Hoechst Aktiengesellschaft v. American Home Products Corporation

[1990] APO 34

PATENTS ACT 1952

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Action:Application for Patent No. 544756 by HOECHST AKTIENGESELLSCHAFT, and Opposition by AMERICAN

HOME PRODUCTS CORPORATION under Section 59

Background
         Hoechst Aktiengesellschaft (HOECHST) lodged application No. 544756 on 28 August 1981.  The application is a convention application which is based on two basic documents lodged in the Federal Republic of Germany on 30 August 1980 and 8 May 1981.  American Home Products Corporation (AMERICAN) lodged a notice of opposition under section 59 and all the evidence stages of the opposition were completed by 13 January 1990.  The opposition was set down for hearing in Canberra on 21 February 1990.  Mr D. Mischlewski, patent attorney of Watermark, represented HOECHST and Mr P. Jones, patent attorney of Phillips, Ormonde & Fitzpatrick, represented AMERICAN.
         The notice of opposition listed grounds (a) and (c) to (i) of sub‑section 59(1) but at the hearing Mr Jones only relied on the grounds of prior claiming, prior publication and non‑compliance with section 40.
The Specification
         HOECHST lodged two requests to amend the specification of application No. 544756 under section 77 after AMERICAN had served

its evidence‑in‑support.  It also lodged another request after AMERICAN had served its evidence‑in‑reply.  The requests were allowed unopposed, consequently I have to consider the specification as amended by these requests.
         The specification commences by stating the subject of the invention is a compound of formula 1a which corresponds to formula 1a in claim 1.  Formula 1a includes three variable substituents and the specification lists six pages of possible functional groups for these substituents.  A statement on page 8 of the specification excludes three specifically named compounds from the scope of the invention.  In my view the exclusion of these three compounds, which are all substituted octahydroindoles, renders the invention not fully described as the compounds of formula 1a are all substituted dihydroindoles.
         The specification states the invention relates to a process for the preparation of compounds of formula I (not formula 1a) and on pages 9 to 13 three general methods are described.  I think this description should be clarified to make certain it relates to the compounds of the present invention rather than compounds which have been excluded by the various amendments to the specification.  For example pages 8, 11, 12 and 13 refer to formulae I, II and VI when it appears formulae Ia, IIa and VIa are intended.  I also note the symbol "P" is used on pages 12 and 13 which does not appear in any of the structural formulae.
         The compounds have a lasting intense hypotensive action and can be employed for combating hypotension of various geneses, either by themselves or in combination with other active compounds.
         The specification describes 367 specific examples including many compounds which are outside the scope of the present claims.
         Claim 1 reads as follows:

"1.A compound of the formula Ia

(CH2)       COOH

N

CO‑CH‑NH‑CH‑COOR3

''

R1 R2

in which

R1 and R2, which are identical or different each represent ..."

the possible substituents for R1 and R2 are listed on 6 pages then the claim concludes as follows:

"or R1 denotes hydrogen, and R3 denotes hydrogen, alkyl having 1 to 6 C‑atoms, alkenyl having 2 to 6 C‑atoms or aralkyl having 7 to 14 C‑atoms, and physiologically tolerated salts thereof."

Claims 2 to 8 read as follows:

"2.A compound as claimed in claim 1, in which R1 is methyl and R2 is phenethyl or phenethyl substituted in the phenyl ring by halogen, methyl or methoxy.

3.The compound according to formula Ia claimed in claim 1, wherein R1 is methyl, R2 is 2‑phenylethyl and R3 is ethyl.

4.A process for the preparation of a compound of the formula Ia, with the exceptions noted in claim 1, which comprises:

reacting a compound of the formula IIa with a compound of the formula III

(CH2)       COOR4

N

CO‑CH‑QQ‑CH‑COOR3

''

R1 R2

IIaIII

in which one Q denotes a nucleofugic group and the other Q denotes ‑NH2, and R4 represents H, methyl, ethyl, benzyl or tertiary‑butyl, and, if approximate (sic), converting an ester which is obtained into the carboxylic acid (R3 and/or R4 is hydrogen).

5.A process for the preparation of a compound of the formula Ia which comprises:

reacting a compound of the formula IV

RpOOC‑CH‑NH‑CH‑COORp

IV

R1 R2

wherein Rp denotes H, but one of the two Rps can also have the meaning of R3 as defined in claim 1, with a compound of the formula Va

(CH2)       COOR4

Va

N

H

in the presence of a condensing agent, and, if appropriate, converting one or both ester groups into the carboxylic acid.

6.A process for the preparation of a compound of the formula Ia, with the exceptions noted in claim 1, which comprises:

reacting a compound of the formula VIa with a compound of the formula VII

(CH2)      COOR4

N

CO‑C=TT=C‑COOR3

''

R1 R2

VIaVII

in which one T represents a hydrogen atom and an NH2 group and the other T represents an oxygen atom, and reducing the Schiff base obtained, and converting the reaction products, if appropriate, into the salts.

7.A pharmaceutical composition containing a compound as claimed in Claim 1.

8.Use, as a medicament, of a compound as claimed in Claim 1.

I think claims 4 and 6 lack clarity because they include the phrase "with the exceptions noted in claim 1" but claim 1 does not define any exceptions.
Evidence
         The evidence lodged in support of the opposition consists of a statutory declaration made by Ronald Lee Weiher and affidavits made by Ronald James McCaully (2), Rosemarie C. Bicksler, Susan L. Zaporowski and Kenneth Heatherington.  The evidence‑in‑answer consists of statutory declarations made by Dr Werner Schmidt and Dr Hansjorg Urbach, who is named as one of the inventors in application No. 544756.  Dr McCaully (2) and Dr. Heatherington swore further affidavits which constituted the evidence‑in‑reply.
         Some of the evidence is no longer relevant to the amended specification.  Therefore I will not summarise the above evidence but I will refer to it at appropriate points in the decision.
Priority Date
Mr Jones argued the present claims define a different invention to the invention disclosed in the basic documents, therefore he submitted these claims were not entitled to derive their priority date from the date of lodgement of these documents (Coopers Animal Health Australia Ltd v Western Stock Distributors Pty Ltd 76 ALR 429). Mr Mischlewski said the judgements in the Coopers Animal Health case confirmed the Mond Nickel rules (Mond Nickel Co Ltd's Application 1956 RPC 189 at page 194) are an appropriate test of fair basis between documents. He submitted the amended specification was fairly based on the basic documents because the claims satisfied this test.
Gibbs, J decided the Mond Nickel rules may be used to test whether the specification of a convention application is fairly based on the disclosure in the basic document (F Hoffman‑La Roche and Co Aktiengesellschaft 1972 ALR 348 at page 352). But he also pointed out these rules merely assist the process of applying the test laid down by the Act and do not substitute for the test. The question in the Coopers Animal Health case (supra) was whether the claim of a petty patent was fairly based on the disclosure in a provisional specification. Both main judgements (Fox J, supra page 436 and Beaumont, J supra page 446) refer to Gibb, J's judgement in the Hoffman‑La Roche case (loc. cit.) but both judges then applied the test laid down in the act rather than using the Mond Nickel rules. For example, Beaumont J decided the claim was not fairly based on the disclosure in the provisional specification because a reader of the provisional specification was not readily lead, even by a process of selection, to what is set forth in the claim of the petty patent specification.
         Turning to the question of the priority date of the present claims I note DE patent application No. P3118191 is no longer relevant as the compounds disclosed in this basic document have been excluded from the scope of the claims.  The other basic document, which is DE application No. P3032709, was lodged on 30 August 1980.  The specification of this application uses a structural formula to describe a group of compounds which have a lasting intense hypotensive action.  But I note this structural formula does not include compounds with the formula Ia in the present claim 1 in which "R1" denotes hydrogen.  Otherwise I note the structural formula in the basic document includes more compounds than formula Ia in the present claim 1.  For example the structural formula in the basic document describes substituted tetrahydro‑
quinolines, tetrahydroisoquinolines and dihydroindoles but the scope of the present claim 1 only includes substituted dihydroindoles.  It seems to me formula Ia in the present claim 1 includes more compounds in which "R1" does not denote hydrogen than compounds in which "R1" does denote hydrogen.  Thus in my view the reader of DE application No. P3032709 is readily lead by a process of selection to the compounds defined in the present claim 1, with the exception of those compounds defined in the present claim 1 in which "R1" denotes hydrogen.  Therefore I do not think claim 1 in the specification of application No. 544756 is concerned with a different invention to DE application No. P3032709 because the majority of the compounds are disclosed in this basic document.  I also think the alternate analysis of the fair basis of the claims using the Mond Nickel rules produces the same results as the above analysis.  It follows the priority date of the present claim 1, insofar as it claims compounds of formula Ia in which "R1" does not denote hydrogen, is according to sub‑section 141(1), 30 August 1980.  I think a similar analysis of the other claims leads to a similar conclusion about the priority date. 
         The structural formula in DE application No. P3032709 does not disclose the compounds with the formula Ia in the present claim 1 in which "R1" denotes hydrogen.  Such compounds are not disclosed in the specification of application No. 544756 as lodged but are disclosed in the specification at the date the application was accepted.  Therefore according to sub‑section 159A(1) I have to treat the priority date of claim 1, insofar as it relates to compounds of formula Ia in which "R1" denotes hydrogen, as the date on which the compounds were disclosed in a statement of amendments proposed under section 49, namely 29 March 1985.
Submissions
         I do not intend to summarise all the submissions made on behalf of HOECHST and AMERICAN and I will deal with these submissions in other parts of the decision.  However I note Mr Mischlewski conceded there is an overlap between the scope of the present claims and the claims of AU patent No. 536316.  Mr Jones said if I agreed the claims of application No. 544756 are not entitled to an early priority date then he would be able to argue the present claims are prior published by the disclosures in this citation.  But for convenience he directed his arguments at the ground of prior claiming by the claims of AU patent No. 536316.
AU Patent No. 536316
         AU patent No. 536316 uses a generic structural formula to describe and claim N‑(3‑mercapto‑2‑alkyl‑1‑oxypropyl)‑2,3‑dihydro‑ 1H‑indole‑2‑carboxylic acids and derivatives.  The specification states the compounds have a hypotensive effect.  The disclosures in the specification are based on two US applications but the compounds, with structural formulae most similar to the compounds described in application No. 544756, are disclosed in US application No. 164992 which was lodged on 1 July 1980.  These derivatives are also disclosed in the specification of the citation as originally lodged in Australia.  Therefore I am satisfied the claims of AU patent No. 536316, which define compounds similar to those claimed by the present claims, have an earlier priority date.  I note that patent No. 536316 is still in force.
         I think claim 4 and appended claims of AU patent No. 536316 are most relevant to the claims of application No. 544756.  Claim 4 and the following appended claims of AU patent No. 536316 read as follows:

"4.A compound of formula 1f

Y

X

O

NC

R5

O=C

CR1R2‑(CHR3)n‑NR13‑CH‑(CH2)m‑R20

COR21

where m is 0, 1, 2 or 3; R13 is hydrogen or lower alkyl; R20 is hydrogen or aryl; and R21 is hydroxy or lower alkoxy, and n, R1, R2, R3, R5, X and Y are as defined in Claim 1.

5.A compound as claimed in Claim 4 in which m is 2, R13 is hydrogen, R20 is phenyl and R21 is ethoxy.

6.A compound as claimed in Claim 4 in which m is 2, R13 is hydrogen, R20 is phenyl and R21 is hydroxy.

9.A compound as claimed in any one of Claims 1 and 4 to 7 wherein R1 is lower alkyl, n is 1 and R2 and R3 are hydrogen or n is 0 and R2 is hydrogen.

11. A compound as claimed in any one of Claims 1, 4 to 7 and 9 wherein R5 is hydroxy.

13. A compound as claimed in any one of Claims 1, 4 to 7, 9 and 11 wherein R1 is methyl."

I note claim 1 of AU patent No. 536316 claims "X" and "Y" may both be a hydrogen atom.
Dr Schmidt concedes there is an overlap between the claims of application No. 544756 and AU patent No. 536316. But he says he finds it impossible to write a notional claim based on this citation which has the scope of the present claim 1 or later claims. He believes there is no support for such notional claims in the citation because the citation does not specifically describe the present compounds. Mr Mischlewski referred me to the relevant case law concerning prior claiming (Daikin Kogyo Co Ltd (Shingu's) Application 1974 RPC 559, Allen and Hanburys Ltd (Hayes') Application 1977 RPC 113 and Badische Anilin‑and‑Soda Fabrik AG (Distler's) Application 1977 FSR 137). In his view the question in each of these prior claiming situations was how far was it fair to go in notionally rewriting the earlier claim. Mr Mischlewski submitted it was not possible to notionally rewrite any of the claims of AU patent No. 536316 so as to prior claim the present claims. Mr Jones directed my attention to one of Dr McCaully's affidavits and he pointed out some of the analysis of the scope of the claims in this affidavit is still relevant to the amended claims. He argued the compounds claimed in application No. 544756 did not represent a selection from the compounds claimed in patent No. 536316 and thus the claims did not avoid the objection of prior claiming (Ethyl Corporation (Cook's) Patent 1970 RPC 227). Mr Jones said the overlap in the scope of the claims was similar to that considered in the Ciba‑Geigy case (Ciba‑Geigy AG's Application 1980 AOJP 966) where the hearing officer decided the later claims had been prior claimed. He submitted the objection of prior claiming could only be overcome if the claims of application No. 544756 are amended to excise the overlap with the claims of AU patent No. 536316.
Neither Dr Schmidt nor Mr Mischlewski explain where the scope of the present claims overlaps the scope of the claims of the citation. Claim 11 of the citation defines "R5" as hydroxy and this claim is appended to claim 9. Claim 9 defines "n" as O, "R1" as lower alkyl of 1 to 4 carbon atoms and "R2" as a hydrogen atom. Claim 9 is in turn appended to claim 4. I conclude the scope of claim 11, when appended to claim 9 and then claim 4, includes a group of compounds with the same structural formula as those defined in the present claim 1 if hydrogen atoms are chosen for the substituents "X", "Y" and "R13" in the cited structural formula. I presume this is the overlap to which Dr Schmidt and Mr Mischlewski referred. In my view the compounds claimed in claim 1 of the present application do not have specific advantages compared to the compounds claimed in the citation. Thus I do not think prior claiming can be avoided by relying on the selection test described in the Ethyl Corporation case (Ethyl Corporation (Cook's) Patent, supra, page 231). Therefore, according to the reasoning in this case, the present overlap between the scope of the claims should be removed by amendment of the present claims. Also it seems to me the inventions defined in the present claims and the cited claims are not as a matter of substance different. Thus I do not think prior claiming can be avoided by relying on the test set out in the Westinghouse Electric case (Westinghouse Electric Corporation (Frost's) Application 1973 RPC 139 at page 145). Therefore I agree with Mr Jones that the present overlap in the scope of the claims is similar to that considered in the Ciba‑Geigy case (loc. cit.). But according to Mr Mischlewski the question I have to consider is whether the claims of AU patent No. 536316 can be notionally rewritten to distinctly claim some of the compounds which are presently claimed (Merck and Co. (Macek's) Patent 1967 RPC 157).
         Graham, J. in the Allen and Hanburys' case (Allen and Hanburys (Hayes') Application, supra, page 117) decided that a claim to a generic structural formula may be notionally rewritten to prior claim later claims to a specific compound if the compound would as a matter of course occur to the reader as being included within and disclosed by the generic structural formula.  In particular he found it is proper to notionally rewrite a claim to include a compound when the substitutents chosen in the cited generic structural formula are hydrogen atoms.  In my view Graham, J's approach to notional rewriting may also be applied to the claims of AU patent No. 536316 to see if they include and disclose a specific group of compounds rather than a specific compound.  I think the compounds the skilled reader would as a matter of course consider included within and disclosed by formula If in claim 11 of the citation, when appended to claim 9 and then claim 4, are those in which "X", "Y" and "R13" are hydrogen atoms.  Earlier in this decision I concluded these compounds are included in the overlap in scope between the present claims and those of the citation.  Thus I consider claim 11 of AU patent No. 536316, when appended to claim 9 and then claim 4 can be notionally rewritten to include and disclose some of the compounds claimed in the present claim 1.  In summary therefore I am satisfied that claim 1 of application No. 544756 is prior claimed by claim 11 of the citation.  I think a similar analysis of claim 13 of the citation when appended to claim 11, then claim 9, then claim 5 or 6 and then claim 4, shows the compounds defined in claim 2 of application No. 544756 are prior claimed by this claim in the citation.
          Claim 3 in application No. 544756 defines a single compound which may exist in several diastereomeric forms.  Claim 13 of the citation as appended to claim 11, then claim 9, then claim 5 and then claim 4 will prior claim the compound claimed in the present claim 3 if the cited claim can be notionally rewritten with both "X" and "Y" as hydrogen atoms in the structural formula.
         I think this situation can be distinguished from that considered in the Badische Anilin case (Badische Anilin‑ and ‑Soda Fabrik AG (Distler's) Application, loc. cit.) where the court found the claims were not prior claimed.  In that case one hydrogen atom and two methyl groups had to be chosen for the substituents in the cited structural formula.  I also note there was prima facie evidence the compound claimed in the later claim had advantages not possessed by the compounds claimed in the earlier claim.  In the present situation there is no evidence the presently claimed compounds have any advantages over those claimed in AU patent No. 536316.  It seems to me the single compound claimed in the present claim 3 is in a similar situation to the single compounds in the Allen and Hanburys case (Allen and Hanburys Ltd (Hayes') Application, supra, page 118).  In that case the earlier claims were notionally rewritten to prior claim the later claimed compounds if the substituents chosen were hydrogen atoms.  Therefore I consider claim 3 of application No. 544756 is prior claimed by claim 13 of AU patent No. 536316.

         I think it follows from the above discussion of prior claiming that other claims of application No. 544756 are prior claimed by the claims of AU patent No. 536316.  I will not describe the detailed arguments which lead me to this conclusion but I consider the situation is as follows:

.claims 4 and 6 are prior claimed by part "f)" of claim 26 and by claim 32;

.claim 7 is prior claimed by claim 39; and

.claim 8 is prior claimed by claim 38.

Earlier in this decision I pointed out the present claim 1, insofar as it relates to compounds of formula Ia in which "R1" is hydrogen, has a priority date of 29 March 1985. This date is after the publication date in Australia of AU patent No. 536316. Thus this citation may satisfy the well known criteria for anticipation, for example clear and unmistakable directions (Flour Oxidizing Co v Carr Co Ltd 1908 RPC 428 at page 457) if the citation discloses compounds with the structural formula 1f in claim 4 in which both "R1" and "R2" are hydrogen. AU patent No. 536316 does not specifically describe or claim any compounds of formula 1f in which "R1" and "R2" are both hydrogen. Thus I consider the structural formula 1f in AU patent No. 536316 may, but does not necessarily, include the compounds defined in claim 1 of application No. 544756 in which "R1" is hydrogen (Ethyl Corp v Commissioner of Patents 1969 AOJP 2860). Therefore I am satisfied the disclosures in this citation do not anticipate the compounds claimed in claim 1 of application No. 544756 in which "R1" is hydrogen. A similar argument applies to the remaining claims of the present application.
Section 40
Mr Jones said Dr Heatherington's affidavits suggested some of the specific examples listed on pages 56 to 124 of the specification were merely postulated examples. That is these compounds had not actually been manufactured and the 1H‑NMR spectral data listed in the specification was postulated rather than measured. In particular Mr Jones pointed out Dr Heatherington had found a characteristic signal in the 1H‑NMR spectrum of compound No. 311 at a value of 8.2 for the hydrogen atom bonded to C7 in the dihydroindole ring. This characteristic signal was not listed in the specification. He said compound No. 311 was the compound claimed in claim 3 of the present specification. Therefore Mr Jones submitted the specification was insufficient. Mr Mischlewski said AMERICAN had not shown that the compounds claimed in the present claim 1 could not be manufactured by the processes described in the specification. He said the fact that the 1H‑NMR spectral data of one of the specific examples may be in error was irrelevant. In his view a chemical compound is identified by its structural formula and many physical properties may be used to characterise the compound, including 1H‑NMR spectral data. Mr Mischlewski submitted on the basis of decisions in the Vidal Dyes case (Vidal Dyes Syndicate Ltd v Levinstein Ltd 1912 RPC 245 at page 268) and the No‑Fume case (No‑Fume Ltd v Frank Pitchford and Co Ltd 1935 RPC 231 at page 243) that any error in the 1H‑NMR spectra of compound No. 311 did not mean the specification was insufficient.
         Dr Heatherington is an expert in the interpretation of 1H‑NMR spectra and is employed by a subsidiary of AMERICAN in England.  During the course of his employment he has observed the 1H‑NMR spectra of some 2,3‑dihydroindoles with similar structural formulae to those presently described and claimed.  Of particular interest in the 1H‑NMR spectra of such compounds is the distinctive signal at a    value of 8 or above caused by the hydrogen atom bonded to C7 in the dihydroindole ring.  Dr Heatherington expected to see this distinctive signal in the 1H‑NMR spectral date of the 2,3‑dihydroindoles described in application No. 544756.  He points out only the 1H‑NMR spectral data for compound Nos. 171 and 316 in the present specification describe a signal appearing at a    value of 8 or more.  Dr Heatherington then discusses in detail the 1H‑NMR spectrum of a particular diastereomer of compound No. 311.  The manufacture of this compound is described in Ms Bicksler's affidavit and the 1H‑NMR spectrum is the exhibit attached to Ms Zaporowski's affidavit.  Dr Heatherington says this 1H‑NMR spectrum is compatible with the structural formula of compound No. 311.  He notes Ms Saporowski's 1H‑NMR spectrum contains a signal at a    value of 8.2 whereas the data recorded in the present specification does not mention this signal.  Dr. Heatherington states the 1H‑NMR spectrum of compound No. 311 recorded in the specification is inconsistent with the structural formula assigned to the compound.  Therefore he concludes compound No. 311 does not have the structural formula given to it in the present specification.  He extends this conclusion to all the specific examples of 2,3‑dihydroindoles which are described in the specification.
         Dr Urbach, one of the inventors named in the present application, thinks the above differences in the 1H‑NMR spectra are of minor relevance.  He provides several explanations of why the distinctive signal above a    value of 8 may have been misinterpreted, for example the conditions under which the spectra were obtained, assigning the signal to "impurities", and the presence of rotational isomers of each compound.  Dr Urbach considers this erroneous interpretation of the 1H‑NMR spectra may be the reason the distinctive signal was not mentioned in the specific examples.  Dr Heatherington's affidavit in reply includes exhibits of several 1H‑NMR spectra of compound No. 311 which show the signal in the 1H‑NMR spectrum of compound No. 311 at a     value above 8 should have been clear irrespective of the conditions used or the presence of rotational isomers.  He also provides a detailed rebuttal of why the signal at a     value above 8 cannot arise from any of the likely "impurities". 
         I think it is clear from Dr Heatherington's affidavit in support of the opposition that he considers all the 2,3‑dihydroindoles described in the present specification should have a signal at a     value above 8 in the 1H‑NMR spectrum, even though AMERICAN has only investigated the 1H‑NMR spectrum of one of these compounds.  HOECHST's evidence‑in‑answer does not dispute this aspect of Dr Heatherington's affidavit.  In his affidavit in reply Dr Hetherington comments that the 1H‑NMR spectrum of a compound is virtually completely predictable.  He also states as follows:

"if the NMR spectrum of the first member in a series of compounds has been run it is possible using the additive properties of NMR to predict quite accurately the NMR spectrum of other members of the series."

Thus I agree all the 2,3‑dihydroindoles described in the present specification should have a signal at a     value above 8 in the 1H‑NMR spectrum which is caused by the hydrogen atom bonded to C7 of the dihydroindole ring.  The specification on pages 54 and 55 lists the values in the 1H‑NMR spectrum which apply for the 2,3‑dihydroindoles listed on page 56 to 124 of the specification.  I note the values listed on pages 54 and 55 do not include a     value above 8.  Pages 56 to 124 of the specification describe the structural formulae of various compounds, including 2,3‑dihydroindoles, along with 1H‑NMR spectral data for each compound.  This 1H‑NMR spectral data gives the features of each spectrum which are different from the features listed on pages 54 and 55 of the specification.  Apart from compound Nos. 171 and 316, none of 1H‑NMR spectra of the 2,3‑dihydroindoles listed on pages 56 to 124 of the present specification describe a signal with a    value above 8.  I note the structural formulae of compound Nos. 171 and 316 contain hydrogen atoms other than one bonded to C7 of the dihydroindole ring which I would expect to have a     value of 8 and above.
         Dr Heatherington considers HOECHST may not have made 2,3‑dihydroindoles with the structural formulae described in the present specification.  Thus the 1H‑NMR spectra recorded by HOECHST may not have included a signal with a     value above 8 because the compound did not have the hydrogen atom which causes this signal.  AMERICAN has not produced any evidence, for example by repeating the processes described in the present specification, which shows the present processes do not produce 2,3‑dihydroindoles with the structural formulae described in the specification.  Consequently I consider there is insufficient evidence for me to find the present specification does not describe processes for making the 2,3‑dihydroindoles with the structural formulae described on pages 56 to 124 of the specification.
         Dr Urbach provides several explanations of how the 1H‑NMR spectra may have been erroneously interpreted.  Dr Heatherington's view is that each of Dr Urbach's explanations is unlikely to account for such a distinctive feature of the spectra being overlooked.  I am a little surprised that HOECHST did not use this distinctive feature in the spectrum to indentify the 2,3‑dihydroindoles.  But there is no evidence before me which shows the signal with a     value of 8 and above was not present in the 1H‑NMR spectra measured by HOECHST.  Dr Urbach points out HOECHST did not have to describe the 1H‑NMR spectral data in the present specification because each compound is described by a structural formula.  For example HOECHST may have decided not to include the distinctive signal in the 1H‑NMR spectral data in the present specification.  Thus I have to consider whether HOECHST's failure to describe the distinctive signal in the 1H‑NMR spectral data means the present specification is insufficient.  I note the following points about the 1H‑NMR spectral data in the present specification:

.there is no description of the conditions under which the spectra were recorded e.g. the hydrogen atom bonded to the nitrogen atom and the hydrogen atom in the carboxylic acid group may have been removed by deuterium exchange (cf the 1H‑NMR spectrum exhibited to Ms Zaporowski's declaration);

.there is only a description of part of the 1H‑NMR spectrum for each structural formula e.g. the spectral data for compound No. 311 only refers to 26 of the 28 hydrogen atoms in the structural formula;

.the description does not specify which hydrogen atom is causing a particular signal e.g. the spectral data for compound No. 311 merely states there are 9 hydrogen atoms causing signals with     values in the range 7.2 to 6.5; and

.the description does not describe the detailed pattern for complex signals e.g. the spectral data for compound No. 311 states the signal with the     values of 7.2 to 6.5 is a multiple series of signals.

There is no evidence before me of how the skilled person in Australia would have interpreted the 1H‑NMR spectral data in the present specification. But I am familiar with what undergraduate students of chemistry at several Australian universities were taught about 1H‑NMR spectra in the years 1964 to 1976. Thus I think the skilled reader of the present specification would note the above points about the 1H‑NMR spectral data and conclude the data is only a means of characterising a particular compound and not an alternative description of a compound. Dr Heatherington expected the 1H‑NMR spectral data described in the specification to include a signal with a value above 8. I do not think the skilled person in Australia would necessarily have had the same expectation. Thus I consider the skilled reader of the specification would not conclude there was a conflict between the structural formula for a compound and the corresponding 1H‑NMR spectral data. Also in light of the above points I think the skilled person would expect some differences between the 1H‑NMR spectral data described in the specification and the actual 1H‑NMR spectrum of the corresponding compound. The skilled person who compared the 1H‑NMR spectrum of a compound with the spectral data described in the specification may note the distinctive signal with a value above 8 was not listed in the specification. But, in my view, this person would not require any use of the inventive faculty to decide which hydrogen atom in the compound caused the signal. Thus I think the skilled person would be able to readily rectify the omission of the distinctive signal from the 1H‑NMR spectral data in the present specification. (AMP Incorporated v Utilux Pty Ltd 45 ALJR 123 at page 128). In summary, therefore I do not consider the specification is insufficient.
         Mr Jones submitted claim 8 of the present specification lacked clarity because of the word "use".  He said the claim was not fairly based on the description because the only use described in the specification was as an anti‑hypertensive agent.  Mr Mischlewski argued claim 8 was effectively a type of method claim and he submitted claim 1 allowed HOECHST to regard any use of the compounds defined in this claim as an infringement.  Thus he said claim 8 represented a narrowing of the scope of what was already claimed in claim 1.
I disagree with Mr Jones that claim 8 is not clear because I think it is apparent the claim is merely claiming the use of the compounds claimed in claim 1 as curative or healing substances. But I do not agree with Mr Mischlewski that it is appropriate to test whether claim 8 is fairly based using an infringement test. Gummow J (Rehm Pty Ltd v Websters Security System (International) Pty Ltd 11 IPR 289 at page 304) considered a claim is fairly based on the description if there is a real and reasonably clear disclosure in the body of the specification of what is claimed, so that the alleged invention as claimed is broadly, that is in a general sense, described in the body of the specification. The broadest description of how the compounds of the invention can be used reads as follows:

"The new compounds of the formula I have a lasting, intense hypotensive action.

They can be employed for combating hypertension of various geneses, and can be applied by themselves or in combination with other hypotensive, vasodilatory or diuretic compounds."

I note this is the broadest description of the use of the compounds in the amended specification as well as in the specification at lodgement.  I think it is apparent the use which is described falls within the scope of claim 8.  But the scope of the claim also includes many uses which are not described and which have not been investigated by HOECHST.  For example the scope of claim 8 includes using the compounds of claim 1 as anti‑viral agents, a use which is not disclosed in the description.  Thus I think there is no real and reasonably clear disclosure, in a general sense, in the body of the present specification of what is claimed in claim 8.  Therefore I am satisfied that claim 8 in the specification of application No. 544756 is not fairly based on the description.
         Mr Jones also had several other minor objections to the claims which I think require amendment, but I do not think it is worthwhile to discuss these objections in detail.  These objections are:

.claim 1 uses the terminology "R1" and "R2" whereas claim 2 uses "R1" and "R2"

.claims 4, 5 and 6 refer to formula 1a and these claims should be appended to claim 1 in which formula 1a appears.

Earlier in this decision I noted three reasons why the specification did not comply with section 40.
Costs
         Mr Jones and Mr Mischlewski agreed the costs prior to the hearing should be awarded to AMERICAN because its evidence had caused HOECHST to amend the specification.  They also agreed the costs associated with the hearing should be awarded to the successful party at the hearing.  But Mr Jones submitted AMERICAN is entitled to the costs of preparation of an earlier deferred hearing, for which it had briefed counsel.  He said just prior to this hearing HOECHST had requested amendment of the specification under section 77.
         I note the following items from the scale of costs in opposition proceedings as advertised in the Official Journal dated 29 June 1989:

"9.Preparation of case for hearing

10.Attendance at hearing by patent attorney trade mark agent or solicitor without counsel

11.Attendance at hearing by patent attorney trade mark agent or solicitor instructing counsel

13.Counsel fees (maximum) and in addition expenses for accommodation and sustenance where interstate attendance is required."

In my view item 13 does not include counsel fees for preparation of a case for hearing because this is covered by item 9.  Thus I have to consider whether  AMERICAN is entitled to claim item 9 twice.  I conclude from the file of application No. 544756 that the parties agreed to defer the earlier hearing, pending resolution of the section 77 request, at least two weeks before the hearing session.  I also note the hearing of the opposition had not been set for a particular date when the parties agreed to defer the hearing.  Thus it seems to me AMERICAN's attorney and counsel would still have had to spend some time preparing the case for hearing when it agreed to defer the hearing.  Moreover as the opposition was eventually heard I think some of this preparation may not have been wasted.  The section 77 request, which was lodged after AMERICAN had served its evidence‑in‑reply, simplified the preparation of the opponent's case for hearing to the extent that Mr Jones only relied on one of the two citations at the hearing.  Thus in my view lodgement of the section 77 request was not merely a tactic whose sole purpose was to delay the hearing of the opposition.  Therefore I do not think AMERICAN is entitled to claim costs twice for preparation of the case for hearing.
         The opponent, AMERICAN, has successfully opposed the granting of a patent on application No. 544756 and therefore I award costs in its favour.
Summary
         I have found claims 1 to 4 and 6 to 8 of application No. 544756 have been prior claimed by the claims of AU patent No. 536316.  I also found the specification did not comply with section 40.  Therefore I give HOECHST 60 days from the date of this decision to propose amendments to overcome these defects.

(M. KENDALL)

Attorneys for the applicant: Watermark