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[2016] ZASCA 57
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Merial and Others v Cipla Vet (Pty) Ltd (20772/2014) [2016] ZASCA 57; 2016 BIP 1 (SCA) (1 April 2016)
Links to summary
THE
SUPREME COURT OF APPEAL OF SOUTH AFRICA
JUDGMENT
Reportable
Case
No: 20772/2014
In
the matter between:
MERIAL
FIRST APPELLANT
MERIAL LIMITED
SECOND APPELLANT
MERIAL
SOUTH AFRICA (PTY)
LTD
THIRD APPELLANT
and
CIPLA VET (PTY) LTD
RESPONDENT
Neutral
Citation:
Merial
v Cipla Vet
(20772/2014)
[2016] ZASCA 57
(1 April 2016).
Coram:
Navsa
ADP, Leach, Petse & Dambuza JJA and Kathree-Setiloane AJA
Heard:
8
March 2016
Delivered:
1
April 2016
Summary:
Patents
–
Validity
– certainty of claim – compound consisting of a number of
ingredients, each fulfilling a specific function
– combination
of potential ingredients to be selected accordingly –
crystallisation inhibitor test to determine whether
crystallisation
inhibitor within scope of claim – whether dual functions of
potential ingredients impact on clarity –
interpretation of
patent a process of construction by a mind willing to understand, not
deconstruction by a mind desirous of misunderstanding
– skilled
addressee capable of understanding ambit of claim, and only real
challenge to clarity based on contrived or ‘mythical’
hypotheticals – patent not invalid for lack of clarity –
infringement – held to have been proved.
ORDER
On
appeal from
:
The Court of the Commissioner of Patents (Murphy J sitting as court
of first instance).
The
following order is made:
1.
The appeal is upheld with costs including the costs of two counsel.
2.
The order of the court below is set aside and substituted as follows:
‘
1. The
defendant is interdicted and restrained from infringing claims 1, 2,
3, 7 to 15 and 18 to 20 of the patent.
2. The defendant is ordered to deliver
up to the plaintiffs all infringing Fiprotec products in its
possession or under its control.
3. An inquiry is ordered in relation
to the damages suffered by the plaintiffs as a consequence of the
infringement of the patent
by the defendant alternatively an inquiry
into the reasonable royalty to which the plaintiffs are entitled.
4. In the event of the parties being
unable to reach an agreement as to the further pleadings to be filed,
discovery, inspection
or other matters of procedure relating to the
inquiry, an order authorising any one of the parties to make
application to the court
for directions in regard thereto.
5. Each of the claims referred to in
para 1 above of South African Patent Number 1996/8057 is certified as
being valid in terms
of section 74 of the Patents Act 57 of 1978.
6. The defendant is ordered to pay the
plaintiffs’ costs of suit, including the costs of two counsel
and the qualifying fees
of the plaintiffs’ expert witnesses.’
JUDGMENT
Navsa
ADP (Leach, Petse & Dambuza JJA and Kathree-Setiloane AJA
concurring):
[1]
This appeal concerns the correctness of the finding of the Court of
the Commissioner of Patents (Murphy J) that the respondent,
Cipla Vet
(Pty) Ltd (Cipla), a South African company, did not infringe Patent
No. 96/8057, entitled ‘
Anti-parasitic
composition for the treatment and protection of pets
’.
The first appellant, Merial, a company incorporated in France is the
patentee and the second and third appellants, Merial
Limited, a
company incorporated in the UK, and Merial South Africa (Pty) Ltd,
are licencees. The Commissioner held that the appellants
had failed
to discharge the onus upon them of proving that Cipla had infringed,
and was continuing to infringe, claims 1, 2, 3,
7 to 15 and 18 to 20
of the patent. The Commissioner, however, also dismissed various
other grounds of defence raised by Cipla
in relation to the validity
of the patent. I shall, in due course, allude to those. The appeal is
before us with the leave of the
Court below.
[2]
Cipla has since 2008 made, used, sold, offered for sale and imported
a composition in the form of a ready-to-use solution for
the
treatment and protection of domestic animals which are infested with
parasites or are likely to be infested with them, under
the trade
mark ‘Fiprotec’, and continues to make, use, exercise,
dispose or offer to dispose of and import the Fiprotec
composition.
Merial and the other appellants alleged that Cipla’s conduct
infringed the claims of the patent referred to
in the preceding
paragraph and that as a result of the infringement they have suffered
damages in amounts which they are at present
unable to quantify. In
the event of their establishing infringement, the appellants sought
an order that Cipla deliver up to them
all infringing Fiprotec
products in its possession and an order directing an inquiry into the
damages suffered by the appellants
as a consequence of the
infringement.
[3]
Like Merial’s product, ‘Frontline’, which Cipla is
accused of infringing, Fiprotec is a ‘spot-on’
composition used in the treatment and protection of domestic animals.
The term ‘spot-on’ refers to a product which
is applied
locally to a limited area of the body of the animal but which, it is
asserted, is effective over the entire body of
the animal. The
specification of the patent in suit states that the invention relates
to a composition for the treatment and protection
of animals such as
cats and dogs, which are infested with parasites such as fleas, ticks
and galls.
[4]
In response to Merial’s claim of infringement in the court
below, Cipla not only denied the infringement but challenged
the
validity of the patent on several grounds. Cipla did not, however,
counterclaim for revocation of the patent as it was entitled
to, in
terms of s 65(4) of the Patents Act 57 of 1978 (the Act).
[1]
In challenging the validity of the patent Cipla raised its lack of
clarity, insufficiency and inutility.
[5]
All the claims listed above, other than claim 1, are dependant
claims. As recorded by the court below, it was agreed by the
parties
that in the event of Merial having established an infringement of
claim 1, it would be entitled to the relief claimed.
[6]
Claim 1 of the patent reads as follows:
‘
Composition
which is useful in particular for the treatment and protection of
domestic animals which are infested with parasites
or are likely to
be infested with them, these compositions comprising in the form of a
ready-to-use solution:
(a)
1-[4CF
3
2,6-Cl
2
phenyl] 3-cyano 4-[CF
3
-SO]
5-NH
2
pyrazole (hereinafter referred to as “fipronil”);
(b)
a crystallization inhibitor which satisfies the test according to
which:
0.3ml
of a solution A comprising 10% (W/V) of fipronil in the solvent
defined in (c) below, and 10% of this inhibitor, are placed
on a
glass slide at 20°C for 24 hours, after which fewer than 10
crystals, preferably 0 crystals, are seen with the naked eye
on the
glass slide;
(c)
an organic solvent having a dielectric constant of between 10 and 35,
preferably of
between 20 and 30;
(d)
an organic co-solvent which is a drying promoter, having a boiling
point below 100°C,
preferably below 80°C, and a dielectric
constant of between 10 and 40, preferably of between 20 and 30,
wherein
fipronil is present in a proportion of from 1 to 20% W/V in the
composition.’
[7]
As can be seen, claim 1 postulates a composition which includes four
constituents, namely, fipronil, a solvent, a co-solvent
and
significantly for the invention, a crystallisation inhibitor. In
relation to the last-mentioned the specification states the
following:
‘
Yet
another object of the invention is to provide such compositions
which, when applied locally, will subsequently diffuse over
the
animal’s entire body and then dry, while at the same time
avoiding any phenomenon of crystallisation as far as possible.
Yet
another object of the invention is to provide such compositions
which, after drying, do not affect the appearance of the coat
and in
particular do not leave crystals and do not make the coat sticky.’
Fipronil
itself was known at the priority date of the patent and appears to
have been first used as an insecticide in crop science.
It was also
used in relation to parasites living externally on animals. So, the
invention does not relate per se to the use of
fipronil together with
a solvent for topical applications on animals. What is claimed to be
the invention is a composition which
will minimize the phenomenon of
crystallisation appearing on the skin of domestic animals such as
dogs and cats. Simply put, the
crystallisation inhibitor was intended
to combat negative effects in relation to the possible appearance of
crystals on the animal’s
coat.
[8]
Importantly, claim 1, by virtue of integer b) provides a test to
determine which constituents or combination of constituents,
will
result in a crystallisation inhibitor within the scope of the claim.
The test requires that a solution be prepared containing
(i) 10%
(w/v)
[2]
of fipronil; and (ii)
10% of the crystallisation inhibitor of the allegedly infringing
formulation (iii) both dissolved in the
solvent present in the
formulation in question. From this solution, 0.3ml is placed on a
glass slide at 20°C for 24 hours.
If, after 24 hours, fewer than
10 crystals are visible to the naked eye on the glass slide, then it
follows that the crystallisation
inhibitor will be within the scope
of claim 1.
[9]
The specification provides guidance on which types of solvents,
co-solvents and crystallisation inhibitors are suitable for
the
claimed fipronil formulations. In this regard, the specification also
provides preferred lists of chemicals for constituents
of the
formulation. Thus, the specification provides a list of potential and
preferred organic solvents which may be used in preparations
in
accordance with the invention of the patent.
[10]
It is important, both in relation to Cipla’s challenge of
invalidity on the basis of lack of clarity
and
the appellants’
assertion of infringement by Cipla, to have regard to the detail of
the patent specification concerning the
preferred organic solvents,
co-solvents and crystallization inhibitors. The following appears:
‘
As
organic solvent c) which can be used in the invention, mention may be
made in particular of:
acetone,
acetonitrile, benzyl alcohol, butyl diglycol, dimethylacetamide,
dimethylformamide, dipropylene glycol n-butyl ether, ethanol,
isopropanol, methanol, ethylene glycol monoethyl ether, ethylene
glycol monomethyl ether, monomethylacetamide, dipropylene glycol
monomethyl ether, liquid polyoxyethylene glycols,
propylene
glycol
, 2-pyrrolidone, in particular N-methylpyrrolidone,
diethylene glycol monoethyl ether
, ethylene glycol, diethyl
phthalate, or a mixture of at least two of these solvents.
The
preferred solvents c) are the glycol ethers, in particular diethylene
glycol monoethyl ether and dipropylene glycol monomethyl
ether.
As
crystallization inhibitor b) which can be used in the invention,
mention may be made in particular of:
-
polyvinylpyrrolidone, polyvinyl alcohols, copolymers of vinyl acetate
and vinylpyrrolidone, polyethylene glycols,
benzyl
alcohol, mannitol, glycerol, sorbitol, polyoxyethylenated sorbitan
esters; lecithin, sodium carboxymethylcellulose; acrylic
derivatives
such as methacrylates and the like. . . .’ (my emphasis.)
[11]
What follows in the specification as potential crystallisation
inhibitors are lists of anionic surfactants,
[3]
cationic surfactants, amine salts, non-ionic surfactants and
amphoteric surfactants. It ends with the statement ‘or
preferably
a mixture of two of these crystallisation inhibitors’.
The specification goes on to note the following:
‘
In
a particularly preferred manner, use will be made of a
crystallisation inhibitor system, namely the combination of a
film-forming
agent of polymer type and a surfactant. These agents
will be chosen in particular from the compounds mentioned as
crystallisation
inhibitor b).
Among
the film-forming agents of polymer type, which are particularly
advantageous, mention may be made of:
-
the
various grades of polyvinylpyrrolidone,
-
polyvinyl
alcohols, and
-
copolymers
of vinyl acetate and vinylpyrrolidone.
As
regards the surfactants, mention will be made most particularly of
non-ionic surfactants, preferably polyoxethylenated sorbitan
esters
and in particular the various grades of polysorbate, for example
polysorbate 80.
The
film-forming agent and the surfactant may in particular be
incorporated in similar or identical amounts within the limit of
the
total amounts of crystallisation inhibitor which are mentioned
elsewhere.’
[12]
As can be seen (and as I have emphasised in the quote above) the
potential organic solvents include propylene glycol (PG) and
diethylene glycol monoethyl ether (DGME) (which is sold by one
company under the trademark Transcutol® and is often referred
to
as such). The preferred organic solvents are said to be the glycol
ethers, in particular DGME (and dipropylene glycol monomethyl
ether
(DPGMME)). The patent teaches that these solvents can be used on
their own or as a mixture of at least two of the listed
solvents.
[13]
In respect of the co-solvent, the patent teaches that ethanol,
isopropanol and methanol are suitable for use in the composition
of
the invention. The patent teaches that the organic co-solvent must
be, in addition to being a co-solvent, a drying promoter.
In simple
terms, therefore, the co-solvent, being a ‘drying promoter’,
ensures that the formulation does not remain
‘wet’ on the
animal’s skin and elsewhere for a prolonged period. In line
with this, claim 1 of the patent provides
that the co-solvent must be
a drying promoter and must have a boiling point below 100°C,
preferably below 80°C.
[14]
When what is set out in the preceding paragraphs is scrutinised, one
will see that an item that appears as a contemplated organic
solvent,
is also envisaged as a crystallisation inhibitor. So, for example a
preferred organic solvent in relation to integer b)
is benzyl
alcohol, which may also be a crystallization inhibitor. There is also
an overlap between the items listed as potential
solvents in terms of
integer c) and the co-solvents in terms of integer d). In particular,
the specification states that ethanol,
isopropanol and methanol may
be used as solvents in relation to integer c), all of which may also
be used as co-solvents in relation
to integer d).
[15]
Further, as can be seen from what is set out above, the specification
lists a number of potential crystallisation inhibitors,
including
several film forming agents of polymer type, and several surfactants.
The list ends with the statement that the crystallisation
inhibitor
(ie. that of claim 1) should ‘preferably [be] a mixture of at
least two of these crystallization inhibitors’.
The
specification further explains that, in a particularly preferred
embodiment of the invention, use will be made of a crystallisation
inhibitor system, namely the combination of a film-forming agent of
polymer type and a surfactant (the subject of claim 11). The
specification identifies certain ‘particularly advantageous’
film forming polymers (including polyvinylpyrrolidone
(PVP)) and
surfactants (including Polysorbate 80/Tween 80
[4]
)
which may be included in the composition of claim 1.
[16]
Simply put, some of the contemplated constituent parts of the
formulation envisaged in claim 1 may serve dual functionalities.
It
is those dual and interchangeable roles that Cipla finds
objectionable. More will be said about this later.
[17]
To enable a proper appreciation of the issues and the evidence
discussed hereafter it is necessary, at this stage, to have
regard to
the constituent parts of Fiprotec. In Cipla’s plea, it admitted
that Fiprotec has the ingredients set out hereafter.
Professor
Barbour’s expert summary indicated the relative weights or
volumes of the ingredients. Para 11 of the judgment
of the court
below noted the constituent parts of Fiprotec. The list that appears
hereunder contains that list together with the
relative value:
(a)
9,7 % fipronil;
(b)
50 % diethylene glycol monoethyl ether (DGME);
(c)
27,7 % propylene glycol (PG);
(d)
1,40 % polyvinylpyrrolidone (PVP) which is a polymeric film-forming
agent;
(e)
1 % polysorbate 80 (Tween 80) which is a non-ionic surfactant;
(f)
10 % ethanol; and
(g)
0,10 % butylated hydroxyanesole and 0,10% butylated hydroxytoluene
which are antioxidants,
as contemplated in claims 7, 8 and 19.
All
of these ingredients are specifically mentioned as preferred
ingredients in the patent in suit, albeit sometimes in alternate
functions. However, Cipla denied that ethanol was a co-solvent in its
Fiprotec product as envisaged in integer d). It did not accept
that
the mixture of DGME and PG served the function of the organic solvent
provided for in integer c) of claim 1. It was also not
accepted that
polyvinylpyrrolidone and the polysorbate 80 operated together as
crystallisation inhibitors within the meaning of
integer b) of claim
1.
[18]
Much of the proceedings in the court below involved evidence in
relation to the integer b) test of claim 1. Both parties adduced
evidence by respective experts in relation to the crystallisation
inhibitor test set out in integer b). The experts reached opposite
conclusions. Merial’s expert, Dr Witchey-Lakshmanan (Dr
Witchey) testified that she had successfully conducted the test set
out in integer b). She concluded that the constituent parts of
Fiprotec matched those of the patent and that Fiprotec satisfied
the
crystallization inhibitor test. As set out in the expert summary of
Dr Witchey, she determined by way of integer b) ‘that
the use
of the PVP and Tween 80 in a ratio of 1,4 to 1
[5]
as a crystallisation inhibitor in the crystallisation inhibitor test
of claim 1 results in fewer than 10 crystals being seen with
the
naked eye on the glass slide used in the test’.
Professor
Barbour who testified on behalf of Cipla stated that he had conducted
an experiment in line with integer b) using the
actual ingredients of
Fiprotec and that it had failed the crystallisation inhibitor test.
He stated that when he conducted experiments
using the method spelt
out in the integer b) test, it resulted in heavy crystallisation
beyond the parameters of that test.
[19]
At this stage, it is important to note that the ingredients used by
Dr Witchey to conduct the integer b) test were supplied
by Merial and
not by Cipla, and so were not the exact same components as those used
in the manufacture of Fiprotec, more especially
from Cipla’s
perspective, the fipronil. However, Dr Witchey, in conducting the
integer b) test used the same concentrations
of fipronil as employed
by Professor Barbour. This aspect on which Cipla relied in
challenging the validity of Dr Witchey’s
integer b) test will
be discussed in due course. It is an aspect which the court below
considered significant in holding that the
appellants had failed to
prove infringement.
[20]
Whilst being critical of the test conducted by Professor Barbour, the
court below reasoned and concluded as follows (para 55):
‘
55.
The evidence of [Cipla] therefore does not conclusively establish
that Fiprotec does
not
include
a crystallization inhibitor that satisfies the test in integer b).
But that does not resolve the question of infringement.
The onus is
on [Merial] to establish positively, on a balance of probabilities,
that Fiprotec does indeed include a crystallization
inhibitor that
satisfies the test in integer b). The weaknesses in [Cipla’s]
case is not to my mind sufficient to warrant
an inference that the
combination of PVP K30 and Polysorbate 80 in a ratio of 1,4:1 (mixed
in a solution of DGME, PG and/or ethanol)
will operate to inhibit
fipronil sourced from “GSP crop science” [the supplier to
Cipla] from producing fewer than
10 crystals. There is no reliable
test before me which adequately demonstrates that fact. [Merial’s]
evidence shows that
the Fiprotec crystallization inhibitor system
will achieve that result in relation to fipronil produced and/or
supplied by Merial.
Neither that fact nor the flawed results of the
tests of the defendant provide sufficient evidence to conclude on the
probabilities
that the crystallization inhibitor system in Fiprotec
achieves the same result in relation to the fipronil used in Fiprotec
supplied
by GSP. A test on the constituents of the patented product
does not prove the constituents of the alleged infringing product
actually
infringe. To my mind it is impermissible, from the
perspective of logic and fairness, to infer that because the
crystallization
inhibitor proved successful in inhibiting the Merial
fipronil from producing crystals that it has equal success in so
inhibiting
the fipronil in Fiprotec. The evidence is insufficient to
reach that conclusion. While the different polymorphs
[6]
of fipronil may be insignificant once in solution, their existence in
different polymorphic form points to different manufacturing
processes that may or may not account for impurities which could
impact upon the process of crystallization. Whether that is or
is not
so can only be established once the actual ingredients in Fiprotec
have been subjected to a reliable integer b) test –
something
which has not happened in this case.
[21]
The court below thus held that the appellants had failed to discharge
the onus upon them to prove that Fiprotec infringes claim
1 of the
patent.
[7]
Nevertheless, the
court went on to discuss the other defences pleaded by Cipla.
[22]
In dealing with Cipla’s challenge to the validity of the patent
on the basis of lack of certainty, the court below said
the following
(para 85):
‘
85.
The lack of clarity attack, however, evolved somewhat during evidence
and argument. A further
contention was made that the claims lack
clarity because the same chemical can serve different functions in
the composition of
claim 1 of the patent. In particular, benzyl
alcohol can serve as the organic solvent in integer c) as well as
being the crystallization
inhibiter in integer b). Also, ethanol and
isopropanol can serve as a solvent in integer c) and as the
co-solvent in integer d).
As mentioned earlier, this prompted counsel
for the defendant to argue that the patent is unclear because “the
skilled addressee
is left to hazard a guess as to whether any
particular composition may constitute an infringement”.’
[23]
On this aspect Murphy J concluded as follows (paras 86 – 87):
‘
86.
I agree . . . that this attack goes to the issue of insufficiency not
clarity in that it essentially
alleges that the specification does
not sufficiently describe the manner in which the invention is to be
performed in order to
enable the invention to be carried out by a
person skilled in the art of the invention. The attack is not
directed at the wording
of claim 1. And, in any event, to the extent
that any clarity issue arises on this basis it was never pleaded by
the defendant
and hence I am disinclined to entertain it.
87.
In consequence, the defendant has made out no case of lack of clarity
upon which it may
rely as a defence to the action for infringement.’
[24]
The appellants, with the leave of the court below, appealed against
the finding that they had failed to discharge the onus
on them of
proving that Cipla had infringed claims 1, 2, 3, 7 to 15 and 18 to 20
of the patent in suit and the consequent order
dismissing the matter
with costs, including the costs of two counsel. Murphy J had also
rejected the defences raised by Cipla,
set out in para 4 above.
Before us
Cipla’s
sole
challenge to the validity of the patent was restricted to one based
on a lack of clarity. Thus, in particular, it is worth
noting that
the defence of insufficiency was not persisted in. Since a decision
in Cipla’s favour on the clarity point would
be dispositive of
the appeal, it is to that issue that I now turn.
[25]
It was submitted on behalf of Merial that this court should refuse to
entertain an appeal on the clarity point, since it had
not been
properly pleaded as a ground of challenge by Cipla. An examination of
the plea reveals that the attack based on lack of
clarity was limited
and related to the meaning of the words ‘solvent’,
‘co-solvent’, ‘crystallization
inhibitor’ and
‘fewer than 10 crystals, preferably 0 crystals, are seen with
the naked eye’. Furthermore, it
was pleaded that the
crystallisation inhibitor test was not clear in that the objective
physical results of that test may vary
depending on the conditions
under which the test is conducted, and that the observed results of
that test may vary depending on
the observer and the conditions under
which they were observed. As can be seen, the ambit of Cipla’s
pleaded challenge to
the validity of the patent was limited. Murphy J
was correct, as noted above, when he recorded that the lack of
clarity attack
evolved during evidence and argument, and that in
essence it was ultimately contended that the lack of clarity was
brought about
because of the dual role of constituent materials.
[8]
There is also some force in the submission on behalf of Merial that
the attack on the validity of the patent as pleaded, more properly
resides under the ground of insufficiency, ie on the basis that the
complete specification does not fully describe and ascertain
the
invention and, where necessary, illustrate or exemplify the invention
and the manner in which it is to be performed.
[9]
However, the question of the lack of clarity of the patent
was
explored fairly extensively when evidence was adduced in the court
below and, in my view, consideration should therefore be given
to
Cipla’s submissions on this aspect.
[26]
Before dealing with Cipla’s submissions and considering whether
they have any merit, it is necessary to remind ourselves
of what a
patent represents, and why the monopoly claimed by way of the patent,
has to be clearly and succinctly defined. In
Colgate-Palmolive Co
v Unilever Ltd
1981 BP 121 (CP) at 124F-125F, Nicholas J said the
following:
‘
[A]
patent represents a
quid
pro quo
as
it was aptly put by
Viscount
Dunedin in Pope Alliance Corporation v Spanish River Pulp and Paper
Mills Limited
[[1929] AC
46 RPC 23].
The
quid
is the monopoly conferred upon the patentee for a number of years;
see sec 28(1) and 32 of the Act. The
quo
is
the new knowledge which he presents to the public, and which, after
the expiry of the patent, will be available for general utilisation.
Hence the function of the claim is to inform prospective rivals of
the limits of the field denied to them while the patent lasts;
and
the function of the body of the specification is to instruct the
public how to carry out the invention when the field is eventually
opened. As regards the claim, the legislature obviously intended that
the monopoly must clearly and succinctly define the limits
of the
field closed to others, so that he who runs may read. As it was put
by Galgut, J in
Transvaal
and OFS Chamber of Mines v Hukki
[1964 BP 1 (T) at 212C-D]:
“
The
public who uses this art, the persons trained in the art, should not
be left to hazard any guess as to what the forbidden field
is.”’
(footnotes omitted.)
[27]
It is necessary to consider the required degree of sufficiency and
clarity of the claims of a patent. In T D Burrell
Burrell’s
South
African Patent and Design Law
3
ed (1999) para 4.37 at 197, the learned author, in dealing with the
degree of clarity required, states that what is needed is
‘reasonable
certainty’. He goes on to note, with reference, inter alia, to
Letraset
Ltd v Helios Ltd
1972
BP 243 (A) at 247D-E and
De
Beers Industrial Diamond Division (Pty) Ltd v General Electric
Company
[1988] ZASCA 82
; 1988 BP 124 (A) at 142C, that ‘[a]bsolutism
does not perch happily upon the banner of our law’. There is,
however,
a statutory obligation on a patentee to state in the claims
clearly and distinctly what the invention is which it desires to
protect.
[10]
[28]
Construing the meaning of the claims of the patent in the context of
the rest of the specification is the first task the court
must
undertake. This was stated in
Gentiruco AG v Firestone SA (Pty)
Ltd
1972 (1) SA 589
(A) at 613F-H. At 614B of that case, which is
still the leading case on the construction of patent specifications,
the following
appears:
‘
Consequently,
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 his intention was as conveyed by the
specification, properly construed . . . .’
[29]
It was submitted on behalf of Cipla that when the words ‘solvent’,
‘co-solvent’ and ‘crystallisation
inhibitor’
are read in conjunction with the body of the specification ‘great
uncertainty arises’. The following
appears in heads of argument
on behalf of Cipla:
‘
[W]hen
read in the context of the specification, it is not possible from the
meanings of these terms to determine the allocation
of individual
ingredients amongst the categories designated by the impugned terms,
thus making it impossible to determine a definitive
solution A, and
thus perform the test for infringement.’
In
short, it was submitted on behalf of Cipla that a contextual
interpretation of the claims of the patent exhibits a glaring
uncertainty.
Cipla contended that when, in addition, regard is had to
the evidence of Professor Barbour that the effect of the
interchangeable
roles of the constituent elements of the formulation
is confusing, its case on this aspect was overwhelming.
[30]
It was not suggested that the meaning of each of the words ‘solvent’,
‘co-solvent’, ‘crystallization
inhibitor’ is
unclear in the abstract. As recorded in para 82 of the judgment of
the court below, those words have ordinary
meanings. What was
postulated on behalf of Cipla was that viewed contextually, more
particularly in relation to the duality and
inter-changeability of
functions set out in the body of the specification, uncertainty
unfolds.
[31]
A reading of claim 1, in conjunction with the parts of the
specification referred to above, does not, at least superficially,
present any problems of comprehension. It is easy enough to
understand the meaning of the words referred to above. Furthermore,
as set out in para 7 above, when regard is had to claim 1 it is
not difficult to understand that it postulates a composition
which
includes four constituents, namely fipronil, a solvent, a co-solvent
and a crystallisation inhibitor. When the material parts
of the
specification on which Cipla relies are considered, one can see that
some of the constituent parts may be used interchangeably,
in
combination, and can serve more than one constituent function. The
question is whether it presents uncertainty from the perspective
of
the skilled addressee and in this regard the evidence of the
respective experts is of assistance.
[32]
As set out in para 29 above, Cipla placed reliance on the evidence of
Professor Barbour. In addition, Cipla pointed to the
difficulties
allegedly experienced by Dr Witchey when she was confronted with
hypothetical formulations which, so it was submitted,
demonstrated
that the patent was unclear. Reliance was placed on the evidence of
Professor Barbour in relation to the alleged lack
of clarity of the
formulation in question, despite the limited field of his experience,
namely, crystallography. In this regard,
Cipla placed reliance on Dr
Witchey’s acceptance that Professor Barbour was qualified to
perform the crystallisation inhibitor
test. Whilst it is true that Dr
Witchey conceded that the patent is addressed to a team of
professionals, as recorded by the court
below, and that Professor
Barbour was qualified to perform the crystallisation inhibitor test,
she did not concede Professor Barbour’s
expertise as a
formulation scientist. Dr Witchey testified that the skilled
addressee would constitute a professional team, including
a
veterinary parasitologist and a formulation scientist. It is beyond
doubt that Dr Witchey was a person skilled in the field of
the
invention of the patent with special knowledge in the area of
formulating veterinary compositions for topical applications.
She is
a skilled formulation chemist whilst Professor Barbour is not. I
shall deal with her evidence first and then consider whether
Cipla’s
reliance on Professor Barbour’s evidence is justified.
[33]
Dr Witchey confirmed what appeared in her expert summary, namely,
that the term ‘co-solvent’ is a chemical term
referring
to a solvent that is used in conjunction with another solvent to
dissolve a solute and that co-solvent systems are routinely
used in
chemical and formulation systems. A co-solvent is simply a second
solvent.
[34]
Significantly, Dr Witchey testified that the patent presents the use
of a variety of solvents, co-solvents and crystallisation
inhibitors
and that from the viewpoint of a formulator this was fairly typical.
She went on to state:
‘
The
lists of these materials are not overwhelming to a formulator because
a formulator is used to these types of chemicals.
’
Dr
Witchey read claim 1 of the patent as comprising a formulation having
four constituent elements and thus four areas of functionality.
First, there is the active ingredient, fipronil. Second, a solvent is
required; third, an additional solvent, which has to be a
drying
agent; and, fourthly and significantly, a crystallisation inhibitor.
[35]
Later in her testimony Dr Witchey stated:
‘
.
. . [A]s I have mentioned formulators will try to formulate with
complements having multiple functions and so it does not bother
me
that a co-solvent and a solvent could be the same thing.’
In
relation to percentage content in relation to what appears in claim
1, Dr Witchey indicated that one would have regard to the
function
served by a particular element.
[36]
As to the suggestion that a formulator would, in relation to the
teaching of the patent, be faced with an infinite number of
permutations from an infinite number of ingredients, Dr Witchey
responded by stating that one would look at the function of a
particular ingredient and follow the teachings of the patent and
would not include an ingredient that does not serve the function
that
is required. Simply put, you would look at what the formula required
and then select ingredients that would fulfil a particular
function.
It is necessary to repeat that the fact that one material might have
more than one function did not trouble Dr Witchey.
[37]
Dr Witchey also considered whether there were attendant difficulties
with the specification, stating that the contemplated
organic solvent
could be a mixture of at least two of them. The same applied to
crystallisation inhibitors. Dr Witchey took the
view that a skilled
formulator would have no problem with a constituent part consisting
of two materials fulfilling the same function.
She reiterated that,
in making a formula based on the patent or in deciding what would not
infringe the patent, a skilled formulator
would explore the functions
of each of the constituent materials.
[38]
It was put to Dr Witchey that in terms of the patent, benzyl alcohol
was envisaged as a potential organic solvent as well as
a
crystallisation inhibitor. She agreed that there were potential dual
functions of constituent ingredients. A document was presented
to Dr
Witchey, which in counsel for Cipla’s own words contained
‘mythical’ compositions. The hypotheticals presented
by
these compositions were put to Dr Witchey. The document contained a
composition in line with the constituents of Fiprotec and
then
variations, which were intended to show that it would not be
possible, if one were to have a mixture of certain crystallisation
inhibitors and solvents, to conduct the crystallisation inhibitor
test. The argument was that, when faced with these ‘mythical’
compositions, a skilled addressee would not be able to objectively
determine which ingredients fell under which integer, and therefore
would not be able to determine which ingredients must be included in
the crystallisation inhibitor test as the solvent (integer
c)), and
which must be excluded as the co-solvent (integer d)).
[39]
When the constituent parts of the hypotheticals were put to Dr
Witchey, she was ‘confused why someone would formulate
this
product in this way’. She was referring here to the substantial
number of contemplated excipients.
[11]
She went on to state:
‘
If
the ingredients are present in the formula they serve some function
within the formula. If they do not serve that function you
do not put
them in . . . . So my first question in looking at the formula is,
why the formula is what it is. It does not make sense
to me
completely as a formulator.’
She
testified that the hypotheticals presented to her showed a naivety on
the part of the formulator. When confronted with the teaching
of the
patent that benzyl alcohol can be used both as a solvent and as a
crystallisation inhibitor and that this would present
problems if one
were to conduct the crystallisation inhibitor test to see if a
product infringes, Dr Witchey stated that a formulator
would work
towards an understanding of what ‘mechanisms each [ingredient]
provides . . . within the formulation and as such
. . . try to make
an assessment as to what the appropriate test would be.’ She
testified as follows:
‘
A
formulator prepares a series of different formulas before they even
get to the integer b) test, to try and understand how the
solution,
the drug, how all of that interacts, how it behaves . . . .’
Later,
Dr Witchey stated:
‘
So
I would hope by the time the formulator gets to the point of sale of
a product . . . the formulator has established in some kind
of
scientific sense . . . [how] to make a better assessment as to what
would be a co-solvent, what would be a solvent, and what
would be
both.’
Dr
Witchey testified that in regard to Fiprotec there could be no
confusion as to its constituent parts and as to the function of
each
element. She testified that in Fiprotec ethanol is the co-solvent,
integer d) and that is why it was not included in the crystallisation
test for Fiprotec. She pointed out that this was accepted by the
parties to the litigation. On this she was essentially unchallenged.
This is an aspect to which I will revert later, when I deal with the
question of infringement.
[40]
In explaining how to decide what functionality to ascribe to an
ingredient and more particularly, determining what is to be
a solvent
and what is to be a co-solvent Dr Witchey said the following:
‘
A
person does not work in a vacuum. A person works to a systematic
scientific method that offers that understanding and that is
what I
am trying to say about the function of the materials.’
[41]
Dr Witchey went on to explain, in relation to claim 1, that the first
information which a formulator would obtain would be
the solubility
of fipronil in the particular constituents. She postulated that there
would be no problem with the solvent and insofar
as the co-solvent
was concerned, it was a solvent with a boiling point below 100°C
and a dielectric constant between 10 and
40 which would serve as a
drying promoter. As can be seen from the evidence of Dr Witchey a
skilled formulator would have no difficulty
in understanding the
parameters of claim 1 and more particularly integer b).
[42]
I now turn to the evidence of Professor Barbour. It is necessary to
record that his expert summary, not unsurprisingly, given
the
initially limited nature of Cipla’s plea in relation to the
patent’s alleged lack of clarity (referred to in para
22
above), does not deal with the multifunctional role of constituent
elements of the formula as presenting a problem other than
rendering
the meaning of the words ‘solvent’ ‘co-solvent’
and crystallisation inhibitor” unclear.
It undoubtedly did not
deal with the propositions put to Dr Witchey or with the ‘mythical’
formulations presented to
her. Professor Barbour’s limited area
of expertise, referred to above, might well be an additional
explanation for this omission
in his expert summary.
[43]
During his testimony in-chief, Professor Barbour stated that he found
the various combinations and multiple potential functions
of
substances confusing. His testimony in this regard was brief. The
‘mythical’ permutations presented to Dr Witchey
were
never put to Professor Barbour. Under cross-examination, Professor
Barbour appeared to limit his criticism in respect of the
lack of
clarity of the patent to the multiple possible identities of
ingredients. Under cross-examination he was asked:
‘
Where
is the lack of clarity?’
His
response was as follows:
‘
The
lack of clarity is in identifying a particular component listed as an
example, that could be either part of the solvent or part
of the
crystallisation inhibitor or both.’
Professor
Barbour was asked what he identified as a problem in relation to the
crystallisation inhibitor test and his response is
not entirely
clear. He conceded that the simple procedure for conducting the
integer b) test was not ambiguous but went on to state:
‘
So
the identification of the compounds that have to be used to make the
formulation, in other words to formulate the test, I have
already
said could be ambiguous in terms of the identification of which has
which identity and making the solution and dispensing
a drop. That is
the easy part. And then at the end, making an observation and making
a judgment about whether things are crystals
or not crystals and so
on, and then whether they should be counted and whether it should be
nine or ten, I believe that is somewhat
unscientific and ambiguous
also in terms of what you count as a crystal.’
[44]
Professor Barbour was cross-examined further about his confusion
concerning the dual identities of certain elements, more particularly
in relation to the integer b) test. He stated that his problem was
the dual identity of, for example, ethanol - being described
both as
a solvent and a co-solvent:
‘
Let
me elaborate on that. If ethanol is both the solvent and the
co-solvent, what do we take from that? That means that some of
the
ethanol is the solvent and some of it is the co-solvent, So in other
words, is it 60% of the ethanol is the solvent and 40%
is the
co-solvent?’
Referred
to the specifics of the integer b) test Professor Barbour accepted
that the problem did not arise in relation to it. He
accepted that
for the purpose of the test he would use ethanol as the solvent. In a
subsequent exchange with counsel on behalf
of the appellants,
Professor Barbour once again suggested hypothetical difficulties that
one might encounter with dual functionalities
of constituent elements
and the problems that might be encountered in attempting to identify
constituent parts of a formulation.
[45]
Cipla also relied on an affidavit by Professor Schuster, which was
part of prior interdict proceedings. Dr Schuster appeared
to have
difficulty with the dual role of ingredients. The content of that
affidavit was put to Dr Witchey at the time that Cipla
was pursuing
the hypotheticals referred to above. According to the affidavit he
had regard to the teaching of the patent that compounds
like
polyethelyne glycol can be the crystallisation inhibitor and also
taught that PG and DGME can be solvents and that solvents
can be used
in combination. Thus the patent contemplated that combinations of PG
and DGME can be present in a formulation of the
invention. Counsel on
behalf of Cipla put it to Dr Witchey that this presented a problem in
relation to the integer b) test, namely,
having DGME as
crystallisation inhibitor but regarding ethanol either as a
co-solvent on the one hand or as a solvent on the other
and that the
same would apply to isopropanol. Dr Witchey responded by stating that
there was no basis to accept that Professor
Schuster knew about the
materials within Fiprotec at the time that the interdict was sought
and there was no way of knowing what
other information he had at his
disposal. She stated the following:
‘
[L]et
us say for the purposes of argument that DGME in this hypothetical
formula also serves some function as a crystallisation
inhibitor. You
would not artificially remove, you would at least allow DGME to serve
its other function as a solvent as well and
that is not what is
happening here.’
[46]
Dr Witchey went on to state:
‘
As
a formulator you try to understand what the functions are of each and
try to apply your knowledge as best you can...[L]et us
say for
example that . . . fipronil were the active ingredient, PVP, benzyl
alcohol and DGME were in fact the crystallisation inhibitor,
ethanol
and isopropanol were the co-solvents, what is left as the solvent?
One has to address the solvent yet still. So certainly
some
assessment must be made to allow for a solvent but taking these step
by step in this fashion gets to the point of not making
sense to a
formulator.’
Later
she stated: ‘I am saying that a formulator given this code, or
a formulator having formulated, would have a better understanding
of
the functions or co-functions of each of these excipients’.
[47]
Professor Schuster did not testify and we do not have the benefit of
the content of his affidavit being subjected to further
scrutiny. We
are left to speculate about what was within his sphere of
information.
[48]
The alleged uncertainty in relation to observance by the naked eye of
the number of crystals set as the outer limit of acceptability
in
terms of the crystallisation inhibitor test was, with good reason,
not persisted in. As recorded by the court below Professor
Barbour
rightly conceded that he had no difficulty measuring the
crystallisation when he conducted the integer b) test with ordinary
vision which, in appropriate circumstances, could be corrected by
spectacles and that the factors that might possibly impact on
crystallisation could be controlled. As to variable environmental
conditions that might impact crystallisation it appears to be
uncontested that normal laboratory conditions would suffice. That
part of Cipla’s case was not persisted in before us.
[49]
In
Integrated
Mining Systems (Pty) Ltd v Chamber of Mines of South Africa
1974 BP 281 (CP) at 310-311 the court said in relation to the
assertion of insufficiency that courts will not find insufficiency
simply because exceptional cases, or unlikely materials might come
within the words of the specification and will not work. The
same
logic would apply to the hypotheticals presented in relation to the
challenge based on lack of clarity.
[50]
Counsel on behalf of Cipla submitted that given the dual and
interchangeable functionalities of elements in the specification
one
would not be in a position to ‘unscramble the egg’. It
was suggested that one would not be able to deconstruct
a
formulation. That of course would not be a problem with an allegedly
offending product. One could subject it to analysis. When,
however,
there is a challenge to the validity of a patent without an allegedly
offending product, on the basis of lack of clarity,
then the question
that must be addressed is whether the patent is reasonably certain.
In
Ausplow
(Pty) Ltd v Northpark Trading 3 (Pty) Ltd
&
others
[2011] ZASCA 123
; 2011 BIP 12 (SCA) Harms JA stated that patents are
about construction and not deconstruction of the text.
[12]
In
Ausplow
this court referred (para 20 fn 10) to what was said in
Lister
v Norton Brothers and Co
(1886) 3 RPC 199
(Ch D), namely, that ‘a patent must be read by
a mind willing to understand, not by a mind desirous of
misunderstanding’.
In my view the hypotheticals appear to have
been employed with focused intent on misunderstanding.
[51]
It was contended on behalf of Cipla that one would not find reported
cases in which one could find pharmaceutical formulations
in respect
of which constituents may be selected from one or more pharmaceutical
ingredients that may be part of an admixture.
However, this is
incorrect. In
Pharma Dynamics (Pty) Ltd v Bayer Pharma AG
(formerly Bayer Schering Pharma AG) & another
[2014] ZASCA
201
;
[2014] 4 All SA 302
(SCA), at para 29 the following appears,
taken from the detailed disclosure of the invention there in
question:
‘
Bayer’s
case is that claim 1 protects the invention described by Prof Davies.
The contrary position taken by Dr Rue and Pharma
is that if there was
indeed an invention as described by Prof Davies - which they denied –
that is not the invention covered
by claim 1. Although directly
contradictory, each party found support for its interpretation in the
body of the patent specification,
which reads in relevant part, under
the heading “Detailed disclosure of the invention”:
“
Drospirenone
. . . is a sparingly soluble substance in water and aqueous buffers
at various pH values. Furthermore, drospirenone
is rearranged to an
inactive isomer under acid conditions and hydrolysed under alkaline
conditions. To ensure good bioavailability
of the compound, it is
therefore advantageously provided in a form that promotes rapid
dissolution thereof.
It
has surprisingly been found that when drospirenone is provided in
micronized form . . . rapid dissolution of the active compound
from
the composition occurs in vitro
(“rapid dissolution”
is defined as the dissolution of at least 70% over about 30 minutes .
. . of drospirenone from
a tablet preparation containing 3 mg of
drospirenone in 900 ml of water at 37ºC determined by the USP
XXIII Paddle Method
using a USP dissolution test apparatus 2 at 50
rpm).
Instead of providing the drospirenone in micronized form,
it is possible to
dissolve it in a suitable solvent, e.g. methanol
or ethyl acetate
, and spray it onto the surface of inert carrier
particles followed by incorporation of the particles containing
drospirenone on
their surface in the composition. . .
The
composition of the invention may be formulated in any manner known in
the pharmaceutical art. In particular, as indicated above,
the
composition may be formulated by a method comprising providing
drospirenone and, if desired, ethinylestradiol in micronized
form in
said unit dosage form, or sprayed from a solution onto particles of
an inert carrier in admixture with one or more pharmaceutically
acceptable excipients that promote dissolution of the drospirenone
and ethinylestradiol so as to promote rapid dissolution . .
. on oral
administration.”’
(my
emphasis.)
[52]
As can be seen, Professor Barbour’s criticism of the patent was
tentative, confusing, at times contradictory and on the
whole rather
diluted. The number of crystals and the test as to whether they are
visible to the naked eye are aspects on which
I will comment in due
course. Cipla bore the onus to prove the invalidity of the patent.
The evidence of Professor Barbour, for
the reasons set out above, is
of no assistance. The evidence of Dr Witchey, by contrast, is a
formidable obstacle in the way of
Cipla’s case on invalidity.
[53]
For all the reasons set out above Cipla’s challenge to the
patent in suit on the basis of lack of clarity must fail.
[54]
It is now necessary to turn to the question whether the appellants
had satisfied the onus of proving infringement of the patent.
A
determination of the question as to whether a plaintiff has proved an
infringement of its patent turns upon a comparison between
the
article or process, or both, involved in the alleged infringement and
the words of the claims in the patent.
[13]
It was accepted that in respect of the integer b) test, to which a
substantial part of the proceedings in the court below was devoted,
it was necessary to have regard to expert evidence. In the present
case the principal actors were again Professor Barbour and Dr
Witchey, whose evidence on this subject will be adverted to in due
course.
[55]
The issues concerning infringement were limited to the question
whether ethanol is an organic co-solvent for the purposes of
integer
d) and whether the mixture of PVP and Tween 80 in Fiprotec is a
crystallisation inhibitor for the purposes of integer b)
and one
which satisfies the test set out therein. In Dr Witchey’s
expert summary she matched the integers of the claims against
the
Fiprotec constituents and confirmed that DGME and PG is an organic
solvent and that ethanol is a co-solvent in Fiprotec. She
persisted
in this view, notwithstanding that the ethanol could also, in certain
formulations, be the solvent. This aspect was dealt
with during the
cross-examination of Dr Witchey as referred to in the discussion
above
[14]
in relation to the
defence based on the lack of clarity. It will be recalled that Dr
Witchey stated emphatically that in regard
to Fiprotec there was no
confusion as to its constituent parts and as to the function of each
element and that it was accepted
by the parties to the litigation
that ethanol served as the co-solvent (integer d)). She was, as
recorded above, essentially unchallenged
in this as counsel on behalf
of Cipla chose to move away from the discussion on the constituent
parts of Fiprotec. Murphy J rightly
recorded that Dr Witchey was
unchallenged on this aspect.
[15]
As pointed out above, the hypothetical formulations put to Dr Witchey
do not detract from her essentially unchallenged and persuasive
evidence on this aspect.
[16]
[56]
Following on the conclusion set out in the preceding paragraph, the
remaining issue relates to the question whether the mixture
of PVP
and Tween 80 in Fiprotec is a crystallisation inhibitor falling
within integer b) and one which meets the requirements of
that test.
The answer to that question turns on the experiments carried out by
the parties’ respective experts.
[57]
It is now necessary to consider the experiments conducted by
Professor Barbour. His expert summary refers to three tests that
he
conducted in support of Cipla’s case of non-infringement. He
conducted tests B1, B2 and C. Cipla abandoned reliance on
test C
during the trial. As stated earlier, it is undisputed that Professor
Barbour used the actual ingredients of Fiprotec and
that the
materials employed by Dr Witchey were supplied by the first
appellant.
[58]
As appears from his expert summary Professor Barbour’s tests,
B1 and B2, used DGME and PG present in Cipla’s product
as the
organic solvent and the PVP and Tween 80 of Cipla’s product, as
the crystallisation inhibitor. These tests were carried
out at
concentrations which accord with the requirements in claim 1. In
other words, fipronil has a concentration of 10% and PVP
and Tween
80, together, have the same concentration. The same solution was used
in both tests and both tests failed according to
Professor Barbour.
[59]
Murphy J took the view that Professor Barbour’s tests were
performed carelessly. In this regard, he accepted criticisms
proffered by counsel on behalf of the appellants. In respect of test
B1 Murphy J said the following (para 52):
‘
The
principal reason for which I hesitate to accept the results of
[Professor] Barbour’s Test B1, as scientifically establishing
the failure of the crystallisation inhibitor in Fiprotec, is that
there is a distinct possibility, if not probability, that an
etching
on the slide used by [Professor] Barbour (caused by a microscope)
contributed significantly to the formation of crystals.
Instead of
using a clean, new slide, [Professor] Barbour used a five year-old
glass slide which he took from his microscope. The
etching was caused
by the pressure of the component of the microscope holding the slide
in place. [Professor] Barbour conceded
that any scratching on a glass
slide could encourage crystallisation. The photographic evidence in
relation to Test B1 reveals
that the solution may have pooled against
the edge of the etching. This alone makes Test B1 unreliable and the
results must be
disregarded.’
[60]
In respect of test B2, Murphy J said the following (para 53):
‘
.
. . I agree . . . that the results of Test B2, conducted by
[Professor] Barbour, are not sufficiently credible to definitively
exclude integer b). In this instance, crystallisation materialised
after 13 minutes, whereas it took 5 hours in Test B1 despite
using
the same solution, in the same laboratory at the same temperature.
Normally, before one would see crystallisation, at least
part of the
solution would have to reach the saturation point of the solute in
the solvent. Dr Witchey estimated that some 45 %
of the solution
would have to evaporate before the concentration of fipronil reached
a point where the crystallisation inhibitor
is even needed. To accept
the results of Test B2 it must be accepted that 45 % of a solvent
system having boiling points of 200°C
(DGME) and 185°C (PG)
evaporated in 13 minutes. The probabilities point to an error of some
kind, inexplicable in the evidence.
[Professor] Barbour might have
been prudent when confronted with the rapid rate of evaporation in
this test to have conducted a
third test.’
[61]
As submitted on behalf of the appellants, it is true that Professor
Barbour conducted his tests at relatively short notice
and within
time constraints. This was evidenced in the inconsistency between the
results he obtained from tests B1 and B2.
[62]
It is also correct that Professor Barbour conceded that he had made
‘a careless mistake’ in his summary when he
spoke of a
mixture of co-solvents. This amplifies the conclusion set out above
in relation to his lack of expertise in relation
to chemical
formulations, but it is also true that his difficulty with dissolving
the active ingredient was related to him not
following the order in
which the constituents were to be mixed. He was also rightly
criticised for measuring the proportions of
Tween 80 and DGME in v/v
despite the facts that (i) Cipla’s own supplier measures these
materials in w/v and (ii) it would
mean that the percentages of the
crystallisation inhibitor would not equal 10%. He also wrongly
described propylene glycol as ‘polyethylene
glycol’ (PG).
All these factors point to a lack of application and
conscientiousness.
[63]
In relation to test B1, the criticisms noted by Murphy J are
justified. Professor Barbour knew that there was an etching on
the
reverse side of the microscope slide brought about by the pressure of
the microscope but ‘hoped’ that the drop
in pursuance of
the integer b) test would not spread beyond the etching. He accepted
that scratching a glass slide was a well-known
technique for
encouraging crystallisation which for the purposes of the integer b)
test had to be avoided. Professor Barbour’s
‘hope’
proved unfounded as the photographs show that the solution placed on
the microscope’s slide pooled against
the edge of the etching.
[64]
In relation to test B2 Professor Barbour claimed that crystallisation
manifested 13 minutes after the commencement of the trial.
This
differs vastly from the time of onset of crystallisation in relation
to test B1. In relation to that test, crystallisation
occurred after
five hours. Professor Barbour used the same solution in the same
laboratory at the same temperature. This was remarkable
and ought to
have given reason to pause.
[65]
In the result, Murphy J was correct to reach the conclusion that one
could not rely on Professor Barbour’s integer b)
tests.
[66]
Murphy J, however, questioned the probative value of the tests
conducted by Dr Witchey. He criticised her for not being able
to
offer any explanation as to why the results of her tests and those of
Professor Barbour differed. This criticism discounts the
Commissioner’s own conclusions in relation to the reliability
of the test conducted by Professor Barbour.
[67]
The court below considered whether the divergent results might have
been due to the fact that Dr Witchey conducted her test
in a weighing
cabinet which may have inhibited evaporation and thus the formation
of crystals, but rightly in my view accepted
her evidence that the
use of the cabinet was legitimate as it avoided artificial means of
enhancing evaporation such as would occur
where a convector flux was
allowed to push across the surface of a slide. Leaving the slide in
an open laboratory would, if it
was exposed to air handling systems,
enhance evaporation. Dr Witchey was satisfied that the cabinet was of
sufficient size and
sufficient configuration to allow free
evaporation.
[68]
Continuing to explore the reason for divergent results, the court
below considered that it might be due to the use by Dr Witchey,
not
of Cipla’s own composition of fipronil, but of fipronil and PG
sourced elsewhere. The Commissioner also noted that the
DGME sourced
by Dr Witchey was Transcutol V and not Transcutol P.
[69]
Murphy J considered fipronil to be the most important ingredient in
the test, particularly since it was the active pharmaceutical
ingredient. He speculated that different processes in producing the
ingredients used by Dr Witchey might have caused the divergent
results. Whilst Dr Witchey did agree that it would have been optimum
to have conducted the test with the exact constituents of
the
infringing product, she did not concede that the tests conducted by
her were therefore invalid. Murphy J also theorised that
the fipronil
supplied by Merial may have been in a different polymorphic form to
that in Fiprotec. Having resorted to the speculation
set out above,
the court below found that there was no reliable test before it which
adequately demonstrated that the crystallisation
inhibitor system in
Fiprotec (i.e. the combination of PVP K30 and Tween 80 (in a ratio of
1,4:1)) would inhibit fipronil sourced
from GSP Crop Science (i.e.
the fipronil used in Fiprotec) from producing fewer than 10 crystals
in the crystallisation inhibitor
test of claim 1.
[70]
As correctly pointed out on behalf of the appellants, there was no
evidence before the Commissioner on which it might be found
that
Cipla’s fipronil was in a different polymorphic form. It
appears from documents put to Dr Witchey when she was testifying
that
the fipronil used by Cipla and that used by Merial had the same
chemical abstract number. Similarly, although Dr Witchey used
a
slightly different form of DMGE (Transcutol V and not Transcutol P),
she explained that these two compounds were ‘virtually
identical’ and this would not have materially affected the
experiments. This was never seriously challenged.
[71]
Furthermore, it is so that there was no evidence adduced that there
were different processes employed in relation to manufacture
of
Merial’s fipronil or Cipla’s, or that Cipla’s
fipronil contained impurities which may have impacted on
crystallisation.
[72]
The most obvious cause for the discrepancies, as noted above, was the
careless manner in which Professor Barbour conducted
his tests as
opposed to the more meticulous manner adopted by Dr Witchey. The high
water mark of Professor Barbour’s evidence
was that fipronil
from different sources might possibly have resulted in different
impurities. The speculation referred to above
discounted Professor
Barbour using the same fipronil during the same series of tests but
obtaining divergent results. I agree as
submitted on behalf of the
appellants that the impurities debate is a red herring.
[73]
Despite having rejected Cipla’s defences relating to the
validity of the patent, Murphy J nevertheless held that Dr Witchey’s
view, that ethanol was the co-solvent in the formulation, was not
persuasive. Although Murphy J found that Professor Barbour, by
using
DGME and PG as the solvents, had, by implication, ‘arguably’
accepted that ethanol was in fact the co-solvent
in Fiprotec, he
thought it important that Professor Barbour had testified that he had
found the teaching of the patent confusing
because of the dual
identity of ethanol. The court below held that Dr Witchey had
experienced difficulty in dealing with the hypotheticals
presented to
her. He concluded that Dr Witchey had failed to prove that Fiprotec
included integer d) by failing to persuade him
that ethanol was
indeed the co-solvent. This aspect has been dealt with in some detail
in relation to Cipla’s challenge to
the invalidity of the
patent and I do not intend to repeat it, save to state that, for the
reasons provided above, the court below
erred in concluding as set
out earlier in this paragraph.
[74]
The contention on behalf of Cipla, that Dr Witchey was evasive and
refused to make concessions which were called for and that
her stock
response was to retreat into her expertise as a formulator is
unwarranted. As stated earlier, she was entitled to rely
on her
expertise as a formulator. She is a formulation chemist trained as a
chemical engineer with 25 years of experience in pharmaceutical
product development. She is, as recorded by the court below,
indisputably a person skilled in the art and thus an addressee of
the
patent. As demonstrated above, she was an impressive witness. The
submission on behalf of Cipla that Professor Barbour, by
contrast,
was an excellent witness is equally unjustified. The weaknesses in
his testimony have been referred to earlier in this
judgment.
[75]
For completeness I record that Cipla presented evidence by a
non-expert witness, a Mr Swiegers, that he had applied Fiprotec
to a
sample of dogs and that they all had crystals on their coats
thereafter. In this regard there was countervailing evidence
on
behalf of the appellants. The court below disregarded Mr Swiegers’
evidence on the basis that claim 1 of the patent presented
no degree
of visibility of crystals on the coat of an animal. The evidence in
relation to the actual application of Fiprotec to
the coat of an
animal was not relied upon before us and need not detain us.
[76]
In my view the court below erred by not concluding that the
appellants had proved on a balance of probabilities that there
was an
infringement of claim 1 and the other dependant claims.
[77]
The following order is made:
1.
The appeal is upheld with costs including the costs of two counsel.
2.
The order of the court below is set aside and substituted as follows:
‘
1. The
defendant is interdicted and restrained from infringing claims 1, 2,
3, 7 to 15 and 18 to 20 of the patent.
2. The defendant is ordered to deliver
up to the plaintiffs all infringing Fiprotec products in its
possession or under its control.
3. An inquiry is ordered in relation
to the damages suffered by the plaintiffs as a consequence of the
infringement of the patent
by the defendant alternatively an inquiry
into the reasonable royalty to which the plaintiffs are entitled.
4. In the event of the parties being
unable to reach an agreement as to the further pleadings to be filed,
discovery, inspection
or other matters of procedure relating to the
inquiry, an order authorising any one of the parties to make
application to the court
for directions in regard thereto.
5. Each of the claims referred to in
para 1 above of South African Patent Number 1996/8057 is certified as
being valid in terms
of
section 74
of the
Patents Act 57 of 1978
.
6. The defendant is
ordered to pay the plaintiffs’ costs of suit, including the
costs of two counsel and the qualifying fees
of the plaintiffs’
expert witnesses.’
________________________
M
S NAVSA
Acting
Deputy President
APPEARANCES:
For
Appellants:
L Bowman SC (with G Marriott)
Instructed
by:
D M
Kisch Inc., Pretoria
Phatshoane
Henney Attorneys, Bloemfontein
For
Respondents:
C Puckrin SC (with R Michau SC)
Instructed
by:
Brian
Bacon Inc., Cape Town
Webbers,
Bloemfontein
[1]
That subsection
provides:
‘
In
any proceedings for infringement the defendant may counterclaim for
the revocation of the patent and, by way of defence, rely
upon any
ground on which a patent may be revoked.’
[2]
W/v is an
abbreviation for ‘weight per volume’.
[3]
In
Chambers
Dictionary of Science and Technology
(1974)
‘surfactant’ is explained as follows:
‘
An
abbreviate form of
surface
active agent
,
ie a substance which has the effect of altering the interfacial
tension of water and other liquids or solids, eg detergent or
soap.’
[4]
Tween 80 appears
to be a trade name.
[5]
The ratio appears
from what is set out in the preceding paragraph.
[6]
Polymorphism is
the property possessed by certain chemical compounds of
crystallising in several forms which are structurally
distinct. See
Chambers
Dictionary
supra.
Professor
Barbour explained the concept as follows:
‘
.
. . [I]t is different crystalline forms of the same compound . . .
the chemical bonding is different.’
[7]
Para 57 of the
judgment.
[8]
Para 85 of the
judgment in the court below.
[9]
See
section
61(1)
(e)
(i)
of the Act as a ground on which a patent may be revoked. It is well
established that a challenge on the basis of insufficiency
differs
from that of a lack of clarity. The main ground of distinction is
that the attack on lack of clarity is directed to the
claims and not
to the body of the specification, whereas in dealing with an
objection based on insufficiency the whole specification
must be
considered. Essentially, the body of the specification (which goes
to sufficiency) teaches how the invention works and/or
how to
operate it, while the claim (which goes to clarity) defines the
limits of the monopoly claimed for the duration of the
patent.
Nevertheless, the evidence on lack of clarity may overlap with that
on the question of insufficiency.See T D Burrell
Burrell’s
South African Patent and Design Law
3
ed (1999) para 4.36 at 196 and the authorities there cited.
[10]
See
Power
Steel Construction Co (Pty) Ltd v African Batignolles Construction
(Pty) Ltd
1955 BP 155 (A) at 162.
[11]
In
Chambers
Dictionary
supra,
‘excipient’ is defined as:
‘
The
inert ingredient in a medicine which makes up and holds together the
other ingredients.’
Wikipedia
defines ‘excipient’ as:
‘
An
excipient is a natural or synthetic substance formulated alongside
the active ingredient of a medication, included for the
purpose of
long-term stabilization, bulking up solid formulations that contain
potent active ingredients (thus often referred
to as "bulking
agents," "fillers," or "diluents"), or to
confer a therapeutic enhancement on the
active ingredient in the
final dosage form, such as facilitating drug absorption, reducing
viscosity, or enhancing solubility.’
Available at:
https://en.wikipedia.org/wiki/Excipient
accessed
30 March 2016.
[12]
Para 20.
[13]
Stauffer
Chemical Co & another v Safsan Marketing and Distribution Co
(Pty) Ltd & others
[1986] ZASCA 78
; 1987 (2) 331 (A) at 342D-E.
[14]
See para 39 above.
[15]
Para 61 of the
judgment in the court below.
[16]
Professor Barbour
in conducting his experiments in fact used ethanol as the
co-solvent, even though he did this on the basis that
Merial had
advised it. He did not have any difficulty in conducting the integer
b) test.