COMMISSIONER'S DECISION
SECTION 41(1): Includes Intermediates "Intended for Medicine"
Section 41(1) applies to chemical substances not themselves medicin-
ally or nutritionally active, where their intended use is conversion
into medicines or foods, but not if the intended use is otherwise.
That the subsection refers to substances "intended for medicine", is
taken as meaning more than if it referred simply to "medicines".
FINAL ACTION: Affirmed.
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Under Section 46(5) of the Patent Rules, the applicant has re-
quested a review of the examiner's Final Action of August 30,
1973, rejecting certain claims in patent application 946,848
(Class 260/235.2). The application was filed on Dec. 2, 1965
and has the title "6-Aminopenicillanic Acid Esters". The invent-
ors are Arthur A. Patchett et al. The Patent Appeal Board
conducted a hearing on the rejection on May 1, 1974, at which
Mr. Roger Goudreau represented the applicant, Merck & Co., Inc.
The examiner has rejected claims 1 to 6 for failure to comply
with the requirements of Section 41 of the Patent Act. These
claims cover certain new esters of 6-aminopenicillanic aid of
the general formula:
(see formula 1)
where R represents various substituents. The exact chemical
structure of these compounds is immaterial to the issues involved.
Suffice it to say that these new compounds are intermediates
which can be converted into novel penicillin compounds that possess
antibacterial activity against microorganisms. According to the
applicant the intermediates themselves are not medicines.
In conformity with directives of the Patent Office to its examining
staff (Patent Office Record, Aug. 29, 1972, p.viii and Section
9.02.03 of the Manual of Patent Office Practice) the examiner re-
jected the product claims because the claims do not include a
restriction to the process by which they are manufactured, such as
would be necessary if the compounds come within the ambit of
Section 41(1) of the Patent Act. The point to be decided by the
Board is whether Section 41(1) is applicable. It is agreed, at least
for the purposes of this appeal that the intermediates are not
medicines, and that they are made by chemical processes. What must
be determined, however, is whether they are "substances intended
for medicine".
In the final action it was stated:
... any process (involving several steps is) a unitary
concept, regardless of the number of individual
operations. This is consistent with the manner in
which most research programs are evolved: when a
scientist undertakes to synthesize a drug his inten-
tions concern the medical field from the beginning.
And later, when a patent application results, the very
patentability of the products will rest precisely
on the intended use disclosed. The intention is
therefore an essential, sine qua non, condition and
this intention is directed to the medicinal field
exclusively.
The application of the process limitations to inter-
mediates is therefore consistent with the wording of
Section 41(1). It is also in line with the spirit
of the Section of, inter alia,loosening the bind
created by the existence of a patent, since an unrestrict-
ed monopoly at one point in a sequence may effectively
block the complete sequence.
Applicants have invoked the difference in wording between
subsection 1 and 4 of Section 41 in support of their
position and they appear to believe that the language "capable
of being used in the preparation of medicine" in subsection
4 covers the intermediates, whereas the absence of such
language in subsection 1 excludes intermediates. This is
not necessarily the case: in fact it is equally logical
that "intended for medicine" includes intermediates in
both sub-sections and then, the inventions "capable of being
used in the preparation of medicine" in subsection 4 are
"processes" since without doubt, processes were intended
to be subject to licensing.
In his response of February 12, 1973, the applicant argued that:
... The position that the expression "intended for medicine"
includes intermediates is believed to be illogical and un-
founded. It is submitted that intermediates are not intended
for medicine but are inventions intended for the preparation
of medicine or in some cases capable of being used in the
preparation of medicine. It is submitted that the expression
"intended for medicine" is really equivalent to the expression
"useful as medicine".
and It has been well established by the Courts that the
scopes of Sub-section 1 and Sub-section 4 were different.
While Sub-section 1 is concerned mainly with one class
of inventions, i.e. substances prepared by a chemical
process and intended for food or medicine, Sub-section 4
includes three other classes and eliminates the restriction
of the preparation by a chemical process. The various
groups of inventions governed by Sub-section 4 are as follows:
a) Inventions intended for medicine
b) Inventions capable of being used as medicine
c) Inventions intended for the preparation of
medicine; and
d) Inventions capable of being used in the preparation
of medicine.
In order to illustrate the type of inventions which are covered
by Section 41(4) the applicant would like to submit the
following examples:
Inventions Intended for Medicine:
In this group it is submitted that two types of inventions
are concerned. First there are the inventions which are
medicines but not prepared by a chemical process, for example
an invention relating to a mixture of pharmaceutical products,
and secondly, inventions prepared by a chemical process
yielding a medicine, for example antibiotics, dieretics, etc.
It is submitted it is only this type of invention which can
be intended for medicine.
Inventions Capable of Being Used for Medicine:
This type of invention would be represented by the discovery
that a compound, capable of an industrial application, had also
been found to be capable of being used for medicine. For
example, a dye which, when discovered, was intended to be used
as a colouring agent, may subsequently become an invention
capable of being used as an antibacterial agent.
Inventions Intended for the Preparation of Medicine:
In this group one will find inventions relating to alternate
processes for preparing known drugs and one will also find
inventions relating to intermediates whose only known utility
is in the preparation of medicine.
Inventions Capable of Being Used in the Preparation of Medicine:
It is submitted that before an invention can be capable of being
used for the preparation of medicine it must be capable of doing
something else, otherwise such an invention would not be
capable of but be only intended for the preparation of medicine.
Such an invention would include, for example, a patented process
used in general chemistry but which could under certain con-
ditions be used for the preparation of medicine. It could also be
for a produce which has already an industrial use b®t which could
be a useful intermediate in the preparation of a medicine and
finally it could even be for a machine having other industrial
applications but for which there would be an application in the
preparation of medicine.
It is again submitted that the expression "intended for
medicine" as used in Section 41(1) and as used in Section
41(4) is identical but it cannot be interpreted as in-
cluding other expressions such as "intended for the prepara-
tion of medicine", otherwise to argue that these two
expressions are equivalent would be saying that in fact
Parliament has used two different expressions to express the
same intention. This point was clearly stated in the case of
Charles E. Frosst & Co. vs Carter Products, 18 Fox Patent Cases
at page 60, where the former Commissioner stated clearly as
follows:
"Furthermore, if Section 41(3) had been intended
to apply only to patents coming under the ambit of
Section 41(1) there would have been no point in
using different language or in adding the word
"any" before the word "patent". Parliament does not
usually use different wording to express the same
intention".
There are many other decisions where the Courts or the Patent
Office have held that there is a difference in scope between
Sections 41(1) and 41(3). For example, in the case of
Parke Davis vs Fine Chemical of Canada, 18 Fox Patent Cases,
page 133, Martland J. indicated as follows:
"It seems to me that Section 41 must be construed as
a whole. Sub-section 1 applies to inventions relating to
substances prepared or produced by chemical processes
and intended for food or medicine. Sub-section 3 goes
somewhat further and also applies to any patent for an
invention capable of being used for the preparation of
food or medicine." (Underlining ours)
As can be appreciated, a clear-cut distinction has been made
between intended for medicine and capable of being used for
the preparation of medicine and again it is submitted that an
intermediate is not intended for medicine but is only, at the
most, capable of being used for the preparation of medicine.
In other words, it is the conversion of an intermediate to a
medicine which constitutes an invention intended for medicine,
while the conversion of a starting material to a new intermediate
useful in the preparation of medicine can only be an invention
intended for the preparation of medicine.
and
That the scope of Section 41(1) and Section 41(4) are not the
same even as far as the expression "intended for medicine" is
also to be drawn from the language used in the French part of
these two sub-sections. The Patent Office' attention is drawn
to Sub-section 1, where the claims of the invention are defined
as those "destin‚es … la medication", while Sub-section 4 refer, to
"une invention destin‚e … des m‚dicaments"
ou
"une invention destin‚e … la preparation de
m‚dicaments"
ou
"une invention susceptible d'ˆtre utilis‚e …
de telles fins", (c.a.d.… des m‚dicaments ou
a la preparation de m‚dicaments)".
It is submitted that the expression "destinee … la
medication" can in no way be interpreted to include "une
invention destin‚e … la pr‚paration de m‚dicaments" which
is the case of an intermediate. In French the verb "destiner"
means to have a use determined in advance (fixer d'avance
pour ˆtre employer a un usage). On the other hand, "m‚dication"
means, in French, "emploi systematique d'agents m‚dicinaux
dans une intention pr‚cise".
Section 41(1) requires that "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." Since the invention relates to a sub-
stance produced by a chemical process, what we must consider is
whether these intermediates are "intended for food or medicine".
Section 41 is derived from Section 38A of the British Patents and
Design of 1919. There are differences between the corresponding British
and Canadian sections and care must be exercised in correlating the two
(vide Commissioner of Patents v Winthrop Chemical Co.,1948 S.C.R. 46).
Nevertheless it is of assistance to look to British jurisprudence
interpreting those parts of the legislation which are in fact similar.
In the matter of application for Patents by W et al, 39 RPC 263,
(1922), it was held that the expression "intended for food" is not
confined to foods so as to exclude inventions which are to become foods,
or substances which are used in and to advance the preparation or
production of food. (We are of course concerned with medicines, but the
principle is analogous.) To quote from the decision:
Turning back to sub-section (1), I cannot accept the
argument that it covers foods only, and not subjects of
inventions which are to become foods, or substances which
are used only in, and to advance, the preparation or pro-
duction of food. "Intended for food" are the word; used -
a phrase to my mind of very wide significance. Very few
substances that are within the section need no further
preparation before they are to be consumed as food. Indeed I think
it was conceded that mere cooking would not prevent a substance
being a food within sub-section (1); but, if one mode is
permissible, why not others? In my judgement, therefore, all
substances fall within sub-section (1) and are "intended for fool
or medicine" whether they are completely ready for
consumption or can be rendered ready by various opera-
tions, or are to be used in the preparation or production
of the article so to make it ready for consumption.
"Intended for food or medicine" means to be used, not
necessarily immediately and as they are, but after due
preparation - to be used when the intention has ultimately
been carried into effect, by the preparation be it by
cooking, mixing or other preliminary steps, which lead
up to effecting their ultimate purpose, namely, user (sic)
as food.
While there are phrases in the above passage which imply "intended
for medicine" is to be interpreted broadly, the facts of the case
(the substance was a dough to be made into bread) and other phrases
could be taken to suggest that the decision goes no further than to
cover materials which, while they require further preparation to
become foods or medicines, are still foods in an elementary form,
much as it was found in Parke-Davis v Fine Chemicals (1957)
Ex. C.R. 300 at 307 and (1959) S.C.R., 219 that substances in bulk
form are nevertheless medicines even though they required further
modification of a simple nature to adapt them to the dosage form
in which they are administered. This conceivably, however, might
exclude chemical intermediates which require a molecular change
before they are converted into the compounds possessing therapeutic
properties and which are those actually used as medicines.
In the matter of an Application for Patent by E.M., 41 RPC 590
(1924) the matter was explored further. Claims for baking powder
which is used in the making of bread were held to be within the
ambit of Section 38. This then makes it apparent that substances
'intended for food' are not restricted to elementary forms of food,
but extends to other substances "... to be used in the preparation
or production of (an) article of food..."
The Canadian Courts have also given a broad interpretation to
"medicine". See, for example, Tennessee Eastman v. Commissioner
of Patents, S.C.R. Dec. 22, 1972, p.8, Imperial Chemical Industries
v. Commissioner of Patents (1961) 1 Ex. C.R. 57, and Parke, Davis v.
Fine Chemicals (supra at 226.
An important submission made by the applicant hinges upon the
differences in the language used in Section 41(1), 4(3), and
41(4) of the Act. These are tabulated below.
41(1) - intended for food or medicine
41(3) - intended or capable of being used for the
preparation of food.
41(4) - intended or capable of being used for medicine
or the preparation or production of medicine
It is his submission that the latter two subsections reflect a differ-
ence between substances which are themselves medicines, and others
which are intended for being used to prepare medicine. To quote from
his response:
"...a clear-cut distinction has been made between intended
for medicine and capable of being used for the preparation
of medicine..."
It must be remembered, however, that there are other differences,
in wording between subsections 41(3) & (4) and subsection 41(1).,
The former deal with "inventions" broadly, while the latter (41-1)
deals with inventions which are substances. This explains the state-
ment made in Parke Davis v Fine Chemicals (supra) at 327, and quoted
by the applicant, that 41(3) goes somewhat further than 41(1). Sec-
tions 41(3) & (4) would cover, for example, a mechanical blender
intended for the preparation of a medicine or capable of being used
for the preparation of medicine. They are not restricted to "substances,"
as is 41(1). While we fully agree with the applicant that the
subsections are of different scope, we do not see that the results
flowing from those differences are those which he has ascribed to them.
The applicant pointed out that these intermediates are not medicines.
Since the examiner did not contend that they were, and since we are
only concerned with whether the intemediates are "intended for
medicines (as distinct from "being" medicines), we need not consider
that point further.
The applicant has advanced another interesting argument based upon
the French text of the Patent Act, which of course is as equally
authoritive as the English version. It is his contention that the
phrase "destin‚es … la medication" in 41(1) can in no way be inter-
preted to include "une invention destin‚e … la preparation de
medicaments." As in the case of the English text, however, we
must recognize that in 41(1) we are concerned with "substances...
destin‚es … la medication" while in 41(3) & (4) we are concerned
with "une invention destin‚e … la preparation de m‚dicaments. Con-
sequently we can draw the same distinctions between the subsections
as that which has already been made in considering the English text.
The compounds claimed in the application are precursors for the
preparation of medicinal substances, i.e. certain novel penicillins.
By chemical conversion they are made into such medicinal substances.
The decision of both the Canadian and British Courts suggest that
"medicine" and "intended for medicine" should be given broad inter-
pretations, and on that basis we conclude that intermediates whose
only utility is for conversion into medicines should be considered
as "intended for medicine". Whether it would also apply to chemical
substances whose intended use is non-medicinal but which may also
be capable of being used to prepare medicines within the meaning of
Parke, Davis v Fine Chemicals (supra 219 at 227 we need not determine
here. if the disclosure is to be believed (page 1 and example 8) these
intermediates provide a route to make certain previously unknown
penicillins which are active against microorganism resistant to
previously known penicillins. To grant per se protection to these
intermediates would preclude others from developing alternate procedures
for making the intermediates and manufacturing the new penicillins from
such intermediates without being obliged to obtain a license, whether
voluntary or compulsory, from this applicant. In that sense,
and to that extent, a per se claim would effectively block the
way to manufacture the new penicillins.
If it had been meant that Section 41(1) applied only to substances
which are themselves medicines, we believe the subsection would
have read "substances prepared or produced by chemical processes
which are foods and medicines." The fact that the expression "in-
tended for food or medicine" was used suggests instead that something
more was meant.
The Board is of the opinion that the rejection made under Section 41
should be affirmed.
G.A. Asher
Chairman, Patent Appeal Board
I concur with the findings of the Patent Appeal Board. Claims 1 to
6 in their present form are refused. The applicant has six months
to amend the claims as required by the Examiner, or to appeal this
decision under the provisions of Section 44 of the Patent Act.
Decision accordingly,
A.M. Laidlaw,
Commissioner of Patents
Dated at Hull, Quebec
this 5th day of June,
1974.
Agent for Applicant
Goudreau, Gage & Associates