Section 41(1): The compound of the application, the role of which is
to eliminate parasites in animal hosts, including destructive and
potentially fatal parasites, is covered by the definition of the term
medicine within the meaning of section 41. Rejection of the petition
affirmed.
This decision deals with Applicant's request for review by the
Commissioner of Patents of the Final Action on application 329,159
(Class 260-479.1). The application, filed June 5, 1979 and assigned
to ROUSSEL UCLAF, is entitled CYCLOPROPANE CARBOXYLIC ACID ESTERS
SUBSTITUTED WITH CYANALCOHOL, THEIR PROCESSES OF MANUFACTURE, THE
PESTICIDE COMPOSITIONS CONTAINING THEM AND THEIR APPLICATION AS A
MEDICINE FOR VETERINARY USE. The inventors are Jacques Martel and
Jean Tessier. The Examiner in charge issued a Final Action on
February 10, 1982.
In her Final Action, the Examiner refused to allow claims 1 to 7 in
the application in view of section 41(1) of the Act, which reads as
follows :
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.
The Examiner stressed that pages 8 to 10 and examples 22 and 23 of the
specification indicate that the compositions disclosed may be used "as
veterinary medicine and administered orally as well as in admixture
with compound animal feeds".
Applicant acknowledges that this assertion is taken from the
disclosure, and that the said disclosure incorporates data covering
the treatment of animals. He firmly maintains, however, that his
compositions should not be subject to the requirements of s. 41(1),
that is, those limiting the application to the process of
manufacture. The Applicant argues that the primary use of his
compounds is not as a veterinary medicine but as an insecticide. He
considers the terms used in chapter 9.02.06 of the Manual of Patent
Office Practice vague. He noted the absence of the term "invasion" in
the aforementioned chapter, and reasons that this situation is
explained by the fact that the use of compounds comparable to those
claimed in the subject application have no effect on an animal's
metabolism. He compares the said compositions to saccharin and other
similar artificial sweeteners which do not qualify as food, and
maintains that the substances claimed do not affect metabolic
behaviour either. Applicant relies on a number of earlier judgments
and previous Commissioner's rulings.
The Board must decide whether claims 1 to 7 are allowable only when
they are dependent on a process, in accordance with the requirements
of s. 41 of the Patent Act, or whether they are allowable in their
present non-restrictive form.
Claim 1 reads as follows:
1. Compounds of formula (I'):
[see original French for formula]
in which n is an integer equal to 1, 2 or 3, the
configuration of the acid copula is (1R, trans) or (1R,
cis), and that of the alcohol copula is (S).
The members of the Board first looked to the Supreme Court of Canada
decision in Parke, Davis & Co. v. Fine Chemicals of Canada Ltd. [1959]
S.C.R. 219, including the passage cited by the Applicant. We have
read Applicant's two observations on this subject and we fail to see
how either the passage cited or the comments thereon can substantiate
his viewpoint on the applicability of s. 41(1). The said passage
deals solely with the applicability of former section 41(3), and it
merely mentions that if the practical value of an invention is to
apply to two sectors, that is, food and medicine on one hand, and a
sector unrelated to food and medicine on the other hand, the invention
is subject to the licensing provisions of section 41 insofar as its
use as food or medicine is concerned. Nowhere in Parke, Davis does
the Supreme Court state that the limitation to process set out in
s. 41(1) does not apply to inventions of this nature.
On the contrary, the judges are silent on this subject. The Board's
interpretation is that the judges' intent was to explain the scope of
the licensing provisions; they even discuss inventions that could well
be viewed as not "relating to substances", which would in itself
exclude them from the operation of s. 41(1). We quote here from
Mr. Justice Rand's observations in this decision, which read in part
as follows:
I agree with Thurlow J. that the word "medicine",
as used in Section 41 of the Act, should be
interpreted broadly...
We shall come back to this later.
As for the two decisions of the Commissioner published in the Patent
Office Record and cited by the Applicant, the Board is not convinced
of their relevance to the instant case. In both these decisions, the
Commissioner assesses the applicability of s. 41(1) in relation to the
intermediate compounds used in a process, that is, compounds having no
medical or therapeutic value. According to the disclosure of the
subject application, the compounds do indeed possess active medical
properties, and there is no doubt that they can be used in the
treatment of animals with no further chemical transformation. We are
not of the view that these Commissioner's rulings substantiate
Applicant's viewpoint because they deal with different issues. While
it is true that in these previous decisions the Commissioner
determined that the sole purpose of the finished products in question
was medicinal, thus making it easier to rule on the issue of the
intermediates used in their preparation, he does not state that their
active compounds are excluded from the operation of s. 41(1) when they
can be used for non-medicinal purposes. Furthermore, in the same two
decisions, the Commissioner found that s. 41 must be interpreted in
its broadest sense, and that subsection (1) should apply to the
intermediates.
Applicant refers to the ruling handed down by the Supreme Court of
Canada in Burton Parsons Inc. v. Hewlett-Packard Ltd. [1976] I S.C.R.
555 to substantiate his claim that not everything administered to the
human body is necessarily a medicine, that a distinction has been made
between the primary and secondary uses of a product, and that this
distinction must be considered in determining the applicability of
subsection (1). In Burton Parsons, the Supreme Court refers to its
judgment in Tennessee Eastman v. Commissioner of Patents [1974]
S.C.R. 111, which reads in part as follows:
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.
The Burton Parsons judgment in no way disturbs this finding, and
states the following at page 570:
It is obviously a matter of some difficulty to
draw the line between what is a medicine and what
is only a product apt to be used in connection
with the treatment of diseases.
In Burton Parsons, the Court ruled that electrode creams could in no
way qualify as medicine, while in Tennessee Eastman, the judges
determined that the use of a method of bonding human tissues
constitutes a medical treatment. Despite its routine use on the skin
of patients, the Court considered that the electrode cream did not act
as a medicine, but merely contributed to the treatment. It is easy to
follow the judges' reasoning. They found that the cream has no known
healing properties, that it does not in itself constitute a treatment,
and that its only role, even in surgery, is to improve electrical
contact with the skin. It can even be considered a component of the
machine to which it serves as an auxiliary. The situation is entirely
different in the instant case. In our view, there is an important
distinction between the invention of a cream which comes in contact
with the skin surface and has electrical but not therapeutic
properties, and the invention of a new medicinal compound which can be
administered to patients as a therapeutic agent. We are persuaded
that, in the present matter, the compound is truly used "in
connection" with a medical treatment when administered to animals.
The administration of the compound represents the treatment, and its
only object is to treat the animal and eliminate parasites. Herein
lies the difference between the subject application and the Burton
Parsons case.
The Board considered the Applicant's argument, which reads in part as
follows:
[translation]
...that section 41(1) was drafted for the purpose of
restricting the legal scope of patents relating to
substances intended solely or primarily for food or
medicine. Section 41(3), on the other hand, was
drafted so as to allow any interested party immediate
access to a licence for products intended not only
specifically for food or medicine but those protected
as such for another purpose and capable of being used
for food or medicine. The fact of allowing an
inventor to obtain product claims per se for chemical
substances intended essentially for a non-medicinal
use but capable of being used for, or in the
preparation of, medicine, in no way renders
section 41(3) of the Act inoperative nor does it erode
the protection Parliament intended to provide to the
public in the highly specific case of inventions
relating to food or medicine.
We do not share this opinion. First, section 41(1) had not yet been
repealed or amended when, in 1969, subsections (3) and (4) governing
the granting of licences were separated so as to distinguish between
a licence covering food and a licence covering medicine, which leads
us to conclude that Parliament recognized the importance of
subsection (1). Furthermore, a licence is not granted on demand as if
it were a right. The Commissioner renders a decision which the
patentee can then contest and appeal. In addition, any such licence
issued creates obligations on the part of the licensee; it is subject
to the terms stipulated and its holder is required to pay a royalty.
This situation, in our view, justifies the significance of
subsection (1). If compounds intended for multiple uses were excluded
from the requirements of subsection (1), the latter would be rendered
virtually inoperative as this would be an easy way of circumventing
the spirit of section 41, as was pointed out in Tennessee-Eastman.
The Board has carefully examined all the other arguments raised by the
Agent for the Applicant in his detailed brief. We do not agree with
his assertion that the expression "or elsewhere" in chapter 9.02.06 of
the Manual of Patent Office Practice lends confusion. Rather, this
expression accurately states Patent Office procedure in the sense that
a compound which has both medicinal and non-medicinal uses is subject
to the restriction set out in subsection (1). As regards the
observations on the case published in the Official Gazette of May 23,
1978, we cannot see how it supports Applicant's viewpoint. The
question of unity of invention does not enter into play in the subject
application. Even if the Applicant had to submit divisional
applications, all these would be subject to the provisions of
subsection (1) owing to the expression "or elsewhere".
The Board does not share Applicant's view that the compounds do not
constitute a medicine even when used to treat animals. Applicant
cites Imperial Chemical Industries Ltd. v. Commissioner of Patents
[1967] 1 Ex. C.R. 57, and the Food and Drug Act. It would appear that
the Applicant interprets the term "medicine" in too narrow a sense.
As we mentioned earlier, we consider that the three Supreme Court
decisions demonstrate that section 41 is to be interpreted without
restrictions. We hold that a compound whose role is to eliminate
animal parasites, including harmful and potentially fatal parasites,
is effectively covered by the definition of the term "medicine" within
the meaning of section 41, whether it be an anti-infective medicine or
a pesticide.
Consequently, the Board is persuaded that claims 1 to 7 are subject to
the provisions of section 41(1), and that they cannot be allowed
unless the Applicant excludes them from the allowable claims on the
process. We recommend that the Final Action rejecting claims 1 to 7
be affirmed.
(signed) (signed)
M.G. Brown S.D. Kot
Acting Chairman Member
Patent Appeal Board
I have reviewed the findings and recommendations of the Patent Appeal
Board and I concur with them. Accordingly, I refuse to grant a patent
containing claims 1 to 7. The Applicant has six months within which
to appeal this decision under the provisions of section 44 of the
Patent Act.
(signed)
J.H.A. Gari‚py
Commissioner of Patents
Hull, Quebec
August 15, 1986