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 of such treatment, said effective amount being below the diagnostic dose of gonadoliberin or its agonists that is necessary to release follitropin or lutropin.

7. The use of a pharmacologically effective amount of gonadoliberin, or of its agonists which are at least as active, for the treatment of renal insufficiency in a patient in need of such treatment, said effective amount being below the diagnostic dose of gonadoliberin or its agonists that is necessary to release follitropin or lutropin.

8. The use of a pharmacologically effective amount of gonadoliberin, or of its agonists which are at least as active, for the treatment of osteoporosis in a patient in need of such treatment, said effective amount being below the diagnostic dose of gonadoliberin or its agonists that is necessary to release follitropin or lutropin."

Note: The level of parathyroid hormone is elevated in both osteoporosis and renal insufficiency.

Submissions

In essence, the examiner's report states that the "use" claims (i.e. claims 6 to 8) are redundant in comparison with the corresponding respective method claims (i.e. claims 1, 4 and 5), or alternatively, the "use" claims are of indeterminate scope.

In response the attorney put forward various written submissions including copies of his responses to examiner's reports on an earlier unrelated case (patent application No. 11105/83).This earlier application also included "use" claims. From one of these responses the attorney's fundamental submission can be extracted:

"The scope of a use claim is somewhat wider than an analogous method claim, but this does not make such a claim inherently objectionable. We think that such a claim catches activities which are ancillary to analogous method claims."

Mr. Murray also provided an example of a "use" claim, viz:

"The use of a fibrinogen formulation as claimed in one of claims 1, 2, 3 and 5 as a fibrinogen concentrate for intravenous use in humans",

which he stated

"appears to catch activities following the preparation of the formulation and prior to its immediate use in the treatment of humans."

Also included within Mr. Murray's submissions were various documents comprising:

(i) a general article by Gruber & Kroher on the patentability of pharmaceutical inventions (which was apparently included on the basis that it states the meaning assigned to "use" claims by the German Federal Supreme Court);

(ii) an extract from the publication, Intellectual Property Decisions, being a condensed version of the decision IPD 6014 Bayer A.G. (Patent Application No. 7911998) which relates to the question of novelty and second medical use of a medicinal compound;

(iii) copies of extracts from the European Patent Convention and the 'Guidelines for Substantive Examination' under the EPC; and

(iv) a copy of an internal Patent Office document relating to standardisation of objections within the former chemical patent examination group B.

I will now consider these submissions. I refer firstly to the article, "Patentability of Pharmaceutical Inventions - A Comparison of the Legal Situation in Germany and some Common Law Countries" by Gruber & Kroher (item (i)); the German Federal Supreme Court's (the BGH) treatment of "use" claims is of little relevance for the purposes of the present consideration because of the differences in the relevant Australian and German law. However, in summary, the BGH has assigned a special patent category to the pharmaceutical use patent which features elements of the product patent category and also contains elements of a process patent. Thus the German law requirement for industrial application is apparently satisfied from the preparation of the substance, whereas novelty and non-obviousness ensue from the application of the substance and the realisation of the pursued purpose. This approach avoids the aspect of German law that methods for the treatment of the human or animal body by surgery or therapy are unpatentable.The extract, Intellectual Property Decision, IPD 6014, (item (ii)), concerns a decision issued by the UK Patent Office which seems to support the view that "use" claims are equivalent to method claims.

In that decision it was held (in part):

"The interpretation of Claim B is that it is a claim to a method. The 'use' of a thing must, I think, involve the doing of an act in which the thing is used. Thus, "the use of compound X in combating medical condition Y" seems to me to be equivalent to saying "combating medical condition Y using compound X", or to "a method of combating medical condition Y using compound X"."

The Hearing Officer also noted that a similar view of "use" claims is set out in the Guidelines for Examination in the European Patent Office at Part C, Chapter III, 4.9 (item (iii)) which reads:

"4.9 For the purposes of examination, a "use" claim of a form such as "the use of substance X as an insecticide" should be regarded as equivalent to a "process" claim of the form "a process of killing insects using substance x".

Thus a claim of the form indicated should not be interpreted as directed to the substance X recognisable (e.g. by further additives) as intended for use of an insecticide. Similarly, a claim for "the use of a transistor in an amplifying circuit" would be equivalent to a process claim for the process of amplifying using a circuit containing the transistor and should not be interpreted as being directed to "an amplifying circuit in which the transistor is used", nor to "the process of using the transistor in building such a circuit"."

Both the IPD decision and the EPC guidelines indicate that use claims are identical in scope to equivalent method claims. This is a view which characterises the practice of the Australian Patent Office, as is evidenced in another document lodged by Mr. Murray as part of his submissions, namely the document relating to the standardisation of objections within B group (item (iv)). The relevant portion of this paper reads:

"Claims of the form:

Use of the compounds of claim 1 as herbicides.

These claims are not objectionable if they are the only process claims present. However if other process claims are present these claims give rise to an objection of ambiguity. Also they are redundant on the other process claims as they cannot be distinguished from them."

I appreciate Mr. Murray's actions in attempting to place all relevant material before me. I cannot see, however, that any of the aforesaid material is contradictory to the examiner's report.

The Decision

The House of Lords in Electric-and Musical Industries, Ltd. v. Lissen, Ltd. 56 RPC 39 at p.41 considered the situation where a claim had a clear, plain meaning:

"I would point out that there is no question here of words in Claim 1 bearing any special or unusual meaning by reason either of a dictionary found elsewhere in the Specification or of technical knowledge possessed by persons skilled in the art. The prima facie meaning of words used in a claim may not be their true meaning when read in the light of such a dictionary or of such technical knowledge; and in those circumstances a claim, when so construed, may bear a meaning different from that which it would have borne had no such assisting light been available. That is construing a document in accordance with the recognised canons of construction. But I know of no canon or principle which will justify one in departing from the unambiguous and grammatical meaning of a claim and narrowing or extending its scope by reading into it words which are not in it; or which will justify one in using stray phrases in the body of a Specification for the purpose of narrowing or widening the boundaries of the monopoly fixed by the plain words of a claim."

In my opinion claims 6 to 8 of the present application, in isolation, have clear, grammatical meanings and are clear in their respective scopes, and consequently the law as set out above from the House of Lords judgement is applicable. Thus, contrary to Mr. Murray's contention, I read no more in these claims than that which they appear clearly to define.

However, this is not necessarily the end of the matter.

Thus, as stated by Lord Esher, in Parkinson v. Simon 11 RPC 493 at 502:

"When you find a patent with several claims in it, you must, if you can, so construe those claims as to give an effective meaning to each of them. If there are several claims which are identical with each other, then some of them have no effect at all. It follows from the ordinary rules of construction that you must construe the different claims so as to make them effective if possible, to be different from each other in some respects, or else they are not effective."

On the other hand, B.W. Budd, Q.C., in David Kahn Inc. v. Conway Stewart & Co. Ltd. 119741 RPC 279 at p.308, observed that in the Parkinson case Lord Esher did not lay down an absolute rule, rather he stated each claim was to be made effective "if possible".

He further observed:

"There is no absolute or invariable rule that different claims should be construed as of different scope. The prima facie presumption that this is so can bend to other considerations if they are weighty enough."

Furthermore, the Patent Office practice regarding "use"

claims supports this view. I note that this practice has been governed by the law as laid down by the Full Bench of the High Court in Wellcome Foundation Ltd. v. Commissioner of Patents-30 ALR 510 at page 516 to 517:

"A further answer to the appellant's submission is that there is no distinction between the claim to the process and the claim to the substance when the substance claim is limited to its use in the process. So much appears from the judgment of Parker J. in Adhesive Dry Mounting Co. Ltd. v. Trapp & Co. (1910) 27 RPC 341 at 353, upon which the appellant, mistakenly in our view, placed reliance."

This judgement indicates that "use" claims must be regarded as serving the same purpose as and being of identical scope to the equivalent method claims. Therefore I cannot agree with the attorney's submission that a "use" claim "catches activities which are ancillary to analogous method claims" and no such activities can be inferred from these claims when properly construed.Consequently, I consider that claims 6 to 8 are identical in scope to the scope of their respective corresponding method claims (i.e.

claims 1, 4 and 5).

It has been said that the question of redundancy is not a serious matter and that any doubt should be resolved in favour of the applicant. I certainly agree with the last part of that statement which is established law. However, in my view, there can be no doubt in the present circumstances. The philosophy behind refusing a claim which is identical in scope to another claim in the same specification, i.e. a redundant claim, is that no effective meaning can be ascribed to the redundant claim or that it represents, if the application proceeds to grant, a double patenting situation. In Beloit Corporation's Application [19741 RPC 478 at p.483 Graham J. held that as there was no difference or no substantial difference between two particular claims then the applicants ought not to be granted a patent:

"I do not consider that the applicants ought to be granted a specification in which two independent claims of the same scope are present. To allow the grant of such a specification would be against the public interest and its effect would be to sacrifice clarity and succinctness, which is required by section 4, and to condone avoidable obscurity and ambiguity."

As I am satisfied that claims 6 to 8 are redundant with respect to claims 1, 4 and 5, and that to allow a specification including such claims to proceed to grant would be contrary to the public interest, I refuse to accept the application in its presently proposed form.

Conclusion

I have decided that there are lawful grounds of objection to application No. 41365/85 and I direct the applicant to lodge a statement of proposed amendments to my satisfaction within the time remaining for acceptance.

J.L. Roveta

Supervising Examiner of Patents

16 MAY 1988

Patent Attorneys for the Applicant: Edwd. Waters & Sons