COMMISSIONER'S DECISION
Patentable Subject Matter: Pharmaceutical Package
The claims were for a package of contraceptive pills so arranged as to
be adapted to the use to which they would be put. The examiner had
considered the package to be an artificial manner of claiming a method
of preventing conception, which method he considered to be unpatentable.
The Board concluded that the package was a novel application of the
discovery made by the applicant, with the pills so arranged in the
new daily order to take advantage of that discovery.
FINAL ACTION: Reversed
This decision deals with a request for review by the Commissioner of
Patents of the Examiners Final Action dated September 14, 1973, on
application 003,772 (Class 167-191). The application was filed on
October 30, 1967, in the name of Gerrit L. Ijzerman and is entitled
"Method For Stimulating Anovulatory Cycles And Pharmaceutical Packages."
The application relates to a package of pills particularly arranged so
that they may be used in a method for stimulating anowlatory cycles
in females by administrating oestrogenic and progestative substances
during a certain period of such cycles.
In the Final Action the examiner rejected all the claims for the reason
that:
a) The oestrogenic and progestative to be used are
known copounds as applicant agrees in his reply
of June 1, 1972.
b) Applicant's alleged invention appears to reside in
the method of usin the known active ingredients in
a de fined sequence i.e. "The Normophasic method for
controlling anowlatory cycles". A method of treating
females mammals does not constitute a patentable
subject matter. The claimed package is an artificial
manner of claiming that method.
In that action the examiner stated (in part):
Applicant argues that:
"Such a position appears to be unreasonable as it could
always be argued that any product needs a process to pre-
pare it and can be used in a method of carrying out some
desired operation".
This argument is not very well founded. Applicant in the
disclosure at page 2 starting at line 14 teaches:
"An entirely new method of treatment (emphasis added) has
now been found which has proved to be fully reliably
and which imitates as accurately as possible the hormonal
ratios during the normal ovulatory physiological cycles
of the subject, so that, for example, the built up of the
uterine membrane and the changes in the cervical membrane
also follow the physiological pattern which is not
the case in the methods that have been adopted so far".
And continues from lines 22 to 30 to explain that:
"The method according to the invention consists in
that the treatment with oestrogenic and progestative
compound (emphasis added) covers a period ......"
Therefore applicant appears that he discovered a new method for
stimulating anovulatory cycles to a female mammal by using known
oestrogenic and progestative compounds in a way to imitate the
physiological ratios and timing of hormones of a female subject
and the statement that "Applicant's claimed package is an
artificial manner of claiming that method" is well founded.
c) In claim 1 the claimed pack containing discrete units
of two different active ingredients acting in sequence
and independently of each other and the printed instruct-
ions represents an aggregation of known components and
does not represent a novel composition of matter and
furthermore the statement in claim 1 "together with written
or printed indications or directions, the indications or
directions and the manner of packing being such as to
provide guidance in relation to and to facilitate the
taking...." is functional and indefinite thereby contrary
to Section 36(2).
d) A doctor can prescribe the two different discrete dosage
units and write a detailed instructions or directions for
the sequence the patient has to follow to obtain the
expected from the "Normophasic method" of stimulating an
ovulatory cycles results and in doing that provide the
necessary guidance. Applicant in claim 1 describes an arrangement
of known medicaments as a convenient way of carrying out a
medical expert's directions.
The applicant in his response dated December 13, 1973 relies on his
previous argument in support of the patentability of claims 1 to 10. His
response of June 1, 1972 reads in part;
Applicants are well aware of the fact that the medicinal compounds
that are specified in the claims are known in the art. However
the "Normophasic Method" and the application thereof in the form
of the claimed package certainly cannot be considered to be known
matter. Such a package containing oestrogenic and progestational
pills in a ratio and a sequence as indicated in the specification
and as set out in the claims has never been made or used before
the present invention was made.
This "Normophasic Method" has been proved to be very reliable in
that no pregnancy occurs which is a claim that cannot be made
with any real basis for any of the previously known methods. A
further and very important advantage of the present method
(which consists in a particular arrangement and respective
particular numbers of both types of pills) as applied in the
package of this invention, is that the hormonal balance corresponds
with that of the normal menstruation cycle resulting in the same
physiological changes is the female body as those occurring in
the normal ovulatory cycle. It will be clear, that this will
only be possible, by using pills having different effects,
which pills must be present in a particular ratio and in a
particular sequence to make sure that they are taken in the
right order (by means of a special construction of the package
and/or indications).
Although the present invention cannot be considered a composition
in the usual sense, applicants do not consider that their in-
vention is concerned with a single medicinal compound nor with
a mere two component package. As indicated above it is the
very combination obtained by composing the described claimed
package which gives the remarkable result of absolutely ex-
cluding unwanted pregnancy. The use of only one type of the
pills or the use of both types in the wrong order or over an other period
will not do this. Hence it is applicants opinion that the present
invention contains all the requirements to be patentable.
The question which the Board must consider is whether the applicant has
made and properly claimed a patentable advance in the art. Claim 1 is
directed to:
A pack of between 20 and 27 discrete dosage units such as tablets,
pills or capsules for human oral administration at the rate of
one unit per day over a period of between 20 and 27 successive
days in order to stimulate anovulatory cycles, comprising a tube,
box or chart in or on which units of two different kinds are
packed in a particular order together with written or printed
indications or directions, the indications or directions and the
manner of packing being such as to provide guidance in relation
to and to facilitate the taking of the said rate first of 6 to
13 units containing an oestrogenic compound only as a hormonal
substance and subsequently 14 to 16 units containing a com-
bination of an oestrogenic compound and a progestative compound.
The claim covers any type of package, for example, a tube, box or chart,
in which the pills are contained. The only limitation is that the number
of the two types of pills should fall within the ranges given, and that
they should be arranged in a particular order. Such a package is to
contain "oestrogenic and progestational pills having different effects,
and in a particular ratio and a particular sequence to make sure they
are taken in the right order."
The applicant claims to have discovered an important improvement in the
so-called (and known) "sequential" treatment to prevent conception. The
known treatment involves the taking of an oestrongenic compound from the
2nd to 5th day after the beginning of the menstrual period until the 20th
day and then taking a combination of oestrongenic and progestative com-
pounds from the 20th to the 25th day. The applicant's improvement, which
he has named the "Normophasic" method, also involves two successive phases.
Preferably it extends for 22 days, beginning not later than the 5th day after the
onset of the last menstruation. In the first period of seven days an
oestrongenic compound is taken. In the second phase lasting 15 days a com-
bined oestrongenic and progestative compound is taken. The Normophasic method
is also claimed to be fully reliable in producing protection against
pregnancy.
The applicant has discovered a new method for chemically induced contraception.
Invention must, however, be differentiated from discovery. Discovery may add
to existing knowledge, but without anything further cannot amount to a useful
invention. A discovery, just as the apprehension of a desideratum, may be
the basis for and progenetor of an invention and, once perceived, the method
of applying the discovery to produce a new and useful result is what
constitutes invention. The application of the discovery may be quite simple.
once the discovery was made. As Lord Simonds observed in Raleigh Cycle Co. Ltd.
et al v. H. Miller & Co. Ltd.: (1948) 1 All, E.R. 308 et 311.
The patentee, having made this discovery, proceeded to
make an article which gave effect to it. It achieved...
an immediate commercial success, and, though, I think, no
great ingenuity was needed for the construction of the
article, I am not prepared to dissent from the view taken by
the Court of Appeal that here there was subject-matter to
support a patent. The discovery was the inventive step which
gave to the invention the necessary merit.
On the same subject Rinfret J. in Electrolier Manufacturing Co. Ltd. v
Dominion Manufacture Ltd. (1943) S.C.R. 436 at 442, stated:
The merit of Pahlow's patent is not so much in the means
of carrying out the idea as in conceiving the idea it-
self (Fawcett v. Homan (1896) 13 R.P.C. 398. He produced
an improved thing as the result of the ingenious
application of a known elastic material (Gadd and Mason
v. Mayor, etc., of Manchester); and, to our mind, there was
just as much inventive ingenuity in his discovery as there
was in the adoption of tubular wire braids in making bristles,
held by the House of Lords to have been good subject-
matter of a patent Thomson v. American Braided Wire Company),
the result attained being a complete article, effective
and capable of being assembled cheaply and expeditiously.
The advance may have been slight - although, as pointed
out by Fletcher Moulton on Patents (p.22), "the general
tendency of the mind is to minimize the difficulty of a
discovery after it has been made" - but there was a real
inventive step upon "what went before"; and the new result
which was obtained was of sufficient importance to make it
a genuine invention. It follows that the patent should be
held good and valid.
It was argued that the pack or card with the attached pills represents
an invention because no one has suggested such a pack or card with these
pills in that order before. The card, it is said, is useful because it
gives the purchaser the protection she wants. Further the card is not
obvious because no one would have thought of arranging these particular
pills in that daily order unless and until he knew of the Normophasic
method. The discovery of a new method of chemical treatment to avoid or
suppress conception may, in our view, give rise to patentable subject
natter in the form of a pack or card of pills adapted to the carrying out
of that method if there is something novel in the constitution of the
pack or card itself, or in the idea of a card with the different pills
arranged in the new daily order particularized for the newly discovered
method of treatment. It may be that the significant discovery lies in
the method of treatment rather than in the arrangement of the pills on
the card. It can not be said, however, that the arrangement or sequence
of pills on the card was obvious to those who did not know of the
Normophasic method.
In our view claim 1 defines a combination which represents the novel and
practical application of a new discovery for a chemically-induced
contraceptive method. The printed instructions referred to in the
claims are, we are satisfied, of no patentable significance, because
the claims also recite "... and the manner of packing being such as
to provide: guidance in relation to and to facilitate the taking of
said rate first of ...." The printed instructions are therefore not
a prerequisite to the patentability of the combination claimed.
We are therefore satisfied that the claims relate to new and useful
"subject matter" which define a patentable advance in the art, and we
recommend that the Final Action be withdrawn.
We note that the corresponding British application was initially re-
fused, but granted after appeal for the same reasons that we have
adopted. See In the Matter of Organon Laboratories Ltd., Patents Appeal
Tribunal, Graham J., as in 1970 R.P.C. 574.
J.F. Hughes,
Assistant Chairman,
Patent Appeal Board.
I concur with the findings of the Patent Appeal Board and withdraw the
Final Action. The application is returned to the examiner for resumption
of the prosecution.
Decision accordingly,
A.M. Laidlaw,
Commissioner of Patents.
Dated at Hull, Quebec
this 4th. day of
July, 1975.
Agent for Applicant
Fetherstonhaugh & Company,
Box 2999, Station D,
Ottawa, Ontario.