Section 2; New Use for known compounds:
In view of Shell Oil v Commissioner of Patents (1982) SCR 536,
the refusal of claims 1 to 4 for a new use of a known compound,
and claims 7 to 9 directed to the use of a compound, were
considered acceptable. Rejection withdrawn.
This decision deals with Applicant's request for review by the Commissioner
of Patents of the Final Action on application 400,261 (class 167-238) filed
March 31, 1982. It is assigned to Wayne State University and is entitled
"Method for Treating Tumor Cell Metastasis and Growth". The inventors are
W.D. Busse, K.V. Honn, E. Moller and F. Seuter. The Examiner in charge
issued a Final Action on June 6, 1985 refusing to allow the application. A
Hearing was originally requested but it was subsequently withdrawn by
Applicant's letter dated June 2, 1988.
The subject matter of the application relates to a therapeutic method for
reducing metastasis and neoplastic growth in a mammal. A therapeutically
effective amount of 3-Methyl-1-[2-(2-naphthyloxy)-ethyl]-2-pyrazolin-5-one
or a pharmaceutically acceptable salt is administered to the patient.
In the Final Action the Examiner refused allowance of claims 1 and 4 based
on the teaching of United States Patent 4,053,621 and claims 7 to 9 on
Section 2 of the Patent Act. That action stated (in part):
The applicant in his letter argues that claim 1 is
patentable because it is directed to a pharmaceutical
composition for reducing metastasis and neoplastic growth
in a mammal. This argument however, does not overcome the
objection to claim 1. As stated in the last Office Action,
the composition of this application is the same as the
composition taught in the United States patent even the
dosage form (the reference is made to page 6 of this
application and that of the U.S. patent). The examiner
recognizes that the applicant has made a discovery, namely
a new use for an old composition however, this newly
discovered use does not made the old composition new and
patentable.
The applicant's argument against the rejection of claim 4
has been noted however, it does not overcome the objection
because again the active ingredient is known and the
effective dosage form is taught in the reference cited above
therefore, the direction does not make this claim
patentable. The only difference between claim 4 and the
teachings of the cited reference is the intended use and
this difference is not enough to make claim 4 patentable.
Claims 7 to 9 directed to the use of a compound are not
within the definitions for patentable invention in Section
(2) of the Patent Act. The use is neither a process nor a
composition. The applicant argues that the use of the
active ingredient should be construed as extending to cover
activities which can be regarded as "industrial" in
character but not extending to the actual treatment of
disease by administration of the active ingredient. This
argument does not overcome the objection because as already
mentioned above, the use describes neither the process nor
the product (composition).
In response to the Final Action the Applicant added new claims 10 to 17.
That response stated (in part):
Applicant's invention resides in the determination that the
compound 3-methyl-1-(2-(2-naphthyloxy)-ethyl]-2-pyrazolin-
5-one or a pharmaceutically acceptable salt of this compound
can be used for reducing metastasis and neoplastic growth.
Applicant has therefore made an important invention.
Indeed, the Examiner recognizes that Applicant has made a
useful discovery. Considerable expense has been incurred in
determining and proving the invention, and Applicant is
naturally anxious to obtain whatever patent coverage is
available to protect the invention. Clearly it is the
intention of Parliament that, except in certain specified
categories, inventions shall be the subject of patent
protection. Furthermore, it is clearly the intention of
Parliament that an Applicant for patent shall be accorded
the benefit of any doubt as to whether he is entitled to a
patent; see Section 42 of the Patent Act and also the words
of Pigeon J. in Monsanto v. Commissioner of Patents in the
Supreme Court of Canada. It is asserted, and the Examiner
apparently agrees, that Applicant has made a valuable
invention. Applicant is therefore entitled to a patent
unless the invention falls within one of the aforementioned
categories for which patent protection is not available.
While, of course the Examiner is not permitted to allow
claims to an invention which falls within one of the
aforementioned categories, it is respectfully submitted that
the Examiner should himself be anxious to allow claims to a
valuable invention if he is permitted to do so.
Claims 1, 4 and 7 to 9 are rejected in the final action of
June 6, 1985. They are rejected for reasons which were
previously expressed in an Official Action of December 19,
1984. A detailed response to that Official Action was filed
on March 19, 1985. Without repeating all the arguments of
the letter of March 19, 1985, we wish to adopt them as part
of the present response.
Applicant now puts forward additional claims for protecting
different aspects of the invention. New claim 10 is
directed to a method for determining antimetastatic or
antineoplastic activity in vitro on particular tumor cells.
This aspect of the invention is clearly not disclosed in the
cited United States Patent No. 4,053,621, which contains no
mention of metastasis or neoplastic growth. It is therefore
respectfully submitted that this subject matter is clearly
allowable.
The issue before the Board is whether or not claims 1 and 4 patentably
differentiate over the cited reference and claims 7 to 9 are within the
definitions for patentable invention under Section 2 of the Patent Act.
Claim 1 reads as follows:
A pharmaceutical composition in dosage unit form suitable
for oral or parenteral administration for reducing
metastasis and neoplastic growth in a mammal, which
comprises as active ingredient 3-methyl-1-[2-(2-naphthyloxy)
-ethyl]-2-pyrazolin-5-one or a pharmaceutically acceptable
salt thereof in an amount effective to reduce metastasis and
neoplastic growth in a mammal, in admixture with a suitable
pharmaceutically acceptable diluent or carrier.
Considering first the refusal of claims 1 and 4 based on the teaching of
United States Patent 4,053,621. From the Final Action we are informed that
the composition of the application is the same as that of the cited patent
but the Examiner recognizes that the applicant has made a discovery "namely
a new use for an old composition". He states that the "only difference
between claim 4 and the teaching of the cited reference is the intended use
and this difference is not enough to make claim 4 patentable".
The applicant argues that his invention resides in the determination that
the compound 3-methyl-1-[2-(2-naphthyloxy)-ethyl]-2-pyrazolin-5-one or a
pharmaceutically acceptable salt thereof can be used for reducing
metastasis and neoplastic growth. He states that considerable expense was
incurred in determining and proving the invention and that he is entitled
to a patent since it is the intention of Parliament that, except in certain
specified categories, inventions shall be the subject of patent protection.
We have reviewed the position of the Examiner and the arguments submitted
by the Applicant. The comments of Mme. Justice Wilson in Shell Oil v.
Commissioner of Patents Supreme Court of Canada November 2, 1982 are
applicable when she stated the following:
If I am right that the discovery of a new use for these
compounds which is capable of practical application is an
"invention" within the meaning of the definition, I can
find nothing in the statute which would preclude a claim
for these compositions. Section 36 does not seem to
present a barrier because the inventive ingenuity here lies
in the new use for the old compounds and not in the
compounds themselves. Having discovered the use, the
appellant has then combined the compounds with the
appropriate carriers for their application to plants. It
is not, in my view, necessary in the case of the discovery
of a new use for an old compound that the combination of
the compound with the adjuvant be itself novel in any sense
other than that it is required in order to give effect to
this particular use of the compound. This is not a case
where the inventive ingenuity is alleged to lie in the
combination; the combination is simply the means of
realizing on the newly discovery potential of the
compounds. This is a case where the inventive ingenuity is
in the discovery of the new use and no further inventive
step is required in the application of the compounds to
that use, i.e. in the preparation of the appropriate
compositions.
Consequently we find that a new use for the known compound is an invention
which may be entitled to patent claim protection. We recommend that the
rejection of claims 1 and 4 be withdrawn.
Turning now to the rejection of claims 7 to 9 as "directed to the use of a
compound are not within the definitions for patentable invention in Section
(2) of the Patent Act". The rejection states that the use described in the
rejected claims describes "neither the process nor the product
(composition)".
The applicant maintains that he has complied with the requirements imposed
under Section 36(2) of the Act as one claims in explicit terms the things or
combinations that he regards as new. Additionally he states that if the
best way of complying with the requirement under Section 36 is to express
the claim in terms of a use, then it is appropriate to do so. He argues
that rejection of the claimed use as not patentable subject matter is not
justified as many inventions involve the use of substances or artifacts.
While it is true that the rejected claims do not describe a process or a
product this does not in this case make them fall outside of the definition
of invention set forth in Section 2 of the Patent Act. The Applicant has
argued that the claims to the use of the active ingredient should be
construed as extending to cover activities which can be regarded as
"industrial' in character. In the Final Action it is acknowledged that the
applicant has made a discovery "namely a new use for an old composition".
We believe that since the Applicant has a new use for an old composition he
should be entitled to claim that use. The fact that the claims do not
describe a process or a product does not by itself constitute a valid basis
for rejection of these claims. Therefore, in our view, the refusal of
claims 7 to 9 should be withdrawn.
We make no comment with respect to claims 10 to 17 which were added to the
application m response to the Final Action.
In summary we recommend that the refusal of claims 1 and 4 and claims 7 to
9 be withdrawn.
M. G. Brown S. D. Kot
Acting Chairman Member
Patent Appeal Board
I have reviewed the prosecution of the application. I concur with the
findings and recommendations of the Patent Appeal Board. Accordingly, I
withdraw the Final Action, and I am remanding the application to the
Examiner for prosecution consistent with the recommendation.
J.H.A. Gari‚py
Commission of Patents
Dated at Hull, Quebec
this 20th day of September 1988
Fetherstonhaugh & Co.
Box 2999, Station D
Ottawa, Ontario
K1P 5Y6