COMMISSIONER'S DECISION
NON-STATUTORY SECTIONS 2 & 41: Medical Treatment In "Strict Sense".
Treatment of animals including humans using a substance within
the judicial meaning of "medicine" under Section 41(1) is not
claimable as an invention under the Act. No distinction is made
between medical treatment of humans and animals which would tend
to overbear the implications of Section 41. A substance intended
for medicinal or surgical purpose is clearly an invention in the
field of "practical application", whether or not apposite to use
in "trade or commerce".
FINAL ACTION: Affirmed.
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This decision deals with a request for review by the Commissioner
of Patents of the Examiner's Final Action dated May 30, 1972 on
application 950,330, Cl. 167 - Sub. Cl. 265. The application
was filed on January 20, 1966 in the name of Paul A. Barrett
and is entitled "Veterinary Pharmaceutical Formulations And
Method of Treatment of Animals".
This application relates to a pharmaceutical composition and to
a method of treating animals (excluding humans) with the composition.
Only the method of "treating animals" is under consideration in
the Final Action.
In the prosecution terminated by the Final Action the examiner
refused claims 6 and 7 for reasons that a method of medical
treatment, even if applied to animals does not constitute patentable
subject matter under Section 2 of the Patent Act.
In the Final Action the examiner stated (in part):
The rejection of claims 6 and 7 is maintained and the reasons
for such rejection is that a method of medical treatment even
if applied to sick animals does not constitute patentable
subject matter under Section 2(d) of the Patent Act, since
a medical treatment does not constitute a new manufacturing
process and does not result in a new and different commercial
product. Furthermore it is up to a practitioner of medicine
in general, or verterinary medicine, to detect and decide
if the ailing animal is suffering from anaplasmosis and
then decide accordingly, which of the ways and methods
for treatment available to him is the best recommended
in any particular case at hand.
The applicant in his response, dated November 29, 1972 to the
Final Action, removed objectionable claims 6 and 7, and requested
allowance of the application.
On December 7, 1972 the applicant added claims 15 and 16. These
claims are the same as rejected claims 6 and 7, except they
excluded humans from the treatment. The applicant presented no
arguments to support his contention that claims 15 and 16 were
allowable, however, this was Patent Office policy at that time.
Essentially the alleged invention is the application of a
composition, comprising an effective amount of a physiologically
active agent and an acceptable carrier, to animals (excluding
humans). It is the use or application of this composition which
was refused in the Final Action, because it is "a method of
medical treatment."
The question to be decided is whether a new use of the new composition
of claim 1, for medical purposes, may be claimed as an invention.
Claim 1, which was not refused in the Final Action, reads:
A veterinary pharmaceutical formulation which contains a
compound of formula (I)
(see formula I)
wherein R is a hydrogen atom or a benzyl group or an alkyl or
hydroxyalkyl group of 1 to 4 carbon atoms and X is a hydrogen
atom or a methyl, ethyl or methoxymethyl group together with
a carrier therefor.
Amended claim 15, filed pursuant to the Final Action, relates to "a
method of using the composition of claim 1," and reads:
A method of treating animals, excluding humans, suffering from
anaplasmosis which comprises the administration of a compound
of formula (I) as defined in claim 1 to the infected animal.
A point of interest is that on October 6, 1972 the Commissioner of
Patents issued a decision in which a method of medical treatment of
animals excluding humans was allowed. This decision was based on
the consideration of what appeared as the state of the law at that
time, with reference to the Exchequer Court decision in Tennessee
Eastman Co. v. The Commissioner of Patents (1970) 62 CPR 117 wherein
Kerr J. after an exhaustive review of authorities stated:
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 profession-
al 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 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 of process within the
meaning of subsection (d) of section 2 of the Patent Act.
(emphasis added).
This decision relates to "a new use for esters of a-cyanoacrylic
acid and more particularly to a surgical method of joining tissue
surfaces through the use of such esters as adhesives," which was
appealed to the Supreme Court. It is the S.C.C. decision which is
the basis for the present Final Action.
Of importance, therefore, in this determination is the rationale of
the Supreme Court in Tennessee Eastman v. Commissioner of Patents
(1973) 8 C.P.R. 202 at pages 206 and 207, wherein Pigeon J. stated:
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 adminis-
stration 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)
Also of interest is the reference by the S.C.C. in Tennessee Eastman
v. Commissioner of Patents, supra, to the Schering AG's application
1971 RPC 337, a decision dealing with a method of contraception, citing
the conclusion of the Patent Appeal tribunal at page 345 as follows:
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 judgement, be allowed to
proceed.... (Emphasis added by the Court)
Accordingly, it is clear firstly, that a new use for surgical or
medical purposes of a "known" substance is an art or process within
the meaning of Section 2 since it has a practical application, and
secondly that the medical or surgical use of a "new" drug governed
by Section 41(1) cannot be claimed as a separate invention from
the drug itself. However, in either situation it may be deduced
that claims for "medical treatment in the strict sense" are
excluded from protection under the Patent Act.
The specific question which must be decided is whether the
application of the composition of claim 1 to animals (excluding
humans) constitutes "medical treatment" within the meaning of
Tennessee Eastman v. Commissioner, supra.
In Imperial Chemical Industries Ltd. v. Commissioner of Patents
(1967) 51 C.P.R. 102 at pages 105-119, there was a lengthy
discussion about the meaning of "medicine" as used in Section
41(1) of deciding whether an anaesthetic is a substance for use
as a medicine. The Exchequer Court decided at page 105 that the
term "medicine" should be interpreted in its ordinary sense. In
reaching that conclusion it considered a number of dictionary
definitions (found at pages 108-119). In general, it is noted
that "medicine" is defined as "a substance used for the treat-
ment or prevention of disease." The court held that "Halothane"
which is an "inhalation anaesthetic," is a substance intended
for "medicine" within the meaning of Section 41 of the Patent
Act. The British Medical Dictionary defines a "drug" as "any
chemical substance, synthetic or extracted from plant or animal
tissue and of known or unknown composition, which is used as
a medicament to prevent or cure disease."
But in Tennessee Eastman v. Commissioner (S.C.C.), supra, Pigeon
J. at pages 208-209 indicates a limitation to the breadth of the
definition of medicine. He referred with approval to the Schering
decision, which held that "a method of contraception involving
the use of a drug" is not a "medical treatment in the strict sense."
Pigeon J. also referred to the Swifts and Company's application
(1962 R.P.C. 37) and National Research Development Corporations'
application (1961 R.P.C. 134) cases as being exceptions to methods
of treatment in general. Swift's application dealt with a method
of tenderizing meat by injecting enzymes into the animal before
slaughtering. The N.R.D.C.'s application covered a method of
eradicating weeds.
Therefore, considering the full import of the meaning of "medicine"
as brought out above, the use to which the applicants puts the
composition should, in our view, be considered a "medical treatment
in the strict sense," as contemplated by the S.C.C. in Tennessee
Eastman v. Commissioner, supra.
The last determination we must make is whether medical treatments
as defined by the Supreme Court in Tennessee Eastman v. Commissioner
of Patents, supra, include the treatment of animals as well as humans.
As previously mentioned the Exchequer Court in Tennessee Eastman
Co. v. Commissioner of Patents, supra, recognized a difference
between methods applied to humans and those to animals. It concluded
that treatment of humans does not produce a result related to trade
or commerce. Particular emphasis was placed on trade and commerce
and the admission of the existence of two possible entities, namely
medical treatment relating to humans and medical treatment relating
to animals.
In the Supreme Court, however, Pigeon J. made no specific mention
of trade and commerce, but (at page 206) concluded that the
alleged invention "...is clearly in the field of practical applica-
tion. In fact, as the record shows, the "invention" essentially
consists in the discovery that a known adhesive substance is
adaptable to surgical use." Pigeon J. further made no distinction
between animals and humans when, at page 206, he stated: "It is
clear that a new substance that is useful in the medical or
surgical treatment of humans or of animals is an invention," and
further that "The sole question is therefore whether a new use
for surgical purposes of a known substance can be claimed as an
invention.... I do not think so, and it appears to me that
Section 41 definitely indicates that it is not so."
If Section 41 of the Patent Act is intended to cover "foods and
medicines" in relation to both humans and animals (See American
Home Products v. Commissioner of Patents Supreme Court of Ontario,
Dec. 18, 1969), it follows then that no distinction is to be
made between medical treatments for humans and those for animals
which would tend to overbear the implications of Section 41 of
the Patent Act.
In the circumstances, therefore, the Board is satisfied that
"medical treatment in the strict sense" whether applied to humans
or to animals, cannot be claimed as an invention under the
provisions of the Patent Act.
The Board therefore recommends that the decision of the Examiner
to refuse claims to "medical treatment" be affirmed.
J.F.Hughes,
Assistant Chairman,
Patent Appeal Board.
I concur with the findings of the Patent Appeal Board. Accordingly,
I refuse to grant a patent on the subject matter of amended claims
15 and 16. The applicant has six months within which to appeal
this decision under the provision of Section 44 of the Patent Act.
Decision accordingly,
A.M. Laidlaw,
Commissioner of Patents.
Signed and dated in
Hull, Quebec this
22nd day of May, 1974
Agent for Applicant
Alan Swabey & Co.