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[2001] ZASCA 4
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Monsanto Company v MDB Animal Health (Pty) Ltd (formerly MD Biologics CC) (467/99) [2001] ZASCA 4; 2001 (2) SA 887 (SCA) (26 February 2001)
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Reportable
Case No 467/99
In the matter between:
MONSANTO
COMPANY Appellant
and
MDB ANIMAL HEALTH
(PROPRIETARY) LTD
(Formerly MD BIOLOGICS
CC) Respondent
Coram: HARMS, STREICHER and NAVSA JJA; BRAND and NUGENT AJJA
Heard: 15 FEBRUARY 2001
Delivered: 26 FEBRUARY 2001
Subject: Patent
interpretation and infringement
JUDGMENT
HARMS JA/
HARMS JA:
[1] In patent litigation an application of Murphy's Law has
special significance: if a word or sentence is capable of two interpretations,
the reader will choose the wrong one. In this case the issue is whether alpha
tocopherol acetate, a synthetic Vitamin E, is an “oil”
within the
meaning of the term as used in the patent in suit, namely No 85/7642 entitled
“Prolonged release of biologically
active polypeptides”. If it is,
the respondent is infringing the patent. In spite of the narrow point of
interpretation
the parties were nevertheless able to generate a record of nearly
1300 pages. (For the sake of convenience I shall use the term
“Vitamin
E” as a synonym for alpha tocopherol acetate.)
[2] For purposes of
this judgment it is unnecessary to deal in any particular detail with the
invention. It will suffice to deal
with claim 1 which claims:
"A
substantially non-aqueous composition useful for parenteral administration
comprising at least about 10% by weight of a biologically
active bovine
somatotropin and, as a continuous phase of said composition, a biocompatible
oil."
A “biologically active bovine somatotropin” is a natural
protein produced by the pituitary gland of a bovine and it promotes
the use of
nutrient energy for milk production. Simply put, it is a hormone which
increases milk production. The purpose of the
oil is to act as a carrier for
the hormone which has to be suitable for parenteral administration, i e, by way
of injection. In
order to provide for the prolonged release of the hormone in
the animal the product has to be substantially non-aqueous. An object
of having
the oil in a continuous phase is to ensure that there is sufficient oil to
envelop substantially the entire hormone.
The oil must be bio-compatible in
the sense of having no intolerable adverse effect on the hormone, the animal,
or, in the case of
animals whose products enter the food chain, the consumers of
such products.
[3] As in Selero (Pty) Ltd and Another v Chauvier and
Another 1984 (1) SA 128 (A) 137 F-H, while appreciating that a patent
specification should be construed without reference to what the alleged
infringer has
done, we deem it nevertheless convenient to focus attention on the
allegedly infringing article in order to delimit and define the
areas of dispute
between the parties. The respondent imports and sells a product known as
“Hilac” which is an injectable
formulation consisting of active
bovine somatotropin and Vitamin E. As mentioned, the only issue at this stage
is whether Vitamin
E is an “oil” as claimed in the claims. If the
answer is in the affirmative, it is common cause that the respondent
is
infringing claims 1, 2, 4 and 5 of the patent. During the trial the witnesses
agreed that Vitamin E is, as ordinarily understood,
an oil. The respondent's
counsel conceded as much in this Court. In its application for the
registration of “Hilac”,
the respondent itself described Vitamin E
as “a high viscous oil”. Vitamin E is sold by chemical
manufacturers as an
oil. The works of authority referred to and relied upon in
evidence describe it as a yellow, nearly odourless, clear, viscous oil
or,
sometimes, as a viscous, oily liquid. Finally, the respondent's expert witness,
Prof van Oudtshoorn, whose evidence the court
a quo preferred, conceded
that Vitamin E performs the function of what is required of an oil by the
specification and that it has all the
characteristics of a bio-compatible oil.
He even on occasion called it an oil. In spite of this, MacArthur J (sitting as
Commissioner
of Patents in the Court a quo) held that Vitamin E is not
ordinarily classified as an oil, a finding the respondent did not rely upon, and
for that reason dismissed
the appellant's claim.
[4] Oils have certain
physical characteristics in common: they are liquid at ambient temperatures,
they have a viscous consistency
and a characteristic unctuous feel, they are
lighter than water and insoluble in it, they are soluble in alcohol and ether,
inflammable
and they are chemically neutral. Fats differ from oils in one
respect only. They are solid at room temperature. With this background
the
attention can now turn to the body of the specification because the respondent
argues that it defines “oil” with
reference to its chemical
characteristics in such a way as to exclude Vitamin E from its
ambit.
[5] The argument focussed on the following passage from the
specification:
“As aforesaid, the compositions of this invention each
contain, as a continuous phase thereof, a biocompatible oil, ie, an oil
having
no intolerable adverse effect on the polypeptide, the animal, or, in the case of
animals whose products enter the food chain,
the consumers of such products.
Preferably such oils are of low acidity and essentially free from rancidity.
As used herein, the term 'oil' means a fatty oil or fat that is liquid at the
body temperature of the animal. Thus, such an oil will melt or at least
begin to melt below about 40° and preferably below about 35°. Oils
that are
liquid at about 25° may facilitate injection or other
administration of some compositions of this invention. In some cases,
polyunsaturated (eg partially hydrogenated) oils may be favoured for greater
biocompatibility with the animal or other reasons.
In a preferred embodiment,
the biocompatible oil is composed essentially of triglycerides, ie, long chain
(generally C8 - C24, preferably C12 -
C18 fatty acid esters of glycerol, or mixtures of triglycerides and
such fatty acids (preferably in only minor proportions, eg less than
about 10%
free fatty acid). In some embodiments, other trihydroxy or polyhydroxy
compounds can be substituted for the glycerol.
Especially preferred oils
include vegetable oils such as olive, sesame seed, peanut, sunflower seed,
soybean, cottonseed, corn,
safflower, palm, rapeseed and mixtures of such oils.
Sesame and peanut oils are highly preferred for many embodiments. Oils of
animal or mineral origin or synthetic oils (including long chain fatty acid
esters of glycerol or propylene glycol) can also be employed
provided they are
sufficiently biocompatible."
(Underlining added.)
[6] According to the
argument, the underlined sentence defines the term “oil”. In order
to understand what an oil for
the purposes of the specification is, one must
determine what the chemical nature of a “fat” is. Generally a
“fat”
is defined in technical dictionaries as a glyceryl ester of
higher fatty acids which forms a class of neutral organic compounds.
Fatty
oils, fats and oils are chemically the same. Since “oil” is defined
in terms of “fat”, the oils
of the patent must likewise be glyceryl
esters of higher fatty acids, something which Vitamin E is not. (It may already
now be noted
that for these propositions reference was made to the same works
that state that Vitamin E is an oil. So much for consistency in
scientific
dictionaries.)
[7 ] The use of the term “fatty oil” in the
specification creates problems. No witness defined it, nor do the chemical
dictionaries that form part of the exhibits. The evidence of one of the
appellant's witnesses was that the adjective “fatty”
does not add to
the definition. This evidence was not gainsaid and appears to be plausible
although the witness may have hovered
on the border of inadmissible evidence, a
common occurrence during the course of this trial. If there is no chemical
difference
between a fat and an oil, the term “fatty oil” must be a
tautology. If I am wrong in this regard, the evidence of van
Oudtshoorn
establishes that what determines whether a compound is a fat or fatty is the
presence of a long aliphatic hydrocarbon
chain in the molecule, something
present in Vitamin E. Although he tried to downplay this evidence by stating
that the aliphatic
hydrocarbon chain in Vitamin E forms but a small part of the
molecule, he later had to recant this qualification.
[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) 614A - 616D may be
emphasised: (a) a specification should be construed like any other document
subject to the interpreter being
mindful of the objects 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 specification 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.
[9] Two qualifications - if they are indeed qualifications -
may be added. The first relates to the reference to the “ordinary
meaning” of words. In Fundstrust (Pty) Ltd (in liquidation) v Van
Deventer 1997 (1) SA 710 (A) 726H - 727B, Hefer JA said
this:
“Recourse to authoritative dictionaries is, of course, a
permissible and often helpful method available to the Courts to ascertain
the
ordinary meaning of words (Association of Amusement and Novelty Machine
Operators and Another v Minister of Justice and Another 1980 (2) SA 636 (A)
at 660F-G). But judicial interpretation cannot be undertaken, as Schreiner JA
observed in Jaga v Dönges NO and Another; Bhana v Dönges NO and
Another 1950 (4) SA 653 (A) at 664H, by 'excessive peering at the language
to be interpreted without sufficient attention to the contextual scene'. The
task of the interpreter is, after all, to ascertain the meaning of a word or
expression in the particular context of the statute
in which it appears
(Loryan (Pty) Ltd v Solarsh Tea and Coffee (Pty) Ltd 1984 (3) SA 834 (W)
at 846G ad fin). As a rule every word or expression must be given its
ordinary meaning and in this regard lexical research is useful and at times
indispensable. Occasionally, however, it is not.”
Something similar was
expressed in the context of the interpretation of a patent specification by the
Full Court (per Nicholas J)
in De Beers Industrial Diamond Division (Pty) Ltd
v Ishizuka 1980 (2) SA 191 (T) 196E - F:
“A dictionary meaning of a
word cannot govern the interpretation. It can only afford a guide. And, where a
word has more than
one meaning, the dictionary does not, indeed it cannot,
prescribe priorities of meaning. The question is what is the meaning applicable
in the context of the particular document under
consideration.”
[10] The second qualification is that even definitions
must be read in context. As said by the Master of the Rolls in The Cleveland
Graphite Bronze Company and Vandervell Products Ld v The Glacier Metal Coy
Ld [1949] RPC 157 (CA) 162 lines 31- 41:
“The vice of the
Respondents' contention appears to me to lie in the fact that for the purpose of
having recourse to the legitimate
use of the body of the specification as a
dictionary they have seized upon a definition therein contained and read it out
of its
context . . .. It is not right to seize upon one passage in the body of
the specification and treat it as though it were an interpretation
section in an
Act of Parliament. In order to make proper use of the body of a specification
for dictionary purposes the whole document
must be considered: and even where a
passage describes itself as a definition it must be read in its
context.”
[11] I do not agree with the respondent's submission that
the underlined sentence should be read in isolation or that it was intended
to
set out an all-embracing definition of the word “oil”, and that the
rest of the specification should be ignored.
The two paragraphs quoted from the
specification focus on bio-compatibility and to a lesser extent on an oil. The
first paragraph
is essentially concerned with the physical characteristics of
oil. If the underlined sentence is read in context, it becomes clear
that its
intention is to extend the meaning of oil to include fats which are liquid (or
oils) only at body temperatures, and not
to limit it to oils at ambient
temperatures (its ordinary meaning). In other words, the substance must be
administrable at body
temperatures. It does not purport to deal with the
chemistry of oils, something the second paragraph does.
[12] Turning the
attention to the second paragraph, the first sentence deals with the chemistry
of the compatible oil in “a
preferred embodiment”: it describes the
glyceryl esters of higher fatty acids. This is a clear indication that by using
glyceryl
esters of higher fatty acids as a preferred embodiment, the
inventor could hardly have intended to limit the invention to them. Then
follows the statement that “in some
embodiments, other trihydroxy or
polyhydroxy compounds can be substituted for the glycerol.” If the
glycerol is substituted,
the product is no longer a glyceryl ester. The
concluding statement that “oils of animal or mineral origin or synthetic
oils
(including long chain fatty acid esters of glycerol or propylene glycol)
can also be employed provided they are sufficiently biocompatible”
is also
significant. If the intention was to limit the oils to esters of glycerol, this
sentence makes no sense because it includes those oils. Propylene glycol
is also not an ester of glycerol.
[13] The inevitable conclusion is
therefore that the specification did not intend to limit the term
“oil” to esters
of glycerol. The invention is concerned with the
physical properties of the carrier and not its chemical composition. It is not
there for its pharmaceutical properties. It must be hydrophobic in order to
retard absorption and liquid at body temperature to
be administered
parenterally. As mentioned, it must exist in a continuous phase with the
hormone. The last sentence quoted makes
it clear that all oils, even synthetic
oils and irrespective of their chemical composition, are included provided they
are bio-compatible.
As stated, alpha tocopherol acetate is a synthetic oil.
[14] “Especially preferred” are vegetable oils, probably
because they were at the date of the patent the oils in use
as carriers as the
examples show. But that does not justify the limiting of the term
“oil” to vegetable oils as van
Oudtshoorn would have it. His
evidence was flawed. Apart from the fact that he had to recant on a number of
statements, he had
regard to extraneous irrelevant matter such as the inventor's
notebook in interpreting the specification in order to arrive at the
conclusion
that the specification was limited to vegetable oils. In addition, because he
regarded the use of Vitamin E by the respondent
as a carrier to be inventive, he
concluded that the specification did not include it within its terms. If one
assumes that it was
inventive, the respondent may have been entitled to a
selection patent or a dependent patent but that does not mean that the patent
in
suit does not cover its use.
[15] Having found that Vitamin E is an oil
within the meaning of the term as used in the claims, it follows that the
respondent is
infringing claims 1, 2, 4 and 5 of the patent. ( The last three
claims have not been quoted because their wording does not add anything.)
In
the result the appeal should be upheld and the appellant is entitled to the
usual orders of an interdict, delivery-up and an
enquiry into damages. There
is, however, a complication. The respondent relied on the invalidity of the
patent as a defence to
the claim for infringement and has a counterclaim for its
revocation. During the course of the trial the parties entered into an
agreement which was made an order of court. The counterclaim was postponed
sine die. The respondent agreed to withdraw the counterclaim if it were
successful in its defence on infringement. In the event of the patentee
being
successful on infringement, the respondent has the right to proceed with the
counterclaim and “the parties are agreed
that such counterclaims shall
proceed as expeditiously as possible.” In the light of this, the
appellant is only entitled
to a declaratory order in respect of the infringement
and the grant of effective relief must depend upon the outcome of the
counterclaim.
[16] In the result the following order is made:
The appeal succeeds with costs, including the costs of two counsel.
The order of the court below is set aside and substituted with an order in the following terms -
(i) It is declared that the defendant, by
importing and selling the product “Hilac”, is infringing claims 1,
2, 4 and
5 of SA Patent 85/7642.
(ii) The defendant is to pay the costs of
the action insofar as it relates to the plaintiff's claim, which costs include
the costs
of two counsel and the qualifying fees of Dr Palmer.
___________________
L T C HARMS
JUDGE OF
APPEAL
AGREE:
STREICHER JA
NAVSA JA
BRAND AJA
NUGENT
AJA