COMMISSIONER'S DECISION
SECTION 2: Double Patenting - Method of Improving the Rate Growth of Animals
It was held that a product used to promote weight increase in animals is a "medicine"
within the meaning of Section 41 of the Patent Act. The application was also
rejected for double patenting since it is a divisional with claims directed to the
intended use of the antibiotic which was patented in the parent application.
Rejection: Affirmed on both grounds.
This decision deals with a request for review by the Commissioner of
Patents of the Examiner's Final Action dated December 4, 1975, on
application 207,229 (Class 99-28). The application was filed on August 16,
1974, in the name of Norimasa Miyairi et al, and is entitled "Method
Of Improving Rate Of Growth Of Animals."
This application is a divisional of application 098757 which issued to
patent (960,168) on December 31, 1974. The application relates to a
method for improving the rate of growth of non-human animals by the admin-
istration thereto of growth promoting amounts of the antibiotic "thiopeptin
A4" (the antibiotic was claimed in the above-mentioned patent). Claim 1
of this application reads as follows:
A method of improving the rate of growth of a normally healthy
non-human animal comprising feeding said animal a feed containing
thiopeptin A4 and a non-toxic carrier, in an amount effective
to improve the rate of growth.
In the Final Action the examiner refused the claims of the application on
the ground that "they claim unpatentable subject matter viz., the medical
treatment of non-human animals," and also that the claims are directed to
the intended use of the antibiotic which was allowed in the parent application
(patent 960,168). In that action the examiner stated (in part):
Claims 1 to 3 claim unpatentable subject matter viz the medical
treatment of non-human animals. It is submitted that the effect
of the antibiotics on growth is due to the antibiotics effects
on parasitic and/or saprophytic organisms present even in
subclinical levels in the animals. By eliminating these organisms
or by preventing these organisms from using nutrients, more
nutrients become available to the animal and thus growth promotion is
achieved. Due to the many variations in chemical, physical and
structural properties of the antibiotics known to induce faster
growth, it is certainly not totally unfounded to postulate, in
the absence of evidence to the contrary, that the growth promotion
effects of these substances is mainly due to their common
antibiotic property i.e.that of eliminating parasites and/or
saprophytes or preventing them from carrying out their normal
functions. Because the visible and measurable effects of the
antibiotics on the animal is one of growth promotion and not of
curing a disease (because of subclinical levels of parasites and/or
saprophytes) one cannot reasonably conclude that there is no medical
treatment. In fact, the contrary conclusion is most evident
based on the present knowledge of antibiotics.
Further, claims 1 to 3 define an obvious method of use of a
compound found allowable to the inventor in one application. Such
claims in a different application of the same inventor are not
allowable.
The applicant's response (in part) is indicated by the following paragraphs:
...
It is pointed out that the claims of the present invention are
directed to a method of improving the rate of growth of normally
healthy non-human animals as opposed to animals which are in a
sick or diseased condition. It is believed that it is well estab-
lished that terms such as "medicine" must be interpreted in their
ordinary sense as laymen would employ them (Imperial Chemical
Industries v. Commissioner of Patents, 51 C.P.R. 102); and it is
submitted that the same should apply to "a medical treatment" and
only those methods should be considered "medical treatments"
which would in the ordinary sense to a layman be considered as
medical treatments.
...
Particularly it will be noted that the method of the present
invention"does not apply any pharmaceutical properties of a
substance to effect a curative or preventive treatment of an
ailment"; and certainly "no step of medical or surgical treatment
is set out in the claims".
Certainly it will be appreciated that the present method is not
one which in use will restrict the professional skills of the
surgeon or doctor. On the contrary, the method will be
carried out by non-medical personnel and in particular by farmers
and their employees.
Reference is further made to the decision of the Patents Appeal
Tribunal in the United Kingdom in the matter of Schering AG's
application. This decision was referred to by the Board in the
aforementioned Commissioner's decision and was concerned with
claims directed to a method of contraception without suppression
of ovulation. The claims had been rejected as being directed
to a method of treatment of human beings. The Patents Appeal
Tribunal were apparently of the opinion that such a method was
not necessarily a "medical treatment" at any rate in the narrower
sense of treatment to cure or prevent a disease.
...
Attention is further directed to Canadian patents 890,188 and
882,618, both of which are directed to methods of improving the rate of
growth of animals; both of these patents were granted after appeal to
the Commissioner and these are reported in The Patent Office Record
of February 15, 1972 and October 5, 1971. The claims of the
present invention are similarly directed to method of improving the
rate of growth of animals which are not in a diseased condition but
in a healthy state.
We note in the parent application, which issued to a patent, that the
essence of the invention resides in the discovery of the useful properties
of the antibiotic. That utility was stated as: "The theopeptin A4
component also possesses antibacterial activities against a number of micro-
organisms and is useful for an animal feed supplement. It is observed that
the same utility is given in the present application and reads as follows:
"The thiopeptin A4 component possesses antibacterial activities against a
number of microorganisms and is useful as an animal feed supplement."
The question which should be asked at this time is whether or not there is
a second invention. The applicant is entitled, of course, to only one
patent for one invention, and claims which differ in no material way should
not be allowed in separate patents. Section 28(1) of the Act authorizes the
granting of a patent, but not of several patents for an invention. Section 46
provides that a patent shall give an exclusive right in the invention, a
condition antagonistic to the existence of other patents for the same
inventive concept. Section 63(2) also reflects the same principle of patent
law, one supported by Montecatini v Standard Oil (1974) 14 C.P.R. (2d) 190
at 194, where we find:
* Reported in the Patent Office Record of April 16, 1974.
...the case of Commissioner of Patents v Farbwerke Hoechst
Aktiengesellshaft Vormals Meister Lucius & Bruning (1963)
(1964) S.C.R. 49 and In the Matter of Two Applications for
Patents for Henry Dreyfus (1927) 44 R.P.C. 291, are authority
for the proposition that there can be only one patent for any
given invention.
See as well Amoco v. Texaco Exploration, Fed. Ct. C., August 13, 1975.
This is not to say, however, that in a proper case a second patent might
not issue where the essence of such an invention was the discovery of a
new and unobvious utility different than that found in the first patent.
The claims in our view, though independent of one another, cannot be read
apart from the description of the invention in the specification. The
applicant has in no way shown that the present claims are directed to a
separate invention distinct from the product (antibiotic) claims. It is
clear that the present claims are directed to the intended use of the anti-
biotic which was allowed in the parent application in 1974. The present
utility is the same as that upon which the patentability of the antibiotic
was predicated.
We are therefore satisfied that there is no further invention in the present
application in having claims "directed to the intended use of the
antibiotic," beyond that protected in the patent which claims the antibiotic.
That is, the present claims are merely directed to a different aspect of
the same invention as that of the parent. To permit a new grant now would
create an unlawful extension of monopoly for the invention.
The Board is mindful of course that there is no direct jurisprudence on
the matter of double patenting, but we will refer to the recognition of
it in Lovell Mfg. Co. v Beatty Bros, Ex. C.R. (1958) 23 Fox Pat. C. 112
at 159, where it is stated: "There is no Canadian decision on the subject
of double patenting...." But in referring to the attack of "double patent-
ing," the court went on to consider it by saying:
Finally, the basic objection to double patenting is that it
would extend the life of the monopoly if a patent were granted
for a device and a patent for the same device were granted
subsequently. This did not happen in the present case for two
patents referred to, indeed, the plaintiffs three patents were
issued on the same day. This puts an end to the matter.
If we are correct in our view that there is no second invention, then there
is no need to decide whether the claims are directed to a method of "medical
treatment." We will, however, consider this point as well. We are of
course mindful that methods of medical treatment are unpatentable (Vide,
Tennessee Eastman v Commissioner of Patents (1970) Ex. C.R. as reported
in (1970) 62 C.P.R. 117; 1974 S.C.R. 111).
We note that the thrust taken by the applicants' argument is that before
a method can be considered as directed to "medical treatment" it must
be related to curing or preventing a disease. The word "medicine" however,
in our view, should be given a broad interpretation. A typical dictionary
description of the word is that it is "the science and art concerned with
the cure, alleviation and prevention of disease, and with the restoration
and preservation of health" (Oxford Dictionary).
The Canadian Courts have given a broad interpretation to the meaning of
medicines. See, for example, p. 119 of the Tennessee Eastman decision
supra (S.C.); Parke, Davis v Fine Chemicals (1959) S.C.R. 219 at 226,
confirming (1957) Ex. C.R. 300 at 307; and Imperial Chemical v. Commissioner
of Patents (1967) 1 Ex. C.R. 57 at 60. In the latter we also find at page 61:
" 'I agree with Thurlow, J. that the word 'medicine' as used in s. 41 of the
Act, should be interpreted broadly....'"
As an appendix to the I.C.I. decision, Mr. Justice Gibson provided a series
of definitions for both medicines and drugs. He goes on to say: (emphasis
added )
A perusal of dictionary definitions, judicial decisions and
text book authorities leads to the conclusion that there is
both a restricted definition and a broad definition of "medicine"
commonly and generally understood and used. The method by
which this conclusion is reached may be stated briefly:
1. A "medicine" in modern parlance has come to mean,
inter alia, a drug, a therapeutic agent, a biological
agent, and a pharmaceutical specialty.
2. "Medicines" are to-day categorized under specifics such
as antihistamines, anti-infectives, autonomic drugs,
cardiovascular drugs, antianemia agents, hemostatics,
diagnostic agents, expectorant and cough preparations,
gastrointestinal drugs, hormones, local anaesthetics,
oxytocics, vitamins, anaesthetics, and spasmolytic
agents and so forth. In other words, generally speaking,
it is seldom that anyone speaks of "medicines" anymore....
3. All of these specifics may be referred to merely as medical
drugs or medical agents, without further categorizing as in
1 above.
4. Some of these medical drugs or medical agents are used to
cure or heal a patient per se, and are sometimes referred
to as therapeutic agents (even though there are many therea-
peutic agents which do not cure or heal per se, but are
used for a particular purpose in the treatment of a patient),
while others are used in the course of the whole treatment of
the patient. In this connection, for instance in the case
of the former kind of medical drugs or medical agents, an
antibiotic, say, e.g., penicillin, comes closest perhaps,
but even then, it often happens that other medical drugs
or agents are necessary as supportive therapy when the
antibiotic appears to be specific for a particular type
of infection.
5. The former kind of medical drugs or agents are "medicines"
in a restricted meaning, while the latter kind are "medicines"
in the broad meaning.
"Halothane" is not a medical drug or agent that cures per se, but
instead is a medical drug or agent used in medicine in the
treatment of patients and is an integral essential part of surgical
therapy of disease, a part of the therapeutic regimen.
Therefore in my opinion, "Halothane" is a substance intended
for "medicine" within the meaning of s. 41(1) of the Patent Act,
and as consequence, the appeal is dismissed with costs.
To the above we would add the definition of "drug" already provided by
Parliament (for the purpose of the Food & Drug Act, (1970) R.S.C. F-27,
Sec. (2)) as "any substance for use in modifying organic functions in man
or animal." (emphasis added )
It appears from the above that Mr. Justice Gibson considered an antibiotic
"in the broad meaning " to be a medicine.
The applicant drew our attention to a decision of the Supreme Court of Canada
in Burton Parsons Chemicals v Hewlett-Packard, (1974) 4-17 C.P.R. (2d); and
in particular to p. 18, where Mr. Justice Pigeon concluded that a case had
not been made that a cream used for taking electrocardiograms in routine
examinations is a medicine. Such compositions differ, however, from a sub-
stance taken into the body itself, and affecting an internal body process.
On such a basis the subject matter before us is, in our view, closer to
that considered in the Imperial Chemical v. Commissioner of Patents case
supra than what was considered in Burton Parsons.
In a previous response the applicant submitted a page from a book entitled
"Microbiology," (Published by McGraw-Hill Book Co. 1972 - Author: Mr. J.
Pelczar) where growth stimulation by antibiotics is classified under the
heading of nonmedical uses of antibiotics. On the same page, however, the
bacteria destroying effect of antibiotics is discussed. That portion reads
as follows;
Antibiotics are now widely used as growth stimulants in
poultry and livestock feeds. After the discovery that
many domestic food-producing animals require vitamin
B12 for optimum growth when fed a diet consisting of
plant protein, it developed that by adding wastes from
fermentation by-products to feeds, growth was stimulated
more than by B12 alone. Even when adequate amounts of
B12 were present in the diet, more rapid growth of young
animals was noted when they were fed mash from the
antibiotic fermenters. Use of pure antibiotics has given
similar results. Commercially, the addition of Aureomycin,
Terramycin, or penicillin to swine or poultry feeds at the
rate of 5 to 20 g per ton of feed increases the rate of
growth of young animals by at least 10 percent and
sometimes by as much as 50 percent. This use of these
substances is so important that antibiotics for medical
purposes may become the by-product of the crude residues
in fermenters produced for use as food supplements.
The stimulating effect of antibiotics on growth of domestic animals may be
explained in several ways:
1 The antibiotics may destroy bacteria and other intestinal
parasites that cause subclinical disease and retard growth
and development. For example, it has been suggested that
pigs respond dramatically to the addition of Terramycin to
their diet because the antibiotic inhibits the growth of
Clostridium perfringens in their intestines and prevents
or reduces a chronic but subclinical toxemia.
2 Removal of the saprophytic bacteria from the intestinal tract
may have a beneficial effect on the nutrition of the animals.
Further to this postulate T.H. Jukes in the Journal of the American Medical
Association (April 21, 1975 Vol. 232 No. 3) reports that antibiotics will
promote growth by inhibiting intestinal microorganisms. Volume No. 3,
starting at line 1, reads as follows:
The use of antibiotics in feeding animals is connected in a
remarkable way to clinical medicine, for this use came as
a by-product of the discovery of a new antibiotic, aureomycin
(now known as chlortetracycline), in 1948. Aureomycin was
the first of the tetracyclines, and it was immediately put to
use for its "broad-spectrum" effectiveness against many pathogenic
microorganisms.
At line 22 he goes on to state:
A few grams of antibiotics such as a tetracycline, penicillin,
or streptomycin in a ton of feed will increase growth,
apparently because farm animals normally harbor susceptible
intestinal microorganisms that are mildly deleterious without
being frankly pathogenic.
He also refers to "the extensive use of antibiotics in veterinary medicine
for 25 years. The report by this committee (Swarm) led to the principal
antibiotics for farm animals being placed on veterinary prescription in
Great Britain...." (emphasis added)
These demonstrate that we are considering a form of "medical treatment"
to cure chronic although subclinical bacterial infections, in farm animals.
In addition, in Dextran Products v Benger Laboratories (1970) 60 C.P.R. 215
the Commissioner of Patents rejected completely a submission that a
veterinary product used to promote weight increase in piglets is not a
medicine within the meaning of Section 41 of the Patent Act.
It is interesting to note the definition of a medicinal product which the
"corporations within the European Economic Community (EEC)" have adopted.
We quote from the "Food Drug Cosmetic Law Journal," of August 1975, Vol. 30,
No. 8, at page 485:
Medical product is defined as meaning:
(1) any substance or combination of substances presented
for treating or preventing disease in human beings or animals;
(2) any substance or combination which may be administered
to human beings or animals; or
(3) any substance or combination of substances which may
be administered to human beings or animals with the view of
making medical diagnosis or restoring, correcting or modifying
physiological functions in human beings or animals.
We are therefore satisfied that in the instant circumstances the claims are
directed to a form of "medicinal treatment" in the preservation of the
health of animals.
Of importance then is the decision in Tennessee Eastman v Commissioner of
Patents, supra, in which the Supreme Court of Canada considered a surgical
method for joining wounds in living animals. Mr. Justice Pigeon made the
following statement:
Just as in the case of "art", the scope of the word "process"
in section 2(d) is somewhat circumscribed by the provision of
section 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... 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 section 41 definitely indicates that it
is not so. (emphasis added)
It is clear from the above that a method of medical treatment cannot be
claimed as an invention.
The applicant referred to two previous decisions of the Board relating to
"methods of improving the rate growth of animals." These decisions were
made prior to the Tennessee Eastman v Commissioner of Patents (S. C.)
decision, supra. Furthermore, there is more evidence available to the
Board, as noted above, with regard to the reasons for the increase in growth
in animals when antibiotics are added to their food. For example, we quote
from the book, "Microbiology" supra: "The antibiotics may destroy bacteria
and other intestinal parasites that cause subclinical disease and retard growth and
development."
In summary, we are satisfied that there is no second invention over that
allowed in the parent, and that the claims were also properly refused on
the ground that they relate to a form of "medical treatment," and should
not, in our view, be claimed as a process apart from the drug itself.
(Vide, Tennessee Eastman v Commissioner of Patents, supra.) As there
is no further patentable subject matter in the application we recommend
that the claims and the application as a whole be refused.
J.F. Hughes,
Assistant Chairman
Patent Appeal Board
I concur with the recommendations of the Patent Appeal Board. Accordingly,
I refuse to grant a patent. The applicant has six months within which to
appeal this decision under the provisions of Section 44 of the Patent Act.
J.H.A. Gari‚py
Commissioner of Patents
Dated at Hull, Quebec
this 29th day of September, 1976
Agent for Applicant
Alan Swabey & Co.
625 President Kennedy Avenue,
Montreal, Quebec