COMMISSIONER'S DECISION
STATUTORY-LIVING MATTER: Products Comprising Living
Microorganisms
Inventions have equal status in satisfying the
prerequisites of patentability whatever the nature of
the subject matter. Novelty and unobviousness were not
grounds of objection. The vaccine composition comprising
living virus is in no sense a fine art and lies in a
useful art. The attenuation of the natural activity
of the virus is produced and controlled by the intervention
of man, and the vaccine composition inevitably follows the
conditions disclosed for its production; thus the pre-
requisites of utility are satisfied and the application
ought not to be refused by the Commissioner (in re Vanity
Fair).
FINAL ACTION: Overruled.
*****************
This decision deals with a request for review by the Commissioner
of Patents of the Examiner's Final Action dated October 28, 1971 on
application 950,086. This application was filed in the name of
Behringwerke Aktiengesellschaft (Othmar Ackermann) and refers to
"Vaccine Against Distemper And Process For Its Preparation".
In the extended prosecution terminated by the Final Action the
examiner refused the application because the process of attenuating
a live virus and the modified living product of such a process, which
form the subject matter of the claims, do not represent a patentable
invention according to Section 2(d) of the Patent Act.
In the Final Action the examiner stated in part:
(a) Section 2(d) of the Patent Act provides a definition of the term
"invention"; it does not affirm that an invention is necessarily
patentable. The requirements for patentability are not confined
merely to novelty and utility. The courts, in interpreting
Section 2(d), have laid down that, for instance, unobviousness
is also an essential condition. Moreover, Section 28(3) intro-
duces a further qualification by stating that no patent shall
issue for certain types of invention. It follows therefore
that, taken literally, Section 2(d) does not set forth all the
requisites for patentability and must be more narrowly construed
than the wording would suggest.
(b) The creation of living things such as new plant varieties, cross
breeds of animals, viruses, bacteria and the like, and the
results of such creation do not fall within the scope of subject
matter to which patentable protection may extend.
(c) The case of the Commissioner of Patents vs Ciba Ltd., which the
applicant has invoked in support of his arguments, relates to
situations where a known process may acquire patentable merit
by virtue of the patentability of the product. In the present
issue the product itself is unpatentable and the case is
therefore irrelevant.
The applicant in his response of January 28, 1972 stated in
part:
It is the applicants' belief that the application is not open
to objection on the grounds stated by the Examiner. Applicants
agree with the third paragraph of the Official Action wherein the
Examiner has stated that the definition of the expression "invention"
must be construed in somewhat narrower terms than those set out in
Section 2 of the Act. However, where the applicants and the Examiner
differ is in who has the authority to make this construction. Applic-
ants believe that construing of the Act is solely the province of the
courts; the Examiner apparently believes that it is within his authority
to make such a construction.
It is the applicants' contention that the Examiner has completely
ignored two relevant pieces of jurisprudence throughout the prose-
cution of this case.
In American Cyanamid Co. v. Charles E. Frost & Co. (1965) 2 Ex.
C.R. 355, patents to the antibiotics tetracycline and chlortetracy-
cline were held to be valid and infringed. The latter was formed
by placing micro-organisms in a fermentation broth containing chloride
ions while the former can be formed either by dechlorinating the
latter or by placing a micro-organism in a nutrient broth with a
controlled chloride content.
Similarly in the case Parke, Davis & Co. v. Laboratoire Pentagon
Lt‚e., 37 Fox P.C. 12, a patent for Chloramphenicol was held valid.
This product was prepared by a stepwise process which included both
a biological step and a physical step but it did not include a
chemical step.
There are many analogies which can be drawn between the anti-
biotic of Parke, Davis patent and the vaccine claimed here. They
are both vendible products, they are both prepared by biological
and physical processes and they both have therapeutic properties.
Both the antibiotic and the vaccine in their pristine product state
are substantially inert. It is in use that their separate therapeu-
tic properties which may be manifested by chemical or biological
reactions are exhibited. However it is not such use which is being
claimed; it is the product in its pristine state which is claimed.
The Examiner appears to be rejecting the product claims on the
basis that the attenuated virus therein, can undergo further biolo-
gical reaction. However in the state in which it is claimed it is
substantially inert. That it might undergo further biological
reaction in use is irrelevant. To be consistent, the office would
have to reject claims to any substance which is capable of further
reaction. To take a spectacular example, a claim to an explosive
compound would have to be rejected because the explosive remains
inert under only a very narrow range of conditions and the risk of
disintegration may be quite high. However there is no doubt that
new and unobvious explosives are patentable.
In summary, the Examiner has not shown that there is any
substantial difference between an antibiotic and the vaccine claimed.
Without such a showing the Examiner completely ignores jurisprudence
and construes Section 2(d) in opposition to the construction made
thereupon by the courts. The Examiner has failed to make a case
against the vaccines being claimed and applicants feel that the
rejection which he has raised should be withdrawn.
This invention relates to a vaccine against distemper containing a
live, attenuated, distemper virus, as will as the process for the manu-
facture of such a vaccine. Claims 1 and 6 read as follows:
Claim 1 - A process for the manufacture of a vaccine obtained from
a distemper virus attenuated by at least 50 successive
passages in the culture tissues of dogs' organs, for
the immunization of mustelines against distemper, process
wherein the attenuated distemper virus is passed through
at least 10 successive passages in the culture tissues of
mustelines.
Claim 6 - A vaccine for the immunization of mustelines against dis-
temper, characterized by a content of distemper viruses
which have been attenuated by at least 50 successive
passages in culture tissues of dogs' organs, and which
have then been passed through at least 10 successive
passages in the culture tissues taken from the tissues
of mustelines.
At the outset the Board would like to make it clear that the Exami-
ner's actions in this case were in conformance with Patent Office guide-
lines relating to the patentability of inventions involving living matter.
Of fundamental importance is the difference between discovery and
invention. Creations or products under the laws of nature are regarded as
being mere discovery; the existence of which man may discover but which
he could not have invented. As utility is a prime requisite of a patentable
invention, nothing is invented that can be the subject of a patent until
a discovery or a formulation of an idea of an end has been united with a
mode of application so as to produce useful results (Gerrard v. Carey,
(1926) Ex. C.R. 170 at 178), in terms of either a new and useful thing
or result or a new mode of producing an old thing or result (Lane-Fox v.
Kensington & Knightsbridge Electric Lighting Co (1892) 9 R.P.C. 413 at 416.
Jurisprudence and long standing practice has established that subject
matter based on the discovery of a vital process, force or phenomenon of
nature, can be the basis of patentable subject matter, provided some
artificial result or effect is produced and controlled by the interven-
tion of man, even though it depends partly or mainly upon the function or
result produced by living matter, and provided it is practically useful
even though solely in connection with an inherent response of a living
thing.
In Continental Soya v. Shorts Millings (1942) 2 Fox Pat C 103 the
Supreme Court of Canada held that: "... manufacture or composition of
matter in Section 2(d) of the Patent Act includes a product, which, as
well as the process by which it is obtained, may be patentable, if it is
new and useful." The subject matter at issue in this case depended upon
the use of an enzyme as a bleaching agent in a process for making bread.
This is held to be a manifestation of man's control over the use of the
enzyme in a process. In any event the Supreme Court held that the use
or effect of the enzyme was entitled to the same protection as the use
or effect of the hormone in the Banting patent.
In American Cyanamid v. Frosst (1965) 2 Ex. C.R. 355, the claims in
dispute involved living matter and, although numerous defences were
raised by the alleged infringer, the patentability of the antibiotic was
not in contest. The decision of Mr. Justice No‰l in this case describes at
length the production of antibiotics made by processes including living
matter; yet whether it is subject matter proper for a patent was not
questioned.
Finally, in the Parke Davis v. Laboratoire Pentagone S.C.C. (1968)
37 Fox Pat. C. 12, the Supreme Court of Canada considered an appeal dealing
with the infringement of a patent for an antibiotic which was produced by
a living micro-organism known as streptomyces venezuela. Again, there
was no question as to the patentability of such subject matter. Moreover,
the practice of United States, Great Britain and other major Patent Offices
is to patent such inventions and the Courts have not been reluctant to
support the validity of these patents... Also, of significant importance
in this decision the Supreme Court of Canada held that, a chemical substance
prepared by a fermentation process followed by purification of the sub-
stance with chemical solvents, or by absorption, is a product of a chemical
process within the meaning of Section 41(1) of the Patent Act.
Consequently, the basic, question which must be decided is whether
the subject matter of this application falls within Section 2(d) of the
Patent Act and satisfies the well established prerequisites which apply
to the subject matter of a patentable invention whatever the nature of
the subject matter, and it can be taken as settled that each kind of
subject matter has equal status and rights as a patentable invention
unless the statute dictates otherwise; e.g. Section 41(1) of the Patent
Act. That is, the principles and criteria governing what is a patentable
invention within the definition must be applied equally, not piecemeal,
in respect of every kind of subject matter.
The term living organism, in its broadest and most popular defini-
tion, covers every self-synthesising or self-reproducing organic entity
from complex mammals down to the simplest organism. But, it is a disputed
question among experts as to whether viruses do in fact fall within this
category in view of their non-cellular structure and lack of a metabolic
system, features which distinguish them from all other organisms, and,
according to some opinions, justify defining them as inanimate forms
of matter. However, since they share with the higher organisms the
nucleic acid mechanism of genetical replication, and can be deemed to
have delegated their metabolism to the cells which they parasitize,
there are sufficient grounds for regarding them for present purposes as
living even though decidedly border line.
As of interest, in Swifts & Co.'s application (1962) R.P.C. 37,
the court found that the British Patent Office did not have authority to
reject an application for a method for tenderizing meat comprising the
injection of enzymes into animals before slaughter.
Also, of interest, in Virginia-Carolina Chemical Corporation applic-
ation (1958) R.P.C. 36, the court held:
At one time it seems to have been thought that any operation
which involved living organisms was excluded from the definition
of invention. That this was unjustified is apparent from the
judgment in Commercial Solvents Corporation v. Synthetic Products
Coy., (1926) 43 R.P.C. 185, and from the considerable number of
patents granted in respect of the preparation of antibiotics.
The increasing use of naturally occurring organisms for initiating
or controlling or modifying manufacturing operations has wholly
outmoded as a rule of thumb guide a restriction of patentability
to inanimate matter. In the case of Standard Oil Development
Company's Application, (1951) 68 R.P.C., p. 114 (See p. 115 at
line 53), I suggested a test which may be useful, namely, an
isolation of the end product of the alleged invention. If to
secure this the development of living animal or vegetable matter
by the operation of natural laws is essential, the applicant
cannot claim to have invented it nor the means of procuring it.
The prerequisite of novelty, an objective consideration, need only
be considered to establish what the subject matter in question is, having
regard to the state of the related prior art, and is not in question in
the present case. Also the prerequisite of unobviousness, a subjective
consideration, is not in question in the present case. In the case at
point, involving living micro-organisms, utility is usually the critical
prerequisite to be considered, particularly as to whether the vital
activity of the subject matter can. be controlled and put to practical
use by the intervention of man.
The established criteria of a useful invention (utility are whether
the subject matter is practically useful in a useful art (manual or pro-
ductive) as distinct from the fine art (practising professional skills
having judgemental content, intellectual meaning and aesthetic appeal).
and particularly whether it is operable (reproducible and controllable)
so that the desired result inevitably follows whenever the subject matter
is worked or used by its users. Moreover, the subject matter must be
beneficial to the public. (Wandscheer v. Sicard, (1946 Ex.C.R. at 112
and 1948 SCR 1; and Mailman v. Gillette Safety Razor, (1932) Ex.C.R.
at 54 and (1932) SCR at 724).
On a consideration of the application at hand the subject matter
is in no sense to be considered a fine art, and lies in a useful art
(manual or productive). Moreover, any advance in this field is inherently
beneficial to the public provided it can be controlled.
Hence, the critical question in the present case is whether the
subject matter is operable (reproducible and controllable). In the
present case the activity of micro-organisms is created in an environment
established by the hand of man through a series of cultivations and
treatments in a controlled manner. It is also established that the
vaccine can be produced in a manner as disclosed in the specification,
for when given the micro-organisms and the appropriate ~~~ditions the
desired result is produced; thus enabling a person skilled in the art
to produce the invention after the monopoly expires. On this point and
of significance is the principle set out by the Court in N.R.D.C's
ration (1961) R.P.C. 147 that: "A distinction has necessarily to
bo drawn between cases of this class (plants) and cases of methods
employing micro-organisms; ... for in the latter class of cases the
process is analogous to a chemical process in that, given the micro-
organisms and the appropriate conditions, the desired result inevitably
follows from the working of the process: see Szuec's case (1956) R.P.C. 25."
(emphasis added)
Of importance is the responsibility of the Commissioner of Patents
as held by the Supreme Court of Canada, in Vanity Fair v. Commissioner
of Patents (1939 S.C.R. 24 at 28, that: "The Commissioner of Patents
ought not to refuse an application for a patent unless it is clearly
without substantial foundation." (emphasis added)
In the circumstance, therefore, assuming novelty and unobviousness,
the Board is satisfied, having regard to the present state of the law,
that the Commissioner ought not to refuse this application since there
is no apparent reason to exclude the subject matter from patent protection,
as not within the meaning of invention under Section 2(d) of the Patent
Act.
The Board recommends that the decision of the examiner, to refuse
the application on the grounds that it does not represent a patentable
invention according to Section 2(d) of the Patent Act, be withdrawn and
that consideration be given as to whether the vaccine product claimed
is governed by Section 41(1) of the Patent Act. Attention is directed
to the Supreme Court of Canada's decision, Parke Davis v. Laboratoire
Pentagone, as noted herein.
J.F. Hughes,
Acting Chairman
Patent Appeal Board
I concur with the finding of the Patent Appeal Board and withdraw
the Final Action and return the application to the examiner for resump-
tion of prosecution, including consideration under Section 41(1) of the
Patent Act.
A.M. Laidlaw
Commissioner of Patents
Dated at Ottawa, Ontario
this 18th day of September, 1972.
Agent for Applicant
Fetherstonhaugh & Co., Ottawa.