Commiessioner's decision
Section 41: Diamines and addition salts of diamines used as medicines and
non-medicines. Claims 17 to 22 are refused because they cover diamine salts,
which are medicines. The examiner's refusal is confirmed.
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Pursuant to s 47(5) of the Patent Rules, applicant L'Oreal has requested a
review of the examiner's final action in patent application 227,052, (Class
260/597.7). The inventors are Bernard Jaequet and Gerard Lang, and their
application is entitled "New diamines, their preparation and use".
The examiner dismissed claims 17 to 22 for failure to comply with the
requirements of s 41 of the Patent Act. These claims relate to certain new
diamines and their addition salts with acids.
Diamine addition salts have interesting germicidal and, in particular,
bactericidal and fungicidal properties, which make them useful in
chemotherapy. As such, they must be restricted to the process by which they
are manufactured. Following the examiner's refusal, applicant withdrew all
claims for the salts themselves (claims 23 and 24). At the same time, he
declared that claims 17 to 22 should not be refused, because they relate to
the diamines themselves, that is, to free amines, while it is only amine salts
that are medicines. Actually, the only independent claim for a product (17)
is made for diamines and their addition salts. The claim reads as follows:
Diamines with general formula I:
(See figure I)
and their addition salts ...
Therefore, claims 18 to 22, which depend directly or indirectly on claim 17,
are not restricted to free amines. Diamine salts are also diamines, because
there are amino radicals in their molecules. Thud, if claim 19, for example,
relies on the diamines in claim 17, it necessarily covers the salts mentioned
in claim 17. If claim 18 had been restricted to free diamines, the salts
would have been excluded, but this was not the case. We conclude that claims
17 to 22 cover free amines and amine salts as well. We cannot agree with
applicant's statement in his letter of December 12, 1979, p 3:
Claims 17 to 22 do in fact relate to free amines. . . .
To settle all the issues, we must also determine whether the free diamines are
also governed by s 41, even if they were claimed separately, that is, without
the salts.
The grounds for the examiner's refusal were stated as follows:
Claims 17 to 22 involve free amines used
as intermediates in preparing the salts
defined in claims 23 and 24 (see examples
of preparation of these salts on pages 17
and 18). These amines are therefore
governed by s 41(1) pursuant to the
Commissioner's decision published in the
Patent Office Record on January 21, 1975.
The fact that the applicant employs these
intermediates in the preparation of
polymers with cosmetic properties in no
way alters the fact that they are also
compounds "intended for medicine".
The examiner cited the Cheney decision, also published in (1975) 17 Canadian
Patent Reporter (2d) 165. References to this decision will be to this
publication.
Applicant argued that, since free amines cannot be used to prepare cationic
polymers for cosmetics, the provisions of s 41 do not apply. He explained
that the polymers moisturize and soften the skin and that this is a
non-medical use.
He added that their germicidal, bactericidal and fungicidal properties make
them useful as preservatives for leather and paper. It should, however, be
noted that when the polymers are used on human skin, their germicidal and
bactericidal properties have a therapeutic effect on skin tissue.
In arguing against Cheney, applicant stated:
Actually, this case concerns
intermediates, whose only utility lies in
the production of medicines. Similarly,
in the British decision (39 CPR 163) on
which the Commissioner of Patents relied
in Lee C Cheney, products were involved
whose sole use was in the production of
food products.
He further said:
At page 172 of Cheney, it is even
indicated explicitly that this decision
is not applicable to products which could
be used in the preparation of medicines,
but which have another use outside the
area of medicine:
Whether it would also apply
to chemical substances
whose intended use is
non-medicinal but which may
also be capable of being
used to prepare medicines
. . we need not determine
here.
In Cheney, the intermediate products, which by themselves would have prevented
access to the penicillins, were the only commercial means available for
preparing a certain type of penicillin. Applicant stated:
In Cheney, the Commissioner of Patents
seems to have based his decision
primarily on the fact that the
intermediates claimed were key products
in the commercial manufacture of known
penicillins, and were an essential step
in preparing other penicillins. In this
case, protection of the intermediates
would have resulted in preventing access
to these important penicillin derivatives.
He argued that this case is different, because:
. . . it is well known that amine salts
can always be prepared directly without
going through the free amine stage.
Nevertheless, in the specification, on lines 22 to 25 of page 5, for example,
we find:
Formula I diamine salts are prepared by
the usual methods, by the addition of
Formula X-H acids to Formula I diamines,
with X defined as above.
Since both applicant and the examiner cited Cheney, we have carefully studied
this decision, particularly pages 169 to 173, published at (1975) 17 CPR (2d).
The decisions which were considered in Cheney clearly indicate that s 41 and
the expression "intended for medicine" should be broadly interpreted, and that
this interpretation applies to all precursors for the preparation of medicinal
compounds. Therefore, free diamines and diamine salts are intended for
medicine.
We do not think it is important that the precursors provide the only means of
manufacturing the medicines. It was a supplementary ground in Cheney, but the
other reasons are sufficient for holding that s 41 applies here.
Applicant emphasized the following statement from Cheney:
Whether it would also apply to chemical
substances whose intended use is
non-medicianl but which may also be
capable of being used to prepare
medicines within the meaning of Parke,
Davis v Fine Chemicals, supra, at
pp 66-7, we need not determine here.
He indicated that this decision is not "applicable to products which can be
used in the preparation of medicines, but which have another use outside the
area of medicine."
However, the excerpt cited does not goes so far. If the intended use is
non-medicinal, but the product is incidentally suited to a medicinal use, it
is possible to argue that it is not intended as a medicine; but if the product
is intended for non-medicinal use and also for use as a medicine, then it is
intended for medicine.
According to the specification, the products were clearly intended to be used
as medicines. See, for example, page 8, line 16 to page 9, line 13.
We find, therefore, that the substances under consideration, free diamines and
also their salts, are intended for medicines. We also find that claims 17 to
22 inclusive cover diamine salts which are themselves medicines, and finally,
that a number of other cosmetic uses have a medicinal character because they
improve the skin and free it of bacteria. We recommend that the refusal of
claims 17 to 22 be confirmed.
(sgd)
G Asher
Chairman of the Patent Appeal Board
I concur with the findings of the Patent Appeal Board and refuse claims 17 to
22. Pursuant to the provisions of s 44 of the Patent Act, the applicant has
six months to appeal this decision or to withdraw these claims.
Agent for the Applicant
Robic, Robic & Associates
1514 Docteur Penfield
Montreal, Quebec
H3G 1X5
(sgd)
JHA Gari‚py
Commissioner of Patents
Dated at Hull, Quebec
This 4th day of September, 1981