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 23,
1973, rejecting certain claims in patent application 965,900
(Class 260/235.2). The application was filed on July 20, 1966
giving Lee C. Cheney et al as inventors, with the title "Preparation
of 6-Aminopenicillanic Acid Esters ". The Patent Appeal Board
held a hearing on the rejection on April 10, 1974, at which
Mr. David Watson, Q.C. and Mr. E.J. McKhool represented the
applicant, the Bristol-Myers Company.
The examiner has rejected claims 21 to 30 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 I)
where W and Z represent certain defined radicals. 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 penicillin compounds that are therapeutically
active, though the intermediates themselves are not therapeutically
active. The new compounds provide an alternate and in some ways a
better route to manufacture both previously known and new therapeutically
active penicillins.
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 rejected
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 at issue to be
determined by the Board is whether Section 41(1) is applicable
or not.
The reason advanced in the final action for the rejection was
that it is
... incorrect to regard the medicinals proper as the
only substances which are "intended for medicine".
When a multi-step synthesis is devised the inten-
tion throughout is really directed to chemotherapy
and does not begin with the last substance. There-
fore all substances participating in the synthesis
of a drug are truly "intended for medicine" and
the claims would properly be rejected for lack of
utility in the absense of a statement of such
intention.
In consequence, it has been decided that, as the only
possible interpretation of the words and spirit of
Section 41(1), substances whose only disclosed
utility resides in the synthesis of drugs are "intended
for medicine" and subject to process limitations.
and
... with the development of synthetic methods involving
a number of steps the grant of an unrestricted monopoly
on any of the substances involved in the synthesis
creates a virtual monopoly on the whole processes and
ultimately on the final product. This is a breach of
the intent of the Section.
In his own response of November 21, 1973, the principal points
made in reply by the applicant were:
Applicant wishes to point out that the intermediates
with which we are concerned in this case do not them-
selves have therapeutic activity and are not themselves
intended for medicine. The intermediates involved here
may be unacceptable from a pharmaceutical point of view
or may be lacking in pharmaceutical utility.
It will be clear that a number of possible routes are
available under modern technology for the preparation
of therapeutic products. An intermediate involved in
the preparation of a pharmaceutical compound by one
route does not necessarily prevent other routes using
different intermediates from being developed by sub-
sequent research.
It has been the policy of the Patent Office for many years
dating back to the inception of the section to regard
intermediates of the type claimed in this case as being
outside the scope of Section 41(1) and the position now
taken by the Examiner represents a change in a long-
standing policy of the Patent Office. In spite of such long-
standing practice and the occurrence of legislative amend-
ments to the other parts of Section 41, there has been no
legislative change to the wording of Section 41(1).
The Commissioner of Patents has issued numerous compulsory
licences purporting to be authorized by Section 41(4) with
respect to patents containing product claims covering
intermediates.
The Examiner has in his argument relied heavily on the
policy of Section 41 and on the influence of technological
advances in chemistry to justify what he refers to as "a
re-assessment of the interpretation of Section 41(1)" as
seen in the third paragraph of his letter. It is submitted
on the contrary that the policy of the section and the
effect of the advances in technology are an important consider-
ation in applicant's favour. It is further submitted that
what the Examiner refers to as a re-assessment is in fact
an amendment to the section.
The Section 41(1) of the Act which is involved here was
derived from a British Statute which has long since been
repealed. It would be desirable if the Canadian section
were also repealed. However,in the absence of such a repeal
it is submitted that the sections should certainly not be
construed broadly,in order to carry out some undefined
"spirit of Section 41(1)".
It is submitted that under modern technology a number of
possible routes are available for the preparation of a
therapeutic product. Accordingly, patent protection for an
intermediate of the type claimed in this case is even less
likely than in the days of simpler technology to provide in
effect a domination of the final therapeutic substance.
and
It is not seen how the number of steps in the process has
any bearing on the patentability of individual steps in the
process, and in the nature of the grant which is permitted
by the Patent Act. Indeed it appears to applicant that with
the development of synthetic methods involving a number of
steps it becomes less and less possible to obtain an unrestrict-
ed monopoly on the production of the final pharmaceutical com-
pound by blocking one of the multiple paths available to a
manufacturer.
It is submitted that the Examiner's extension of the section
to substances which are not themselves intended for medicine
is an amendment of Section 41(1) and that the extension of
the scope of this section so as to discourage product
invention should not be made at this late state by distorting
tile wording of the Statute and reading the Statute as if it
included words which are not there. The Examiner's view
would be applicable if the Statute applied to "sub-
stances intended for medicine or for the preparation
or production of medicine". This is not however, how
Section 41(1) of the Patent Act reads: That is how
Section 41(4) of the Patent Act reads on the other hand.
It seems likely that the difference in wording between Sections
41(1) and 41(4) is intended to convey some significance,
and this difference has been appreciated in the past by the
Commissioner and by our courts. If the legislature had
intended to expand Section 41(1) to apply to intermediates
it would have been simply enough to have provided this in
sub-Section (1). The Examiner states that the grant of an
unrestricted monopoly on a substance involved in the synthesis of
a pharmaceutical compound creates a virtual monopoly on the
whole process and that this is a breach of the intent of the
Section. Even if this were so, which is denied, it is up to
the legislature to make the necessary amendments to Section
41(1) of the Patent Act. The Patent Office should apply this
section as it stands and as it has been understood by the
Patent Office and by the courts for many years, and not apply
it as if it had been amended in accordance with the Examiner's
conceptive of desirable policy. The Patent Office must also
consider carefully the effect of this serious change in
practice, and must not proceed as though it were interpreting
a new provision of the Statute, which had not previously
been considered by the court.
If the Patent Office feels that it is serving some social
purpose in limiting a monopoly granted to pharmaceutical
manufacturers for their new discoveries, this is believed
to be unnecessary under the present state of the law. The
mere fact that a patent is granted for a pharmaceutical
compound does not confer any absolute monopoly of any kind
on the patentee, in view of the provisions of Section 41(4) of
the Patent Act. On the contrary, the willingness of the
Commissioner of Patents to grant licences under Section 41(4)
of the Patent Act renders the limitation of Section 41(1) of
the Patent Act even more anachronistic, redundant, and academic
than would otherwise be the case, in the absence of Section 41(4).
As mentioned above, Section 41(1) is believed to be anachronistic
in its intent in any case.
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
substance produced by a chemical process, what we must consider is
whether these intermediates are "intended for food or medicine".
As was brought out at the hearing, 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 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 words 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 food or medicine" whether they are
completely ready for consumption or can be rendered ready
by various operations, 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 more in-
volved reaction and 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 all substances "...to be used in the preparation
or production of (an) article of food..."
The Canadian Courts have also considered that a broad interpretation
should be given 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,
or Parke, Davis v Fine Chemicals supra at 226.
A principal argument developed by the applicant hinges upon the
differences in the language used in Section 41(1), 41(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
Le demandeur pretend que l'addition des mots "ou susceptible d'ˆtre utilis‚e …
de telles fins" dans les deux derniers paragraphes reflŠte une diff‚rence entre
les substances qui sont d‚j… des m‚dicaments et les autres, qui sont susceptibles
de servir … la preparation de m‚dicaments. Voici un extrait de son m‚moire … la
commission:
La diff‚rence dans l'‚nonc‚ des paragraphes 41(1) et 41(3)
ou (4) indique qu'il y a une distinction entre les
substances destin‚es … la m‚dication et celles susceptibles
d'ˆtre utilis‚es … la preparation ou … la production de
m‚dicaments".
Il faut toutefois se rappeler que les paragraphes 41(3) et (4) diffŠrent du
paragraphs 41(1) sous un autre aspect important. Ils portent sur des "inventions"
en g‚n‚ral, alors que le paragraphs 41(1) ports sur des inventions qui sort des
substances. Ce qui explique l'argument avanc‚ dans Parke, Davis c. Fine Chemi-
cals (327), voulant que le paragraphs 41(3) aille un peu plus loin que le para-
graphs 41(1). Les paragraphes 41(3) et (4) pourraient par exemple couvrir un
m‚langeur m‚canique pouvant servir … la preparation des m‚dicaments. Ils ne se
restreignent pas aux "substances" comme c'est le cas pour 41(1). Nous sommes
parfaitement d'accord avec le demandeur que les deux phrases ont une port‚e
diff‚rente, mais nous ne croyons pas que la diff‚rence soit cells qu'il leur
attribue.
Le demandeur fait longuement valoir que ces interm‚diaires ne sont pas des
m‚dicaments. Etant donn‚ que l'examinateur n'a pas pr‚tendu qu'ils l'‚taient et
que noun noun pr‚occupons seulement de savoir si les interm‚diaires sont
"destin‚s" … la medication (et non s'ils sont des m‚dicaments), il n'est pas
n‚cessaire de nous attarder plus longtemps sur ce point.
Le demandeur soutient ‚galement que l'examinateur pretend que toutes les
substances entrant dans la synthŠse d'une drogue sont destine‚s … la medication.
Avec une tells interpr‚tation, toutes les substances du genre seraient r‚gies
par l'article 41 (si elles sont fabriqu‚es par des proc‚d‚s chimiques). A
l'examen du rapport de l'examinateur, noun pouvons constater qu'il ne s'applique
qu'aux substances elles-mˆme converties en m‚dicaments, c'est-…-dire les inter-
m‚diaires chimiques. De toute fa‡on, nous estimons que cela ne devrait pas aller
au del… des substances chimiques qui, une foil converties, deviennent des
m‚dicaments.
As for the extensive submissions respecting the "spirit and intent"
and the "policy" of Section 41 we do not believe it necessary to
go into them in detail. We need only consider the wording of
the statute itself, and in particular the phrase "intended for medicine."
Nor need we consider whether, as suggested by the applicant, the sub-
section as a whole is anachronistic. Since it exists in the
legislation, it is tire responsibility of the examiner to apply it.
Admittedly it was at one time the policy of the Patent Office to regard
intermediates as being outside the scope of Section 41. If, however,
that policy was inconsistant with a proper legal interpretation of
the Act, then it should be corrected. Policy is not a matter for
stare decisis, and should be corrected if found improper.
The compounds claimed in the application are precursors for the
preparation of medicinal substances, i.e. penicillins. By acylation
and hydrolysis they are converted into such medicinal substances.
The decision of both the Canadian and British Courts suggest that
Section 41 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 cap-
able 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 (p.1) these intermediates
provide the only commercial route to make certain previously known
penicillins, and the only known route to make other penicillins.
To grant per se protection to the intermediates would preclude others
from developing alternate procedures for making the intermediates
and manufacturing the penicillin without being obliged to obtain a
license, whether voluntary or compulsory, from this applicant, if
they wish to manufacture the penicillins themselves. In that sense,
a per se claim would effectively (if not completely) block the way
to manufacture important penicillin products.
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 "intended for food
or medicine" was used instead clearly suggests that soothing more
is involved.
Having explored this problem at length, and examined all the arguments
raised by the applicant, we recommend that the rejection made under
Section 41 be confirmed.
G.A.Asher
Chairman, Patent Appeal Board
I concur with the findings of the Patent Appeal Board. Claims 21 to
30, 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.
Decision accordingly,
A.M.Laidlaw,
Commissioner of Patents.
Dated at Hull, Quebec
This 31st. day of May
1974.
Agent for Applicant
Gowling & Henderson