1 to 3.

5. A method of treatment of renal insufficiency as claimed in one of claims 1 to 3.

6. The use of a pharmacologically effective amount of gonadoliberin, or of its agonists which are at least as active, for the treatment of climacteric complaints and pathological conditions with an elevated level of parathyroid hormone in a patient in need…

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: Hoechst Aktiengesellschaft [1988] APO 14
Case: [1988] APO 14
Decision Date: 16 May 1988

CaseChat Overview and Summary

Hoechst Aktiengesellschaft, an applicant for a patent, challenged the decision of a supervising examiner of patents who found that the proposed claims in the application were ambiguous and redundant. The application in question was for a patent concerning the use of gonadoliberin or its agonistic analogs in the treatment of climacteric complaints and pathological conditions where the level of parathyroid hormone is too high. The central legal issue revolved around the interpretation and scope of "use" claims versus method claims, and whether certain claims were redundant and thus objectionable. The court had to decide whether the "use" claims (claims 6 to 8) were redundant in comparison to the corresponding method claims (claims 1, 4 and 5), or whether they were of indeterminate scope.

The court examined submissions made by the applicant's attorney, Mr. Murray, who argued that "use" claims have a wider scope than method claims and are not inherently objectionable. The court also reviewed various documents submitted by Mr. Murray, including articles, patent decisions, and guidelines from the European Patent Office. Despite the submissions, the court found that the "use" claims were identical in scope to the corresponding method claims, as supported by relevant case law and the practice of the Australian Patent Office. The court concluded that claims 6 to 8 were redundant with respect to claims 1, 4 and 5, and that allowing such redundancy would be contrary to the public interest. Therefore, the court refused to accept the application in its current form.

In summary, the court held that the "use" claims were redundant and objectionable because they did not differ in scope from the method claims. The decision required the applicant to lodge a statement of proposed amendments to address the redundancy within the remaining time for acceptance.

Orders