COMMISSIONER'S DECISION
SECTION 41 & 36: Anti-arthritic Steroids
The applicant's invention related to a microbiological process to
make certain steroids, followed by extraction with chemicals to
obtain the medically useful form of the product. His claims to the
final product satisfied Section 41, but he also claimed the intermediate
or unpurified product in per se form. The intermediate product was held
to be intended for medicine, to be made by a chemical process, and as
failing to define the invention made. Certain process claims were
refused for failing to define the invention adequately, and as broader
than the invention disclosed.
FINAL ACTION: Affirmed
The Final Rejection of two applications for patent assigned to
Merck & Co. Inc. were referred to the Patent Appeal Board for
consideration. The applications were 154365 (Class 260/69), for
16-Methyl-1, 4-Pregnadiene-17~-o1-3, 20-Dione Compounds (Glen E.
Arth et al, inventors) and 154366 (Class 260/69) for 11,21-Bis-
oxygenated-17~( -Hydroxy-16.beta.-Methyl steroid-3,20-Diones (David
Taub et al, inventors). There was a hearing before the Board
on November 27, 1974, at which Mr. David Watson, Q.C., and
Mr. Bassford of the Merck company represented the applicant.
The two applications are cognate, dealing with essentially the
same issues, so that the findings on one will apply mutatis
mutandis to the other.
Our first consideration is application 154365. It contains 195
claims directed to certain pregnadiene compounds (their exact chemical
structure need not concern us), and processes for preparing and
extracting them. It is a division of Canadian Patent 914151 which
affords the applicant protection for the pregnadienes when prepared
by certain chemical processes. The compounds possess therapeutic
properties, and are useful to treat arthritis. Claims 1, 44, 90,
134, 154 and 167 which are given below, illustrate various aspects
of the protection sought.
1. A pharmaceutically impure 16(-methyl-11, 21-bis-oxygenated-1,
4-pregnadiene-17(-o1-3, 20-dione having the following formula:-
<IMG>
wherein X is hydrogen or fluoro, W is keto or~-hydroxy; and R
is hydroxy, phosphoryloxy or lower hydrocarboncarbonyloxy.
...
44. A method of making a pharmaceutically pure 16~ -methyl-11, 21-
bis-oxygenated-1, 4-pregnadiene-17~ -01-3, 20-dione having the
following formula:-
<IMG>
wherein X is hydrogen or fluoro, W is keto or~-hydroxy; and R
is hydroxy, phosphoryloxy or lower hydrocarboncarbonyloxy, which
comprises subjecting the corresponding pharmaceutically impure
compound to an extraction process, whereby to remove the impur-
ities therefrom.
90. A pharmaceutically pure 16~-methyl-11, 21-bis-oxygenated-1,4-
pregnadiene-17~-01-3,20-dione having the following formula:-
<IMG>
wherein X is hydrogen or fluoro, W is keto or~-hydroxy; and R
is hydroxy, phosphoryloxy or lower hydrocarboncarbonyloxy, when-
ever prepared or produced by the process of Claim 44.
...
134. A process for the production of a pharmaceutically pure 16~-
methyl-11,21-bis-oxygenated-1,4-pregnadiene-17~-01-3,20-
dione having the following formula:-
<IMG>
wherein X is hydrogen or fluoro; W is keto or .beta.-hydroxy; and R
is hydroxy ,phosphoryloxy or lower hydrocarbon carbonyloxy
which comprises subjecting a compound of the formula:-
<IMG>
where W and X are as above or a 21 estor thereof to the dehydro-
genating activity of Schizomycete microorganisms, and when R
is required to be phosphoryloxy reacting the product obtained
with a phosphorylating agent and when R is required to be lower
hydrocarbon carbonyloxy reacting the product obtained with a
lower hydrocarbon carboxylic acid acylating agent, and subject-
ing the resulting product to an extraction process.
...
154. A process for the production of a pharmaceutically impure ring
unsaturated 16~-methyl-11-oxygenated-steroid-17~-01-3,20-dione
compound of the pregnene series where thera is unsaturation in
both the 1,2 or 4,5 positions or a 21-ester thereof where the 21-
ester substituent is selected from phosphoryloxy or a lower
hydrocarbon carbonyloxy which comprises contacting the correpond-
ing pregnene compound with unsaturation only in the 1,2 position
to the dehydrogenating activity of Schizomycete micro-organisms
and when the 21-ester is required esterifying the 21 hydroxy
group in the product.
...
167. A 16-methyl-11,21-bis-oxygenated-4-pregnene-17~-01-3,20-dione
having the following formula:
<IMG>
wherein X is selected from the group consisting of hydrogen and
fluoro; and W is selected from the group consisting of keto and ~-hydroxy.
The claims cover a series of steps and products, viz, a bacteriological
process for dehydrogenating pregnenes to produce dehydrogenated preg-
nerves (cl. 154 and others); impure products resulting from such
dehydrogenation claimed in independent (per se) form (cl.1 to 43); the
step of purifying the impure products by extraction with chemical solvents,
or by chromomatic adsorption or by crystallization (c1. 44 etc.); the
purified products (such claims are made dependent upon the extraction step)
(c1. 90 etc.); the starting compounds used in the dehydrogenation process
(c1. 167 etc.); the process of bacteriological dehydrogenation coupled
with extraction (c1. 134 etc.); and chemical processes for preparing the
starting materials (claims 172-195).
The examiner refused all the product claims not dependent upon the pro-
cess of preparing them for failure to comply with the requirements of
Section 41 of the Patent Act. He also objected to the claims to the ex-
traction (or purification) step for failing to satisfy Section 36. In
addition he noted that Section 38 was contravened by virtue of the variety
of processes and products claimed. The applicant has accepted the
validity of that objection, and there is no need for the Board to pursue
it. It may be resolved at the conclusion of the current proceedings.
The examiner expressed his objections made under Sections 41 and 36 in
the following terms:
The objection to claims 167 to 171, 174, 176, 178 and 187
to 195 is maintained and the reason for such objection is that
the compounds claimed is the aforementioned claims are con-
sidered to be governed by Section 41(1) of the Act. Since the
courts have consistently maintained during the last few years
that the word, "medicine", for the purpose of Section 41(1) must
be interpreted in the broad and ordinary sense it is the Patent
Office position that the term, "medicine", includes not only
those substances which are intended for direct use as medicines
but also those substances which are capable of being used for
the preparation or production of medicines. The compounds
claimed in claims 167 to 171, 174, 176, 178 and 187 to 195
are compounds which fall within the latter category i.e. they
are substances which are capable of being used for the preparation
of medicines and which are prepared by chemical processes and
as such are considered to come within the scope of Section 41(1)
of the Act.
Furthermore to permit an application to claim an intermediate
whose use is for the preparation of a medicine in "per se"
form would be to allow a circumvention of the intent and spirit
of Section 41(1). In the case of Tennessee Eastman v.
Commissioner of Patents, Supreme Court, 1972 it was stated that
inventions relating to medicine must comply with the requirements of
Section 41(1) of the Act and that to permit applicants to claim
a medicinal invention in "per se" form by means of a method of
medical treatment would be to negate the intent of Section 41(1)
and would give the applicants an easy way out of the restrictions
of the Section. Since the present situation with regard to
intermediates capable of being used for the preparation of
medicines is considered to be analogous to the situation which
occurred in the Tennessee-Eastman case cited above the philosophy
behind said case is considered to apply to the medicinal intermediates
as well i.e. that only claims which comply with the requirements
of Section 41(1) will be allowed. Claims 167 to 171, 174, 176,
178 and 187 to 195 must therefore either be amended to comply
with the requirements of Section 41(1) or be deleted in their
entirety.
The objecaion to claims 1 to 43, which are directed to pharmaceu-
tically impure compounds, is maintained and the reason for such
objection is that the claims are not restricted to impure com-
pounds when produced by applicant's claimed microbiological pro-
cesses but cover the said impure compounds when produced by any
process, chemical or microbiological. To maintain, "per se",
type claims to the impure products described in claims 1 to 43
the applicant must include in the claims the limitation that the
said impure compounds are produced by microbiological processes
since otherwise the claims cover the impure compounds when prepared
by chemical processes and are not allowable since they fail
to comply with the requirements of Section 41(1) of the Act for
the reason given earlier in this Final Action. The applicant
must therefore eith amend claims 1 to 43 by including in the
claims the limitation that the impurities are those which arise from the
disclosed microbiological processes or by making the claims depend-
ent on process claims describing the disclosed microbiological
processes.
The objection to claims 44 to 89 (equivalent to former claims 87
to 132) is maintained and the reason for such objection is that
the claims do not define processes in the clear and explicit manner
required by Section 36(2) of the Act in that they do not define
the purification processes used in sufficient detail and do not
state that the impurities being removed are those which arise from
applicant's disclosed microbrological processes. Furthermore the
claims as written apply to any process for preparing the compounds
in question and would, if allowed, give the applicant a monopoly
over every process, chemical or microbiological, known or unknown,
thus allowing the applicant to ovade the restrictions of Section
41(1) of the Act. Since one of the purposes of Section 41(1) is
to encourage the discovery of new processes for the preparation of
medicines claims which give an applicant a monopoly over a particular
medicine either by a "per se" product claim or by a process claim
which is so broal as to be almost equivalent to "per se"
product claim cannot be allowed. Claims 44 to 89 must there-
fore either be amended to refer only to the purification of
compounds obtained by applicant's microbiological processes
or be deleted in their entirety along with dependent claims
90 to 133.
Because of the large number of claims, it may be useful to indicate their
status in tabular form.
Refused Not Refused
1 - 43 - Product claims, - impure form
44 - 89 - Process claims, - extraction
90 - 133 - Product claims, dependent on
cls. 44 - 89
134 - 166 - Process cls.
bacteriological
with oxtraction
167 - 171- Product cls., starting material
172 - 173 - Chemical process
clms. to make
starting material
174 - Product claim, starting material
176 " 175 "
177 "
178 "
187 - 190 " 179 - 186 "
191 - 195 "
The applicant's countering arguments were presented in comprehensive
detail in his response of April 25, 1974, in his appeal brief, and as
part of his oral submissions to the Board. Because those submissions were
so extensive it would be impractical to reproduce them fully here, and
we will content ourselves with summarizing them as we proceed to discuss
the rejection of the various groups of claims.
At the hearing Mr. Bassford stressed the importance of drug research
and the need to promote such research. He also represented that his
company was a responsible firm making important contributions to the
advancement of medical science. With that there can be no quarrel and
we second such statements. We are concerned here, however, with narrower
issues. We must Decide whether the applicant is legally entitled to
the various aspects of the invention claimed, and in what manner they
may be claimed. We must limit our attentions to the legal requirements
of the Patent Act, and to the jurisprudence interpreting such legislation.
Many of the issues raised in this case have already been considered
by the Board and by the Commissioner of Patents in a decision published
in the Patent Office Record of January 21, 1975, beginning at page xiii.
We have not been persuaded that those findings were incorrect in so far as
they apply here and to the extent that they apply here. In the interest
of brevity we do not think we need cover the same ground a second time,
and consequently reference should be made to the earlier decision for the
reasoning given in it.
The applicant has agreed that the compounds covered by claims 167-171
and 187-190 are themselves active medicinally, is willing to place them
in process-dependent form, and has withdrawn his appeal with respect to
them (Appeal Brief, page 2). Consequently they need not be considered
further.
In addition, the only objection to claims 90-133 is that they are dependent
on rejected claims 44-89, and their allowability will stand or fall with
those claims. Consequently they need not be reviewed.
Claims 174, 176, 178 and 191-5 are for chemical compounds, made by chemical
processes, which are intermediates to prepare medically active products,
but which are themselves therapeutically inactive. For that reason, the
applicant contends, Section 41 does not apply to them. It is his position that
chemical compounds are not "intended" for medicines if they themselves
arc not useful medicinally. To quote:
But this objection is unsupported in law since it would
require interpreting the words "intended for... medicine"
in Section 41(1) as having the same meaning as the words
"intended or capable of being used for medicine or for the
preparation or production of medicine" in Section 41(4).
Such interpretation is directly contrary to the decision of
the Supreme Court of Canada in Parke Davis & Co. vs Fine
Chemicals (1959) 30 C.P.R. 59, at page 67, where Martland, J.
with whom Locke and Cartwright JJ, concurred, states:-
"It seems to me that s. 41 must be construed as a whole.
Subsection (1) applies to inventions relating to sub-
stances prepared or produced by chemical processes and
intended for food or medicine. Subsection (3) goes
somewhat further and also applies to any patent for an
invention capable of being used for the preparation or
production of food or medicine."
Accordingly, former subsection 41(3), which contained similar
language to Section 41(4), was specifically interpreted as
going further than Section 41(1).
The interpretation adopted by the Examiner is also contrary
to well established principles of statutory interpretation.
Thus, Maxwell on Interpretation of Statutes" 12th Edition
(1969) at page 282 states:
"From the general presumption that the same expression
is presumed to be used in the same sense throughout an
Act or a series of cognate Acts, there follows the
further presumption that a change of wording denotes
a change in meaning."
The applicant also referred to Magor v. Newport (1952) Appeal Cases 189,
which, he says, "shows that the wording of the statute (Section 41)
is to be applied as it reads and that to 'fill in gaps' is to legislate."
In other words, ha contends that to take the words "intended for
medicine" as being applicable to substances which are to be made into
medicine is contrary to the plain meaning of that phrase, and that to
so interpret them would be to legislate. With this we do not agree. The
situation corresponds to what was considered in the published decision,
in which, after reviewing numerous earlier decisions we concluded as
follows (p.xviii):
The decisions of both the, Canadian and British counts suggest
that Section 41 and "intended for medicine" should be given
broad interpretations, and on that basis we conclude that inter-
mediates whose only utility is for conversion into medicine
should be considered as "intended for medicine."
Mr. Watson has suggested that the examiner has been improperly troubled
with the legislative intent behind Section 41. That concern, however, was
also dealt with in the earlier decision, again at p. xviii:
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."
When considering the differences in wording between the various subsections
of Section 41, it must be remembered that subsections (3) and (4) deal
with "inventions" broadly, while subsection 1 is limited to inventions which
are substances. We believe this explains the statement from Parke, Davis v.
Fine Chemicals quoted above by the applicant that subsection (3) goes
further than subsection 1. The two latter subsections would cover, for
example, a mechanical blender capable of being used for the preparation of
a medicine. Such a blender would not be a "substance" within the meaning
of subsection (1), but it would be an "invention" capably of being used
for the preparation of a food or medicine within the meaning of subsections
(3) and (4).
The applicant has made a further argument, which we quote:
It is furthermore submitted that the interpretation of Sec-
tion 41(1) to include not only substances intended for
medicine, but also those capable of beinb used for the prepara-
tion or production of food or medicine, is entirely inconsistent
with the theory and philosophy underlying the Section, and would
bring all substances, not only medicines, within the ambit of
Section 41(1). The first subsection of Section 41 is intended, as
has been held by the Courts, to encourage process inventions by
limiting the inventor of a new medicine, when prepared by a
chemical proces, to protection for that medicine only when
prepared by that chemical process, thus leaving open to others
the opportunity of contributing improved alternative chemical
processes for preparing the said medicine. Section 41(1)
certainly did ndt intend that such process limitation should be
extended ad infinitum to intermediate after intermediate merely
because such intermediates are "capable of being used for the
preparation of ...medicine" To so construe the word "medicine"
as used in Section 41, even when "interpreted in the broad and
ordinary sense" is clearly unwarranted since, under such construct-
ion, almost any substance could be alleged to be curable of use in
production of medicine; and the proposed interpretation would
abrogate for Canada all per se product protection for any substance
whatsoever. (underlining added)
We point out, however, that we are not concerned with inventions"capable
of being used for the preparation of medicine," as the applicant puts it,
but those which are intended to be used for the production of medicine.
This in no sense means that all new chemical compounds are subject to Sec-
tion 41 because they are capable of being made into medicine and might in
some unseen eventuality be used to make a medicine. If it is intended that
they be used for another purpose, Section 41 would not apply. However when
the only possible known use for them is conversion into a medicine, whether
that be one or several steps removed, then in our view they are intended
for medicine.
We see no need to belabour further the points made in the earlier decision.
We consider that the rejection of this group of claims (174, 176, 178 & 191-5)
for failure to comply with Section 41 was proper.
That brings us to claims 1-43, those for "pharmaceutically impure" compounds.
These claims would cover compounds no matter how they are prepared, including
chemical processes. With respect to them the applicant stated:
The Examiner has objected to claims 1-43, which are directed
to pharmaceutically impure 16~ -methyl-11,21-bisoxygenated-1,
4-pregnadiene-17~ -o1-3,20-diones, on the ground that applicants
"must include in the claims the limitation that the said impure
compounds are produced by microbiological processes since
otherwise the claims ...fail to comply with the requirements of
Section 41(1)". But the pharmaceutically impure compounds
defined in claims 1-43 are not medicines. This was established in
Laboratoire l'entagone vs. Parke Davis & Co. (1968) 55 C.P.R. 111,
at page 114, where Pigeon, J. who delivered the judgment of the
Supreme Court stated:
It is clearly proven that this antibiotic, chloramphenicol,
is secreted by micro-organisms in the culture medium, but
it is dilated, mixed with numerous impurities and not usable
in this impure state. The extraction process is indispensable
for obtaining a usable substance for therapeutic purposes,
the evidence demonstrates this and the respondent has
admitted it before this Court. Consequently, the whole
litigation on the seconJ question comes down to deciding
whether the fermentation and extraction be chemical
processes within 'he meaning of the Patent Act, as the
appellant claims, or as the respondent and its experts
maintain, that the fermentation is a biological process
and extraction a purely physical process."
Moreover, in the Tennessee-Eastman case (1974 S.C.R.111), it was
held that, for a substance to be intended for medicine, such sub-
stance must be usable in the treatment of disease. If this
principle is considered in conjunction with the Laboratoire Pentagone
case, wherein the Court held that the impure product of a
microbiological process is not usable for medicine, it will be
clear that, according to existing jurisprudence, claims 1-43 are
not claims for medicine, and do not fall within Section 41(1) of
the Patent Act.
Read carefully, and properly, neither the Laboratoire Pentagone case nor
the quotation from it relied upon by the applicant say that the pharmaceut-
ically impure compounds "are not medicines." What they say is that such a
substance is not "a useable substance for therapeutic purposes." That is
an important distinction.
The applicant's suggestion that the compositions are not medicines is
specious, and comparable to what was rejected by the Supreme Court in
Parks, Davis v. Fine Chemicals, 1959 S.C.R. 219 at 221, when it discarded
the proposition that a substance was not a medicine because it was in bulk
form. Whether in bulk form, or in impure form, the substance in question
is a medicine.
In any event, there is no doubt in our mind that it is a substance "intended"
for medicine, for the same reasons as we advanced above against the other
product claims.
In the immediately preceding quotation froth his response, the applicant
stated:
Moreover, in the Tennessee-Eastman case, it was held that for a
substance to be intended for medicine, such substance must be
useable in the treatment of disease.
We have reread the Tennessee decision (1971 S.C.R. 111) several times,
and have not located any passage justifying such a statement. If the
applicant wished to predicate that in the Tennessee-Eastman case it was
held that for a substance to be a medicine, such substance must be
useable in the treatment of disease, his interpretation would be more
reasonable. But that is far different from stating the decision holds
that for a substance to be intended for medicine it must itself be
useable in treatment. As we stressed before, there is an important
difference between "medicine" and "intended for medicine." We suppose
the application had in mind the following passage, which does appear in
the decision:
There is no doubt that when a new substance is claimed as an
invention of a 'medicine', it has to be shown that it is
active and non-toxic in therapeutic doses.
If so, his interpretation of it is much broader than we think is
justifiable.
Having determined that claims 1-43 cover substances intended for medicine,
we must next consider whether they are prepared by chemical processes
within the meaning of Section 41(1). The applicant's arguments on that
point were put as follows:
Furthermore, the pharmaceutically impure 16 -methyl-11,
21-bis-oxygenated-17 -01-3,20-diones of claims 1-43
are substances produced by a microbiological process,
not by a chemical process. The Quebec Cours of Appeals
in the Pentagone case followed the decision of
Continental Soya vs. Short Hilling 2C.P.R.~, (1942
S.C.R. 187) in which the Supreme Court held that a
biological process is not a chemical process; and this
ruling was not disturbed by the Supreme Court in its
decision on the l'entagone appeal.
This issue presents several interesting questions. First, we must
square the Continental Soya decision (supra) with both Laboratoire
Pentagone (supra), and with Dairy Foods v. Co-operative Agricole
do Granby 4 C.P.R. (2d) 38 and 8 C.P.R. (2d)1. We must also decide
whether it is permissible to break up a complete invention which is
governed by Section 41 into bits and pieces, and by approving claims
to non-chemical portions effectively circumvent Section 41.
The applicant relies upon the Continental Soya decision as holding
that microbiological processes are not chemical. It is correct that
faced with the particular facts before it, both the lower Court (1941)
Ex.C.R. 69) and the Supreme Court concluded that the process in
question was not chemical, and Section 40 (now 41) did not apply.
That process, however, was for the preparation of a soy-bean flour
from soy hcans in such a manner that the flour retained an enzyme
which pre-existed within the bean. The enzyme was useful to bleach
wheat flour, but previous methods for preparing the flour lod to
destruction of the enzyme (1941 Ex.C.R. 84, lines 27-34). The enzyme
was neither created by the patentee's process, nor destroyed by it.
The finding of the court was predicated upon the conclusion that the
invented substance (i.e. the enzyme) had not been prepared by a
chemical process. Whether the Continental Soya decision has wider
implications has been questioned in the Dairy Foods case (supra).
Mr. Justice Noel stated (4 C.P.R. (2d), p. 100):
There really are but two decisions which may be of some
assistance in determining whether plaintiff's process is
chemical or not within the meaning of s. 41(1) of the
Patent Act and these are Continental Soya Co. Ltd. v.
J.R. Short Milling Co. (Canada) Ltd. (142), 2 C.P.R.
1 at p. 5, (1942) 2 D.L.R. 114, (1942) S.C.R. 187, where
it was held that the application of heat for drying alone
was not chemical nor was the addition of water to
stimulate germination as this was a vital precess. The
nature of the evidence, however, in the last case, is not
clear and it may well be that the matter of whether
biological processes can still be considered as chemical,
is still open, if one considers that in the decision of
the Supreme Court of Canada in Laboratoire Pentagone Lt‚e
v. Parke, Davis Co. (1968), 55 C.P.R. 111 at p. 118,
69 D.L.R. (2d) 267, (1968) S.C.R. 307 the first phase of
the production of an antibiotic by means of living
organisme. (~ ~., a vital process) was not considered.
it was indeed decide in this case that as an examina-
tion of the extraction process was sufficient to
disposed of the appeal, it was not necessary to cunsi-
der the fermentation proress. The extraction process
consisted of alternatives of solvent extraction or the
use of activated charcoal to separate the product. The
evidence here was that the processes of extraction by
absorption or by solvents are in the field of physical
chemistry. It was also held that extraction by a
solvent use(s) the chemical properties of a chemical
substance and it is of some interest to point out that
the Court noted with approval that fractional distilla-
tion (which is merely the heating up of something and
the distilling it over) is a chemical process as was a
process for the manufacture of activated charcoal.
A passage from Maclean, J., in the Continental Soya case,
supra, which decision was approved by the Supreme Court,
indicates the difficulties involved in determining the
line of demarcation between what should be considered as
a chemical process within the meaning of s. 41(1) and
what should not. It was pointed out in the J.R. Short
Milling Co. Ltd. v. Geo. Weston Bread and cakes Ltd. et
al., (1940) 4 D.L.R. 579, (1941) Ex.C.R. 69 (affirmed
(1942), 2 C.P.R. 1, (1942) 2 D.L.R. 114, (1942) S.C.R.
187), that it was not because a chemical reaction occurred
in the application of a process that it had to be held to
be a chemical process, even though a chemical reaction
took place, as happens in all kinds of ordinary operations
such as in the making of bread and the ordinary biological
processes which no one classifies as chemical processes in
everyday language. (underlining added)
On appeal the decision was affirmed, with special consideration given
to whether the process would considered chemical in the "popular"
sense. To quote from Chief Justice, Mr. Jackett (8 C.P.R. 1 at 4):
Counsel went on to submit that the learned trial Judge had
over-emphasized the importance of the chemical reactions
which occur in the process and bring about the formation
of the aggregates and had not addressed his mind to the
question of whether the process as described was a
chemical process in the propular or ordinary sense.
In dealing with the question, however, the learned trial
Judge appears to me to grave considered not only the fact
that several reactions, which are properly regarded as
chemical reactions and which are essential to the formation
of the product, are involved in the process but as well the
fact that what he refers to as the "instrumentalities of
chemistry" are put to work to achieve the desired result....
...On the facts as found by him I reach the same conclusion.
It is clear from the Continental Soya and Pentagone cases that
the matter is not to be resolved simply by reference to the fact
that chemical reactions do occur in the process. But the fact that
chemical reactions do occur in the proccess and in addition
bring about the result must be of some importance in the situ-
ation as a whole and connot be disregarded entirely.
There is no more process of nature. Nor is it a~in to the purely
mechanical process of sawing logs into lumber or grinding grain
into flour. Nor yet is it like the baking of bread which,
while involving chemical reactions, is not popularly regarded
as a chemical process. On the other hand it is a process which
besides involving chemical reactions to produce the desired
result, employs the substances involved in particular propor-
tions and exploits their chemical characteristics in sequential stages
under particular conditions at particular temperatures and for
particular times. These, to my mind, are things that chemists do
in carrying out chemical processes and, as I see it, these things
coupled with the fact that important chemical reactions and little
else are involved, give the process its character. To my mind
these features of the matter are sufficient to indicate that the
process is properly called a chemical process in the ordinary sense
and I do not think that conclusion is weakened by the consideration
that some of the features of the process as a whole are carried out
by mechanical means or that technicians or operators can be trained
to carry out the process efficiently without their becoming chemists.
The decision was appealed further to the Supreme Court, which heard oral
submissions last November. While the judgement might provide further
assistance in considering the present matter - and we have purposely delayed
concluding our recommendation for that reason - as yet no decision has been
handed down and we think it would be improper to delay further.
When we look at the applicant process (e.g. claim 154) for preparing the
product of claim 1-43, we see that it involves a change in the chemical
structure of the starting chemical compound to introduce a double bond into
the 4:5 position of the ring. A new chemical compound results, and the
change produced is chemical in nature. The change is brought about micro-
biologically using the microorganism Schizomyctes. Claims 1-43 also cover
esters of that product, esters which, to use the words of the specification
(p. 12) are made from the corresponding alcohol:
...by reaction with an acylating agent e.g. a phosphorylating
agent, a lower hydrocarbon carboxylic acid acylating agent such
as benzoic anhydride, tertiary butyl acetyl chloride, a lower
alkanoic anhydride or lower alkanoyl halide such as acetic
anhydride, propionic anhydride, a polybasic acid anhydride such as
B,B-dimethyl-glutaric anhydride, succinic anhydride, and the like.
By any standard this is a chemical step and the product of such a step
is made by a chemical process. We are consequently, irresistibly drawn
to the conclusion that claims such as 1-4, (6-9), and others which cover the
esters are subject to Section 41.
We are including to the view that the products of the
microbiological step would in the "popular" sense referred to by
Mr. Justice Jackett be considered chemical. They involve chemical
changes. The starting materials are made by chemical means (sec
page 4, beginning at line 8 of the specification to the end of
page 6). The reaction is carried out in such chemical solvents as
dialkyl ketone or acetone (p. 8 line 25). Buffered solutions may be
used (p. 7, line 10). Those are significant distinctions serving to
differentiate the process here from the more mechanical steps used
in Continental Soya.
In any event, there are other reasons why we think Section 41 governs
here. But before proceeding to them we refer to the Laboratoire
Pentagone vs. Parke, Davis decision, which was also relied upon by
the applicant. In the Quebec Superior Court (1968, 46 C.P.R. 171),
it was held, despite the hesitation expressed in the quotation which
follows, that the fermentation process being considered there was not
a chemical process:
With regard to the fermentation process, there is, in my
opinion, no doubt that from a purely scientific philoso-
phical point of view the process is a chemical process
or, at any rate, that chemical reactins occur during the
process resulting in the excreting by the organism of the
chemical compound chloramphenicol, but I am unable to
find that this purely scientific description is that which
is meant by the phrase "chemical processes" in s. 41(1) of
the Patent Act. Despite the fact that such a process
would seem to the lay mind or, at any rate, of the mind of
the undersigned, to refer to oranic chemistry, there is
the possibility, which seems to be a very real one, that
in the mind of the legislator or, at least, of the
draftsman of the Act, of a distinction between a biological
and a chemical process.
The Quebec Court of Queen's Bench, Appeals came to
the same conclusion (1968), 53 C.P.R. 236)
The Supreme Court of Canada (1968, 55 C.P.R. 111) explicitly did not
decide whether the fermentation process was chemical. We quote from
p. 114:
To decide this appeal, it dots not seem necessary
to decide the question regarding the fermentation
process.
On the other hand it did decide that the subsequent extraction process
was chemical, so that taken as a whole, the fermentation step followed by
extraction was chemical, and Section 41 applicable. Consequently we do
not think that it can properly be said that the Supreme Court's decision
stands for the proposition that claims 1-43 are not chemically produced
products.
Previously we referred to another obstacle to granting claims 1-43. We
have no reservations in holding that the result of the complete process
(fermentation followed by extraction) must be considered chemical and
governed by Section 41. Both the Laboratoire Pentagone v. Parke, Davis
and the Dairy Foods v. Co-op Agricole decisions support that view. If
the applicant is entitled by virtue of Section 41 to protect the final
purified product (the only form in which it is useful) only by the
particular method which he has described and claimed, it would indeed be
anomalous if he could by another claim prevent any one else from making
that product by any other method whatsoever. Yet that is precisely what
claim 1 (and others like it) would accomplish. It is directed to pharma-
ceutically impure pregnadiene - period, without further restriction or
limitation. No matter what other process is devised for making the
pregnadiene, such a process must of necessity go through the preliminary
step of an impure pregnadiene, and so came within the net of claim 1.
This we feel would be clearly contrary to the meaning of Section 41.
We should not be led astray by the terminology utilized by the applicant.
As was said by Mr. Justice Jackett in an as yet unreported decision,
Wolfe W. Gruber v. the Queen, June 4, 1975:
What we are concerned with is the substance
of the matter, and we must not let ourselves be
misled by the words used.
Though this was not a patent case the principle it expresses seems
appropriate.
There are two other objections to claim 1 and those like it which
should be mentioned. They are directed to but a preliminary portion of
the invention. The impure products are not what is desired, and are
useless until purified. They are not for the invention which the
applicant made and even if such incomplete inventions might be claimed
they are broader than what the applicant has achieved. This impure
pregnadiene contains only such impurities as would arise from his
particular fermentation process. He never prepared impure pregnadiene
where the impurities are those which arose from other fermentation processes
or those which would be present if the product were made by chemical
syntheses.
For such reasons as we have given, we are satisfied that the refusal of
claims 1-43 was proper. The applicant proposed at the hearing (Appeal
brief, p. 3) to amend claims 1-43 to refer to the fact that the impurities
result from the production of said composition. We see no objection to
such an amendment, but its entry is immaterial, since it would in no way
alter the objections made, or the refusal of the claims.
Finally we turn to claims 44-89, and those for a process of extracting
pure pregnadienes from impure pregnadienes. Once again the applicant has
proposed certain amendments (appeal brief, p. 6), in this case to
specify that the extraction is done by two-phase solvent extraction or
chromatographic absorption or crystallization. These amendments do add
further specificity to the process, and in our view overcome one of the
examiner's objections, viz that the steps of the purification are not
defined in sufficient detail. We will consider such amended claims and
determine whether they satisfy the other objections (for those objections
it is immaterial whether the amendments are made or not).
The applicant has argued that the rejection of these claims is contrary
to the findings in:
Commissioner of Patents v. Ciba (1959) 30 C.P.R. 135 at 141
1959 S.C.R. 378,
General Tire v. Dominion Rubber (1967) 53 C.P.R.
and Laboratoire Pentagone v. Parke, Davis (supra)
These cases were cited as authority for the proposition that when a chemical
product is patentable the process of preparing it would normally be
patentable. Accepting that proposition, the process must, of necessity,
be properly defined. The examiner has not suggested that the process
would not be patentable when properly defined. Indeed he has called for
amendments to do so and make the process allowable. He has stated that
the starting material has not been properly defined (with which we agree)
and that the step of purification has not been adequately defined (we
consider that proposed amendment overcomes that branch of the objection).
The starting material used in the applicants purification process and to
which his purification steps have been found applicable, is one containing
such impurities as would exist in the impure product resulting from his
particular fermentation procedure. The applicant does not know, or at
least did not know at the time of his invention, that the steps he
proposes would be successful with pregnadienes made by other still unknown
processes, containing different impurities.
We are also persuaded that allowing claims of such breadth as proposed
by the applicant is an improper cirrumvention of Section 41 unless it is
tied to the full process of the applicant, i.e, fermentation plus puri-
fication. The reasons for that were explained fully above.
For such reasons we find claims 44-89 were properly refused and require
amendment.
Turning now to application 154366, we find it contains 56 claims. It is
a division of Canadian patent 913613 in which the same products are
claimed when prepared according to certain chemical processes. The
issues here parallel those raised by the rejection of application 15466
which we have just considered, anti the subject matter is cognate, with
different isomers of the pregnadiene being covered.
Claims 13, 15, 16, 18, 22, 24, 26, 28, 29 & 44-49 were refused because
of Section 41, and are unallowable for all of the reasons we have already
advanced. Similarly claims 33-43 should be refused because of the
objections we made to claims 44-89 in 154365, unless amended along similar
lines. Claims 50-56 stand or fall with claims 33-43.
Claims 30, 31 & 32 were refused because the applicant company had already
claimed those processes in his Canadian patent 872,223. In his response
of April 25, the applicant indicates he withdraws those claims. He has
also proposed certain other minor amendments which do not affect what has
been refused. Similar comments apply to the more recent amendments
proposed in the appeal brief.
For the reasons given, we consider the refusals made by the examiner should
be affirmed.
G.A. Asher
Chairman
Patent Appeal Board
I concur with the finding of the Patent Appeal Board. The claims
rejected by the examiner in both applications are refused. If any
appeal is contemplated under Section 14 of the Patent Act, it must
be commenced within six months of the date of this decision.
Decision accordingly,
A.M. Laidlaw
Commissioner of Patents
Dated at Hull, Quebec
this 29th day of August, 1975
Agent for Applicant
Gowling & Henderson
Box 466, Terminal A
Ottawa, Ontario