Help

Supreme Court Judgments

Decision Information

Decision Content

Supreme Court of Canada

Patents—Surgical method for bonding living tissues—New use for a known substance—Patentability—Patent Act, R.S.C. 1952, c. 203 (now R.S.C. 1970, c. P-4), ss. 2(d), 28(3), 41.

The Commissioner of Patents refused to grant a patent to the appellants for a surgical method for joining or bonding the surfaces of incisions or wounds in living animal tissue by applying certain compounds. The discovery that these compounds had an unexpected property of bonding human tissue is new and useful and unobvious but the compounds are old and well known. The Commissioner decided that the method did not constitute patentable subject matter under s. 2(d) of the Patent Act in that it is neither an art, or a process within the meaning of the section. The decision of the Commissioner was affirmed by the Exchequer Court. An appeal was launched in this Court, the sole question being whether a new use for surgical purposes of a known substance can be claimed as an invention.

Held: The appeal should be dismissed.

The scope of the word “process” in s. 2(d) is somewhat circumscribed by the provision of s. 28(3) excluding a “mere scientific principle or abstract theorem.” The claims are limited to a method, i.e., process, which in this case is nothing else than a new use for a known substance. Section 41 of the Act was enacted for the purpose of restricting the scope of patents “relating to substances prepared or produced by chemical processes and intended for food or medicine.” This necessarily implies that, with respect to such substances, the therapeutic use cannot be

[Page 112]

claimed by a process claim apart from the substance itself.

APPEAL from a judgment of Kerr J. of the Exchequer Court of Canada[1], affirming the decision of the Commissioner of Patents. Appeal dismissed.

G.F. Henderson, Q.C., G.A. Macklin and R. Jackson for the appellants.

G.W. Ainslie, Q.C., and A.P. Gauthier, for the respondent.

The judgment of the Court was delivered by

PIGEON J.—This case was submitted on an Agreed Statement of Facts and Issues in the following terms:

For the purpose of this hearing only, it is agreed that:

1. The claims generally describe a surgical method for joining or bonding the surfaces of incisions or wounds in living animal tissue by applying the compounds described in the claims in a liquid state, directly to at least one of the tissue surfaces to be bonded.

2. The discovery that these particular compounds had an unexpected property of bonding human tissue is new and useful and unobvious but the compounds described in the claims were old and well known.

3. The ground on which the Commissioner refused to grant a patent to the applicant was that the method for surgically bonding the surfaces of living animal tissue as covered by the claims in the said application does not constitute patentable subject matter under subjection (d) of section 2 of the Patent Act, in that it is neither an art, or a process within the meaning of said subsection.

4. The issue before this Honourable Court is whether the method for surgical bonding of body tissues by applying to one of the tissue surfaces to be bonded, one of the compounds described in the claims, is an art or process or an improvement of an art or process within the meaning of subsection (d) of section 2 of the Patent Act.

[Page 113]

5. The parties agree that on the hearing of this appeal any of the documents appearing in the record file of this application, together with the matters therein contained, may be adduced in evidence without formal proof thereof, and the facts stated in the affidavit of David W. Fassett and in patent application serial number 884,804 are accepted as true.

6. The parties agree that the issue stated in paragraph 4 is the only one which was considered by the Commissioner, and in the event the appeal is allowed and the Commissioner’s decision to refuse to grant a patent is set aside, the appellant Ethicon, Inc. will be at liberty to resume the prosecution of its application.

The Examiner’s first report on the patent application was made on February 9, 1965, as follows:

SURGICAL METHOD 884,804

This application has been examined as filed.

Applied Reference:

United States Patent
2,721,858 Oct. 25, 1955 Joyner et al. Cl.260-67

The above patent teaches the production of the composition, the use of which is the subject matter of the instant application. The reference teaches that the esters produced “are excellent adhesive compositions for bonding almost any type of material to itself or to a dissimilar material”. The use of the material as an adhesive is therefore old.

The use of such an adhesive specifically for medical purposes is within the judgement or discretion of the medical practitioner. The material itself when prepared for medical purposes would not be patentable per se under the provisions of Section 41 of the Patent Act. It would be even less in the public interest to grant a monopoly on the use of the material and thus hamper the medical profession.

Grant of a patent is refused.

The substance of the Examiner’s report on reconsideration is in the following paragraph:

Inasmuch as applicants claims are directed to a process limited solely to a medical or surgical treatment of animals including humans, and inasmuch as it

[Page 114]

is held such medical or surgical processes are not involved in commerce, trade and industry and are therefore outside the scope of a process which fall under Section 2(d) of the Patent Act, it is held that the claims are outside the scope of a process which falls under Section 2(d) of the Patent Act and that therefore, even if the arguments presented by applicant are accepted as proof of novelty, utility and unobviousness, the claims must fail for lack of subject matter.

This conclusion was upheld by the acting Commissioner in a decision dated July 19, 1968, the essential part of which reads:

In applicant’s application, we are concerned with a process of medical or surgical treatment of living tissues.

Applicant’s arguments with respect to the words “art” and “process” also have been noted. However, not all methods or processes fall within the meaning of “art” under Section 2(d) of the Patent Act. The word “art” cannot be taken in its broadest meaning for there are arts which are excluded by statutes for instance by Section 28(3), others by well known and accepted court rulings such as business system, method of teaching, etc., and other by other statutes such as the Design Act and the Copyright Act.

Affirming the decision of the Commissioner, Kerr J. said, after an exhaustive review of authorities:

In my view the method here does not lay in the field of manual or productive arts nor, when applied to the human body, does it produce a result in relation to trade, commerce or industry or a result that is essentially economic. The adhesive itself may enter into commerce, and the patent for the process, if granted, may also be sold and its use licensed for financial considerations, but it does not follow that the method and its result are related to commerce or are essentially economic in the sense that those expressions have been used in patent case judgments. The method lies essentially in the professional field of surgery and medical treatment of the human body, even although it may be applied at times by persons not in that field. Consequently, it is my conclusion that in the present state of the patent law of Canada

[Page 115]

and the scope of subject matter for patent, as indicated by authoritative judgments that I have cited, the method is not an art or process or an improvement of an art or process within the meaning of subsection (d) of section 2 of the Patent Act.

The provisions of the Patent Act (R.S.C. 1952, c. 203, now R.S.C., c. P-4) relevant to this case include first, the definition of “invention” namely subs. (d) of s. 2 above referred to:

(d) “invention” means any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter;

This must be read subject to s. 28(3) which is as follows:

(3) No patent shall issue for an invention that has an illicit object in view, or for any mere scientific principle or abstract theorem.

At the date of the patent application, subs. 1, 2 and 3 of s. 41 read:

41. (1) In the case of inventions relating to substances prepared or produced by chemical processes and intended for food or medicine, the specification shall not include claims for the substance itself, except when prepared or produced by the methods or processes of manufacture particularly described and claimed or by their obvious chemical equivalents.

(2) In an action for infringement of a patent where the invention relates to the production of a new substance, any substance of the same chemical composition and constitution shall, in the absence of proof to the contrary, be deemed to have been produced by the patented process.

(3) In the case of any patent for an invention intended for or capable of being used for the preparation or production of food or medicine, the Commissioner shall, unless he sees good reason to the contrary, grant to any person applying for the same, a licence limited to the use of the invention for the purposes of the preparation or production of food or

[Page 116]

medicine but not otherwise; and, in settling the terms of such licence and fixing the amount of royalty or other consideration payable the Commissioner shall have regard to the desirability of making the food or medicine available to the public at the lowest possible price consistent with giving to the inventor due reward for the research leading to the invention.

On June 27, 1969, subs. 3 was, by s. 1 of c. 49, 17-18 Eliz. II, replaced by new provisions the relevant part of which is the new subs. 4:

(4) Where, in the case of any patent for an invention intended or capable of being used for medicine or for the preparation or production of medicine, an application is made by any person for a licence to do one or more of the following things as specified in the application, namely:

(a) where the invention is a process, to use the invention for the preparation or production of medicine, import any medicine in the preparation or production of which the invention has been used or sell any medicine in the preparation or production of which the invention has been used, or

(b) where the invention is other than a process, to import, make, use or sell the invention for medicine or for the preparation or production of medicine,

the Commissioner shall grant to the applicant a licence to do the things specified in the application except such, if any, of those things in respect of which he sees good reason not to grant such a licence; and, in settling the terms of the licence and fixing the amount of royalty or other consideration payable, the Commissioner shall have regard to the desirability of making the medicine available to the public at the lowest possible price consistent with giving to the patentee due reward for the research leading to the invention and for such other factors as may be prescribed.

In this decision, the Commissioner pointed out that the generality of the meaning of the word “art” in the definition of “invention” was effectively circumscribed, not only by s. 28(3) but also by other statutes such as the Design Act and the Copyright Act. This principle obviously applies equally to the construction of the

[Page 117]

word “process” with which we are concerned in this case. This is clearly what is being claimed as a “method”. I can perceive no material difference between those two expressions in this context. In the Shorter Oxford English Dictionary, one of the definitions of “process” is “A particular method of operation in any manufacture”. Similarly, in the Robert dictionary, one of the definitions of “procédé” (process) is [TRANSLATION] “Way in which an operation is performed. Means or method used or available for obtaining a given result”.

Just as in the case of “art”, the scope of the word “process” in s. 2(d) is somewhat circumscribed by the provision of s. 28(3) excluding a “mere scientific principle or abstract theorem”. There is no question here of the alleged invention being such. It is clearly in the field of practical application. In fact, as the record shows, the “invention” essentially consists in the discovery that a known adhesive substance is adaptable to surgical use. In other words, the subject-matter of the claimed invention is the discovery that this particular adhesive is non-toxic and such that it can be used for the surgical bonding of living tissues as well as for a variety of inert materials. In this situation, it is clear that the substance itself cannot be claimed as an invention and the appellants have not done so. Their claims are limited to a method, i.e. process, which in this case is nothing else than a new use for a known substance. The sole question is therefore whether a new use for surgical purposes of a known substance can be claimed as an invention.

There is no doubt that when a new substance is claimed as an invention of a “medicine”, it has to be shown that it is active and non-toxic in therepeutic doses. Otherwise the patent fails for lack of utility and this is so if a class of substances is claimed some of which are useful as a

[Page 118]

“medicine”, some of which are not (Société des Usines Chimiques Rhone-Poulenc v. Jules R. Gilbert Ltd).[2] Here, we have to deal with a substance that was known and also with its previously known essential properties, that is to form an adhesive by polymerization on application. Therefore, the only element of novelty is in its application to surgical use and the discovery is limited to the unobvious adaptability to such use. This is why the claims, as previously pointed out, are only for a surgical method of joining tissues by means of such an adhesive rather than with thread or clips. Is such a method an “art” or “process” within the meaning of the definition of “invention”?

It is clear that a new substance that is useful in the medical or surgical treatment of humans or of animals is an “invention”. It is equally clear that a process for making such a substance also is an “invention”. In fact, the substance can be claimed as an invention only “when prepared or produced by” such a process. But what of the method of medical or surgical treatment using the new substance? Can it too be claimed as an invention? In order to establish the utility of the substance this has to be defined to a certain extent. In the case of a drug, the desirable effects must be ascertained as well as the undesirable side effects. The proper doses have to be found as well as methods of administration and any counter‑indications. May these therapeutic data be claimed in themselves as a separate invention consisting in a method of treatment embodying the use of the new drug? I do not think so, and it appears to me that s.41 definitely indicates that it is not so.

Section 41 was enacted for the purpose of restricting the scope of patents “relating to substances prepared or produced by chemical pro-

[Page 119]

cesses and intended for food or medicine”. The first principle proclaimed is that in the case of such inventions, “the specification shall not include claims for the substance itself, except when prepared or produced by the methods or processes of manufacture particularly described in the claim or by their obvious equivalents”. In my view, this necessarily implies that, with respect to such substances, the therapeutic use cannot be claimed by a process claim apart from the substance itself. Otherwise, it would mean that while the substance could not be claimed except when prepared by the patented process, its use however prepared could be claimed as a method of treatment. In other words, if a method of treatment consisting in the application of a new drug could be claimed as a process apart from the drug itself, then the inventor, by making such a process claim, would have an easy way out of the restriction in s.41(1).

Having come to the conclusion that methods of medical treatment are not contemplated in the definition of “invention” as a kind of “process”, the same must, on the same basis, be true of a method of surgical treatment. In this connection, I would note that in Imperial Chemical Industries v. Commissioner of Patents[3], the Exchequer Court decided that an anaesthetic was a substance “intended for medicine” within the meaning of s.41(1), relying on the decision of this Court in Parke Davis & Co. v. Fine Chemicals of Canada Ltd.[4], in which it was held that the word “medicine” should be interpreted broadly so as to include the product in bulk as well as in dosage form.

[Page 120]

Counsel for the appellants heavily relied on the decision of the Queen’s Bench Division on Swift & Company’s Application[5] following the decision of the High Court of New Zealand on Swift & Company’s Application[6] and that of the High Court of Australia on the National Research Development Corporation’s Application[7].

Concerning those cases, I would first observe that I doubt whether decisions dealing with the patentability of inventions under the U.K. Act are entitled in Canada to the weight which authors such as Fox (Canadian Patent Law and Practice, 4th ed. p. 19) seem to think they should have. There are substantial differences between the British and Canadian statutes which need not be enumerated. In Hoffmann-Laroche & Co. Ltd. v. Commissioner of Patents[8], Kerwin C.J., speaking for the majority and dealing with the refusal of the Commissioner to allow “process dependent product claims”, said (at p. 416):

The difficulty in the appellant’s way is not only that the Act does not so provide but s. 2(d) and s. 35(2) demand a negative answer. The statement as to the English practice in Patents for Inventions by Mr. T.A. Blanco White, at p. 59, “it is of course very common to insert such a claim” is borne out by three English patents filed as exhibits but in view of our statutory provisions that practice cannot be followed here.

In Commissioner of Patents v. Winthrop Chemical Co. Inc., Estey J. noted at p. 49 “the Canadian Act is not modelled on the British Act”, Kellock J. referred to the meaning of the French version, a meaning that would be irrelevant on the assumption that decisions respecting subject-matter under the British statute are controlling, Rand J. said (at p. 57):

[Page 121]

the intention of a legislature must be gathered from the language it has used and the task of construing that language is not to satisfy ourselves that as used it is adequate to an intention drawn from general considerations or to a purpose which might seems to be more reasonable or equitable than what the language in its ordinary or primary sense indicates.

In the second place, what was actually decided in those cases is not related to a medical or surgical method. Swift’s application dealt with a method of tenderizing meat by injecting enzymes into the animal before slaughtering. The National Research Development Corporation’s application covered a method of eradicating weeds using for this new purpose substances which were otherwise already known. The conclusion of the High Court was (at p. 147):

We are here concerned with a process producing its effects by means of a chemical reaction, and the ultimate weed-free, or comparatively weed-free condition of the crop‑bearing land is properly described as produced by the process. The fact that the relevance of the process is to agricultural or horticultural enterprises does not in itself supply or suggest any consideration not already covered in this judgment for denying that the process is a patentable invention.

While those decisions may be of some interest in dealing with the patentability of inventions related to slaughtering or agricultural processes, I fail to see anything that would tend to overbear the implication of s. 41(1) with respect to the exclusion of a surgical or medical method per se from the area of patentable process.

It might be noted that in the latest reported case brought to our attention, Re Schering A.G.’s Application[9], a case dealing with a method of contraception by means of gestagen, the conclusion of the Patents Appeal Tribunal was (at p. 345):

[Page 122]

Although, however, on a full consideration of the matter it seems that patents for medical treatment in the strict sense must be excluded under the present Act, the claims the subject of the application do not appear to fall within this prohibition and, on the law as it stands today, they should, at least at this stage in our judgment, be allowed to proceed. As Swift’s Application (1962) R.P.C. 37 in the Divisional Court of the Queen’s Bench Division clearly established, the Office and the Patents Appeal Tribunal are at this stage not deciding the question of “actual patentability”, as the phrase was used in that case, and unless there is no reasonable doubt that a manner of manufacture is not being claimed or the application is plainly without justification, it is their duty to allow the claim. The applicants will then have the opportunity in due course, if the matter arises, of having “actual patentability” decided in the High Court. (Emphasis added.)

The only case in which a contrary view appears to have been taken is the decision of the U.S. Patent Office Board of Appeals in Ex parte Scherer[10]. This has to do with a method of injecting fluids into the human body by means of a high pressure jet. The persuasive authority of this decision is minimal because of a strong dissent supporting the conclusion of the examiner based on the judgment in Morton v. New York Eye Infirmary[11].

I would dismiss the appeal with costs.

Appeal dismissed with costs.

Solicitors for the appellants: Gowling & Henderson, Ottawa.

Solicitor for the respondent: D.S. Maxwell, Ottawa.

 



[1] (1970), 62 C.P.R. 117.

[2] [1968] S.C.R. 950, 55 C.P.R. 207, 69 D.L.R. (2d) 353.

[3] (1966), 33 Fox Pat. C. 153, 51 C.P.R. 102, [1967] 1 Ex. C.R. 57.

[4] [1959] S.C.R. 219, 30 C.P.R. 59, 17 D.L.R. (3d) 153.

[5] [1962] R.P.C. 37.

[6] [1961]R.P.C. 147.

[7] [1961] R.P.C. 134.

[8] [1955] S.C.R. 414, 15 Fox Pat. C. 99, 23 C.P.R. 1.

[9] [1971] R.P.C. 337.

[10] (1954), 103 U.S. P.Q. 107.

[11] (1862), 5 Blatchford 116.

 

Lexum

For 20 years now, the Lexum site has been the main public source for Supreme Court decisions.


>

Decisia

 

Efficient access to your decisions

Decisia is an online service for courts, boards and tribunals aiming to provide easy and professional access to their decisions from their own website.

Learn More