Farbwerke Hoechst AG Vormals Meister Lucius & Bruning v Commissioner of Patents [1971] HCA 7; (1971) 124 CLR 654 (1 April 1971)

HIGH COURT OF AUSTRALIA

FARBWERKE HOECHST A.G. VORMALS MEISTER LUCIUS & BRUNING v. COMMISSIONER OF PATENTS [1971] HCA 7; (1971) 124 CLR 654

Patents

High Court of Australia
Gibbs J.(1)

CATCHWORDS

Patents - Complete specification - Application to amend - Refusal - Appeal - Amendment introducing uncertainty - Patent for chemical substance - Presumed formula - Whether amendment widens field of possible infringements - Patents Act 1952-1966 (Cth), s. 81.

HEARING

Melbourne, 1971, March 9, 10.
Sydney, 1971, April 1. 1:4:1971
APPEAL under the Patents Act 1952-1966 (Cth).

DECISION

April 1.
GIBBS J. delivered the following written judgment: -
This is an appeal from a decision of the Deputy Commissioner of Patents Act") refusing a request by the appellant for leave to amend the complete specification of the appellant's Australian patent. The complete specification is entitled "Water-soluble Derivatives of the Tetracyclines". It may be said by way of explanation that tetracycline and a group of its chemical derivatives known as the tetracyclines are chemical substances used as antibiotics; one of this group is particularly well known under the name aureomycin. The complete specification commences by stating (at p. 1) that the tetracyclines are, in a wide pH range, sparingly soluble in water and that this fact led to difficulties in their use for pharmaceutical purposes, e.g. in intramuscular injection. It goes on (at p. 2) to describe the invention in the following words:

"The present invention is based on the observation that
tetracyclines, for example, tetracycline, oxytetracycline and
chlorotetracycline as well as their isomers (epi-tetracyclines)
and anhydro compounds hereinafter referred to as
tetracyclines
can be reacted with formaldehyde or such substances
as supply formaldehyde under the conditions of the reaction,
for instance chloromethyl-methylether and appropriate amines
in the sense of the aminomethylation (Mannich reaction; cf.
Organic Reactions (1942), I, pp. 303-341; Angewandte Chemie
(1956), vol. 68, pp. 265 et seq.). The same products are
obtainable by reacting tetracyclines with aminomethyl
compounds
in the sense of a trans-aminomethylation.
Thus the present invention provides compounds of the
general formula

SEE DIAGRAM 124 CLR 657

in which R1 represents hydrogen, alkyl of 1 to 4 carbon atoms,
cycloalkyl, hyroxyalkyl group or a diethylamino ethyl group,
R2 hydrogen, alkyl of 1 to 4 carbon atoms, cycloalkyl or
hydroxyalkyl group, R3 hydrogen or chlorine, R4 hydrogen or
a hydroxyl group, and in which NR1 R2 may stand for the
radical of a heterocyclic amine of the pyrrolidino, piperidino,
piperazino, methyl piperazino or morpholino group, and the
physiologically tolerable acid addition salts thereof.
The new products which, in the form of free bases and also
of salts, show an excellent water-solubility in a wide pH
range, exhibit the full biological activity of the starting
substances
and represent thus a valuable enrichment in the
medical field. Owing to their excellent water-solubility they
are suitable for the preparation of products which can be
administered orally, intramuscularly and also intravenously
and which can be adjusted to a neutral pH-value. When
applying these compounds, the precipitation of the sparingly
soluble free tetracycline base observed in the case of the
known tetracycline compounds is completely avoided, whereby
tolerability and absorption are considerably improved. This
leads rapidly to high blood level data."

The specification goes on to describe the method by which the new compounds may be prepared and then (at p. 4) introduces a number of examples by saying:

"The following Examples illustrate the invention but they
are not intended to limit it thereto. The products of each of
the examples given is (sic) in each case within the form of the
general formula given above." (at p658)

2. The claims in the complete specification are of three kinds. First, there is a claim (claim 1) to "a compound of the general formula" which is then stated. The formula is exactly the same as that set out in the body of the specification (at p. 2). Secondly, there are seven claims (claims 2, 3, 4, 5, 6, 7 and 8) for a process for the manufacture of aminomethylation products of the tetracyclines. Claim 2 reads as follows:

"A process for the manufacture of aminomethylation
products of tetracycline, oxytetracycline and
chlorotetracycline
of the general formula given in claim 1 and their
isomers and anhydro compounds thereof, wherein
tetracycline,
oxytetracycline, chlorotetracycline, their isomers or
anhydro compounds are subjected to the Mannich reaction
with formaldehyde and piperidine, morpholine, pyrrolidine,
or N-methylpiperazine (3rd October 1956)."

Claims 3, 6 and 8 similarly include the words "of the general formula given in claim 1". Claims 4 and 5 are dependent on claims 2 and 3. Claim 7 does not, either directly or by reference to another claim, incorporate the formula. It reads:

"A process for the preparation of new water-soluble
derivatives of the tetracyclines, conducted substantially as
described in any one of the Examples 1, 2a, 3, 4 and 5 herein
(3rd October 1956)."

Thirdly, there are claims for products of processes. Claims 9 and 10 are claims for "aminomethylation products of the tetracyclines of the general formula given in claim 1, and their isomers and anhydro compounds" whenever obtained according to the process of any of claims 3 to 6 (claim 9) or according to the process of claim 2 (claim 10). Claim 11 reads as follows:

"Compounds of the general formula given in claim 1,
whenever
obtained according to the process substantially as
described
in any one of Examples 1 to 15 (30th September 1957)." (at p658)

3. The appellant's application for a patent was lodged in Australia on 30th September 1957. It was a convention application, being based on a basic application lodged in Germany on 3rd October 1956. In the complete specification as originally lodged in Australia claim 1 was a claim to a compound of the same formula as now appears in claim 1, but no other claim contained any reference either to claim 1 or to that formula. It is unnecessary to trace in detail the history of the various applications made by the appellant to amend the complete specification. The appellant places some reliance on the fact that the claims other than claim 1 were finally amended by the insertion of the words "of the general formula given in claim 1" for the purpose of overcoming objections contained in an examiner's report which was first communicated orally to the appellant on 26th February 1960, three days before the last date for acceptance of the application for the patent, and for the purpose of securing acceptance of the patent within time; in other words, the identification of the products of the process claims with the substance whose formula is given in claim 1 was only done to satisfy the examiner's requirements given at a stage when little or no time was available to argue the matter. However, it seems to me that nothing turns on those circumstances. The complete specification was finally accepted in Australia on 29th February 1960 and the patent was sealed on 15th July 1960. (at p659)

4. On 12th August 1964 the appellant sought leave to amend the complete specification. The reason for the proposed amendments was stated to be "To render the description and claims more clear and correct". The amendments sought may be regarded as falling into two categories. In the first category are proposed amendments to page 2 of the specification and claim 1 of the claims. The object of these amendments is to indicate that the formula which appears at page 2 and in claim 1 is only a "presumed" formula. For this purpose it is sought to amend claim 1 by inserting "presumed" after "the" and to amend page 2, lines 1 to 14, of the body of the specification (being the part of the passage quoted above which commences with the words "cyclines with aminomethyl compounds" and ends with the graphic formula) so that this part of the specification will read as follows:

"cyclines with aminomethyl compounds in the sense of
transaminomethylation.
The observations and experience of the
inventors have led them to presume that in these reactions
the aminomethylation takes place in the ring A in the graphic
formula next hereinafter appearing, and thus the present
invention provides compounds of the presumed general
formula -

SEE DIAGRAM 124 CLR 600

It is also sought similarly to amend the formula set out in claim 1. However, the only object of the proposed amendment to the formula itself is to insert within ring D an hydroxyl group (OH) which was omitted from the printed copy of the specification because of a printing error. This error will be corrected and needs no further mention. The formula as proposed to be amended is otherwise the same as that which already appears in the complete specification, with the exception that it is proposed that the formula in the body of the specification should identify the four benzene rings by the letters A, B, C and D. In the affidavit of Dr. Soder, filed in support of this appeal, the formula is shown with the rings lettered in order from right to left, rather than from left to right as in the proposed amendment. Throughout this judgment I shall refer to the rings by the identifying letters shown in the proposed amendment rather than by those used in the affidavit of Dr. Soder. (at p660)

5. The second category of the proposed amendments comprise those to claims 2, 3, 6, 9, 10 and 11. In each of these claims, except claim 11, the amendment sought is to delete from the claim the words "of the general formula given in claim 1". The amendment proposed to claim 11 is to delete the words "compounds of the general formula given in claim 1" and insert in lieu thereof the words "aminomethylation products of the tetracyclines". The Deputy Commissioner, in his decision on the request for leave to amend, said that the second category of amendments "is directed to removing the limitation in the claims that the end products referred to are of the general formula depicted, for example, in claim 1", but the submission of the appellant is that upon the proper construction of the specification the words which refer to the general formula in claim 1 do not in truth operate to limit the scope of the claims. (at p660)

6. Finally, the request lodged by the appellant seeks leave to amend claim 8, not by deleting the words "of the general formula given in claim 1", but by inserting in that expression the word "presumed" after the word "the". The appellant now concedes that this was a mistake, since no reason exists for treating claim 8 in any different way from the other claims in the second category, and the appellant now wishes to amend claim 8 by deleting the words "of the general formula given in claim 1". (at p661)

7. In support of the appeal the appellant placed before me evidence which was not available to the Commissioner. This evidence took the form of an affidavit sworn by Dr. Soder, a research chemist and one of the co-inventors of the invention in question. This evidence reveals the following facts. (at p661)

8. In April 1955 the inventors, who were employed as research chemists by the appellant, which is a German company, discovered that the tetracyclines can be aminomethylated in the Mannich reaction and that it was thereby possible to synthesize a tetracycline derivative which had the full biological and therapeutic activity of the tetracycline itself but was also soluble in water. They later discovered that the same results could be obtained in varying degrees when any of the tetracyclines or their isomers or anhydro compounds were aminomethylated when subjected to the Mannich reaction with formaldehyde in the presence of any of the bases mentioned in claim 2 of the specification. These discoveries made possible the effective intramuscular and intravenous administration of the tetracyclines for use as antibiotics. In 1958 the appellant began to use the invention commercially by manufacturing and marketing a product of the invention which is described in example 10 (a) of the specification and which proved to be an immediate commercial success. It is sold under the trade name "Reverin" and has been imported into and sold in Australia in substantial quantities since 1959. (at p661)

9. In organic chemistry it is often difficult to prove exactly the chemical composition and structure of a new compound. In 1955 and 1956 it seemed to the inventors that there were three places in the tetracycline molecule where the substitution of the aminomethyl radical was theoretically possible, viz., the 7 and 9 positions in ring A and the 2 position in ring D. At the time of filing the basic application in Germany in October 1956 the inventors believed that the substitution took place at the 7 or the 9 position in ring A, rather than by substitution for one of the hydrogen atoms in the carboxylic acid amide group (-CONH2) in the 2 position, and the weight of opinions published by other scientists appeared to incline in favour of this view. The inventors at that time did not consider that the correct formula had been conclusively established but they did consider that there were powerful reasons for thinking that it was far more probable than not that the aminomethyl substitution was in the 7 or the 9 position in ring A. Continued research during 1957 and 1958 tended to confirm this view but doubts arose as to its correctness during the year 1959. It is irrelevant to a consideration of the present question to discuss the scientific considerations that first led the inventors to the belief that the substitution took place at the 7 or the 9 position in ring A and that later shook and finally destroyed that belief. By the year 1961 the inventors had come to think that there was a slight balance of probability in favour of the view that the aminomethylation took place at the carboxylic amide group at the 2 position in ring D although it could not be said with confidence that this was so. This was still their opinion when the present application was lodged in 1964. Since that time newly discovered physical methods have made it possible to prove that the aminomethylation products of the tetracyclines and their isomers (but not the anhydro compounds) the subject of the invention have the aminomethyl radical substituted at the 2 position in ring D of the molecule, and accordingly are compounds of the following general formula:

SEE DIAGRAM 124 CLR 662

It is still believed that the products of the anhydro compounds are aminomethylated at the 9 position in ring A but those products are not of the formula presently set out in claim 1 which was never intended to claim the aminomethylated products of the anhydro tetracyclines. The formula in claim 1 therefore is not the correct formula of any of the tetracycline derivatives. In fact there is no known compound of any kind of the formula which appears in claim 1. (at p662)

10. The appellant would have preferred to amend claim 1 by inserting the true formula but has been advised that it would be difficult successfully to apply for such an amendment in view of the fact that at the date of the Australian patent the appellant did not know or believe that the compounds were of the true formula. I mention this circumstance to explain the course that has been taken by the appellant, but express no view one way or another on the question whether an amendment by the substitution of the true formula would have been permissible since that question was not argued before me. (at p663)

11. The Deputy Commissioner disallowed the amendments in the first category on the ground that the introduction of the word "presumed" would render the patent uncertain. In the exercise of the power given to him by s. 81 of the Act, the Deputy Commissioner has a discretion to refuse to allow amendments notwithstanding that they do not contravene the express prohibitions of s. 78, and it is a sufficient ground to refuse an amendment that it introduces uncertainty or ambiguity into a patent: Re Parkinson's Patent (1896) 13 RPC 509, at p 514 ; Re Kirk's Application (1929) 49 RPC 412, at p 414 ; Re Howlett's Application (1941) 58 RPC 238, at p 249 ; Weiss v. Lufft [1941] HCA 19; (1941) 65 CLR 528, at pp 534, 540 ; Sly v. United Development Corporation Pty. Ltd. [1962] HCA 16; (1962) 106 CLR 633, at p 640 . In my opinion a claim to a compound described only by reference to a "presumed" general formula is uncertain. A "presumed" formula is one which is assumed or expected to be correct, but whose correctness has not been established. To describe a compound by reference to a "presumed" formula is to indicate that the formula of the compound is not known for certain, although it is supposed that the formula given is probably correct. If the only identification of the compound consists in the formula, and the claim itself indicates, by using the expression "presumed formula", that it is not known for certain whether the compound is of that formula, it seems to me that there is no proper description of the compound. The only definition of the thing claimed is to be found in the formula, but is is not certain whether the formula is correct. The use of the word "presumed" introduces an uncertainty into the definition of the monopoly claimed. If there were some additional characteristic by which to distinguish the compound, the uncertainty as to its formula might well not matter. On behalf of the appellant it was submitted that claim 1, properly interpreted in the context provided by the specification as a whole, is a claim to a compound produced by one of the processes described in the specification. I find it impossible to construe claim 1 in that way. The words of the claim show clearly that it is a claim to a compound described only by reference to a formula, and a comparison with claims 9, 10 and 11 supports this view. In my opinion, therefore, the amendment of claim 1 by converting it into a claim for a compound of a "presumed" formula would render it uncertain. I am not concerned with the question whether the claim in its present form, understood in the light of the knowledge available at the time the specification was published, should be regarded as a claim to an ascertainable compound. Whether or not the claim in its present form is effective, the proposed amendment would result in an uncertain claim. I hold that the Deputy Commissioner correctly exercised his discretion in refusing to allow the amendment to claim 1. (at p664)

12. The proposed amendment to page 2 of the body of the specification would not necessarily introduce uncertainty into the specification. If claim 1 were expunged from the specification, there might be no objection to amending page 2 of the body of the specification in the manner requested. However claim 1 must be fairly based on the matter described in the specification, and it seems to me that if the amendment to claim 1 is disallowed the proposed amendment to page 2 should also be disallowed. If this were not so there would be a disconformity between claim 1 and the body of the specification. (at p664)

13. Before passing from the first category of amendments, I should notice an argument put on behalf of the appellant that the amendments ought to be allowed unless as a result the patent would plainly be rendered bad. In the case of an appeal against a refusal by the Commissioner to accept a specification, the Appeal Tribunal will allow the appeal unless it clearly appears that a patent granted on the specification will be invalid, because a refusal is final whereas an acceptance is not (McDonald v. Commissioner of Patents [1913] HCA 10; (1913) 15 CLR 713, at pp 717, 719 ; Commissioner of Patents v. Microcell Ltd. (1959) 102 CLR 232, at pp 236, 244-245 ). The same principle is applicable to an appeal from a direction by the Commissioner to amend a specification, because the direction is tantamount to a refusal to accept the specification in its unamended form (Hopman v. Commissioner of Patents [1960] HCA 48; (1960) 103 CLR 24, at p 25 ; Re Minnesota Mining and Manufacturing Co.'s Application (1961) 108 CLR 651, at pp 655-656 ; F. Hoffman-La Roche & Co. Aktiengesellschaft v. Commissioner of Patents [1971] HCA 3; (1971) 123 CLR 529 ). The same approach was taken in relation to a voluntary application to amend by O'Connor J. in Minerals Separation Ltd. v. Potter's Sulphide Ore Treatment Ltd. [1909] HCA 42; (1909) 8 CLR 779, at pp 800-801 . It is true that the grant of leave to amend the specification would not be final in the present case because it would be necessary under s. 81 of the Act to advertise particulars of the request and it is possible that opposition would be lodged to it under s. 82. However, there are some statements in the authorities (including Weiss v. Lufft (1941) 65 CLR, at pp539-540 that suggest that an onus lies on an applicant for an amendment to establish that the amendment ought to be allowed. Since in the present case I regard it as clear that the proposed amendments in th first category would make the patent bad and ought to be refused, it is unnecessary for me to consider whether, in a case where a doubt does subsist, the benefit of it ought to be given to the person applying for the amendment. (at p665)

14. I turn now to the amendments in the second category. The Deputy Commissioner held that the amendment of the claims by deleting the words "of the general formula given in claim 1" would have the result that the claims would not in substance fall within the scope of the claims before amendment. If this view is correct the amendments are not allowable (s. 78 (2)), unless made for the purpose of correcting a clerical error or an obvious mistake (s. 78 (3)). (at p665)

15. On behalf of the respondent it was submitted that an amendment which has the result that the process claims and the product claims cease to be tied to the formula will necessarily widen the claims themselves and the field of possible infringements. It was submitted that, upon the proper construction of the specification, the formula forms an essential part of the description of the invention, and that to delete by amendment this part of the description would have the result that the claims as amended would not in substance fall within the scope of the claims before amendment. On the other hand, on behalf of the appellant, it was submitted that the reference to the formula in these claims is merely an incidental and erroneous statement of theory as to the molecular construction of the compounds, and that this unnecessary addition to the claims does not detract from the force of the leading words of the description, namely those that refer to the process by which the compounds are produced, and that the amendment of the claims by deleting the reference to the formula would not widen the scope of the claims. (at p665)

16. The question that arises is primarily one of the interpretation of the claims in their present form. A reading of the specification as a whole shows that the substance of the invention is the discovery of a process which will produce chemicals having particular properties and whose formula is unimportant. However, there is no doubt that read literally, and in the absence of any evidence, the claims now in question define the invention by reference not only to the process but also by reference to the formula of the resulting product. However, evidence is admissible to identify the object to which the description in the specification is to be applied, that is, to identify the compound of the given formula. This evidence, so far as it has been led before me, reveals that there is no compound that answers to that formula. The definition of the invention in the claims now under consideration therefore comprises two parts - a correct description of the nature of the process and an incorrect statement of the formula of the resulting products. On ordinary principles of construction, if the correct part of the description defines the subject matter with certainty, the incorrect part may be rejected to enable effect to be given to the document as a whole. The decisions in "Z" Electric Lamp Manufacturing Co. Ltd. v. Marples, Leach & Co. Ltd. (1910) 27 RPC 737, at p 746 and Adhesives Pty. Ltd. v. Aktieselskabet Dansk Gaerings-Industri [1935] HCA 83; (1935) 55 CLR 523, at pp 545-546,596 , support the view that an error in science does not necessarily vitiate a claim in which the invention is clearly defined. Of course, if, in the present case, the formula applied to some of the compounds produced by the process, it could not be rejected as a mere erroneous addition to the description, but would have to be given effect as limiting the class of compounds to which the description applied. However, since the formula is not applicable to any compounds, it cannot have any such effect. In this respect the present case is distinguishable from Chevron Research Co.'s Patent (1970) RPC 580 , on which the respondent relied. In that case there was a claim for a composition comprising a mixture of alkenyl sulphonic acids in which the double bond was in the 1 position, but it was subsequently discovered that the bodies produced by the process in question had their double bonds distributed at a number of positions and not only at the 1 position, and it was held that the claim could not be construed as if it were not limited to bodies whose double bonds were in the 1 position (see (1970) RPC, at p586 ). That, of course, was a case in which the words in question did apply with accuracy to some of the compounds produced by the process and thus operated as a true limitation on the other words of the claim. (at p666)

17. It follows that the reference to the formula in the claims now under consideration did not operate as an effective limitation of those claims, and that the removal of that reference would not widen the claims or have the result that the claim as amended would not in substance fall within the scope of the claims before amendment. Of course, it may be said that in this situation the amendment is unnecessary, and that may well be so, but that seems to me no ground to refuse the amendment in the present case. This is not a case in which the claims were, covetously or recklessly, stated in terms that were too wide; on the contrary, they were defined as precisely as possible by reference to a formula then accepted to be correct. The amendments, even if strictly unnecessary, may in a practical sense make more clear the scope of the monopoly and render it more effective. (at p667)

18. The appellant has taken a somewhat dilatory course in prosecuting this matter. Although an adverse report was on 27th August 1964 issued in respect of the application to amend, no request was made until 22nd May 1967 for a hearing before the Commissioner. After the Deputy Commissioner had heard the matter he gave his decision on 31st January 1968 but the appellant did not take out a summons for directions until December 1970. Part of this delay may be explained by the necessity, first, to make submissions to the Examiner and, later, to obtain evidence, and by the fact that the head office of the appellant is in Germany. However, it is well accepted that delay, although a matter for consideration in the exercise of the discretion, is not an absolute bar to success. In the present case the appellant has not deliberately delayed for any ulterior purpose, there is no evidence that anyone has been or is likely to be prejudiced by the delay, there is a good reason for the amendments sought and in all the circumstances, in my opinion, this appeal should not be refused on the ground of delay alone. (at p667)

19. I have reached the conclusion that the amendments in the second category are not forbidden by s. 78 (2) and that there is no sufficient reason for refusing to allow them to be made, even at this late stage in the life of the patent. (at p667)

20. I propose, therefore, to allow the amendments sought to claims 2,3,6,9,10 and 11. The appellant now desires similarly to amend claim 8 by deleting the words "of the general formula given in claim 1" and it follows from what I have said that I consider that such an amendment ought to be allowed. However, the amendment now sought to claim 8 is different from that sought in the request lodged at the Patent Office and it is not open to me on this appeal to make any formal order in relation to it. I have, however, no doubt that if a proper request for leave to make this amendment is lodged the Commissioner will give effect to my intimation in this regard. (at p668)

21. Somewhat by way of afterthought, the appellant now also seeks to amend p. 4 of the body of the specification by deleting the words:

"The products of each of the examples given is in each case
within the form of the general formula given above."

Again, I cannot formally deal with this question, but may say that, as at present advised, I consider that there is no objection to allowing that amendment if properly requested. (at p668)

22. I allow the appeal in part, reverse the decision of the Deputy Commissioner refusing the request for leave to make the amendments sought to claims 2,3,6,9,10 and 11 of the specification, and allow such amendments. I make no order as to costs. (at p668)

ORDER

I allow the appeal in part. I reverse the decision of the Deputy Commissioner refusing the request for leave to make the amendments numbered 4,5,6,8,9 and 10 in the request dated 12th August 1964, lodged by the appellant at the Patent Office, to claims 2,3,6,9, 10 and 11 respectively in the specification of patent No. 227105. I declare that the request for leave to make the said amendments to claims 2,3,6,9,10 and 11 should not have been refused. I make no order as to costs. Usual order in respect to the exhibits.