COMMISSIONER'S DECISION
Obviousness: Synthetic D-Penicillamine Compositions
The invention is directed to a completely synthetic D-penicillamine
composition and is predicated on the discovery of unexpected and
surprising properties of synthetic D-penicillamine. The reference
relied upon disclosed natural penicillamine. It was decided that
an invention has been described, and the application was returned to
the examer to determine what compositions were novel and particularly
adapted to the specified new and unobvious use.
Final Action: Reversed in part.
*****************
This decision deals with a request for review by the Commissioner of
Patents of the Examiner's Final Action dated February 1, 1977, on
application 167,082 (Class 167-188). The application was filed on
March 26, 1973, in the name of Friedrich Asinger et al, with the title
"Process For Producing D-Penicillamine And Preparation Containing Same."
The Patent Appeal Board conducted a hearing on September 6, 1978,
at which Mr. N . Hewitt represented the applicant.
The application is directed to a pharmaceutical composition comprising
a completely synthetic D-penicillamine and a pharmaceutically acceptable carrier,
and is predicated on the discovery of unexpected and surprising properties
which the completely synthetic D-penicillamine has been found to have
over and above the properties displayed by natural D-penicillamine.
In the Final Action the examiner refused the claims because they "do not
differ inventively from prior knowledge." In that action the examiner had,
inter alia, this to say:
...
It is held that the mere discovery of unknown properties of a
known compound, with known utility in the treatment of disease,
does not confer further patentability to the compound or its
compositions with mere carriers or diluents. A new property per se
is not patentable unless it can be claimed in the form of a
patentable process, apparatus or product. In this case, synthetic
D-penicillamine and the process for its production are known, its
utility in the treatment of various diseases, for example,
poisoning by heavy metals, Wilson's disease and primary chronic
polyarthritis is the same as that for naturally produced
penicillamine (since the active ingredient is the same in
each case it is submitted to be obvious that their utility
would be similar) and the compositions and processes for
producing compositions of synthetic D-penicillamine with a
carrier are classical in the administration of such medicines.
The discovered fact that synthetic D-penicillamine shows no
side effects or lesser side effects upon administration
may constitute an advance in the art but does not constitute
a patentable improvement under the Patent Act and Rules
as far as the present claims are concerned.
...
In response to the Final Action the applicant stated (in part):
...
As previously stated in the Final Action the Examiner in
rejecting the claims has taken the position that claim 1 which is
directed to a composition containing completely synthetic D-
penicillamine and a pharmaceutically acceptable carrier or
diluent does not differ inventively from prior knowledge. The
Examiner then sets forth what he considers to be prior knowledge.
The prior knowledge is as set forth in the specification on
page 1. In particular, D-penicillamine produced from natural
penicillin (hereinafter referred to as natural D-penicillamine)
is known and has given satisfactory results in the treatment of
various diseases such for example as poisoning caused by heavy
metals, Wilson's disease and primary chronic polyarthritis.
However, it has been found with natural D-penicillamines to
cause allergies such as skin reactions, fever and the like and
other side effects when administered to the patient. This has
greatly restricted the use of natural D-penicillamine in the
treatment of the various diseases. Applicants would refer in
this direction to pages 4 to 6 of the response of July 5, 1976.
Further, as the Examiner states in the Official Action, completely
synthetic D-penicillamine and its salts are known. Completely
synthetic D-penicillamine is penicillamine produced completely
synthetically from synthetic penicillin. However, heretofore
while the art may have realized that completely synthetic D-
penicillamine could be used for the treatment of the same diseases
as natural D-penicillamine, due to the fact inter alia of the
difficulty of preparing completely synthetic D-penicillamine and
that the cost of such preparation was substantially increased for completed
synthetic D-penicillamine as compared with natural D-penicillamine.
These disadvantages mitigated against the use of completely synthetic
D-penicillamine in the treatment of the aforesaid diseases. Thus
to a person skilled in the art at the time of the present invention
and before the present invention, natural D-penicillamine was
cheaper and more easily made than completely synthetic D-penicillamine
and thus had substantially economical advantages in the treatment
of the aforesaid diseases and thus completely synthetic D-
penicillamine has remained a laboratory curiosity and has
never bean used to the applicant's knowledge in the treatment
of the aforesaid disease. Thus a person skilled in the art
could only see disadvantages in the production of completely
synthetic D-penicillamine for the treatment of the aforesaid
diseases, there being no advantages in use apparent to a
person skilled in the art to compensate out the aforesaid
disadvantages and therefore natural D-penicillamine has been
used to the applicant's knowledge, exclusively for the
treatment of the aforesaid diseases and the completely syn-
thetic penicillamine has remained a laboratory curiosity.
Thus referring to the third paragraph of the final action,
applicants would stress the word "same" in the Examiner's
comments as heretofore it would have been expected by a person
skilled in the art that completely synthetic D-penicillamine
would have exactly the same usefulness as natural D-
penicillamine with the same side effects and allergic reactions
and would have no advantages whatsoever over the natural D-
penicillamine.
...
At the Hearing Mr. Hewitt set forth the background of what is, in his view,
a patentable advance in the art. He argued strongly that an invention is
defined in the claims because of the discovery of "unexpected and surprising
properties" of the completely synthetic D-penicillamine.
We have carefully reviewed the prosecution of this application and find no
reason to question that the applicant has discovered unexpected and surprising
properties in synthetic penicillamine, specifically the absence of, e.g.
side effects when used in the treatment of arthritis, even though such product
was known for many years. Whether or not this can be claimed as an invention
is predicated solely on the condition that the synthetic D-penicillamine was
never used before in the treatment of arthritis, because no valid patent may
issue for such discovery until in its practical application, a new and useful
result has been produced. The inventive step, of course, may lie in such
discovery. The problem lies in defining such subject matter in the claims
because the applicant is precluded from claiming medical processes (see
Tennessee v Commissioner of Patents (1974) SCR 111).
The examiner argued that what the applicant has done "does not constitute
a patentable improvement under the Patent act and Rules as far as the present
claims are concerned." We are satisfied however, that such an approach is
valid only where the substance was used for the intended purpose previously
and/or the claims lack novelty. A novel practical composition particularly
adapted to a new use is in our view, patentable. However claims which are
directed to a novel composition particularly adapted for the specified new
use are the only claims which should be accepted in the present circumstances.
At the present time the applicant is claiming synthetic D-penicillamine and
its salts mixed with pharmaceutically acceptable carriers, Unfortunately, as
was brought out at the Hearing, synthetic D-penicillamine mixed with Pharma-
ceutically acceptable carriers is already known, disclosed for example, in the
prior Canadian patents cited by the examiner during earlier prosecution, viz:
518069 Sheehan et al Jan. 8, 1955
499718 Mozingo Feb. 2, 1974
These patents show synthetic D-penicillamine and its salts mixed with
various pharmaceutically acceptable carriers, such as water, ether and alcohol.
These are among the carriers included in the applicant's own disclosure, and
mixtures of synthetic penicillamine with them are not novel, Moreover the
applicant has not shown that any of the other carriers listed in the application
are in any way different from the carriers of the prior art, and consequently
it cannot be said they are particularly adapted to the new use to which they
are to be put.
At the Hearing Mr. Hewitt indicated he was quite willing to limit his claims to
novel subject matter. In such circumstances we consequently believe the
application should be returned to the examiner to determine whether there are
indeed any novel compositions disclosed which are particularly adapted to a
new use for synthetic D-penicillamine.
J.F. Hughes
Assistant Chairman
Patent Appeal Board, Canada
I have reviewed the prosecution of this application and agree with the
recommendation of the Patent Appeal Board. Accordingly, I return the applica-
tion to the examiner for further prosecution along the guidelines set out
by the Board.
J.H.A. Gariepy
Commissioner of Patents
Dated at Hull, Quebec
this 4th. day of October, 1978