COMMISSIONER'S DECISION
SECTION 2 - Reducing The Desire For Smoking
A method of administering a substance to a patient falls under Section 2 of the
Patent Act. The Applicant's amended claims are not directed to a medical
treatment.
Rejection Affirmed - Amended claims accepted.
****
Patent application 261,672 (Cl. 167-247) was filed on September 21, 1976 for an
invention entitled METHOD FOR ELIMINATING OR REDUCING THE DESIRE FOR SMOKING.
The inventor is Emanuel Revici. The Examiner in charge of the application took
a Final Action on December 11, 1979 refusing to allow it to proceed to patent.
The application is directed to a method of preventing or reducing the desire for
smoking tobacco in humans by administering a sulfurized polyunsaturated oil.
In refusing the method claims under Section 2 (the composition claims were found
allowable) the Examiner had this to say (in part):
The applicant in his letter argues that the process claimed
in this application is not a medical treatment because the
composition of the invention is not a medicine. He also
argued in his letter in response to the Office action dated
September 27, 1978 that the method was not for effecting the
prevention or cure of an ailment in humans. These arguments
however do not overcome the objection because the examiner
is convinced that the composition comes under the definition
of medicine. The applicant's attention is directed to the
definition of drug provided by Parliament for the purpose of
the Food and Drug Act (1970) R.S.C. modifying organic func-
tion in man or animal. According to this definition, the
composition of this application is clearly a drug and the
process of administering it to a human is therefore a method
of medical treatment. As to the second argument, the exam-
iner is convinced that a method for reducing or eliminating
the desire for tobacco in a human is a method of preventing
ailment. For example it is well-known that heavy smoking
causes lung cancer. The method of this application there-
fore falls well-within the definition of non-patentable sub-
ject matter, namely a method of preventing ailment using
drug.
Claims 1 to 19 and 38 to 40 must be removed since they are outside of
the scope of patentable invention as set forth in Section 2 of the
Patent Act.
In response to the Final Action the Applicant stated (in part):
The proper approach for considering whether or not the com-
position employed in the method of the invention, is a
"medicine" would therefore seem to be that one should consi-
der if in the ordinary and popular sense, rather than the
scientific sense, it would be considered a medicine. In
other words if the laymen or ordinary person should consider
the composition a medicine. It is respectfully submitted
that the ordinary person would not consider a composition
employed to reduce the desire for smoking to be a "medi-
cine". It is known, for example, to chew gum and suck pep-
permints or boiled sweets to alleviate the craving for
tobacco, however, such use would hardly be considered a
medical treatment by the ordinary person, and chewing gum,
peppermints and boiled sweets would hardly be considered
"medicine". It is also known to employ materials that will
produce an unpleasant taste during smoking, whereby smoking
is discouraged, it is not thought that this would be consi-
dered a medical treatment by the ordinary person in the or-
dinary and popular sense as opposed to the scientific sense.
Even materials apt to be used in medicine or during surgery
have been considered as not being medicines. For example,
in Burton Parsons Chemicals Inc. et al v. Hewlett-Packard
(Canada) Ltd. et al, reported in 17 CPR (2d) 97, the Supreme
Court found that an electrocardiograph cream was not a medi-
cine or even "intended for medicine". In the Decision of
the Court it was commented -
"It is clear that such (that is the use) is primarily
and mainly for the taking of electrocardiograms in
routine examinations, not necessarily or mainly in
connection with the treatment of diseases. It is ob-
viously a matter of some difficulty to draw the line
between what is a medicine and what is only a product
apt to be used in connection with medical treatments."
The composition of the present invention is neither a medi-
cine nor a product apt to be used in connection with medical
treatments.
It is respectfully submitted that the approach taken in the
Official Action, by reference to the definition of drug in
the Food and Drug Act, is not the proper approach, and is
not the approach that has been sanctioned by the Courts, and
that the rejection on this ground therefore fails.
The issue before the Patent Appeal Board is whether or not method claims fall
under the provisions of Section 2 of the Patent Act. Method claim 1 reads:
1. A method for eliminating or reducing the desire for tobacco in a
human which comprises, internally administering thereto a liquid
composition produced by the process comprising oxidizing a liquid
containing allylic unsaturation of the type
-CH=CH=CH2-CH=CH-
and/or
-CH=CH-CH=CH-CH2-
selected from fatty acids and fatty esters for a period of time
sufficient to produce a peroxide titer substantially greater than that
of the untreated compound, in an amount sufficient to eliminate or
reduce the craving for tobacco.
On a complete review of the prosecution of the application we find nothing to
change our stand on whether or not a method of administering a substance to a
patient falls under Section 2 of the Patent Act. Our stand is that any
substance for use in modifying organic functions in man or animal is a medicine
in the broad sense and any method directed to a medical treatment falls under
Section 2 of the Patent Act. There is no doubt but that the presently claimed
substance "a sulfurized polyunsaturated oil" modifies the organic functions of
the body as a consequence of use.
With this in mind, we contacted the Agent Mr. K. Murphy and discussed our view
with him. After due consideration, Mr. Murphy, on September24, 1981 cancelled or amended
all of the method claims and renumbered the composition claims accordingly.
No further discussion is therefore deemed necessary and we recommend that the
composition claims be accepted.
J.F. Hughes
Assistant Chairman
Patent Appeal Board, Canada
I have reviewed the prosecution of this application and concur with the
easoning and findings of the Patent Appeal Board. Accordingly, I direct that
prosecution should resume on the basis of the amended claims.
J.H.A. Gari‚py
Commissioner of Patents
Dated at Hull, Quebec
this 29th. day of October, 1981
Agent for Applicant
Swabey, Mitchell, Houle & Sher
111 Richmond Street West
Suite 200
Toronto, Ontario
M5H 2G4