Wellcome Foundation Ltd v Commissioner of Patents

[1980] HCA 21

HIGH COURT OF AUSTRALIA

Gibbs, Stephen, Mason, Murphy and Wilson JJ.

WELLCOME FOUNDATION LTD. v. COMMISSIONER OF PATENTS

(1980) 145 CLR 520

24 July 1980

Patents

Patents—Application—Package claim—Whether process claim—Claim for known substance in container bearing directions for use for previously unknown purpose—Manner of manufacture—Process claim—Substance used in process or produced by it—Patents Act 1952 (Cth), ss. 40, 49.

Decision

1980, July 24.
The Court delivered the following written judgment:-
The present appeal concerns the validity of claims in a Convention application made by the appellant, The Wellcome Foundation Ltd., on 5th March 1971 for the grant of letters patent for an invention entitled "Treatment of Anaplasmosis in Cattle". The claims in dispute are package claims, i.e. claims to a container with its contents together with a set of written directions. The circumstances in which such package claims will be valid are limited. Novelty in the process for which the package may be used will not be sufficient. Unless the package itself is novel and constitutes a manner of new manufacture, claims to the package will be too wide. As will appear, this is the case here. (at p524)

2. Pursuant to s. 48 (2) (a) and s. 48 (3) of the Patents Act 1952 ("the Act") the examiner in a written report dated 10th April 1974 rejected claims 1 to 15 of the appellant's complete specification. In a further report dated 3rd July 1975 the examiner maintained the objections to claims 1 to 15 raised in the first report. The examiner found the claims to be "prior published", "not novel in the light of Australian Specification No. 261,991" and held that they did "not define patentable combinations". (at p524)

3. Pursuant to s. 49 of the Act the appellant requested a decision on the examiner's report. This was referred to the Deputy Commissioner of Patents who gave his written decision on 12th December 1975, together with directions pursuant to s. 49 (6) of the Act. The appellant appealed to this Court from that decision. We have before us a special case stated by the Chief Justice which refers the following matters to this Court for determination:
"(1) Whether the Deputy Commissioner's determination was erroneous in point of law.
(2) Whether a claim in the form proposed for claim 1 lacks novelty in the light of the disclosure in Australian Letters Patent 261,991.
(3) Whether or not a claim in the form of the proposed claim 1 defines a patentable invention with the meaning of s. 40 of the Patents Act 1952.
(4) Whether a claim in the form proposed for claims 11 or 12 lacks novelty in the light of the disclosure in Australian Letters Patent 261,991.
(5) Whether or not a claim in the form of the proposed claims 11 or 12 defines a patentable invention within the meaning of s. 40 of the Patents Act 1952.
(6) Whether or not a claim defined in terms of a unit dosage which is unsuitable for previously known uses of a known substance but is suitable for a new nonobvious use of that substance defines sufficiently a patentable invention within the meaning of s. 40 of the Patents Act 1952." (at p524)

4. The requirements for a patentable invention are set out in the Act. Section 35 sets out the form of the application and states that:
"(1) An application for a patent -
(aa) shall be in respect of a manner of new manufacture the subject of letters patent and grant of privilege within section six of the Statute of Monopolies;"
Section 40 deals with the complete specification:
"(1) A complete specification -
(a) shall fully describe the invention, including the best method of performing the invention which is known to the applicant; and
(b) shall end with a claim or claims defining the invention. (2) The claim or claims shall be clear and succinct and shall be fairly based on the matter described in the specification." (at p525)

5. The requirements that an invention should not be prior published, and should be novel are specified in s.48(3) in that before reporting that an application and specification be accepted, the examiner has to report on whether the invention satisfies these requirements. (at p525)

6. The appellant's application relates to a new use for an old range of chemicals, polybasic compounds. The questions before the Court concern the relationship of the appellant's application to Australian Letters Patent No. 261,991 (which corresponds to United Kingdom Letters Patent No. 1,007,334) which is entitled "Process for Preparing Polybasic Compounds", a patent which has since expired but was still valid at the time of the appellant's application. The appellant's application "relates to methods of treating and preventing anaplasmosis in cattle and to preparations suitable for administration to cattle". For the purposes of this case only, it is agreed by the Deputy Commissioner that in the light of Letters Patent No. 261,991 the appellant has discovered that low dosages of certain of these polybasic carbanilides should be successful in the treatment of anaplasmosis in cattle. (at p525)

7. The Deputy Commissioner allowed claims 17 to 28 inclusive which are method or process claims setting out a method of administering the low dosage designed to treat anaplasmosis. The claims in dispute, claims 1 to 15 inclusive, are claims to the known chemical substance in a container together with a set of directions indicating how to use the substance for the previously unknown purpose of treating anaplasmosis in cattle. (at p525)

8. The Deputy Commissioner's objections to claims 1 to 15 are not directed to the discovery of the new use for the known chemical compound which is the subject of claims 17 to 28. The Deputy Commissioner's objections are directed to claim 1, upon which claims 2 to 15 are dependent. (at p525)

9. Claim 1 is in these terms:
"1. A container having in physical relation thereto written indications of the suitability of its contents for the treatment, sterilisation or prevention of anaplasmosis in cattle, the said contents comprising a compound of formula (I) or a therapeutically acceptable acid addition salt thereof H NH-CO-NH H
)
N N< ) Scetch
R4 R5 (1)< ) Omitted
N )
R3 N R6< )
wherein r3, r4, r5 and r6 are the same or different and each is a hydrogen atom or an alkyl group having 1 to 4 carbon atoms, as an active ingredient, in association with a pharmaceutically acceptable carrier therefor, said written indications prescribing for the parenteral treatment of anaplasmosis the administration of the contents at a dosage which is equivalent to 2 to 3mg of active ingredient/kg bodyweight of animal per administration, or said written indications prescribing for the oral treatment of anaplasmosis the administration of the contents at a dosage which is equivalent to about 5 to 10mg of active ingredient/kg bodyweight of animal per administration, or said written indications prescribing for the 'sterilisation' of anaplasmosis the repeated administration to carrier animals of the contents at a dosage which is equivalent to 2 to 3mg of active ingredient/kg bodyweight of animal per administration over a period from a few days up to a few months, or said written indications prescribing for the prevention of anaplasmosis the repeated administration of the contents at a dosage which is equivalent to about 1 to 2 or 3mg of active ingredient/kg bodyweight of animal per administration over a period from a few days up to about 1 month." (at p526)

10. The problems raised by claims to an old substance in a container, frequently accompanied by directions for use, have been examined in a number of cases in England, notably Ciba-Geigy A.G. (Durr's) Applications (1977) RPC 83 ; Organon Laboratories Ltd.'s Application (1970) RPC 574 ; L'Oreal's Application (1970) RPC 565 . In the Ciba-Geigy Case, Russell L.J., who delivered the opinion of the Court of Appeal, upheld the decision of Graham J. that the package claim there under consideration was not valid. After reviewing earlier authorities, his Lordship stated (1977) RPC, at p 89 :
"There seems to us to be nothing inventive about parcelling up the known material in any and every convenient package or container having written thereon the information that it can be used for the stated purpose in the stated loci. There is no interaction between the container with its contents and the writing thereon. The mere writing cannot make the contents in the container a manner of new manufacture. There is nothing novel in the mere presentation of information by ordinary writing or printing on a container."
For there to be novelty in a package claim there must be an interaction between the container with its contents and the writing so that the instructions or directions are novel by virtue of their link with the process. Needless to say, novelty is not often found in a package claim. Organon provides a striking illustration of a successful claim. There, the directions consisted of a card with the pills so arranged on it that it indicated that the pills were to be taken in a certain sequence, the sequence being part of the applicant's inventive improvement. Graham J. said (1970) RPC, at p578 :
"The discovery of a new method of treatment, which may itself be very meritorious even though not patentable, may it seems to me give subject matter to a pack or card of pills suitable for the carrying out of that method if, first, there is something novel in the constitution of the pack or card itself." (at p527)

11. On the other hand, the L'Oreal Case provides a more typical example, though the claims did not rest on the existence of instructions. There, the claim for a package of two components for use in a process for treatment of hair was refused. Graham and Whitford JJ. said (1970) RPC, at p 572 : "In substance the present applicants are really seeking to secure an extension of the protection they have already got or may get for their process." (at p527)

12. Here, counsel conceded that the essence of the invention is the dosage (which is much lower than previously administered dosages of the chemicals) resulting in its suitability for a new use. An examination of the specification discloses that the instructions are merely directions as to use. They do not interact with the container and its contents. There is admittedly nothing novel about the container, nor its contents. The placement and design of the instructions are not novel. (at p527)

13. Counsel for the appellant argues that to sustain a claim to the substance in a package with directions where a claim to the process has been allowed would provide a solution to the problem of policing the patent and thereby deter rival manufacturers from destroying the efficacy of the patent by selling the container and contents with instructions to use the contents in the patented process. (at p527)

14. As Russell L.J. noted in Ciba-Geigy (1977) RPC, at p 89 , it is questionable whether "a rival manufacturer of the known substance would be entitled to sell it with instructions that it is suitable for use in a manner which would infringe the appellants' patent". Even if this were possible, it would not be a sufficient justification for extending a patent monopoly beyond what is properly within the scope of the invention. There is no support in the authorities for such a proposition. (at p528)

15. Mr. Bannon,for the appellant,argues that the claim should be upheld as a process claim or, as he puts it, a disguised process claim. He says that if the process claims are allowed, as they have been, why is it that the appellant cannot have a patent for that process in written or printed form on the container? The answer lies in the fact that, on its true construction, claim 1 makes no claim to the written exemplification of the process as such; it seeks a monopoly based on the existence of a physical relationship between the container and its contents and the instructions written on the container. This, as we have said, cannot be sustained. (at p528)

16. The appellant also relies on National Research Development Corporation v. Commissioner of Patents (1959) 102 CLR 252 , which, despite the well-accepted principle that "mere new use for an old thing" is not patentable (Blanco White, Patents for Inventions, 4th ed. (1974), pp. 18-19), decided that a discovery, itself involving ingenuity or novelty, that an old substance may be used so as to produce a new result may ground a patentable invention. In such a case the old substance is treated as if it were new, its hitherto unknown or unsuspected potentialities being revealed by the discovery which is itself a consequence of scientific ingenuity (1959) 102 CLR, at p 265 . This principle extends to a process which does not produce a new substance but results in "a new and useful effect". If the new result is "an artificially created state of affairs" providing economic utility, it may be considered a "manner of new manufacture" within s.6 of the Statute of Monopolies (N.R.D.C. (1959) 102 CLR, at p 277 ). It was presumably on this footing that the Deputy Commissioner allowed claims 17 to 28 as process or method claims. However, there is nothing in N.R.D.C. or in the judgement of the Court in that case which gives support to a package claim when the package claim, apart from the process itself, is devoid of ingenuity or novelty. (at p528)

17. Accordingly, claim 1 is not novel; nor is it fairly based on matter described in the specification (s. 40 (2)). (at p528)

18. In connection with question 6 the appellant further submits that it is entitled to a monopoly of the substance when used in the process, viz. the method of administration of the dosage, and that this Court should remit the case to the Deputy Commissioner with a direction to this effect. According to the appellant, when an invention consists of a process it is possible to claim a monopoly in the product of the process. (at p529)

19. We have an initial difficulty with question 6. The claims the subject of the appeal are not accurately described as claims defined in terms of a unit dosage. Claims 11 and 12, which refer to unit dosage, are basically claims to a container, as described in claim 1, having a relationship with the unit dosage described in the two claims. Question 6, as the appellant concedes, raises a question which does not arise from any of the claims as they have been expressed. For this reason we are unwilling to answer it. (at p529)

20. However, as the appellant's submission is a development of other arguments which have been canvassed, it merits some consideration. The principle invoked by the appellant which is said to entitle the inventor of a process to a monopoly in the product is subject to limitations - see Mullard Radio Valve Co. Ltd. v. British Belmont Radio Ltd. (1938) 56 RPC 1 ; Interlego A.G. v. Toltoys Pty. Ltd. (1973) 130 CLR 461, at p 480 ; Olin Corporation v. Super Cartridge Co. Pty. Ltd. (1977) 51 ALJR 525, at p 537 . For present purposes there is no need for us to discuss the precise scope and extent of these limitations. It is sufficient to say that the principle has no application here. What the applicant seeks is a monopoly in an old substance limited to its use in the process which is the subject of claims 17 to 28. It is one thing to say that the inventor of a process is entitled to a monopoly, albeit limited, in the product of that process. It is quite another and different thing to say that the inventor of a process is entitled to a monopoly in a substance which is used merely as an ingredient in that process. In the latter case the invention claimed makes no contribution to the manufacture of the substance. At best, it takes advantage of properties in the substance hitherto unknown or unsuspected. (at p529)

21. 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 Company Ltd. v. Trapp &Co. (1910) 27 RPC 341, at p 353 , upon which the appellant, mistakenly in our view, placed reliance. There, the first claim in the patent specification was a process claim. The second claim was either a claim to a pellicle or to the use of the pellicle in the process described in the first claim. Parker J. observed that, if the second claim was a claim to the use of the pellicle in the process, it added nothing to the first claim for it was already included in that claim. Later, his Lordship said (1910) 27 RPC, at p 353 : "The idea of using an old material for an entirely new purpose, not being analogous to purposes for which it has theretofore been used, may be good subject-matter, but such idea, however ingenious, can hardly justify a claim for the material itself." (at p530)

22. For these reasons we would answer the questions asked as follows:
1. No. 2. Not answered as the appellant presented no argument on the question.
3. A claim in the form of the proposed claim 1 does not define a patentable invention within the meaning of s. 40 of the Patents Act 1952. 4. Not answered as the appellant presented no argument on the question.
5. A claim in the form of the proposed claims 11 or 12 does not define a patentable invention within the meaning of s. 40 of the Patents Act 1952.
6. Not answered. (at p530)

Orders

Appeal dismissed with costs. Order that the questions asked in the Special Case be answered as follows:
Question 1: Whether the Deputy Commissioner's determination was erroneous in point of law. Answer: No.
Question 2: Whether a claim in the form proposed for claim 1 lacks novelty in the light of the disclosure in Australian Letters Patent 261, 991. Answer: Not answered as the appellant presented no argument on the question.
Question 3: Whether or not a claim in the form of the proposed claim 1 defines a patentable invention within the meaning of s. 40 of the Patents Act 1952.
Answer: A claim in the form of the proposed claim 1 does not define a patentable invention within the meaning of s. 40 of the Patents Act 1952.
Question 4: Whether a claim in the form proposed for claims 11 or 12 lacks novelty in the light of the disclosure in Australian Letters Patent 261,991. Answer: Not answered as the appellant presented no argument on the question.
Question 5: Whether or not a claim in the form of the proposed claims 11 or 12 defines a patentable invention within the meaning of s. 40 of the Patents Act 1952.
Answer: A claim in the form of the proposed claims 11 or 12 does not define a patentable invention within the meaning of s. 40 of the Patents Act 1952.
Question 6: Whether or not a claim defined in terms of a unit dosage which is unsuitable for previously known uses of a known substance but is suitable for a new nonobvious use of that substance defines sufficiently a patentable invention within the meaning of s. 40 of the Patents Act 1952.
Answer: Not answered.

Order that the appellant pay the Commissioner of Patents his costs of and incidental to this Special Case.

Remit to a Justice of this Court for any necessary action in conformity with this order.