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[2015] ZASCA 175
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Merck Sharpe Dohme Group v Cipla Agrimed (Pty) Ltd (20282/2014) [2015] ZASCA 175; 2016 (3) SA 22 (SCA); 2015 BIP 101 (SCA) (27 November 2015)
THE SUPREME COURT OF
APPEAL OF SOUTH AFRICA
JUDGMENT
Reportable
Case no:
20282/2014
In the matter
between:
MERCK SHARPE DOHME
GROUP
APPELLANTS
MERIAL
LLC
and
CIPLA AGRIMED (PTY)
LTD
RESPONDENT
Neutral
citation:
Merck
Sharpe Dohme Group v Cipla Agrimed (Pty) Ltd
(20282/2014)
[2015] ZASCA 175
(27 November 2015)
Bench:
Ponnan, Theron, Wallis, Petse and
Willis JJA
Heard:
10 November 2015
Delivered:
27
November 2015
Summary:
Patent – alleged lack of novelty –
requirements of disclosure and enablement – selection patent –
conditions
for validity of.
ORDER
On appeal from
Court of the Commissioner of Patents (Teffo J,
sitting as court of first instance):
1.
The appeal is upheld with costs, including the costs of two counsel.
2.
The order of the court below is replaced with the following:
‘
(a)
The application for revocation of South African Patent Number
1998/10975 is dismissed.
(b)
Each of the claims of South African Patent Number 1998/10975 is
certified as being valid
in terms of section 74 of the Patents Act No
57 of 1978.
(c)
Costs are awarded to the joint patentees, including the costs of two
counsel.’
JUDGMENT
Ponnan JA (Theron,
Wallis, Petse and Willis JJA concurring):
[1] ‘An old
question and answer runs as a follows: "Where does a wise man
hide a leaf? In a forest." It is,
at least faintly,
ridiculous to say that a particular leaf has been made available to
you by telling you that it is in Sherwood
Forest. Once identified,
you can of course see it. But if not identified you know only the
generality: that Sherwood Forest has
millions of leaves.
The
contention has no logical stopping place. . . .
’
That excerpt from
Dr
Reddy’s Laboratories (UK) Ltd v Eli Lilly and Company Ltd
[2009] EWCA Civ 1362
para 26 and 27
appears
particularly apt when considering the issue raised by this appeal,
which is whether or not, and the extent to which, a generalised
description in a prior art document discloses and enables a specific
matter falling within that broad description for the purpose
of
anticipation. The issue arises for determination in this context: The
appellants, Merck Sharpe Dohme Corp and Merial LLC, the
joint
patentees of South African Patent 98/10975, appeal against an order
of the Commissioner of Patents (Teffo J) revoking their
patent. The
patent (the 98 patent) was revoked at the instance of the respondent,
Cipla Agrimed (Pty) Ltd, on the basis that it
was invalid for lack of
novelty in terms of s 61(1)(c) read with s 25(1) of the Patents Act
57 of 1978 (the Act).
[2]
A
patent represents a
quid pro quo
(per Viscount Dunedin in the UK Privy Council case of
Pope
Applicance Corporation v Spanish River Pulp and Paper
Mills Ltd
[1929] AC 269
at 281). The
quid
is
the monopoly conferred upon the patentee for a number of years and
the
quo
is
the new knowledge presented 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 open’ (
Letraset Ltd v
Helios Ltd
1972 (3) SA 245
(A) at 249
F-G).
Under the Act a patent may be granted
for an invention only if, amongst other things, the invention is new
and involves an inventive
step (
s 25(1)).
It follows that a patent granted for an
invention that does not meet those criteria may be revoked (s
61(1)(c))
. In
terms of s 25(5) an invention is deemed to be new if it does not form
part of the state of the art immediately before the priority
date of
any claim to the invention.
[3] The rules
relating to the interpretation of patents are well-settled.
[1]
The onus of proving anticipation (or lack of
novelty) in this case was on the respondent as the applicant for
revocation.
[2]
The general principles relevant to the
determination of the novelty of the claims of a patent were recently
restated in
Standard Bank of SA v
3MFuture Africa (Pty) Ltd
(47/2013)
[2013] ZASCA 157.
As Nugent JA put it (para 9):
‘
The
classic formulation of the test to be applied when asking whether an
invention has been anticipated (whether the invention is
“novel”
or “new”) is that expressed by Trollip JA in
Gentiruco
AG v Firestone SA (Pty) Ltd
[
1972
(1) SA 589
(A)] . . .
in
which the learned judge said the following:
“
[The
objection of anticipation] relates to the claims and not the
description of the invention in the body of the specification.
. . .
Hence the particular claim must be construed to ascertain its
essential constituent elements or integers. For the purpose
of this
objection the claim so construed is assumed to be inventive. . . .
The prior printed publication or patent alleged to be
anticipatory is
then construed. . . . The two documents are then compared to
ascertain whether . . . the prior printed publication
“describes”, the same process, etc., as that claimed. . .
. In regard to a prior publication, the ordinary meaning
of
“describe” means “to set forth in words or recite
the characteristics of” . . . Hence for it to “describe”
the invented process etc., it must 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.”’
[4] Accordingly, the
scope of each of the claims of the patent in suit must be
construed
[3]
and then compared with the prior art document upon
which the attack is based.
[4]
Moreover, the disclosure must be found in one
document as the mosaicing of more than one prior art document is not
permitted.
[5]
It is important to appreciate that a finding of
anticipation requires more than a throw-away reference to the same
subject matter
in a prior art document. In this regard, the subject
matter must be taught in the prior art document in a way which
enables the
skilled person, on reading the prior document, to
appreciate the import of, and implement, its teaching. (See
Synthon
BV v SmithKline Beecham plc
[2005]
UKHL 59
;
[2006] 1 All ER 685
para 14.)
[6]
[5] The House of
Lords (per Lord Hoffmann) explained in
Synthon
that there are two requirements for anticipation: prior disclosure
and enablement. ‘Disclosure’, stated Lord Hoffmann
(para
20),
has been explained in what he
described as two judgments of unquestionable authority -
Hill
v Evans
(1862) 31 LJ (NS) 457
[7]
and
General Tire and
Rubber Co v Firestone Tyre and Rubber Co Ltd
[1972]
RPC 457.
[8]
Lord Hoffmann summarised the effect of those two
judgments thus (para 22):
‘
.
. . the matter relied upon as prior art must disclose subject matter
which, if performed, would necessarily result in an infringement
of
the patent. That may be because the prior art discloses the same
invention. In that case there will be no question that performance
of
the earlier invention would infringe and usually it will be apparent
to someone who is aware of both the prior art and the patent
that it
will do so. But patent infringement does not require that one should
be aware that one is infringing: “Whether or
not a person is
working [an] invention is an objective fact independent of what he
knows or thinks about what he is doing”
(see
Merrell
Dow Pharmaceuticals Inc v H N Norton & Co Ltd
[1995] UKHL 14
;
(1995)
33 BMLR 201
at 213
[1995] UKHL 14
; ,
[1996] RPC 76
at 90). It follows that, whether or
not it would be apparent to anyone at the time, whenever subject
matter described in the prior
disclosure is capable of being
performed and is such that, if performed, it must result in the
patent being infringed, the disclosure
condition is satisfied. The
flag has been planted, even though the author or maker of the prior
art was not aware that he was doing
so.’
‘
Enablement’,
according to Lord Hoffmann (para 26), ‘means that the ordinary
skilled person would have been able to perform
the invention which
satisfies the requirement of disclosure.’ He added (para 28):
‘
As
Laddie J said in relation to sufficiency in
University
of Southampton’s Applications
[2005] RPC 220
, 236:
“
In
my view, devising an invention and providing enabling disclosure are
two quite different things. Although both may be necessary
to secure
valid protection, as section 14 of the [UK Patents Act, 1977] Act
shows, they relate to different aspects of the law
of patents. It is
very possible to make a good invention but to lose one’s patent
for failure to make an enabling disclosure.
The requirement to
include an enabling disclosure is concerned with teaching the public
how the invention works, not with devising
the invention in the first
place”.’
[6] In
Synthon
(para 30) Lord Hoffmann emphasised that
it is important to keep in mind that disclosure and enablement are
distinct concepts - each
of which has its own function and rules and
each of which has to be satisfied.
[9]
And, that in deciding whether there has been
anticipation, there is a serious risk of confusion if the two
requirements are not
kept distinct. As Lord Walker of Gestingthorpe
observed in a separate concurrence in
Synthon
(para 64):
‘
The
practical importance of keeping the two requirements distinct will
vary with the factual situation. In the case of the low-tech
invention . . . the simple disclosure of the invention will probably
be enough to enable the skilled person to perform it. By contrast
in
the case of a high-tech invention in the field of pharmaceutical
science the bald assertion of the existence of the invention
may have
to be accompanied by detailed disclosure enabling the skilled person
to perform it. But in testing the adequacy of the
enablement it may
be assumed that the skilled person will have to use his skill, and
may have to learn by his mistakes . . .’
[7] Thus, in order to
constitute anticipation, the prior disclosure must not only identify
the subject matter of the claim in the
latter patent, but must also
do so in a way that enables the skilled person to make or obtain
it.
[10]
Importantly, the test of enablement of a
prior disclosure for the purpose of anticipation has been held to be
the same as the test
of enablement of the patent itself for the
purpose of sufficiency (
Synthon
para
22)
. Equating the necessary test for
enablement to that for sufficiency, ‘produces a degree of
symmetry in the law’ (
Synthon
para
63). And, ‘on the issue of sufficiency expert evidence is
admissible as to whether or not the body of the specification,
properly construed, affords adequate information to the skilled
addressee about how to perform the invention or the particular
embodiment of it’ (
Netlon Ltd and
Another v Pacnet (Pty) Ltd
1977 (3) SA
840
(A) at 868 H).
[8] To round off the
applicable legal principles, an issue of some moment between the
parties to this appeal concerns the proper
approach to be adopted
when considering the validity of what has come to be described as a
selection patent. Under pre-1977 law
in the United Kingdom,
disclosure of a class (typically a class of chemical compounds) prima
facie amounted to disclosure of each
and every member of that class.
The general rule was that ‘disclosure of the class prima facie
deprives its members of novelty’
and ‘prima facie a
general disclosure of a class is disclosure of all members of the
class, however obscure and whatever
the consequences’ (
Dr
Reddy’s Laboratories
para 35). It
was however possible to obtain a valid patent for a specific compound
or subclass as a so-called ‘selection patent’
if it could
be shown that the subclass possessed some special advantage which was
enjoyed by the subclass as a whole but also peculiar
to it. Those
rules were famously formulated by Maugham J in
IG
Farbenindustrie’s Patents
(1930)
47 RPC 289
at 322-3
.
B-M
Group (Pty) Ltd v Beecham Group Ltd
1980
(4) SA 536(A)
at 558D-F summarises those rules thus:
‘
First,
a selection patent to be valid must be based on some substantial
advantage to be secured by the use of the selected members
. . .
Secondly, the whole of the selected members must possess the
advantage in question. Thirdly, the selection must be in respect
of a
quality of a special character which can fairly be said to be
peculiar to the selected group.’
[9] As is pointed out
by
Simon Thorley et al in
Terrell
on the Law of Patents
17ed (2006) para
11-61, the ‘subsequent application of those rules (the
IG
rules) gave rise to problems in
reconciling them with the statute and the other authorities on
novelty, since there was nothing
in the 1949 Act which recognised any
special approach for selection patents as a special category’.
[11]
In
Dr Reddy’s
Laboratories
, the English Court of
Appeal held that the pre-1977 jurisprudence including the
IG
rules were part of legal history not
living law. The court took the view (para 104) that there was
‘nothing in the 1977 Act
(any more than there was in the 1949
Act) which recognises, or even implies, a special approach to, or
even the existence of, selection
patents as a special category of
patent, which requires a different approach when determining validity
from other patents’.
Logic dictates, so held the court (para
30), the ‘rejection of the argument that a disclosure of a
large class is a disclosure
of each and every member of it.’
Following on
Dr Reddy’s
Laboratories
, selection patents are no
longer to be treated as a special class forming an exception to the
ordinary rules. They now fall to
be treated in accordance with the
general approach to patent validity.
[10]
Dr
Reddy’s Laboratories
rejected the
broad proposition that the disclosure of a generalised class
necessarily amounted to disclosure of each and every
member of it. It
pointed out (para 30): ‘So what one must look for by way of
anticipation is an “individualised description”
of the
later claimed compound or class of compounds’. The Court of
Appeal illustrated the point thus (para
29):
‘
Similarly
it makes no sense to say that a generalised prior description
discloses a specific matter falling within in. The Judge's
example
illustrates the point. A prior disclosure of "fixing means"
is not a disclosure of a particular fixing means
e.g. welding or
riveting even though you could list out a whole number of ways of
fixing things together which would include these
means’.
The court did not
deem it necessary (para 31) to go into what is sufficient to amount
to an ‘individualised description’
because that obviously
may partly be one of degree and other considerations may also come
into that question. The court emphasised
(para 32-33) that on this
score its view of the law accorded with the decision of the House of
Lords in
Synthon.
Moreover,
it was at pains to point out that its approach was consistent with
that of the European Patent Office and the German Courts.
[11] The court a quo
appears not to have had any regard to the principles outlined in
Synthon
and
Dr Reddy’s Laboratories
.
In my view, applying those principles ought to have led it to a
contrary conclusion.
Here, it is common
cause that: (a) the 98 patent has the priority dates of 3 December
1997 and 7 May 98; (b) the prior art relied
upon by the respondent is
contained in the second appellant’s own earlier patent
specification with number 92/7457 (the 92
patent); and (c) the 92
patent was made available to the public on 30 March 1993. The court
below held that all of the claims of
the 98 patent were anticipated
by the disclosure of the 92 patent. Inasmuch as the respondent’s
case had been that only some
of the claims of the 98 patent had been
disclosed in the prior art, it abandoned those parts of the judgment
which held that claims
8 to 17, 25, 27 and 28 of the 98 patent were
invalid.
[12] What the 92
patent discloses: By way of background, the 92 patent begins by
describing the ‘avermectin series of
compounds’ as
‘potent anthelmintic agents against internal and external
parasites’. Reference is then made to
an earlier named US
Patent, in which the natural product avermectins are disclosed.
Avermectin is an anti-parasitic
theraupeutic agent (API).
The 92 patent
discloses an injectable formulation, which is described thus:
‘
This
invention consists of an injectable formulation of a hydrogenated
castor oil and an avermectin compound in a hydrophobic carrier
which
has been found to have a considerably prolonged duration of activity
against internal and external parasites.’
Broadly stated the
injectable formulation disclosed in the 92 patent specification
comprises:-
(a)
hydrogengenated castor oil;
(b)
an avermectin compound; and
(c)
a hydrophobic carrier.
In the specification of the
92 patent there is the following disclosure:
‘
The
hydrogenated castor oil formulation contains the avermectin compound
in a hydrophobic physiologically acceptable injection solvent
in
which the avermectin compound is readily soluble. Any physiologically
and pharmaceutically acceptable carrier may be used so
long as the
avermectin compound is soluble therein. Examples of such carriers are
glyceryl triacetate (Triacetin) distilled acetylated
monoglycerides
(Myvacet), miglyol 812, safflower seed oil and the like, or a
combination of such carriers.’
[13] For the purposes of
this appeal it is, in truth, only claim 1 of the 98 patent that needs
be considered, for, if it is not
anticipated none of the other
(dependant) claims will be. Claim 1 provides:
‘
A
long-acting injectable formulation comprising:
(a)
a therapeutic agent selected from the group consisting of
insecticides, acaricides,
parasiticides, growth enhancers and
oil-soluble NSAIDS,
(b)
hydrogenated castor oil, and
(c)
a hydrophobic carrier comprising:
(i)
triacetin, benzyl benzoate or ethyl oleate or a combination thereof;
and
(ii)
acylated monoglycerides, propyl dicaprylates/dicaprates,
caprylic/capric acids; triglycerides,
or a combination thereof.’
There is little that
requires interpretation in this claim. It simply lists the
ingredients in the formulation of the claim.
[14] It is common
ground that integers (a) and (b) are disclosed in the 92 patent. The
only question therefore is whether the particular
combination of
hydrophobic carriers claimed in integer (c) of claim 1 of the 98
patent is disclosed in the 92 patent. In this regard,
as is clear
from claim 1, the 98 patent contemplates the selection of a
particular combination of specific compounds to make up
the
hydrophobic carrier including, on the one hand, triacetin, benzyl
benzoate or ethyl oleate or a combination thereof and, on
the other,
acylated monoglycerides, propyl dicaprylates/dicaprates,
caprylic/capric acid triglycerides, or a combination thereof.
The 98
patent teaches that by using the specific combinations of hydrophobic
carriers of the patent in suit results in a ‘considerably’
prolonged duration of activity, of up to 180 days, when compared to
prior art formulations, including those disclosed in the 92
patent.
[15] The advantages, as is
confirmed by the evidence, of such a long duration of action are
plain. Professor Gerald Swan, one of
the joint patentee’s
experts, explains:
‘
49.
The increase in duration of action gives rise to very significant
benefits in veterinary practice.
Long acting anti-parasitic
formulations that provide for an extended duration of efficacy
achieve better control of parasites for
a longer period. This in turn
results in significantly improved productivity in production animals
such as cattle because the harmful
effects of parasites are avoided
more effectively and for longer periods.
50.
Furthermore, a longer acting formulation more comprehensively
controls parasites. By way
of explanation, in order to be effective
against parasites, the API [active pharmaceutical ingredient] must be
ingested by, or
exposed to, the parasite in sufficient quantities to
kill or paralyse the parasite. It is, in general, easier to kill
adult parasites
because they ingest more blood or body fluids and
tissue from the host animal than immature parasites do. However, by
using a long
acting formulation, even immature parasites ingest or
take up sufficient quantities of the API (over a particular period)
to kill
or paralyse them before they become adults. This is
preferable, from a treatment perspective, to permitting the parasites
to become
adults before the treatment is effective.
51.
Long acting formulations also ensure that re-infestation of the
animal with parasites is
prevented for longer periods. With
conventional shorter acting formulations such re-infection would need
to be retreated.
52.
Finally, a wider spectrum of activity against parasites, particularly
against ticks, may
also be achieved using a formulation with an
activity beyond 42 days. Certain ticks are “multi-host”
(two- or three
host) parasites. This means that they require a number
of hosts in order to complete their life cycles and only infest the
final
host (e.g. cattle) as adults. By maintaining the minimal
effective concentration of the API in the animal’s blood over
an
extended period, the formulation could achieve control of these
tick species as all new tick infestation will be controlled for
the
duration of long action. A short acting formulation would only
potentially affect ticks on the animal at the time of treatment
and
will not be effective against any new infestation.’
[16] On the question
of the hydrophobic carriers, the 92 patent discloses that ‘[a]ny
physiologically and pharmaceutically
acceptable carrier may be used
so long as the avermectin compound is soluble therein’. It goes
on to list examples of such
carriers as being ‘glyceryl
triacetate (Triacetin), distilled acetylated monoglycerides
(Myvacet), miglyol 812, safflower
seed oil and the like, or a
combination of such carriers.’ The 92 patent teaches in the
‘example of the invention’
the use of a single
hydrophobic carrier, namely Triacetin. In line with this, claim 12,
which is the only claim in the 92 patent
directed at preferred
hydrophobic carriers, claims the use of Triacetin alone as the
hydrophobic carrier. The teaching of the 92
patent is therefore that
any
carrier can be used in the formulation of the 92 patent.
[17] The only
‘individualised description’ in the 92 patent of a
hydrophobic carrier is that of Triacetin (alone). Both
Dr Leonore
Witchey-Lakshmanan (another of the joint-patentee’s experts)
and Professor Swan make this plain. The former stated:
‘
The
92 patent teaches in the examples of the specification (like the EP
patent) that triacetin is to be preferred. Additionally,
in the
claims of the 92 patent only triacetin is singled out as a potential
vehicle (see claim 12). The 92 patent teaches that
triacetin is the
preferred hydrophobic carrier but, as I have said, is not limited in
this respect.’
And, the latter added:
‘
42.
The 92 patent does however suggest possible hydrophobic carriers
which might be used. These include
glyceryl triacetate (triacetin),
distilled acetylated monoglycerides (Myvacet), miglyol 812, safflower
seed oil and the like, or
a combination of such carriers. . . . The
example given on page 9 of the 92 patent pertains to a single
hydrophobic carrier namely
triacetin, and does not disclose any
particular combination of hydrophobic carriers.
43.
In line with this teaching, claim 1 of the 92 patent is not limited
to a particular type
of hydrophobic carrier. Claim 1 makes clear that
any carrier can be used. Claim 11 of the 92 patent is limited to the
particular
carriers referred to in the paragraph above. Importantly,
however, claim 12 is limited specifically to triacetin, in line with
the only example in the 92 patent. Thus, the 92 patent, consistent
with the EP patent, again teaches that the most preferable
formulation
is one which includes only triacetin as the hydrophobic
carrier in the formulation.’
[18] Indeed, as Professor
Swan further explains:
‘
44.
It is clear from the disclosure of the specification as a whole that
the inventors of the ’92
patent placed no significance on the
choice of hydrophobic carrier, stating expressly that
any
carrier
could be used. This is accepted by Dr Cromarty in paragraph 20 of his
affidavit where he states that the inventors of the
’92 patent
equated triacetin and monoglyceride – which have very different
properties as hydrophobic carriers. Reading
the ’92 patent as a
whole, it is clear that the important addition to the formulation of
the ’92 patent (particularly
when regard is had to the EP
patent) was that of hydrogenated castor oil in the formulation. The
’92 patent teaches only
that a hydrophobic carrier must be
added – the nature and characteristics of that carrier would be
understood by the reader
of the patent not to be prescriptive.
45.
A person skilled in the art of the ’92 patent would have
therefore understood from
reading it that any hydrophobic carrier
could be used in the formulation provided avermectin was soluble in
that carrier.’
[19] Furthermore, while
specific examples are given in the 92 patent, there is no suggestion
or teaching that any of them, or any
combination of them, have any
utility or advantage over other hydrophobic carriers or combinations
of carriers. By contrast the
92 patent is specific in requiring a
combination of hydrophobic carriers selected from two clearly
identified groups of such carriers.
The possibility of a combination
of carriers is no longer a random matter but a carefully delineated
requirement.
Indeed, save for the
reference to these hydrophobic carriers there is no teaching at all
in relation to the properties or benefits
of these carriers in a
formulation containing avermectin. Moreover, the 92 patent teaches
that the formulation of that patent will
be efficacious up to 42
days. There is no teaching of the very significant advantages (up to
180 days of efficacy) which arise
from the selection of the
particular hydrophobic carriers disclosed in the 98 patent.
[20] In that regard as
Professor Swan points out:
‘
48.2.
the formulation claimed in the patent in issue allows for the API to
remain active for up to 140 days as the patent
in issue explains:
“
While
the previously reported avermectin formulation containing
hydrogenated castor oil in triacetin did produce prolonged plasma
level compared to a formulation without hydrogenated castor oil, it
did not achieve a plasma level efficacious against all relevant
parasitic species at the 42 day target. In contrast the present
formulation using avermectins or milbemycins surprisingly provides
a
significantly higher plasma [sic: level] at day 42 and beyond. The
present formulation is also efficacious against ticks and
Dermatobia
hominis for up to 75 and 140 days, respectively.”
Thus,
the formulation of the patent in issue provides significantly higher
blood plasma concentration levels of the API at day 42
than the
formulation of the ’92 patent . . . and provides significantly
longer protection than the formulation of the ’92
patent (and
the EP patent).’
[21] Finally, Dr
Witchey-Lakshmanan and Professor Swan both make clear that the
skilled person could not, armed only with the 92
patent, arrive at
the combinations of hydrophobic carriers disclosed in the patent in
suit without a significant amount of ingenuity
and experimentation.
This is because the elements of the formulation, including the active
pharmaceutical ingredient, react with
each other and in the animal
body (
in vivo
) in wholly unpredictable ways. This evidence is
not disputed by Dr Allan Cromarty, the respondent’s expert. If
anything,
both of the respondent’s witnesses effectively
concede that the 98 patent is not anticipated by the disclosure in
the 92
patent. Mr Jan Wentzel, the respondent’s general
manager, stated in reply:
‘
The
92 patent specification, as explained by Dr Cromarty, clearly
discloses most of the subject matter of the 98 patent. Where the
subject matter is not fully disclosed only experimentation, not
invention, would be needed to obtain the specific formulation
claimed.’
Whilst, in answer to Prof
Swan’s assertion that ‘. . . a further difference between
a number of subsidiary claims and
the prior art is the specific
limitation to particular proportions of hydrophobic carrier of the
patent in issue’, Dr Cromarty
stated the following:
‘
.
. . suffice it to say here that where the proportions are not fully
disclosed in the 92 specification, experimental work, and
not
invention, would be needed to achieve these proportions.’
[22]
Critically,
for the present appeal, if something remains to be ascertained which
is necessary for the useful application of the
discovery, there is
sufficient room for another valid patent.
[12]
To anticipate the patentee’s claim the prior
publication must therefore contain clear and unmistakable directions
to do what
the patentee claims to have invented.
[13]
The Federal Court of Australia (per Middleton J)
in
Eli Lilly and Company Limited v
Apotex (Pty) Ltd
[2013] FCA 214
para
272 and 273 put the position thus:
‘
The
view I have reached in this proceeding is that even if the prior art
theoretically includes all of the integers of the invention
(among
other possible combinations), this is
not
necessarily
to anticipate a later patent. Such a view is particularly apt where
the prior art discloses a class of chemical compounds, often
by way
of generic formula, as in the present case. Everything will depend
upon the extent of disclosure in the prior art document,
and the
context in which that disclosure appears. It will be necessary to
consider the disclosure in its entirety to determine
what it clearly
and unmistakably discloses. It is true to say as a matter of logic
that a very generalised prior description in
a prior art document
does not necessarily disclose a specific item falling within that
generalised description.
Undoubtedly,
a prior document may disclose more than one thing. It may disclose
many things, and in doing so, anticipate a later
invention. However,
a prior disclosure of many things must still provide “clear and
unmistakable directions” to the
claimed invention.’
[23] The 92 patent
does not ‘plant the flag at the precise destination’ of
the claims of the 98 patent. Rather, it appears
to do no more than
offer a ‘signpost’ on the road to the invention. But even
if the flag had been planted, it still
remains to be considered
whether the skilled person would have been enabled by it.
On
the respondent’s own version, armed with the 92 patent, the
skilled person would still have to conduct further experiments
and
gain further information regarding the hydrophobic carriers broadly
discussed in the 98 patent before he or she would appreciate
the
import of the very substantial advantages which flow from the
invention of 98 patent. Even with the benefit of the 92 patent,
therefore, ‘something’ (namely, the knowledge that
particular selections of hydrophobic carriers will lengthen the
duration of activity considerably) ‘remains to be ascertained
which is necessary for the useful application’ of the
formulation of the 92 patent. In these circumstances, as
Synthon
makes clear, there is sufficient room for another valid patent.
[24] Carrying out the
92 patent would not necessarily result in an infringement of the 98
patent. For example, using Triacetin alone
as the hydrophobic carrier
in a formulation which includes integers (a) and (b) of claim 1 of
the 98 patent would not be an infringement
of any of the claims of
the 98 patent. Similarly using ‘any physiologically and
pharmaceutically acceptable carrier . . .
so long as avermectin is
soluble therein’ not specifically claimed in the 98 patent
would not infringe any of the claims
of the 98 patent. As such, again
on the authority of
Synthon
,
the 98 patent is not anticipated by the disclosure in the 92 patent.
[25] Moreover,
applying
Dr Reddy’s Laboratories
,
there is no individualised description of the specific combinations
of hydrophobic carriers of claim 1 of the 98 patent, and the
advantages which flow from using them in combination in the 92
patent. The 92 patent teaches that any hydrophobic carrier will
do;
and where preference is expressed it is for Triacetin alone. 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 92 patent and his or her ‘general technical
knowledge’.
Instead, the skilled person would have had to have applied 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 significant technical advance which those specific
combinations represent over the disclosure of
the 92 patent.
[26] There is thus no
merit in the attack on the patent in suit. It follows that the
revocation application should have been dismissed
with costs,
including the costs of two counsel, and a certificate of validity in
terms of s 74 of the Act given.
[27] In the result:
1.
The appeal is upheld with costs, including the costs of two counsel.
2.
The order of the court below is replaced with the following:
‘
(a)
The application for revocation of South African Patent Number
1998/10975 is dismissed.
(b)
Each of the claims of South African Patent Number 1998/10975 is
certified as being valid
in terms of
section 74
of the
Patents Act,
57 of 1978
.
(c)
Costs are awarded to the joint patentees, including the costs of two
counsel.’
_________________
V M Ponnan
Judge of
Appeal
APPEARANCES:
For
Appellants:
L
Bowman SC (with him G Marriott)
Instructed by:
DM Kisch Inc., Pretoria
Phatshoane Henney Attorneys, Bloemfontein
For Respondent:
C E Puckrin SC (with him M Seale and H Worthington)
Instructed by:
Brian Bacon Inc., Cape Town
Webbers, Bloemfontein
[1]
Harms JA put it thus in
Monsanto Co v MDB Animal Health (Pty) Ltd
(formerly MD Biologics CC)
)
[2001] ZASCA 4
; (2) SA 887 SCA para
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 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, ie 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,
ie 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.’
[2]
Netlon v Pacnet
1977
(3) SA 840
(A) at 861E-F.
[3]
See
Monsanto
(above)
paras 8 and 9.
[4]
Gentiruco AG
(above)
at 646B-647B.
[5]
Letraset Ltd v Helios Ltd
(above)
at 264D-F.
[6]
Referred to with approval in
Sunsmart
Products (Pty) Ltd v Flag and Flagpole Industries (Pty) Ltd t/a
National Flags
[2007] ZASCA 50
; BIP 44
(SCA) para 22.
[7]
In
Hill v Evans
(1862) 31 LJ (NS) 457 at 463 Lord
Westbury LC stated:
‘
I
apprehend the principle is correctly thus expressed: the antecedent
statement must be such that a person of ordinary knowledge
of the
subject would at once perceive, understand and be able practically
to apply the discovery without the necessity of making
further
experiments and gaining further information before the invention can
be made useful. If something remains to be ascertained
which is
necessary for the useful application of the discovery, that affords
sufficient room for another valid patent.’
[8]
In
General Tire and
Rubber Co v Firestone Tyre and Rubber Co Ltd
[1972]
RPC 457
at 485–486 the Court of Appeal (Sachs, Buckley and Orr
LJJ) stated:
‘
To
determine whether a patentee’s claim has been anticipated by
an earlier publication it is necessary to compare the earlier
publication with the patentee’s claim. . . . If the earlier
publication . . . discloses the same device as the device which
the
patentee by his claim . . . asserts that he has invented, the
patentee’s claim has been anticipated, but not otherwise.
. .
.
When the prior inventor’s publication and the patentee’s
claim have respectively been construed by the court in the
light of
all properly admissible evidence as to technical matters, the
meaning of words and expressions used in the art and so
forth, the
question whether the patentee’s claim is new . . . falls to be
decided as a question of fact. If the prior inventor’s
publication contains a clear description of, or clear instructions
to do or make, something that would infringe the patentee’s
claim if carried out after the grant of the patentee’s patent,
the patentee’s claim will have been shown to lack
the
necessary novelty. . . . The prior inventor, however, and the
patentee may have approached the same device from different
starting
points and may for this reason, or it may be for other reasons, have
so described their devices that it cannot be immediately
discerned
from a reading of the language which they have respectively used
that they have discovered in truth the same device;
but if carrying
out the directions contained in the prior inventor’s
publication will inevitably result in something being
made or done
which, if the patentee’s claim were valid, would constitute an
infringement of the patentee’s claim,
this circumstance
demonstrates that the patentee’s claim has in fact been
anticipated.
If, on the other hand, the prior publication contains a direction
which is capable of being carried out in a manner which would
infringe the patentee’s claim, but would be at least as likely
to be carried out in a way which would not do so, the patentee’s
claim will not have been anticipated, although it may fail on the
ground of obviousness. To anticipate the patentee’s claim
the
prior publication must contain clear and unmistakable directions to
do what the patentee claims to have invented . . . A
signpost,
however clear, upon the road to the patentee’s invention will
not suffice. The prior inventor must be clearly
shown to have
planted his flag at the precise destination before the patentee.’
[9]
Significantly, in the context of anticipation, the Supreme Court of
Canada in
Apotex Inc v Sanofi-Synthelabo Canada Inc
[2008] 3
SCR 265
para 49, relying heavily on jurisprudence from the United
Kingdom, adopted the two-step approach of disclosure and enablement.
That represented a refinement of the approach set out in
Beloit
Canada Ltd v Valmet OY
(1986) 8 CPR (3d) 289 (FCA). As the
Supreme Court put it (para28), ‘the
Beloit
decision by
which the applications judge rightly felt bound dealt with only one
aspect of anticipation, that is, whether or not
the invention in a
patent had been disclosed in a single prior publication or patent.’
[10]
Simon Thorley et al
Terrell on the Law of
Patents
17ed (2006) para 7-33.
[11]
Terrell on the Law of Patents
(above) para 11-61.
[12]
Synthon
(above)
para 20 quoting
Hill v Evans
(above) at 463.
[13]
Synthon
(above)
para 21 quoting
General Tire and Rubber
CO v Firestone Tyre and Rubber Co
(above)
at 485-486.