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[2014] ZAGPPHC 96
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Ciplaagrimed (Pty) Ltd v Merck Sharp Dohme Group and Another (1998/10975) [2014] ZAGPPHC 96 (11 March 2014)
IN COURT OF THE
COMMISSIONER OF PATENTS
(REPUBLIC OF
SOUTH AFRICA)
PATENT
NO: 1998/10975
DATE:
11 MARCH 2014
In the matter
between:
CIPLA AGRIMED
(PTY) LTD
..................................................
Applicant
AND
MERCK SHARP DOHME
GROUP
...............................
Joint
Patentees
MERIAL LLC
JUDGEMENT
TEFFO, J:
[1] The applicant
seeks an order for the revocation of the South African Patent Number
1998/10975 (“the 1998 patent”)
held by the joint
patentees (“the respondents herein”).
[2] The application
is based on the ground that the invention as specified in claims 1 to
29 of the 1998 patent, is not patentable
in terms of section 25 of
Act 57 of 1978 ( “the Patents Act”). Further that the
invention lacks novelty in that it
was not new as at the priority
date of its invention.
[3] The applicant
contends that claims 1 to 29 of the 1998 patent is disclosed in, and
therefore anticipated by, the specification
of patent number 92/7457
(“the 1992 patent”), which was made available to the
public on 30 March 1993 in terms of sections
43(1) and 43 (3) of the
Patent Act
[4] The application
is opposed.
[5] Claim 1 of the
1998 patent provides as follows:
“A long -
acting injectable formulation comprising:
(a) a therapeutic
agent selected from the group consisting of insecticides, acaricides,
parasiticides, growth enhancers and oil-
soluble NSSIDS,
(b) hydrogenated
castor oil, and
(c) a hydrophobic
carrier comprising:
(i) triacetin,
benzyl benzoate or ethyl oleate or a combination thereof; and
(77) acylated
monoglycerides, propyl dicaprylates/ dicaprates, caprylic / capric
acid, triglycerides, or a combination thereof.
”
[6] It is common
cause between the parties that integers (a) and (b) referred to supra
are disclosed in the 1992 patent.
[7] It is also
common cause between the parties that the 1998 patent has the
priority dates of 3 December 1997 and 7 May 1998. Further
that the
1992 patent was made available to the public before the relevant
priority dates of the claims.
[8] The respondents
deny that the invention claimed in claims 1 to 29 did not involve an
incentive step and that the invention would
have been obvious to a
person skilled in the art of having regard to the specification of
the 1992 patent in the light of the knowledge
of the skilled
addressee immediately before the relevant priority dates. They also
seek certification in terms of section 74(1)
of the Patents Act that
each of the claims of the 1998 patent is valid.
[9] The issue for
determination is whether the particular combination of hydrophobic
carriers claimed in integer (c) of claim 1
of the 1998 patent is
disclosed in the 1992 patent and whether the 1992 patent anticipates
the claims of the patent under review.
[10] The following
parts of section 61 and 25 of the Patents Act are relevant to the
relief sought:
Section 61 (1) (c)
reads as follows:
“Grounds for
application for revocation of patent
“(1) Any
person may at any time apply in the prescribed manner for the
revocation of a patent on any of the following grounds
only, namely:-
(c) that the
invention concerned is not patentable under section 25;
(3) The commissioner
shall decide whether the patent shall be revoked or whether and, if
so, subject to what amendments, if any,
of the specification or
claims thereof, the patent shall be upheld: Provided that the
commissioner shall not allow any amendment
which is in conflict with
the provisions of section 51(6) or (7): Provided further that the
commissioner may in the exercise of
his discretion as to costs take
into consideration the conduct of the patentee in framing his
specification and claims and permitting
them to remain as so framed.
”
Section 25 reads:
“Patentable
inventions
(1) A patent may,
subject to the provisions of this section, be granted for any new
invention which involves an inventive step and
which is capable of
being used or applied in trade or industry or agriculture.
(5) An invention
shall be deemed to be new if it does not form part of the state of
art immediately before the priority date of
any claim to that
invention.
(6) The state of the
art shall comprise all matter (whether a product, a process,
information about either, or anything else) which
has been made
available to the public (whether in the Republic or elsewhere) by
written or oral description, by use or in any other
way.
(7) The state of the
art shall also comprise matter contained in an application, open to
public inspection, for a patent, notwithstanding
that that
application was lodged at the patent office and became open to public
inspection on or after the priority date of the
relevant invention,
if:-
(a) that matter was
contained in that application both as lodged and as open to public
inspection, and
(b) the priority
date of that matter is easier than that of the invention.
(10) Subject to the
provisions of section 39(6), an invention shall be deemed to involve
an inventive step if it is not obvious
to a person skilled in the
art, having regard to any matter which forms, immediately before the
priority date of the invention,
part of the state of the art by
virtue only of subsection (6) and disregarding subsections (7) and
(8).”
[10] The rules for
interpreting a patent were confirmed by Harms JA in Monsanto Co v MDB
Animal Health (Pty) Ltd (Formerly MB Biologies
CC)
2001 (2) SA 887
(SCA) as follows at p891 para 8 et seq:
“[8] The rules
relating to the interpretation of patents have often been stated and
do not need any reformulation. The problem
lies in their sensible
application in any given case. For present purposes the following
rules as they appear in Gentiruco AG v
Firestone SA (Pty) Ltd
1972
(1) SA 589
(A) at 614 A- 616 D may be emphasised:
(a) a specification
should be construed like any other document, subject to the
interpreter being mindful of the object of a specification
and its
several parts;
(b) the rule of
interpretation is to ascertain, not what the inventor or patentee may
have had in mind, but what the language used
in the specification
means, i.e. what the intention was as conveyed, by the specification,
properly construed;
(c) to ascertain
that meaning the words used must be read grammatically and in their
ordinary sense;
(d) technical words
of the art or science involved in the invention must also be given
their ordinary meaning, i.e. as they are
ordinarily understood in the
particular art or science;
(e) if it appears
that a word or expression is used, not in its ordinary sense, but
with some special connotation, it must be given
that meaning since
the specification may occasionally define a particular word or
expression with the intention that it should
bear that meaning in its
body or claims, thereby providing its own dictionary for its
interpretation;
(f) if a word or
expression is susceptible of some flexibility in its ordinary
connotation, it should be interpreted so as to conform
with and not
to be inconsistent with or repugnant to the rest of the
specification; and
(g) if it appears
from reading the specifications as a whole that certain words or
expressions in the claims are affected or defined
by what is said in
the body of the specification, the language of the claims must then
be construed accordingly. ”
[11] In
Ensign-Bickford (South Africa) (Pty) Ltd and others v AECI Explosives
and Chemicals Ltd
1999 (1) SA 70
SCA, Plewman JA made the following
remarks with regard to interpretation:
“ It will, I
think, suffice to say that nothing contained in the body of the
specification in this regard purports to provide
a dictionary for the
claims or even (in a more limited sense) to affect the wording of the
claims. To construe the claims in this
way would offend against a
fundamental principle of patent law, namely that found in the famous
dictum of Lord Russell in the case
of Electrical and Musical
Industries v Lissen
[1939] 56 RPC 23
at 39 ([1938]
4 All ER 221
at
224H-225A and 227 C-D). It is a rule adopted by this court in the
([1938]
4 All ER 221
at 224H-225A and 227 C-D). It is a rule adopted
by this court in the case of Power Steel Construction Co (Pty) Ltd u
African Batignolles
Contructions (Pty) Ltd
1955 (4) SA 215
(A) at 224
D-F. The dictum reads: The claims must undoubtedly be read as part of
the entire document, and not as a separate document;
but the
forbidden field must be found in the language of the claims, and not
elsewhere. It is not permissible, in my opinion, by
reference to some
language used in the earlier part of the specification to change a
claim for one subject matter into a claim
for another and a different
subject matter, which is what you do when you alter the boundaries of
the forbidden territory ...
A claim is a portion
of the specification which fulfils a separate and distinct function.
It and it alone, defines the monopoly;
and the patentee is under a
statutory obligation to state in the claims clearly and distinctly
what is the invention which he desires
to protect. ”
[12] In the
Gentiruco AG matter referred to supra it was held that an objection
of anticipation relates to the claims and not the
description of the
invention in the body of the specification. Further to this the
following was said:
“Hence the
particular claim must be construed to ascertain its essential
constituent elements or integers...The two documents
are then
compared to ascertain whether the prior patent was granted for, or
the prior printed publication ‘described’,
the same
process, etc., as that claimed. Prior patenting will be dealt with
later. In regard to a prior publication, the ordinary
meaning of
‘describe’ means to set forth in words or recite the
characteristics of (concise Oxford English dictionary).
Hence for it
to ‘describe’ the invented process ,etc., it must be set
forth or recite at least its essential integers
in such a way that
the same or substantially the same process is identifiable or
perceptible and hence made known, or the same
or substantially the
same thing can be made, from that description.
‘Substantially
the same means practically the same, or, to use Lord Westbury’s
phrase adopted by WESSELS, J.A in Veasey’s
case, p. 269, the
same ‘for the purposes of practical utility”, i.e.,
substance and not form must be regarded. Consequently,
if on the
comparison of the two documents it appears that the same or
substantially the same process, etc., is described in the
above sense
in both, the claim has been anticipated and is not novel; conversely,
the description in the prior document differs,
even in small respect,
provided it is a real difference, such as the non-recital of a single
essential
[13] In RG Murray v
Vodacom (Pty) Ltd and another 2008 BP 31 (CP) 57 Murphy J said:
“The courts in
interpreting patent claims should have recourse to the full context
and background of a specification in order
to decide what the skilled
addressee would have understood the claims to mean - Vari-Deals 101
(Pty) Ltd v Sunsmart products (Pty)
Ltd 2007 SCA 123 (RSA) at para
11”
[14] In support of
its case the applicant relies on the expert evidence of Wentzel and
Cromarty while the respondent relies on the
evidence of
Witchey-Lakshamanan and Swan. This evidence will only serve as a
guide to the various integers which require comparison.
[15] The applicant
contends that the respondents’ witnesses cannot be regarded as
independent in that Lakshamanan was previously
employed in the
laboratory in which the 1998 patent was conceived and he was involved
in the formulations containing ivermectin
at that time while Swan was
an employee of Merck Sharp and Dohme in South Africa.
[16] After comparing
the wording of the 1992 and 1998 patents, Cromarty concluded that
claim 1 of the 1998 patent has been anticipated
by the 1992 patent
for the following reasons:-
16.1 That the 1992
patent discloses a long acting injectable formulation;
a) a hydrogenated
castor oil;
b) the avermectin
compound ( parasiticide); in
c) a hydrophobic
physiologically acceptable solvent comprising in combination:
i) glyceryl
triacetate (Triacetin); or
ii) distilled
acetylated monoglycerides (Myvacet); or a combination of such
carriers.
ii) distilled
acetylated monoglycerides (Myvacet); or a combination of such
carriers.
16.2 The 1992 patent
thus discloses a list of ingredients for the formulation and
specifies, expressly, that one of the combinations
will contain both
glyceryl triacetate and distilled acetylated monoglyceride. It
discloses a formulation which includes an antioxidant,
of which
several are disclosed in the specification and it also states that
the preferred compound is ivermectin. The formulation
of claim 1 of
the 1998 patent specification includes a combination of hydrogenated
castor oil, a parasiticide (avermectin) in solution
in a hydrophobic
carrier consisting of triacetin and acetylated monoglycerides. The
1992 patent provides directions to produce
what claim 1 of the 1998
patent claims as an invention.
[17] Counsel for the
applicant submitted that it is apparent that the 1992 patent
describes the 1998 patent’s essential integers
in such a way
that the same or substantially the same formulation is identified and
made known. The same product, the formulation
defined in class 1 of
1998 patent, can be made from the description of the formulation
contained in the 1992 patent specification.
The paragraph found at
page 7 lines 25 to 29 of the 1992 patent reveals that it discloses
the formulation referred to it in the
1998 patent. The alleged
inventive formulations set out in claim 1 of the 1998 patent are
therefore nothing more than a repetition
of the disclosure in the
1992 patent. The subject matter of claims 2,5,6,7,18,19,20,21,22,23
and 25 are disclosed in the 1992 patent.
[18] Counsel for the
respondent submitted that the teaching of the 1992 patent in so far
hydrophobic carriers is concerned, is extremely
limited. It provides,
vaguely, that “any physiologically and pharmaceutically
acceptable carrier... so long as avermectin
is soluble therein”
may be used in the formulation disclosed in the 1992 patent. The
patent carriers on to list examples
of such carriers as being
glyceryl triacetate (Triacetin) distilled acetylated monoglycerides
(Myvacet), miglyol 812, safflower
oil and the like, or a combination
of such carriers. It is clear from the words used “ and the
like” that any carrier
can be used in the formulation of the
1992 patent. The 1992 patent teaches the use of a single hydrophobic
carrier, namely Triacetin,
and does not disclose any particular
combination of hydrophobic carriers. In support of this submission,
claim 12 has been referred
to in that it is specifically limited to
Triacetin. It is contended that the 1992 patent considered that
Triacetin, alone, constituted
the preferred hydrophobic carrier for
the triacetin, benzyl benzoate or ethyl oleate or a combination
thereof; and on the other
hand, acetylated monoglycerides, propyl
dicaprylates/ dicaprates, caprylic/ capric acid triglycerides or a
combination thereof.
The particular combinations of specific
hydrophobic carriers claimed in the patent have not been specifically
identified in the
prior art. All what the 1992 patent teaches is that
the skilled person can use any hydrophobic carrier in which
avermectiri is
soluble.
[19] He further
submitted that while particular specific examples are given in the
1992 patent, there is no suggestion or teaching
that any of them,
have any utility or advantage over other hydrophobic carriers or
combinations of carriers. Save for the throw-
away reference to these
hydrophobic carries (which, interestingly, was deleted in the patent
as it was granted) there is no teaching
at all in relation to the
properties or benefits of these carriers in a formulation containing
avermectin. The teaching of the
1992 patent is, therefore of the sort
which can be described as “purely intellectual content”
and which does not amount
to a teaching of the “technical
action” which was later achieved using the specific
combinations of hydrophobic carriers
disclosed in the patent in suit.
The 1992 patent teaches that the formulation of that patent will be
efficacious up to 42 days.
By contrast, by using the specific
combinations of hydrophobic carriers of the patent in suit, efficacy
of up to 180 days can be
achieved. There is no teaching of the very
significant advantage (“technical action) which arise from this
longer duration
of activity in practice and which are obtained
through the use of the particular hydrophobic carriers disclosed in
the patent in
suit. The skilled person is not therefore able to
produce the invention of claim 1 of the patent in suit on the basis
of the “indication”
in the 1992 patent and his or her
“general technical knowledge”. Instead the skilled person
would (even armed with
the 1992 patent and with the significant
knowledge that the Merck scientists had regarding the active
pharmaceutical ingredient)
have to apply a significant amount of
ingenuity and undertaken an extensive amount of pharmacokinetic and
efficacy testing to arrive
at the specific combination of hydrophobic
carriers disclosed in the patent in suit, and the signification
technical advance which
those specific combinations represent over
the disclosure of the 1992 patent.
[20] As regards the
submission by the applicant’s Counsel that the expert witnesses
of the respondents cannot be regarded
as independent for the reason
that one was employed by the respondent (Merck Sharpe & Dohme)
and the other was employed at
the laboratory where the 1998 patent
was conceived, the respondents submitted that that argument was
absurd and referred to a number
cases where such expert witnesses who
were former parties’ employees’ evidence was preferred as
against that of the
independent expert witnesses.
[21] It is important
to note that the meaning to be given to a claim, and whether the
claim has been anticipated by prior disclosure,
are not matters for
expert opinion, but are matters for the court to decide, albeit that
a court, in deciding those questions will
often need to be guided by
experts on the state of the art (Gentiruco AG v Firestone SA (Pty)
Ltd referred to supra). It is therefore
immaterial whether the expert
evidence is that of an independent witness or whatsoever, but at the
end of the day the decision
lies with the court. The argument by the
applicant has therefore no merit in this regard.
[22] It is clear
that the formulation of claiml of the 1998 patent specification as
referred to in para 5 supra includes the combination
of hydrogenated
castor oil, a parasiticide (avermectin) in solution in a hydrophobic
carrier consisting of triacetin and acetylated
monoglycerides.
[23] The 1992 patent
discloses a long acting injectable formulation which comprises of>
a hydrogenated castor oil; the avermectin
compound (parasticide); in
a hydrophobic physiologically acceptable solvent comprising in
combination: glyceryl triacetate (Tricetin);
or distilled acetylated
monoglycerides (Myvacet); or a combination of such carriers.
[24] The formulation
referred to above in para 22 supra for the 1998 patent is expressly
disclosed in the 1992 specification referred
to in para 23 supra.
[25] I do not agree
that there is no limitation in the 1992 patent as to the hydrophobic
carrier which is to be used in the formulation
of that patent.
Reference is also made to both triacetin and acetylated monoglyceride
in the 1992 specification as possible carriers
that could be used. It
can therefore not be said that the 1992 patent teaches that the most
preferable formulation is one which
includes only triacetin as the
hydrophobic carrier in the formulation while the other carriers,
e.g., acetylated monoglycerides,
miglyol 812, safflower seed oil or
mixtures thereof are also mentioned.
[26] It is therefore
my view after comparing the 1992 and 1998 specifcations that the 1992
patent describes the essential integers
in such a way that the same
or substantially
the same; process is
identifiable and made known. I agree that the formulations set out in
the 1998 patent are nothing more than
a repetition of the disclosure
jn the 1992 patent. For the reasons advanced above claims 1 to 29 of
1998 patent are invalid and
fall to be revoked. Claims 1 to 29 of the
1998 patent are therefore anticipated in the 1992 patent. The 1998
patent fails to comply
with section 25 of the Act.
[27] In the result I
make the following order:
27.1 The application
succeeds with costs including the costs of two counsels.
TEFFO J
JUDGE OF THE
NORTH GAUTENG HIGH COURT
COUNSELS FOR THE
APPLICANT INSTRUCTED BY
COUNSELS FOR THE
RESPONDENT
CEDRIC PUCKRIN SC
& MARK SEALE BRIAN BACON & ASSOCIATES INC
LIONEL BOWMAN SC
& GAVIN MARRIOT
INSTRUCTED BY DM
KISCH INC