IN THE CANADIAN PATENT OFFICE
DECISION OF THE COMMISSIONER OF PATENTS
Patent application number 484,723, having been rejected under
Subsection 47(2) of the Patent Rules, the Applicant asked that
the Final Action of the Examiner be reviewed. The rejection has
consequently been considered by the Commissioner of Patents.
Agent for Applicant
Smart & Biggar
P.O. Box 2999, Station D
Ottawa, Ontario
K1P 5Y6
This decision deals with the Applicant's request for a review of
the Examiner's Final Action on patent application number 484,723
(Class 195-1.22) which was filed on June 21, 1985 for an
invention entitled "TRANSGENIC ANIMALS". The inventors are
Philip Leder and Timothy A. Stewart and the application was
assigned to the President and Fellows of Harvard College. The
Examiner in charge issued the Final Action on March 24, 1993
refusing claims 1 to 12 and declaring claims 13 to 26 to be
allowable. The Applicant replied on September 24, 1993
requesting a review by the Commissioner of Patents and an oral
hearing before the Patent Appeal Board and subsequently a hearing
was held on July 28, 1994 at which Joy Morrow represented the
Applicant. I have subsequently reviewed the prosecution of the
application and discussed the rejection with the Board before
rendering my decision.
The application is directed to a transgenic mammal, in particular
a transgenic mouse which can be used as a test vehicle for
substances suspected of being carcinogenic or for substances
thought to confer protection against the development of
neoplasms.
The inventors have constructed myc gene-containing plasmids by
deleting selected regions from a specific plasmid and replacing
them with myc regions to construct the required plasmid. Copies
of the linearized myc gene-containing plasmid are injected into
the male pronucleus of fertilized one-cell mouse eggs derived
from matings between C57BL/6J and CD-1 types of mice. The
injected eggs are transferred into pseudo-pregnant foster females
sad allowed to develop to term. Introducing the myc gene
sequence at the fertilized one-cell egg stage ensures that the
gene will be present in all of the germ cells and the somatic
cells of the transgenic animal.
Offspring are tested for the retention of the injected sequences
by Southern blot analysis of DNA extracted from the tail.
Several offspring referred to as founder mice, were found to have
integrated the myc gene. The presence of the myc gene in the
germ cells of the transgenic founder animal in tuna means that
all the founder animal's offspring that inherit the gene will
carry the gene is their germ cells and somatic cells. The
founder animals were then mated to uninjected mice and analysis
of the DNA of the resulting transgenic offspring indicated that
the injected oncogene was transmitted through the germline in a
ratio consistent with Mendelian inheritance of single loci.
The application contains 26 claims with claims 1 to 12 being
directed to transgenic mammals and claims 13 to 26 being directed
to processes for producing the transgenic mammals, to the
transgenic cell culture and a process for producing it, to
various plasmids bearing the oncogene and towards the use of the
invention to test a material suspected of altering neoplastic
development in a mammal. Claims 1, 11 and 12 which are
representative of the rejected claims are as follows:
1. A transgenic non-human mammal whose germ cells and somatic cells
contain an activated oncogene sequence introduced into said mammal, or an
ancestor of said mammal, at an embryonic stage.
11. The mammal of claim 1, said mammal being a rodent.
12. The mammal of claim 11, said rodent being a mouse.
In his rejection of claims 1 to 12 the Examiner stated, inter
alia, that the Commissioner has both a right and an obligation to
consider the public interest in the granting of a patent. There
is some implication in this interpretation of the Commissioner's
duty under the Patent Act that the Commissioner can decide that a
particular invention can be found unpatentable as a matter of
policy or discretion rather than as a result of an interpretation
of the provisions of the Act.
In this regard the Commissioner's duty is clear from the
statement of the Supreme Court in Monsanto Co. v. Commissioner of
Patents 4a C.P.R. (2d) 161, addressing section 40 (then section
42) of the Patent Act at page 177, that:
In this respect it is important to note that s. 42 of the Patent Act reads:
42. Whenever the Commissioner is satisfied that an applicant is
not by law entitled to be granted a patent he shall refuse the application
and, by registered letter addressed to the applicant or his registered
agent, notify the applicant of such refusal and of the ground or reason
therefor.
I have emphasized by law to stress that this is not a matter of discretion: the
Commissioner has to justify any refusal. As Duff, C.J., said in Vanity Fair Silk
Mills v. Commissioner of Patents, [1938] 4 D.L.R. 657, [1939] S.C.R 245 at p.
246:
No doubt the Commissioner of Patents ought not to refuse an
application for a patent unless it is clearly without substantial
foundation.
I note also that in the case relied on by the Examiner,
Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft
Vormals Meister Lucius & Bruning 41 C.P.R. 9 there is no
suggestion in the decision that it was based on anything other
than an interpretation of the Patent Act as to what constitutes
an invention, the Court stating, at page 17, that:
................There is no inherent common law right to a patent. An inventor gets
his patent according to the terms of the Patent Act, no more and no less.
It follows that in order to reject an application as being
directed to unpatentable subject matter, I must be satisfied that
by law the applicant is not entitled to a patent and be able to
give reasons based on an interpretation of the Patent Act and any
applicable jurisprudence.
The issue that I have to decide is therefore whether or not
claims 1 to 12 of the application claiming non-human mammals are
directed to patentable subject matter as defined by Section 2 of
the Patent Act which reads follows:
"invention" means any new and useful art, process, machine, manufacture or
composition of matter, or any new and useful improvement in any art, process,
machine, manufacture or composition of matter,
This definition refers to five categories of invention, clearly
the first three, "art", "process" and "machine" are inapplicable
when considering claims directed towards a non-human mammal
prepared using the techniques of genetic engineering.
The patentability of inventions involving genetic engineering has
been considered by the Supreme Court in Pioneer Hi-Bred Ltd. v.
Commissioner of Patents 25 C.P.R. (3d) 257. The Court identified
two types of genetic engineering (at page 263). The first type
involves crossing different species or varieties by
hybridization, altering the frequency of genes over successive
generations, this being the method by which Pioneer Hi-Bred's new
variety of soybean was produced. The second type is that which
requires a change in the genetic material, an alteration of the
genome affecting all the hereditary material since the
intervention occurs in the gene itself at the molecular level.
While the first type of genetic engineering implies as evolution
based strictly on heredity and Mendelian principles, the second
employs a sharp and permanent alteration of hereditary traits by
a change in the quality of the genes. In conclusion the Court
stated on page 264 that:
The intervention made by Hi-Bred does not in any way appear to alter the
soybean reproductive process, which occurs in accordance with the laws of
nature. Earlier decisions have never allowed such a method to be the basis for a
patent. The courts have regarded creations following the laws of nature as being
mere discoveries the existence of which man has simply uncovered without
thereby being able to claim he has invented them. Hi-Bred is asking this court to
reverse a position long defended in the case-law. To do this we would have, inter
alia, to consider whether there is a conclusive difference as regards patentability
between the first and second types of genetic engineering, or whether distinctions
should be made based on the first type of engineering, in view of the nature of
the intervention. The court would then have to rule on the patentability of such
an invention for the first tame.
In view of the complexity presented by the question as to the cases in
which the result of genetic engineering may be patented, ....., and since I share
the view of Pratte J. that Hi-Bred does not met the requirements of s. 36(1) of
the Ad, I choose to dispose of this appeal solely on the latter point.
It is apparent that the Supreme Court deliberately chose not to
decide whether the soybean resulting from artificial cross-
breeding was a patentable invention under Section 2 of the Act.
I do note however, although obiter, the Court commented on the
patentability of creations that occur in accordance with the laws
of nature. It suggests that creations of the reproductive
process have never been allowed to form the basin of a patent
because they are following the laws of nature, they are mere
discoveries the existence of which man has simply uncovered.
I now turn to the Federal Court of Appeal decision is Pioneer Hi-
Bred 14 C.P.R. (3d) 491, which did consider the refusal of the
application on the grounds that a cross bred variety of soybean
was not a manufacture or composition of matter within the meaning
of Section 2 of the Act. The Court considered the decision of
the U.S. Supreme Court is Diamond v. Chakrabarty (1980). 447 U.S.
303 in examining the expressions "manufacture" and "composition
of matter" as they appear in s. 2 of the Patent Act and noted:
...especially to the following definitions relied upon by the United States Supreme
Court in Chakrabarty:
manufacture : the production of articles for use from raw
materials prepared by giving to these materials new forms,
qualities, properties or combinations whether by hand labor or
machinery
composition of matter : all compositions of two or more substances
and ... all composite articles whether they be the result of chemical
union or of mechanical mixture, or whether they be gases, fluids,
powders or solids.
I have not bees convinced. Even if these definitions were held to be applicable to
a micro-organism obtained as a result of a laboratory process, I am unable to go
further and accept that they can also adapt to a plant variety produced by cross-
breeding. Such a plant cannot really be said, other than on the most metaphorical
level, to have been produced from raw materials or to be a combination of two or
more substances united by chemical or mechanical means. It seems to me that
the words "manufacture" and "composition of matter" would be distorted if a
unique but simple variety of soybean were to be included within their scope.
The Federal Court of Appeal also noted that plant breeding was
well established when the Patent Act was passed so that if a new
plant variety had been intended to be included in the definition
of invention. Parliament would have included special provisions
in the statute. The Court summarized their finding as follows,
at page 497:
In sum, relying on the common meaning of the words of the definition of
"invention" as it appears in the Act and on the legislative context in which they
are found, in so far as the intention of Parliament may be derived therefrom, I
am satisfied that the soybean variety developed by the appellant cannot be the
subject-matter of a patent of invention.
In his Final Action, the Examiner stated that he was bound by the
Federal Court of Appeal decision in the Pioneer Hi-Bred case.
However the Applicant has argued that the Examiner is not bound
by that decision since the Supreme Court made its decision on
grounds different from those used by the Federal Court and also
on a different factual basis. In support of its argument the
Applicant has referred to the decision in R. v. Secretary of
State for the Home Department, ex parte Al-Mehdawi [1989] 1 All
E.R. 777 where it was held that where the House of Lords had
decided that an issue which was argued in the Court of Appeal was
not required to be decided on appeal to the House and where the
House expressed no view as to the soundness or otherwise of the
Court of Appeal's reasoning on that issue, the Court of Appeal's
decision on that issue was not binding on another division of the
Court of Appeal.
Since the situation in the Pioneer Hi-Bred case is similar to
that in the Mehdawi case in that the Supreme Court decided the
appeal in Pioneer Hi-Bred on different grounds than those used in
the Federal Court, I agree with the Applicant that the Federal
Court decision in Pioneer Hi-Bred is not binding on me, or on the
Examiner. I do however note that the Mehdawi case stated (at
page 781) that, while the lower court decision was not binding,
it was of high persuasive influence on subsequent decisions.
My predecessor had to consider claims directed towards micro-
organisms in Re Application of Abitibi Co. 62 C.P.R. (ad) 81
wherein the invention related to microbial cultures taken from
domestic and modified or acclimated sulfite liquor. The
Commissioner was satisfied that micro-organisms such as yeast,
mold, fungi, bacteria, actinomycetes, unicellular algae, virus or
protozoa can be the subject of patent protection. However, the
Patent Appeal Board, on whose recommendation the Commissioner's
decision was based, was reluctant to consider claims to higher
life forms patentable stating, at page 90, that:
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 micro-organism. 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.
In its argument the Applicant has referred to the practice before
the United States Patent and Trademark Office pointing out that
its corresponding United States application issued on April is,
1988 as patent number 4,736,866 containing claims to a transgenic
non-human mammal. The definition of invention is the U.S. which
is embodied in 35 U.S.C. s. 101 employs language which is very
similar to that found in s. 2 of the Patent Act. Since the
statutory definitions of invention used is both countries are so
similar, the Applicant argued that I should follow the same
practice with regard to life forms as is followed in the United
States. I do not however consider that much weight can be given
to United States practice in interpreting Canadian legislation.
In my view the words "manufacture" and "composition of matter" as
found in Section 2 apply to something that has been made under
the control of the inventor. In the case of "manufacture" it is
the production of articles for use from starting materials,
prepared by giving these materials new forms, qualities.
properties or combinations whether by hand labour or machinery.
As to the term "composition of matter" I would construe the term
broadly to include not only the result of chemical union or
mechanical admixture but also microbiological, or genetic
engineering techniques so long as they are performed and
controlled by the human hand. At the same time the resulting
product moat be reproducible in a consistent manner.
What the inventors have done in the instant application is to
genetically engineer mvc gene containing plasmids which are
thereafter injected into the mouse eggs which in turn are
injected into the female mouse and allowed to develop to term.
To my mind there are two distinct phases involved, firstly the
preparation of the genetically engineered plasmid and secondly
the development of a genetically engineered mouse is the uterus
of the host mouse. In the first phase it is human intervention
that controls the production of the plasmid by choosing the
necessary enzymes and processing conditions to make the plasmids.
In the second phase it is the laws of nature that take over to
produce the mammalian end product. In my view different
considerations apply between claims to the lower life forms of
the Abitibi decision and the higher life forms claimed in the
instant application.
Since the plasmids and the transgenic unicellular material are
produced under the full control of the inventor and are
reproducible, I am satisfied that they are a "manufacture" or a
"composition of matter" under Section 2 of the Act. I note that
no objections, based on Section 2, were raised against such
claims in the instant application.
However I cannot extend the meaning of "manufacture" or
"composition of matter" to include a non-human mammal. On the
plain and ordinary meaning of the words, and here I am strongly
influenced by the Federal Court of Appeal decision in Pioneer Hi-
Bred, I do not find that a non-human mammal like a mouse falls
within the definition of "invention". The inventors do not have
full control over all the characteristics of the resulting mouse
since the intervention of man ensures that reproducibility
extends only as far as the cancer forming gene.
Having regard to the above and in applying the test enunciated in
Section 40 of the Act, I am satisfied that the Applicant is not
by law entitled to be granted a patent containing.claims 1 to 12
and therefore I refuse to grant a patent containing these claims
on this application.
M. Leesti
Commissioner of Patents
Dated at Hull, Quebec
this 4th day of August 1995