COMMISSIONER'S DECISION
SECTION 2 - 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.
Rejection: The refusal of the claims to the method of use of the
product was affirmed.
This decision deals with a request for review by the Commissioner of
Patents of the Examiner's Final Action dated May 2, 1975, on applica-
tion 047,754 (Class 260-302.5). The application was filed on April 3,
1969, in the name of Wehrmeister, Herbert L. et al, and is entitled
"Linked Fused Carbocyclic 5 Membered Heterocyclic Compounds." The
Patent Appeal Board conducted a Hearing on June 2, 1976, at which
Messrs. D. Watson, Q.C. and Mr. F. Pole represented the applicant.
The application relates to heterocyclic compounds which exhibit estro-
genie activity or aid in increasing the rate of growth in meat producing
animals.
In the Final Action the examiner refused claims 46 to 66 as not falling
under Section 2 of the Patent Act. He cited as authority the decision
on Tennessee-Eastman v The Commissioner of Patents (CPR 8 2nd. series, 202).
In the Final Action the examiner stated (in part):
Claims 46 to 66, which are directed to a method of increasing
the body weight of normally healthy meat-producing animals,
are again rejected in view of the Tennessee-Eastman vs. the
Commissioner of Patents C.P.R. 8, 2nd. series, 202. As
mentioned in the Office Actions of October 9, 1973 and January
31, 1974, since this application is governed by Section 41(1)
of the Patent Act, the scope of the compounds of the invention
is restricted as they must be dependent upon their process of
preparation. Therefore the method of use of the compounds of
the invention cannot be claimed by a process claim apart from
the substance itself. Otherwise it could mean that, while
the compounds could not be claimed except when prepared by
the patented process, their use however prepared could be claimed
as a method of treatment. Therefore these "method of use"
process claims are giving the applicant an easy way out of the
restriction of Section 41(1) of the Patent Act.
The applicant's position is shown from the following paragraphs in his
request for review:
...
We submit that the Examiner's assumption that Section 41(1)
applies is inconsistent with recent decisions of the Supreme
Court of Canada as well as being inconsistent with a previous
ruling of the Commissioner of Patents.
In the recent decision of Burton-Parsons Chemicals Inc. vs. Hewlett
Packard Canada Ltd. Pigeon J., who delivered the decision of
all nine members of the Supreme Court of Canada, stated as follows:
"... I agree with the trial judge's finding that this
cream is not 'intended for medicine' within the meaning
of S. 41. Cases on the meaning of this expression were
recently reviewed in Tennessee Eastman vs Commissioner of
Patents (1974 S.C.R. 111). Substances intended for use
in surgery were held to be included. I have no doubt that
a conductive cream is apt to be used whenever electrodes are
applied to the skin during surgery. However, there is
nothing in the evidence which would justify the conclusion
that such is the main or primary use of the product. It is
clear that such is primarily and mainly for the taking of
electrocardiograms in routine examinations, not necessarily
or mainly in connection with the treatment of diseases."
This quotation clearly establishes the following propositions:
(1) Not everything administered to the body is necessarily a
medicine;
(2) "Medicine" requires the treatment of disease;
(3) The main or primary use is to be considered. Even
more specific to the facts of this case is the Tennessee Eastman
decision of the Supreme Court of Canada (1973) 8 C.P.R. (2d)
202 at page, 208, where it was stated:
"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".
...
It is well established that methods will be regarded as
medical only if they involve the treatment of disease.
We have already noted the Burton-Parsons case in support
of this proposition. If any further authority is needed,
it will be found in Schering AG's Application (1971)
R.P.C. 337 at page 341, where applicant's argument was
accepted "that a process for contraception is not a process
for 'medical treatment' in the sense of treatment to cure
or prevent disease and that the established practice relates
only to medical treatment". The Schering case was referred
to with approval in the Tennessee Eastman case at page 209
and emphasis was added in a quotation to the statement that
"patents for medical treatment in the strict sense must be
excluded". Yet another authority is Joos vs Commissioner of
Patents (1973) R.P.C. 59, particularly at page 63, where it
is stated:
"To be treatment, in the relevant sense, it seems
to me that the purpose of the application to the body whether
of a substance or a process must be the arrest or cure
of disease er diseased condition or the correction of
some malfunction or the amelioriation of some incapacity
or disability"
The claims in question are directed to the treatment of "normally
healthy" meat-producing animals. It is therefore evident that
the substances are not being administered for the treatment of
disease. In this connection, emphasis is placed on the principle
established by the Burton-Parsons case that the main or
primary use must be considered. It is of no importance that
there might be the occasional diseased animal.
...
Either the method for which protection is sought falls within
Section 41(1) as interpreted by decisions such as the
Tennessee-Eastman case and the Burton-Parsons case, or it
does not. It does not matter whether the compound used in
the process is new or old. It is submitted that the Commissioner's
decision in Application 862,758 was correct and is in accordance
with the laws as established by Tennessee Eastman and
Burton Parsons, that no proper basis for distinction exists
on the facts, and that it should be followed.
The issue to be considered is whether claims 46 to 66 which are directed
to a method of increasing the rate of growth of normally healthy meat-
producing animals, using a new substance, are allowable. Other allowable
claims in the application relate to novel compounds and the process of
preparing them. Claim 46, which is illustrative of the refused claims,
reads as follows:
A method of increasing the rate of growth of normally healthy
meat-producing animals which comprise feeding to said animals
a feed composition which includes a growth-promoting amount
of a compound having the formula
(See formula 1)
wherein T is a radical selected from the group consisting of
-CH=CH- and -CH2CH2-; Z is a radical selected from the group
consisting of =C=O, =CH2, and =CHOR; R is selected from the group
consisting of hydrogen, lower alkyl, lower acyclic acyl radicals,
and monocyclic aralkyl radicals containing up to about 10 carbon
atoms; X is selected from the group consisting of hydrogen, -OR
and -OR'; R' is selected from the group consisting of benzoxazolyl,
benzothiazolyl and phenyltetrazolyl; X' is selected from the group
consisting of X and tetrahydropyranyloxy; Y is selected from the
group consisting of hydrogen, amino, nitro and hydroxyl; and
provided that unless at least one of X and X' is selected from the
group consisting of tetrahydropyranyloxy, benzoxazolyloxy, benzo-
thiazolyloxy, and phenyltetrazolyloxy, then at least one of X and
X' is hydrogen.
At the hearing Mr. Watson ably discussed the jurisprudence relating to the
matter before us. He also strongly urged, both in his written and oral
submissions, that he is not claiming a medical treatment. It was conceded
by Mr. Watson that medical treatments are unpatentable (cf. Tennessee Eastman
v Commissioner of Patents 1970 Ex. C.R. as reported in (1970) 62 C.P.R. 117; 1974
S.C.R. 111). The thrust taken by the applicant's argument is that before a
process can be considered medical it must be related to curing or preventing
a disease. He contends that the treatment of normally healthy meat-producing
animals,as claimed, "does not involve a medical treatment in the sense to cure
or prevent disease."
The applicant directed our attention to the allowance in the United Kingdom
of several applications relating to similar subject matter presently before us.
It will suffice, we believe, to say that prior to 1962 in the U.K. any treat-
went of humans or of animals was not considered to be patentable subject
matter. With the findings in N.R.D.C.'s Application (1961) 1 R.P.C. 134
(an Australian decision), Swift's Application (1961) R.P.C. 141 (a New Zealand
decision) and Swift and Company's Application (1962) R.P.C. 37 (a British
decision) however, there has been a change. Distinctions have been made
between processes applied to animals and those applied to humans, and the
scope of what has been considered a medical process has been narrowed. At
that time (1962), however, there was no appeal beyond the Patent Appeal
Tribunal. This was a significant factor in the allowance of the Swift
case (and others that followed), for if it did not proceed no further judicial
review was possible.
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 thera-
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 )
The applicant states (in response to the Final Action) that the substances
"have a physiological effect on the growth pattern [of the animal]...."
Surely this would be considered as having modified the organic function
of the animal, and could appropriately be considered as "a biological
agent" viz. "a medicine." He goes on to say that: "The situation is
therefore undistinguishable from the Swift application which application
the Supreme Court specifically found not to be related to a medical method."
The Swift decision related to a situation where an enzyme was injected
into an animal for the purpose of tenderizing meat. We must remember,
however, that in the Swift decision the action of the animal's body was
purely mechanical and non-metabolic. In any event Mr. Justice Pigeon in
Tennessee Eastman v. Commissioner of Patents (1974 S.C.R. 111 at 120) made
it clear that caution must be exercised in transposing from a United Kingdom
context to Canadian law the conclusions of the Swift and N.R.D.C. decisions.
Mr. Watson 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
substance 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.
We think it is fair to say that the experts in the field are not sure just
why a particular substance, when added to animal food, increases the rate
of growth of the animal. The effect, however, of using an antibiotic in
animal food may be of interest. It was discussed in the book entitled
"Microbiology." (Published by McGraw-Hill Book Co. 1972 - author, Mr. M.J. Pelczar.)
Page 487 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, 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 micro-organisms.Volume 232 starting at line l,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 [Swann]led to the principal
antibiotics for farm animals being placed on veterinary prescription in
Great Britain...."
The above information was brought to the applicant's attention before the
hearing. At the hearing Mr. Watson made it clear that the substance of
this application was not an antibiotic. There is, however, no explanation,
as to what produces the increase in the rate of growth when using the
substance of the instant application.
We are persuaded, however, that the substance modifies the organic functions
of the body. The substance claimed is a hormonal compound which exhibits
extrogenic activity. We are satisfied that it is "a biological agent,"
and, in our view, it is a "medicine" in "the broad meaning"(See the I.C.I.
Decision supra.). Any substance taken orally which effects the
metabolism of the body must, of necessity, be classed as a "food or medicine."
Furthermore, there is no doubt that the substance is produced by a chemical
process. 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.
The applicant argues that he is not offending Section 41 of the Patent Act
because he has claimed the product in process dependent form in other claims
as required by that section.
In Tennessee Eastman v Commissioner, supra, however, Pigeon J., at page 118,
stated:
Section 41 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". 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). (emphasis added )
The applicant referred to a previous decision (on application 862,758)
of this Board relating to "methods of improving the rate growth of animals."
That decision was made prior to the Tennessee Eastman v Commissioner of
Patents (S.C.) decision supra. As a matter of fact it was the rationale of
the Tennessee Eastman decision that predicated the Final Action refusing
the present method of use claims.
The applicant's attention is directed to an article in the 1974 edition
of the "Ottawa Law Review" Vol. 6 entitled: "Industrial Property," which
is of interest. In referring to the above Patent Appeal Board decision on
application 862,758 the writer states at page 475: "It is not clear whether
this decision can stand in view of the Supreme Court decision in Tennessee
Eastman, as this would appear to be a method of using a veterinary food,
which would appear to fall under Section 41 of the Patent Act, if the
Tennessee Eastman argument is followed."
There is one other point.When we consider the large number of compounds
used in the process of claim 46, we find they run to tens if not hundreds
of thousands. While obviously they all possess certain structural similarities,
we are not convinced that so many compounds do in fact promote growth rates
in animals, nor that it can be seriously contended that they do. Undoubtedly
this comes close to the type of overclaiming found objectionable in
Boehringer Sohn v Bell Craig, 1962 Ex. C.R. 201, and elsewhere. Since,
however, there were other grounds for rejecting claim 46, this point need not
be explored further.
In summary, we are satisfied that the present claims are directed to a method
of treatment with a biological agent (hormonal compound), which modifies
the organic functions of the body, and should not, in our view, be claimed as a
process apart from the drug itself. (Vide, Tennessee Eastman v Commissioner,
supra.)
We recommend that the decision in the Final Action refusing claims 46 to 66
"as not falling under Section 2 of the Patent Act" be affirmed.
J.F. Hughes
Assistant Chairman
Patent Appeal Board
I Concur with the findings of the Patent Appeal Board. Accordingly, I
refuse to allow claims 46 to 66. The applicant has six months in which to
cancel claims 46 to 66, or appeal this decision under the provision of
Section 44 of the Patent Act.
J.H.A. Gari‚py
Commissioner of Patents
Dated at Hull, Quebec
this 13th day of August, 1976
Agent for Applicant
Gowling, MacTavish, Osborne
and Henderson,
116 Albert St.
Ottawa, Ontario