COMMISSIONERS DECISION
Subject Matter - Section 2 - Bovine Cell Line
Applicants claim to a continuous cell line useful to produce insulin was rejected
as to unpatentable subject matter, being a form of living matter. The claims
were allowed for the reasons advanced in C.D. 933. Rejection reversed.
****
Patent application 291870 (Class 195-46), was filed on November 28, 1977 by
Connaught Laboratories Ltd., of Willowdale, Ontario, assignee of the invent-
ors George M. Healy et al. It is directed to a "Continuous Bovine Beta
Cell Line." Claims 1-7 were rejected on October 10, 1980. The rejection was
reviewed by the Patent Appeal Board, which held a Hearing on April 15, 1981
to consider the rejection. At the Hearing Connaught Laboratories was represent-
ed by Mr. Michael I. Stewart, of the firm of Sim & McBurney.
In claims 1-7 of the application, the Applicant is claiming a new bovine cell
line useful to produce insulin. These claims were refused under Section 2 of
the Patent Act for being directed to living matter. Claims 3 and 4 are typical.
3. A cell culture of a continuous bovine beta-cell line
for the production of insulin in association with a nutrient
culture medium, said cell line having a morphology very
similar to that of beta cells of the bovine pancreas, the
diploid number of chromosomes for the bovine species, a
generation time of not more than 24 hours and is capable of
producing insulin.
4. The cell culture of claim 3 wherein said cell line
is one as deposited with the American Type Culture Collection
under accession number ATCC CRL 1407.
The issue is whether such claims are patentable. Mr. Stewart presented several
convincing reasons why they should be allowed, but we need not go into them
extensively. In another case heard shortly before the present one, the same
question arose. That involved patent application 257177 of the Abitibi
Company, for which a Hearing took place on March 11, 1981. Mr. David Watson, Q.C.,
represented Abitibi. The arguments both of Mr. Stewart and of Mr. Watson,
together with the results of our own investigation of the development of
patent law throughout the world, have brought us to the conclusion that
we can no longer be satisfied that at law a patent for a microorganism
or other new life forms would not be held allowable by our own courts.
That is the criterion specified in Section 42 of the Patent Act, without
which the Commissioner ought not to reject an application.
The decision in the Abitibi case was taken on March 18, 1982, and is now
a public document. It is consequently not necessary to repeat here all the
ratiocination developed there. However it may be useful to repeat from it
the requirements which we think should be met by an Applicant before claims
such as 1-7 of the application should be allowed. In it we said:
It is of some importance, we think, to recognize how far our
recommendation, if accepted, will carry us, and we believe
clear guidelines should be set down for the benefit both of
applicants and examiners. Certainly this decision will extend
to all microorganisms, yeasts, molds, fungi, bacteria,
actinomycetes, unicellular algae, cell lines, viruses or
protozoa; in fact to all new life forms which are produced en
masse as chemical compounds are prepared, and are formed
in such large numbers that any measurable quantity will possess
uniform properties and characteristics. That is, for example,
the working standard of the Japanese Patent Office (see Japan
Patents & Trademarks, No. 27, the Suzuye Report, Nov. 1980:
The standards state that microorganisms, such as
yeast, mold, fungi, bacteria, actinonomycetes,
unicellular algae, virus or protozoa, can be the
subject of patent protection.
We can see no justifiable reason for distinguishing between these
life forms when deciding the question of patentable subject matter.
Whether it reaches up to higher life forms - plants (in the popular
sense) or animals - is more debatable. Certainly the U.S. Court
of Customs and Patent Appeals and the U.S. Supreme Court shied away
from that extrapolation. For example in the first Bergy decision,
In re Bergy et al, U.S.C. CPA, Oct 6, 1977, Judge Kashwa,
concurring, said:
I agree with the result and the reasoning of the opinion
by Judge Rich joined by Chief Judge Markey. Nevertheless,
I wish to emphasize, out of a super-abundance of caution,
that I read the majority opinion as setting forth an
extremely limited holding. While the PTO and the dissenting
opinion raise the specter of patenting higher forms of
living organisms, quite clearly the majority opinion does
not support such a broad proposition. Each case must
necessarily be considered on its own facts. On the facts
of this case, I join the narrower confines of the majority
opinion.
The majority opinion stated (at p. 18):
...The nature and commercial uses of biologically pure
cultures of microorganisms ... are much more akin to
inanimate chemical compositions such as reactants, reagents,
and catalysts than they are to horses and honeybees or
raspberries and roses...
...they have come to be used to produce a vast variety of
chemicals and drugs such as alcohols, ketone, fatty acids,
amino acids, vitamins... and enzymes... In short, microorganisms
have come to be important tools in the chemical industry...
and when a new and useful tangible industrial tool is invented
which is unobvious, so that it complies with the prerequisite
to patentability...we do not see any reason to deprive it or
its creator or owner of the protection and advantage of the
patent system...As for the board's fears that our holding
will of necessity, or "logically," make all new, useful,
and unobvious species of plants, animals, and insects created
by man patentable, we think the fear is far fetched."
We ourselves are not persuaded that the idea is so far fetched or so
illogical. If an inventor creates a new and unobvious insect which
did not exist before (and thus is not a product of nature), and can
recreate it uniformly and at will, and it is useful (for example to
destroy the spruce bud worm), then it is every bit as much a new tool
of man as a microorganism. With still higher life forms it is of
course less likely that the inventor will be able to reproduce it
at will and consistently, as more complex life forms tend to vary more
from individual to individual. But if it eventually becomes possible
to achieve such a result, and the other requirements of patentability
are met, we do not see why it should be treated differently.
One of those requirements is that the application satisfy Sec. 36.
That section requires applicants to describe their inventions fully so
...as to enable any person skilled in the art or science
to which it pertains, or with which it is most closely
connected, to make, construct, compound or use it....
That axiom of patent law has been stressed repeatedly in our jurisprud-
ence. It was quoted by the Supreme Court of Canada in Western Electric
v Baldwin (1934) S.C.R. 570 @pp. 571-573 and repeated as recently as
January 19, 1982, by the Federal Court of Appeal in Beecham & Calgon v
Proctor & Gamble, at p.9
...the patentee must particularly describe and ascertain
the nature of his invention. In order that, after this
privilege is expired, the public may be able to do what
the patentee has invented, a must particularly describe
and ascertain the manner in which the same is to be
performed. (22 Hals. 161, Cert. 338)
Section 36 requires that the application should set forth the steps
of making the invention, in this case the new microorganism. Now the
creation of a new microorganism by mutation, or by other means, is
fraught with considerable difficulty, and it is by no means certain
that the inventor, or others following his directions, will be
able to produce it again using the original method of manufacture.
However a microorganism, being living matter, will reproduce itself on
the proper culture medium, so that the inventor can maintain his
supply indefinitely. If he places samples of the organism in a culture
collection to which others have access, they too will be able to
reproduce the organism, and thus have access to his invention, and
use it once the patent expires. The question will consequently arise:
is the deposition of the invention in the culture collection sufficient
to satisfy the requirements of Section 36?
We do not see why it would not be. It would certainly permit others to
make the invention, i.e. the microorganism. It will enable the
public "to do what the patentee has invented," as called for by Sec. 36,
i.e. to make the microorganism, and in most instances by the easiest,
most certain, most efficient, and best mode. This, we think, satisfies
the requirement of the Act.
This is indeed the solution accepted by the House of Lords in the
case of the American Cyanamid Company (Dannis) Patent, 1971 RPC 42,
which recognize that deposition of a microorganism in a national culture
collection would be an adequate description of the invention in
question because a person of ordinary skill could put the invention
into practice.
If deposition of a microorganism in a culture collection is sufficient
disclosure of it when an applicant claims a process utilizing that
organism, it seems strange indeed to hold it is inadequate when the
organism itself is claimed.
In both instances the public needs the organism to work the invention,
and in both instances it has it, through the culture collection.
What we should be concerned with is making the invention available.
Certainly the inventor should describe his original method of production,
and with such clarity that if it can be repeated others could do
so. But if the organism can subsequently only be reproduced from
itself, we do not see why the inventor should be deprived of his
reward provided, by deposition, he makes it available to others. Indeed
where it is possible we believe he should make use of both methods of
disclosure to reduce the danger of his invention being lost to mankind.
The organism, to be claimed should not of course have existed pre-
viously in nature, for in that event the "inventor" did not create it,
and his "invention" is old. It must also be useful, in the sense that
it carries out some useful known objective, such as separating oil from
sand, producing antibiotics or the like. It cannot be a mere
laboratory curiosity whose only possible claim to utility is as a
starting material for further research. And it must be sufficiently
different from known species that it can be said that its creation
involved the necessary element of inventive ingenuity.
In the present case we believe the product claims meet these tests,
and the objection should be withdrawn.
G.A. Asher
Chairman
Patent Appeal Board, Canada
I have reviewed the prosecution of the application and considered the
recommendations of the Patent Appeal Board. I concur with the reasoning
and findings of the Board. The rejection is withdrawn. The application
is remanded to the Examiner for further prosecution consistent with
this decision.
J.H.A. Gariepy
Commissioner of Patents
Dated at Hull, Quebec
this 22nd. day of June, 1982
Agent for Applicant
Sim & McBurney
330 University Ave.
Toronto, Ont.