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[2012] ZASCA 108
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Cipla Medpro (Pty) Ltd v Aventis Pharma SA, Aventis Pharma SA and Others v Cipla Life Sciences (Pty) Ltd and Others (139/2012, 138/2012) [2012] ZASCA 108; 2013 (4) SA 579 (SCA); 2012 BIP 30 (SCA) (26 July 2012)
THE
SUPREME COURT OF APPEAL OF SOUTH AFRICA
JUDGMENT
Case No: 139/2012
In the matter between:
CIPLA MEDPRO (PTY) LIMITED
…...........................................
.Appellant
and
AVENTIS PHARMA SA
…...........................................................
Respondent
and
TREATMENT ACTION CAMPAIGN
…..............................
Amicus
Curiae
Case No: 138/2012
In the matter between:
AVENTIS PHARMA SA
….........................................................
1
st
Appellant
SANOFI AVENTIS SOUTH AFRICA
(PTY) LTD
….............
2
nd
Appellant
WINTHROP PHARMACEUTICALS (PTY)
LTD
….............
3
rd
Appellant
and
CIPLA LIFE SCIENCES (PTY) LTD
…................................
1
st
Respondent
CIPLA MEDPRO (PTY) LTD
…...........................................
2
nd
Respondent
MEDPRO PHARMACEUTICA (PTY) LTD
…....................
3
rd
Respondent
and
TREATMENT ACTION CAMPAIGN
Amicus Curiae
Neutral citation:
Cipla
Medpro v Aventis Pharma
(139/12)
Aventis Pharma SA v Cipla
Life Sciences
(138/12)
[2012] ZASCA 108
(26 July 2012)
Coram:
NUGENT, HEHER,
SNYDERS, TSHIQI JJA and McLAREN AJA
Heard:
15 MAY 2012
Delivered: 26 JULY 2012
Summary: Patent –
validity – whether claim vague or otherwise revocable –
contributory infringement – interim
interdict – relevance
of public interest.
___________________________________________________________
ORDER
___________________________________________________________
On appeal from:
Commissioner of Patents (Southwood J sitting as court of first
instance):
1. The appeal in the
s 51(1) proceedings (Case No 139/2012) is dismissed with costs
that include the costs of two counsel.
2. The appeal in the
infringement proceedings (Case No. 138/2012) is upheld with costs
that include the costs of two counsel, to
be paid by the respondents
jointly and severally. The order of the Commissioner in those
proceedings is set aside and the following
order is substituted:
‘
(a)
Pending the outcome of the action for final relief the respondents
are interdicted from procuring or inducing, aiding and abetting,
advising, inciting or instigating or assisting any other person to
infringe claim 1 of South African Patent no 93/8936 in the Republic,
and from disposing of or offering to dispose of CIPLA DOCETAXEL and
CIPLA DOCETAXEL solvent.
(b) The respondents,
jointly and severally, are to pay the costs of the application,
including the costs of two counsel, and the
costs of the expert
witness Prof Davies.’
___________________________________________________________
JUDGMENT
___________________________________________________________
NUGENT JA (HEHER, SNYDERS,
TSHIQI JJA and McLAREN AJA CONCURRING)
[1] There are two appeals before
us. The protagonists in each appeal are one or more companies within
the Aventis group, on the
one side, and one or more companies within
the Cipla group on the other. There is no need to name each of the
companies and for
convenience I will refer to the companies in each
group interchangeably as Aventis and Cipla respectively.
[2] Both appeals concern South
African Patent 93/8936, which is registered in the name of Aventis.
1
The patent is due to expire on 30
November 2013. Claim 1 of the patent specification was amended on two
occasions. The first amendment
is not relevant to this appeal. The
second amendment was made in 2007. For convenience I will refer to
the claim before its amendment
in 2007 as the ‘original claim’
and to the claim after that amendment as the ‘amended claim’.
[3] Aventis sells in South Africa
a pharmaceutical product known as Taxotere, which has been registered
for sale under the
Medicines and Related Substances Act 101 of 1965
.
The active ingredient is docetaxel – a chemical compound in the
taxoid family, also referred to as a taxane derivative.
Docetaxel was
synthesized in 1986 and was the subject of a patent that expired in
2007. It is used in the treatment of various
cancers, diluted in a
perfusion solution, typically a solution of saline,
2
and administered by way of a
drip. The components of Taxotere are presented for sale separated in
two vials. The contents of the
two vials are mixed together
immediately before use so as to produce a composite solution that is
injected into the bag of saline
solution. Aventis says that Taxotere
falls within the terms of its patent.
[4] Early in 2011 Aventis became
aware that Cipla had applied for registration of, and intended
importing and selling, a generic
equivalent of Taxotere that it calls
Cipla Docetaxel. In all material respects the components of Cipla
Docetaxel correspond with
those of Taxotere. Its components are also
presented for sale separated into two vials – one containing
what it calls Cipla
Docetaxel and the other containing Cipla
Docetaxel solvent – to be mixed together and administered in
the same way as Taxotere.
[5] On 9 May 2011 the attorneys
for Aventis wrote to Cipla’s attorneys alleging that ‘the
exploitation of Cipla Docetaxel
and Cipla Docetaxel solvent’
would infringe its patent, and calling for an undertaking that Cipla
would not ‘make,
use, exercise, dispose or offer to dispose of
or import the Cipla Docetaxel or Cipla Docetaxel solvent products’
until expiry
of the patent.
[6] Cipla declined to give the
undertaking and two applications were brought before the Commissioner
of Patents. The first was an
application by Cipla for an order
setting aside the 2007 amendment of claim 1.
3
That was followed shortly by an
application by Aventis for an interim interdict against infringement
pending the outcome of an action
for a final order to that effect.
4
[7] The two applications were
heard together by Southwood J sitting as the Commissioner of Patents.
Both applications were dismissed
and the respective parties now
appeal with his leave.
[8] Before turning to the
specific issues that arise in each appeal it is convenient to set out
some background that is common to
both.
[9] Taxane derivatives are not
easily soluble in water. To hold a taxane derivative in solution when
it is introduced into the saline
solution, according to the patent
specification, it had been found necessary first to prepare a stock
solution of the taxane derivative,
dissolved in a mixture of solvents
comprising a surface-active agent (a wetting agent) and ethanol. For
reasons that are not material
the ethanol is then withdrawn leaving
the taxane derivative dissolved in the stock solution. It was found,
however, that when the
stock solution was introduced into the saline
solution, it formed a gel that inhibited its dissolution. Various
techniques existed
to prevent the formation of gel or to break down
the gel when it formed and the patent relates to one such technique.
[10] The invention of the patent
consists in an intermediate solution containing the taxane derivative
dissolved in a surface active
agent, mixed with an additive (ethanol)
that breaks the gel or prevents its formation when the intermediate
solution is introduced
into the saline solution. The invention –
titled ‘New Taxoid-Based Compositions’ – was
claimed as follows
in the original claim 1:
‘
An
injectable composition comprising a taxane derivative in a
surface-active agent and an additive which prevents the formation
of,
or breaks, a gelled phase during the mixing of the solution with an
aqueous medium.’
[11] In 2007 Aventis sought and
was granted an amendment to claim 1 under
s 51
of the
Patents Act 57
of 1978
. After amendment the invention was claimed as follows:
‘
An
injectable composition comprising (a) a taxane derivative in a
polysorbate and (b) an additive, (a) and (b) being provided in
ampoules, bottles or a double compartment device, the injectable
composition being produced by mixing (a) and (b) to form an
intermediate
solution, wherein the additive prevents the formation
of, or breaks, a gelled phase during mixing of the intermediate
solution
with an aqueous medium’.
[12] The ‘polysorbate’
referred to in the amended claim is a ‘surface-active agent’
of the kind referred
to in the original claim and is not significant.
The material amendment lies in the words ‘provided in ampoules,
bottles
or a double compartment device, the injectable composition
being produced by mixing (a) and (b) to form an intermediate
solution’.
The First Appeal: The
Amendment of Claim 1 (SCA Case No. 139/2012)
[13]
Section 51(1)
of the Act
allows a patentee at any time to apply to the registrar for the
amendment of a patent specification. Under
s 51(1)
an amendment that
has been made in conflict with the provisions of the Act may be set
aside on application to the Commissioner.
An amendment will be in
conflict with
s 51(7)
of the Act
‘
if
the specification as amended would include any claim not wholly
within the scope of a claim included in the specification before
amendment.’
That section is aimed at
preventing the patentee from broadening the monopoly that was
originally claimed. Whether the amendment
indeed does so is a matter
for construction and comparison of the claim before and after
amendment.
5
[14]
Gentiruco
A.G. v Firestone SA (Pty) Ltd
6
remains the leading case on the
construction of patent specifications, in which it was said that
‘
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, … since he is
presumed to
have intended what his language means. To ascertain that meaning the
words used must be read grammatically and in their
ordinary sense.’
7
[15] The affidavits in both
applications need to be read together for the purpose of each appeal.
They contain considerable evidence
by experts on each side concerning
the proper construction of the claims. I return presently to the role
of experts in construing
a specification. For the moment I need only
say that it is common cause, and the Commissioner approached the
matter on those lines,
that the claim before and after amendment must
be given its ordinary meaning. The evidence of the experts does no
more than to
advance the meaning that each attributed to the claim on
the ordinary meaning of language. That evidence is neither helpful
nor
admissible and I say no more about it at this stage.
[16] Counsel on both sides
approached the matter on the basis that the amendment altered the
original claim so as to claim what
was called at times a ‘two
vial composition’ – whatever that might mean – or
what counsel for Cipla called
a ‘kit’ from which the
composition was to be made. That was said by Cipla to have broadened
the original claim and
by Aventis to have narrowed it. The
Commissioner approached the matter in the same way. He summarised the
case put forward by Cipla
as follows:
‘
The
applicant … contends in the founding affidavit that the
amended claim 1 is intended to cover an unmixed collection of
the
specified ingredient substances which Mr Puckrin SC on behalf of the
applicant referred to as a ‘kit’ to distinguish
it from
the composition.’
but said that
‘
amended
claim 1 cannot be properly interpreted in that way. It still refers
to an injectable composition, i.e. something which is
obtained by
mixing the ingredients referred to, and the method of mixing is
expressly provided for.’
and he concluded that
‘
by
amending the claim as it has done the patentee has restricted its
monopoly and not extended it’.
[17] The ordinary meaning of a
‘composition’ in the present context is ‘a
substance formed by combination of various
ingredients’.
8
It goes without saying that
before they were combined the two ingredients described in the
original claim existed separately. And
if they were solutions then
they must necessarily each have been held in impervious containers –
whether bottles or ampoules
or any other kind of impervious
container. All of that is silently stated by mere description of the
invention as a ‘composition’
of the stated constituents.
[18] The words added by amendment
do not purport to claim a different invention. The invention of the
amended claim remains a ‘composition’
with the same
constituents and effect as stated in the original claim. The added
words do no more than describe the prior state
of those constituents
before they were brought together to form the composition. In so
doing they merely express what was silent
in the original claim and
neither broaden nor narrow it. It matters not that the Commissioner
found that the claim was narrowed
– it is sufficient if it was
not broadened, which it was not, and on that basis the application
was rightly dismissed.
The Second Appeal:
Infringement (SCA Case No. 138/2012)
[19]
Section 65(4)
of the Act
allows any ground upon which a patent may be revoked under
s 61
to be
raised as a defence to an infringement claim. Four grounds for
revocation of claim 1 were raised by Cipla. First, that the
claim was
not clear.
9
Secondly, that the invention
claimed was not a new invention.
10
Thirdly, that the invention
claimed did not involve an inventive step.
11
And fourthly, that the prescribed
declaration lodged when the patent was applied for contained a false
statement or representation.
12
[20] The Commissioner found that
claim 1 was not clear and thus invalid and for that reason he found
it unnecessary to deal with
the other grounds for revocation, though
he expressed the view that none placed the validity of the claim in
serious doubt. On
the view that I take it becomes necessary to deal
with each of the grounds of alleged invalidity, other than one. The
statement
in the declaration that was alleged to have been false was
a statement that the invention was new. If the invention was not new
then the patent is invalid on that ground. The statement to the
contrary in the declaration thus takes the matter no further and
I
need say no more about that ground.
[21] It is curious that the
Commissioner, having found sufficient meaning in the claim to enable
him to find that the original claim
had been narrowed, then proceeded
to find that its meaning was uncertain. The explanation lies in the
approach that he took to
the admissibility of expert evidence. The
approach adopted by the Commissioner when construing the claims for
purposes of the
s 51
was that expert evidence was not admissible
and it fell to be construed according to its ordinary language.
However, he said that
expert evidence was admissible to determine
whether the claim was ‘clear’ for purposes of
s 61(1)(f)(i).
In that respect he preferred the evidence that
had been given by the expert on behalf of Cipla – who expressed
the view that
the amended claim was ambiguous – and held that
the patent was invalid on that ground. In my respectful view that
approach
was erroneous. It seems to me to confuse the clarity of the
claim with the sufficiency of the specification.
[22] Patent protection provides
an inducement for new knowledge to be brought into the public domain.
In return for the monopoly
that is conferred upon the patentee for a
fixed period the patentee must describe the invention sufficiently to
enable it to be
performed once the monopoly expires. For that reason
a patent may be revoked under
s 61(1)(e)
if
‘
the
complete specification concerned does not sufficiently describe,
ascertain and, where necessary, illustrate or exemplify the
invention
and the manner in which it is to be performed in order to enable the
invention to be carried out by a person skilled
in the art of such
invention’.
[23] As pointed out in
Burrell’s
South African Design and Patent Law,
13
‘
an inquiry as to this
ground of revocation involves a question of fact, namely, whether to
a person skilled in the art the specification
contains proper
instructions for enabling the invention to be put into use’.
For that purpose expert evidence is admissible,
but only for that
limited purpose. As Nicholas J expressed it in
De
Beers Industrial Diamond Division (Pty) Ltd v Ishizuka
14
‘
[i]nsufficiency
is a matter on which the opinion of expert witnesses is admissible.
It is one of those cases where the court is,
by reason of a lack of
special knowledge and skill, not sufficiently informed to enable it
without the assistance of an expert
to come to any useful conclusion
…. An expert witness is therefore “entitled to say
whether in his opinion that which
is described in the specification
on
a given hypothesis as to its meaning
is
capable of being carried into effect by a skilled worker”’
(my
emphasis).
[24] It is a different question
whether a claim is clear. Holmes JA pointed out in
Letraset
Ltd v Helios Ltd
15
that the function of the claim
(in contradistinction to the body of the specification) is to ‘inform
prospective rivals of
the limits of the field denied to them while
the patent lasts’ and for that purpose ‘the monopoly must
clearly and
succinctly define the limits of the field closed to
others so that he who runs may read.’
16
In determining whether the limit
of the monopoly is sufficiently defined ‘technical term[s]
[are] to be interpreted in the
light of evidence given by witnesses
learned or skilled in the relevant art’ but
‘
[w]ords
which have no special technical meaning are to be interpreted, not by
witnesses, but by the Court, and are to be given their
natural and
ordinary meaning’.
17
[25] I have already found, when
dealing with the
s 51
application, that the invention of the amended
claim remains a composition with the same constituents and effect as
stated in the
original claim, and that the added words merely
describe what was previously silent. What is claimed is clearly and
unambiguously
stated and does not offend
s 61(1)(f)(i).
[26] For a patent to be granted
the invention must be new.
Burrell
points out that ‘the best
workable method to test for novelty is to take the integers of a
given claim seriatim and to look
for their counterparts in the
alleged anticipation’.
18
Leaving aside the superfluous
words that I referred to earlier, the integers of the claim are (a)
an injectable composition comprising
(b) a taxane derivative (c) in a
polysorbate and (d) an additive (e) wherein the additive prevents the
formation of, or breaks,
a gelled phase during the mixing of the
intermediate solution with an aqueous medium. I do not think it is
necessary to refer to
any of the documents that are said to
anticipate the claim. Suffice it to say that none describes integer
(e).
[27] An invention must not only
be new in order to qualify for a patent but must also involve an
inventive step – as it is
usually expressed, it must not be
obvious. Reading
ss 25(1)
, (6) and (10) together – described in
Ensign-Bickford (South
Africa) (Pty) Ltd v AECI Explosives and Chemicals Ltd
19
as constituting a ‘statutory
code’ on the subject – the enquiry involves the following
steps:
20
‘
(1)
What is the inventive step said to be involved in the patent in suit?
(2) What was, at the
priority date, the state of the art (as statutorily defined) relevant
to that step?
(3) In what respect
does the step go beyond, or differ from, that state of the art?
(4) Having regard to
such development or difference, would the taking of the step be
obvious to the skilled man?’
[28] The inventive step claimed
for the invention is the addition of an additive (ethanol) to the
intermediate solution, having
the effect of preventing or breaking a
gelled phase during the mixing of the solution with an aqueous
medium. The expert opinion
of Dr Parolis – who deposed to an
affidavit on behalf of Cipla – was that if that step did indeed
go beyond or differ
from the state of the art at the priority date,
then it would have been obvious to the skilled addressee to take that
step. His
evidence on that issue was countered by Dr Davies, who
deposed to an affidavit on behalf of Aventis. Counsel for Aventis
readily
accepted that it was not open to us to resolve that dispute
on the affidavits, and that it falls to be resolved in the action
that
has been commenced for final relief. Nonetheless, the evidence
on affidavit, and particularly the description in the specification
of the methods that had previously been used to overcome the
difficulty, is sufficient to establish prima facie – and in
my
view strongly so – that the taking of that step was far from
obvious, and that the patent is not susceptible to revocation
on that
ground. That being so Aventus has established at least prima facie an
entitlement to enforce its patent.
[29] But here Aventis encounters
a complication that precludes its main claim – that is, its
claim for an interdict against
infringement. The Act confines
infringement to ‘making, using, exercising, disposing or
offering to dispose of, or importing
the invention’.
21
I have already found that the
invention claimed in claim 1 is a composition made up of the
components, and having the effect, stated
in the claim. The product
being imported and offered for disposal by Cipla is not that
composition but only its components. A health
worker who mixes the
contents of the two vials ‘makes’ the composition that is
the subject of the claim, thereby infringing
the patent, but the
infringement is by the health worker who made the composition, and
not by Cipla who supplied the means for
infringing.
[30] Nonetheless, it is clear
that Cipla imports and supplies its product with the direct and sole
intention that that act of infringement
should occur. Indeed, the
insert that accompanies the product directs health workers to use the
product in that way. It is on that
basis that Aventis claims, as an
alternative to its main claim, pending the outcome of its action for
final relief, an order interdicting
Cipla
‘
from
procuring or inducing, aiding and abetting, advising, inciting or
instigating or assisting any other person to infringe claim
1 of [the
patent] by [Cipla], in the Republic, disposing of or offering to
dispose of CIPLA DOCETAXEL or CIPLA DOCETAXEL solvent’.
[31] The unlawfulness of what has
come to be known as ‘contributory infringement’ has
widespread acceptance internationally.
In England, under s 60(2) of
the Patents Act 1977, a person infringes a patent if, without the
consent of the proprietor, he
‘
supplies
or offers to supply in the United Kingdom a person other than a
licensee or other person entitled to work the invention
with any of
the means, relating to an essential element of the invention, for
putting the invention into effect when he knows,
or it is obvious to
a reasonable person in the circumstances, that those means are
suitable for putting, and are intended to put,
the invention into
effect in the United Kingdom’.
[32] In
Grimme
Maschinenfabrik GmbH & Co KG v Derek Scott (t/a Scotts Potato
Machinery)
22
the Court of Appeal explained
that the section has its origins in Art. 26 of the Community Patent
Convention – which requires
that as far as possible the same
legal rules should apply across all the countries where the
provisions of the Convention have
been implemented. That Article is
in substantially the same terms as s 60(2) of the English Act. It
also observed that that form
of infringement has been recognised in
the United States for more than 100 years and said that
‘
[t]he
specific origin of the term [contributory infringement] appears to
have been s.271 of the US Patent Act 1952, in which it
is
specifically mentioned. Section 271(c) has marked similarities to
Art. 26.1, and is as follows:
“
Whoever
offers to sell or sells within the United States or imports into the
United States a component of a patented machine, manufacture,
combination or composition, or a material or apparatus for use in
practising a patented process, constituting a material part of
the
invention, knowing the same to be especially made or especially
adapted for use in an infringement of such patent, and not
a staple
article or commodity of commerce suitable for substantial
non-infringing use, shall be liable as a contributory infringer.”
Section 271(b) also
makes anyone who “actively induces infringement liable as an
infringer”.’
[33] There are no comparable
provisions in our Patents Act but our law would be most deficient if
it had no remedy against intentionally
aiding and abetting
infringement of a patent and in my view there is indeed no such
deficiency.
[34]
Almost a century ago, in
McKenzie
v Van der Merwe,
23
it was accepted by this court that a
person is delictually liable if he aids and abets another to commit a
delict. Although the
court was divided on the outcome that principle
was endorsed by both the minority and the majority.
Solomon
JA, with whom De Villiers AJA and Juta AJA concurred,
24
expressed the law on the
point as follows:
‘
Under the
Lex
Aquilia
not only the
persons who actually took part in the commission of a delict were
held liable for the damage caused, but also those
who assisted them
in any way, as well as those by whose command or instigation or
advice the delict was committed. To a similar
effect is the passage
which was quoted from
Grotius
(3, 32, 12, 13) that
everyone is liable for a delict "even though he has not done the
deed himself, who has by act or omission
in some way or other caused
the deed or its consequence: by act, that is by command, consent,
harbouring, abetting, advising or
instigating".’
(On the facts, the
majority held the defendant not to be liable.) In a dissenting
judgment C.G. Maasdorp JA said on that point of
law:
‘
According to
the
Digest
(47,
2, 54, 4), "he who knowingly furnished instruments for stealing
is liable, although he did not counsel the theft."
This law we
find laid down also by
Van
der Linden
(2, 1, 8),
and
Matthaeus,
in
his work on Crimes (1, 11). Here the writers speak of crimes from
which a civil liability for damages arises. In
Voet
(47, 2, 7) special
mention is made of the liability of a person who lends a thief a
ladder, well knowing what it was to be used
for.’
[35] The principle is not
confined to inducing or aiding and abetting the commission of a
delict. In
Atlas
Organic Fertilizers (Pty) Ltd v Pikkewyn Ghwano (Pty) Ltd
25
it was held to be a delict for a
person to induce another to breach a contract. Van Dikhorst J
expressed it as follows:
‘
A
delictual remedy is available to a party to a contract who complains
that a third party has intentionally and without lawful justification
induced another party to the contract to commit a breach thereof.
Solomon
v Du Preez
1920
CPD 401
at 404;
Jansen
v Pienaar
(1881)
1 SC 276
;
Isaacman
v Miller
1922
TPD 56
;
Dun
& Bradstreet (Pty) Ltd v SA Merchants Combined Credit Bureau
(Cape) (Pty) Ltd
1968
(1) SA 209
(C) at 215.’
[36] In
Esquire
Electronics Ltd v Executive Video
26
a submission that for there to be
an infringement of a trade mark there must be use by the alleged
infringer personally or through
his servant or agent was disposed of
by this court as follows:
‘
I
do not think that this argument has any merit. The modern law of
trade mark infringement is statutory, but its origins are to
be found
in the common law rule that it is an actionable wrong, ie, a delict,
to filch the trade of another by imitating the name,
mark or device
by which that person has acquired a reputation for his goods (see
Policansky
Bros Ltd v L & H Policansky
1935
AD 89
at 97). A delict is committed not only by the actual
perpetrator, but by those who instigate or aid or advise its
perpetration.
See
McKenzie
v Van der Merwe
1917
AD 41
.... In the present case Executive Video produced the video
cassettes and disposed of them, knowing and intending that they would
be put to use for the purpose for which they were purchased or hired
and that such use would necessarily involve the visual representation
of the trade mark. In the circumstances it is idle to contend that
Executive Video is innocent of infringement.’
[37] In
Bayerische
Motoren Werke AG v Auto Body Spares SA (Pty) Ltd
27
it was not
disputed that the decision in
Esquire
Electronics
applied
equally to aiding and abetting infringement of a design registered
under the
Designs Act 195 of 1993
.
[38] The principle was asserted
in relation to patent infringement in
Viskase
Corporation v Columbit (Pty) Limited and Harold Henry Zeh.
28
In that case the managing
director of a company that was alleged to have infringed a patent was
sought to be held liable, on the
grounds that he had ‘caused
and/or procured the First Defendant to infringe the said patents and
in the premises [had] aided
and abetted the First Defendant in the
... infringement.’
29
Harms J appears to have accepted
it as self-evident that one who intentionally aids and abets
infringement of a patent commits a
delict. Although not necessary for
the decision in that case (the company was found not to have
infringed) he made the following
observations:
‘
As indicated,
it is not alleged that second defendant committed an act of
infringement but that he aided and abetted the first defendant.
The
whole case against second defendant was that he, as Managing Director
of first defendant, controlled its affairs and was instrumental
in
the purchase and sale of the infringing casings by the first
defendant. That fact may establish that the second defendant did
aid
the first defendant but it does not establish any abetting by him. I
fail to see how a person can abet unless he knows or has
reason to
believe that the act in question is a tortuous act. The concept of
aiding and abetting applies only to delicts committed
with intent (or
dolus).
In casu
there is no evidence that second defendant had a
"weder-regtelikheidsbewussyn". I do not believe that the
statement
of the English law in
Morton-Norwich
Products Inc & Others v Intercen Ltd
1978 RPC 501
(Ch. D) is in accordance with our law where it was
stated at 515 that:
"I
hold that if there is a concerted design by two persons to sell goods
which in fact infringe an English patent, then the
parties who have
such design and do so sell are in fact joining tortfeasors and both
infringe the patent whether they knew that such
a sale would be an infringement or not. Once tortfeasance is proved
the knowledge
as to whether the act in question is or is not a tort
does not affect liability."
On
the other hand I do believe that
Rainham
Chemical Works Ltd (In Liq) v Belvedere Fish Guano Co Ltd
(1921) 2 AC 465
(HL) is in accordance with our law and I quote at
page 476:
"If the company
was really trading independently on its own account, the fact that it
was directed by Messrs. Feldman and Partridge
would not render them
responsible for its tortuous act unless, indeed, they were acts
expressly directed by them. If a company
is formed for the express
purpose of doing a wrongful act or if, when formed, those in control
expressly direct that a wrongful
thing should be done, the
individuals as well as the company are responsible for the
consequences.”’
[39]
I think it is plain from
McKenzie
,
and the authorities relied upon in that case, that, upon ordinary
delictual principles, it is unlawful to incite or aid and abet
the
commission of a civil wrong, and I do not think it matters whether it
is a wrong at common law or whether it is a wrong created
by statute.
Indeed, the decision of this court in
Esquire
Electronics
seems
to me to be directly in point. That it concerned a trade mark, and
this case concerns a patent, does not seem to me to be
a material
distinction. It is clear that Cipla’s product is to be imported
and disposed of with the specific and sole intention
that it will be
used in a manner that will infringe the patent, and its conduct in
doing so will be unlawful.
[40]
I have already held that, but for the question of obviousness, no
grounds have been shown for revocation of the patent. The
question of
obviousness will be determined in the pending action but the material
before us establishes, at least prima facie,
that the patent is
valid, and that Cipla is intent upon inciting, aiding and abetting
its infringement.
Where the existence or
otherwise of a right asserted by an applicant cannot be decided
finally on affidavit, but is nonetheless
‘prima facie
established though open to some doubt’, it is trite that a
court has a discretion to grant an interdict
pending the outcome of
proceedings for its final determination. The classic formulation of
how that discretion is to be exercised
is that of Holmes J in
Olympic
Passenger Service (Pty) Ltd v Ramlagan
:
30
‘
In
such cases, upon proof of a well grounded apprehension of irreparable
harm, and there being no adequate ordinary remedy the Court
may grant
an interdict – it has a discretion, to be exercised judicially
upon a consideration of all the facts. Usually this
will resolve
itself into a nice consideration of the prospects of success and the
balance of convenience – the stronger the
prospects of success,
the less need for such balance to favour the applicant: the weaker
the prospects of success, the greater
the need for the balance of
convenience to favour him.’
[41] Cipla contends that damages
will be an adequate remedy if it is found in due course that the
patent is valid but I do not think
that can seriously be considered.
The very nature of the market is such that it will be almost
impossible to determine what sales
would have been made but for the
presence of Cipla’s product. Nor is it an answer to its claim
for an interdict that Aventis
might be awarded a reasonable royalty
as an alternative to damages.
31
That is a remedy available at the
option of a patentee and it cannot be compelled in effect to license
the use of its patent. The
case resolves itself, then, into balancing
against one another its prospects of success in the action it has
commenced and the
balance of convenience if an interdict were to be
granted or withheld, as the case may be.
[42] There is some mention in
Cipla’s affidavits of prejudice to cancer sufferers if an
interdict were to be granted but it
is perfectly plain that in
reality Cipla’s resistance to an interdict is founded upon its
commercial interests. It explains,
quite frankly, the advantage to be
had from being the first in the market for the supply of cheaper
generic products once a patent
expires. It says that a generic can be
expected to expand the market for the medicine and that the first
generic on the market
can be expected permanently to capture about
70% of the expanded market within about eighteen months, leaving the
remaining 30%
to be shared amongst the original product and other
generics that come onto the market. At the time its answering
affidavit was
filed Cipla was due to receive stock of Cipla
Docetaxel, had already taken orders, and was in a position to
immediately enter the
market to secure that commercial advantage.
[43] The Treatment Action
Campaign (TAC) was admitted to the appeal as amicus curiae, with the
consent of both parties. Although
purporting to act as an amicus
curiae in truth it aligns itself with Cipla’s opposition to the
grant of an interdict. Its
objections to an interdict were more
widely framed.
[44] The TAC founded its
objections upon s 27(1) of the Constitution, which guarantees to
everyone the right to have access to health
care services, which, it
has been said, includes a right to have access to affordable
medicines.
32
In its heads of argument the TAC
submitted that the Patents Act must be construed ‘through the
prism of the Constitution’
and in a way that appropriately
balances the rights of a patentee against the constitutional rights
of others, and that it ‘must
be interpreted and applied to
ensure the public interest in patent protection is in fact served and
ensuring other rights are not
unreasonably limited thereby’.
[45] What we are to make of
viewing the legislation through the prism of the Constitution was not
developed by the TAC. Section
39(2) indeed calls upon a court to
‘promote the spirit, purport and objects of the Bill of Rights’
when interpreting
legislation, as pointed out by the TAC, but that
does not open the door to changing the clear meaning of a statute. If
the clear
meaning conflicts with the Bill of Rights then the remedy
is to strike it down, but there has been no challenge to the
constitutional
validity of any of the provisions of the Act that are
now material. There is also no suggestion that the meaning of those
provisions
is not clear. The disputes centre instead on the
application of those provisions to the facts of this case. On the
assumption that
the patent is not revocable for want of an inventive
step I cannot see how s 39(2) or the prism of the Constitution comes
into
play so as to deny Aventis its right to enforce its patent.
[46] The TAC is on stronger
ground when it advances factors to be taken account of when weighing
the balance of convenience. In
that respect it submitted that the
broader public interest, and not only the interests of the litigating
parties, must be placed
in the scales when weighing where the balance
of convenience lies. Apart from decisions to that effect in this
country,
33
we were referred to cases in
other jurisdictions, particularly the United States, where
injunctions against infringement have been
refused on that ground.
[47] In
EBay
Inc. v Mercexchange, L.L.C
.
34
the United States Supreme Court
affirmed that the ordinary requirements in that country for the grant
of a permanent injunction
35
–
which include
demonstrating that ‘the public interest would not be disserved’
by an injunction – applied as much
to injunctions against
patent infringement. We were referred by counsel for the TAC to four
decisions in that country in which
that requirement played a material
role in the refusal of an injunction.
[48] In
Innogenetics,
N.V. v Abbott Laboratories
36
the court took account of the
fact that ‘enjoining [the defendant] from selling its product
could pose a serious risk to the
public health if plaintiff [the
patentee] cannot fill the diagnostic market need.’ Whether that
would occur was not decided
but was referred for the hearing of
evidence, at which the
‘
plaintiff
will bear the burden of proving by the preponderance of the evidence
that the needs of the Hepatitis C diagnostic market
could continue to
be met if an injunction issued against the defendant.’
[49] In
Bard
Peripheral Vascular, Inc v W.L.Gore & Associates, Inc
,
37
the fact that the infringer’s
product had superior medical features weighed against the grant of an
injunction.
[50]
Johnson
& Johnson Vision Care, Inc v Ciba Vision Corporation
38
concerned the sale of contact
lenses in infringement of a patent. At the time the injunction was
sought the infringing lenses had
been on the market for five years,
they were the largest single-selling lenses in the United States,
they were being worn by approximately
5.5 million patients, and they
were the preferred choice for first fits amongst eye care
practitioners. In refusing an injunction
the court said that the
evidence
‘
convinces
the Court that millions of innocent contact lens wearers will suffer
real adverse consequences if sale of [the infringing
lenses] is
enjoined … There will also be significant disruption,
confusion and cost (estimated to be in the hundreds of
millions of
dollars) caused by [infringing lens] patients being abruptly told
that the contact lens for which they have been fitted
and with which
they are satisfied, is no longer available. Choosing a new lens will
at minimum require refitting and the new lens
may not prove as
efficacious as the [infringing lens]. Moreover, patients may have to
be refitted more than once until an appropriate
lens is found. An
unidentified number will not be able to be refitted appropriately at
all.’
[51] In
Edwards
Lifesciences AG and Edwards Lifesciences LLC v Corevale Valve, Inc
and Medtronic Corevalve, LLC
39
an injunction was sought against
the manufacturing of a prosthetic cardiac valve that could be
implanted without surgery. The infringing
valve was being
manufactured in the United State but was being sold abroad. The
evidence established that the infringer was capable
of moving its
manufacturing operation to Mexico immediately if an injunction was
granted. In refusing an injunction the court said
that
‘
[t]he
public interest would not be substantially advanced or harmed by the
issuance of an injunction, since [the infringer] would
be able to
continue manufacturing accused product abroad without seriously
affecting the supply of the product available to the
public.’
[52] The requirements for an
interim interdict in this country are more flexible than those for a
permanent injunction in the United
States. Counsel for Aventis
accepted, nonetheless, that the ‘public-interest’ factors
identified in those cases can
and ought to be taken into account in
the exercise of our discretion, but amply demonstrated that none of
those concerns arise
on the facts of this case.
[53] Bearing in mind the
commercial advantage of first-entry to the generics market, it is
common for a patentee of a pharmaceutical
product to enter the market
shortly before its patent expires with an alternative product that
will compete with anticipated generics.
No doubt it was with that in
mind that Aventis obtained Medicines Control Council registration in
2006 of a product that it calls
Docetere. Docetere is the same
product as Taxotere, but re-branded and priced to compete with
generics that can be expected to
enter the market when the patent
expires. At the time the affidavits in this matter were filed
Docetere had not yet been placed
on the market.
[54] Both parties filed
supplementary affidavits placing new evidence before us and in each
case the evidence was admitted unopposed.
It emerges from the
affidavit filed by Cipla that after the interdict had been refused it
launched its product onto the market
and that by the end of March
2012 it was being used in the treatment of some 65-70 patients. On
the other hand, Aventis has also
now placed Docetere on the market.
[55] There is no suggestion that
Aventis is not able to meet demand for Taxotere or Docetere, which
was the disputed issue in
Innogenetics,
N.V. v Abbott Laboratories.
Nor
can it be said that Cipla’s product offers superior medicinal
benefits, which was the case in
Bard
Peripheral Vascular, Inc v W.L.Gore & Associates, Inc.
It
is also clear that there will be no material disruption to patients
if an interdict were to be granted, as there would have been
in
Johnson & Johnson
Vision Care, Inc v Ciba Vision Corporation
.
When the application was heard there were no users of Cipla
Docetaxel. By March 2012 there were some 65-70 users, and I assume
that by now there are probably more, but switching to Taxotere or
Docetere for future treatment involves no medicinal disruption.
This
is also not a case like
Edwards
Lifesciences,
in which
an interdict will have no practical effect.
[56] The TAC’s opposition
to the grant of an interdict really comes down to no more than
opposition to the monopoly that the
law confers upon a patentee. It
submits that those who cannot afford Taxotere, but are able to afford
the price of Cipla Docetaxel,
will be prejudiced if distribution of
the latter were to be prohibited. Where the public is denied access
to a generic during the
lifetime of a patent that is the ordinary
consequence of patent protection and it applies as much in all cases.
To refuse an interdict
only so as to frustrate the patentee’s
lawful monopoly seems to me to be an abuse of the discretionary
powers of a court.
But in any event there will be no material
prejudice of that kind on the facts of this case.
[57] Taxotere, Docetere and Cipla
Docetaxel are each sold in dosages of 20 mg and 80 mg. The maximum
price at which a medicine may
be sold to the public is what is called
its ‘single exit price’. The single exit price of
Taxotere is R2 048 for
20 mg and R7 532 for 80 mg.
40
The price at which it is sold to
the state by Aventis is R680 for 20 mg and R2 327 for 80 mg. The
single exit price of Docetere
is R1 100 for 20 mg and R3 850
for 80 mg. The single exit price of Cipla Docetaxel is R1 000
and R3 500 for
20 mg and 80 mg respectively.
[58] It will be apparent, then,
that Taxotere is considerably more accessible than Cipla Docetaxel to
patients who are dependent
upon public health care, and there will be
no prejudice at all to those patients, or to the state, if an
interdict were to be granted.
Patients who are dependent upon private
health care will continue to have access to Taxotere (albeit at a
considerably higher cost)
and will have access to Docetere at only a
marginally higher cost than Cipla Docetaxel (R100 more for a 20 mg
dosage and R350 more
for a dosage of 80 mg). Many of those patients
will have access to medical insurance that will meet the additional
cost, and for
those who do not, the additional cost of Docetere is
marginal.
[59] Thus the only implication
for health care of granting an interdict is that patients who receive
private health care, and who
are not able to recover the cost of
treatment from a private medical fund, will be obliged to pay 10%
more for treatment than they
might have done had Cipla’s
product remained on the market. Neither Cipla nor the TAC has
identified any other prejudice
that might be suffered by the public.
[60] As to the commercial
prejudice to Cipla if an interdict were to be granted – the
loss of the advantage of having the
first generic on the market –
Aventis has as much interest as Cipla in establishing the first
foothold in the generic market
and the prejudice to it if an
interdict is refused will be precisely the same.
[61] But as appears
from
Olympic Passenger Service
the balance of convenience is
not evaluated in isolation: the stronger the prospects of success in
the main proceedings, the less
need for the balance to favour the
applicant, and vice versa. If Aventis eventually establishes the
validity of its patent, and
has meanwhile been denied an interdict,
it will have lost the advantage given to it by its monopoly of
establishing itself unimpeded
in the generic market before the patent
expires. In the interim it will also have lost sales of Taxotere or
Docetere. On the other
hand, if Aventis does not establish the
validity of its patent, and an interdict has meanwhile been granted,
Cipla will have been
denied that same opportunity to establish a
foothold in the market, and will have lost sales of its product. In
either event the
public interest will not have been materially
affected. The most that can be said is that patients who receive
private health-care,
and who are not able to recover the cost of
treatment from a private medical fund, will have been required to pay
10% more for
treatment than they might otherwise have done. In those
circumstances the balance of convenience does not seem to me to fall
substantially
on one side or another and the prospects of success or
failure in the action become prominent. In that respect I have
already said
that such doubt as there might be as to the validity of
the patent seems to me to be slight and that becomes decisive. In
those
circumstances I can see no proper ground for denying Aventis
the relief that it claims.
[62] For those
reasons
1. The appeal in the
s 51(1) proceedings (Case No. 139/2012) is dismissed with costs that
include the costs of two counsel.
2. The appeal in the
infringement proceedings (Case No. 138/2012) is upheld with costs
that include the costs of two counsel, to
be paid by the respondents
jointly and severally. The order of the Commissioner in those
proceedings is set aside and the following
order is substituted:
‘
(a)
Pending the outcome of the action for final relief the respondents
are interdicted from procuring or inducing, aiding and abetting,
advising, inciting or instigating or assisting any other person to
infringe claim 1 of South African Patent no. 93/8936 in the
Republic,
and from disposing of or offering to dispose of CIPLA DOCETAXEL and
CIPLA DOCETAXEL solvent.
(b) The respondents,
jointly and severally, are to pay the costs of the application,
including the costs of two counsel, and the
costs of the expert
witness Prof Davies.’
__________________
R W NUGENT
JUDGE OF APPEAL
APPEARANCES:
Case 139/2012
For
appellant: C Puckrin SC
R
Michau SC
Instructed
by:
Adams
& Adams, Pretoria
Honey
Attorneys Inc, Bloemfontein
For
respondent: L Bowman SC
A
P H Cockrell SC
B
du Plessis SC
Instructed
by:
Brian
Bacon & Associates Inc, Cape Town
Webbers,
Bloemfontein
For
Amicus Curiae: S Cowen
A
Hassim
U
Rugege
Instructed
by:
Section
27, Johannesburg
McIntyre
& Van der Post, Bloemfontein
Case 138/2012
For
appellant: L Bowman SC
A
P H Cockrell SC
B
du Plessis SC
Instructed
by:
Brian
Bacon & Associates Inc, Cape Town
Webbers,
Bloemfontein
For
respondent: C Puckrin SC
R
Michau SC
Instructed
by:
Adams
& Adams, Pretoria
Honey
Attorneys Inc, Bloemfontein
For
Amicus Curiae: S Cowen
A
Hassim
U
Rugege
Instructed
by:
Section
27, Johannesburg
McIntyre
& Van der Post, Bloemfontein
1
Aventis
Pharma SA, a French corporation, to be precise.
2
The
perfusion solution need not necessarily be a saline solution but for
convenience I refer to it as such.
3
SCA
Case No 139/2012.
4
SCA
Case No 138/2012.
5
Kimberly-Clark
of South Africa (Pty) Ltd v Proctor & Gamble SA (Pty) Ltd
1998 (4) SA 1
(SCA) 12H-I.
6
Gentiruco
A.G. v Firestone SA (Pty) Ltd
1972 (1) SA 589
(A).
7
At
614B-C.
8
Meaning
III 1. In The Shorter Oxford English Dictionary.
9
Section
61(1)(f)(i).
10
Section
61(1)(c) read with s 25(1).
11
Section
61(1)(c) read with s 25(1).
12
Section
61(1)(g).
13
Timothy
Donald Burrell
Burrell’s South African Design and Patent
Law
3 ed (1999) para 4.22.
14
De
Beers Industrial Diamond Division (Pty) Ltd v Ishizuka
1980 (2)
SA 191
(T) 198H.
15
Letraset
Ltd v Helios Ltd
1972 (3) SA 245
(A).
16
At
249F-G.
17
At
250C-E. As to the limits of expert evidence generally see
Gentiruco
,
above, at 617G-618A, quoting with approval from
British Celanese
Ltd v Courtaulds Ltd
(1935) 52 RPC 171
at 195.
18
Para
4.71.2.
19
Ensign-Bickford
(South Africa) (Pty) Ltd v AECI Explosives and Chemicals Ltd
1999 (1) SA 70
(SCA) at 80F.
20
At
80H-J. See, too,
Roman Roller CC v Speedmark Holdings (Pty) Ltd
1996 (1) SA 405 (A).
21
Section
45(1).
22
Grimme
Maschinenfabrik GmbH & Co KG v Derek Scott (t/a Scotts Potato
Machinery)
[2010] EWCA Civ 1110.
23
McKenzie
v Van der Merwe
1917 AD 41.
24
Innes
CJ decided the matter on a different basis and did not touch
directly on the point.
25
Atlas
Organic Fertilizers (Pty) Ltd v Pikkewyn Ghwano (Pty) Ltd
1981 (2) SA 173
(T).
26
Esquire
Electronics Ltd v Executive Video
1986 (2) SA 576
(A).
27
Bayerische
Motoren Werke AG v Auto Body Spares SA
(Pty) Ltd 1999 BP 51 (T).
28
Viskase
Corporation v Columbit (Pty) Limited and Harold Henry Zeh
1986
BP 432 (CP). See, too,
Grande Paroisse SA v SASOL Ltd
2003
BIP 11 (CP).
29
At
434D.
30
Olympic
Passenger Service (Pty) Ltd v Ramlagan
1957 (2) SA 382
(D) at
383E-F.
31
Section
65(6).
32
Minister
of Health v New Clicks SA (Pty) Ltd
2006 (2) SA 311
(CC) per
Ngcobo J para 514 and Moseneke J para 706.
33
See
Bamford v Minister of Community Development and State Auxiliary
Services
1981 (3) SA 1054
(C) at 1061D-E;
Marinpine Transport
(Pty) Ltd v Local Road Transportation Board, Pietermaritzburg
1984 (1) SA 230
(N) at 234D-F;
Corium (Pty) Ltd v Myburgh Park
Langebaan
(Pty) Ltd
1993 (1) SA 853
(C) at 858E-G;
Verstappen
v Port Edward Town Board
1994 (3) SA 569
(D) at 576H-I.
34
EBay
Inc v Mercexchange
, L.L.C.
547 US 388
(2006) at 392.
35
A
plaintiff who seeks a permanent injunction must demonstrate: ‘(1)
that it has suffered irreparable injury; (2) that remedies
available
at law, such as monetary damages, are inadequate to compensate for
that injury; (3) that, considering the balance of
hardships between
the plaintiff and the defendant, a remedy in equity is warranted;
and (4) that the public interest would not
be disserved by a
permanent injunction’ -
EBay Inc
at 391.
36
Innogenetics,
N.V. v Abbott Laboratories
578 F. Supp 2d 1079
(W.D.Wis 2007) at
1105.
37
Bard
Peripheral Vascular, Inc v W.L.Gore & Associates, Inc
2009
WL 920300 (D.Ariz.).
38
Johnson
& Johnson Vision Care, Inc v Ciba Vision Corporation
712
F.Supp.2d 1285
(M.D.Fla. 2010).
39
Edwards
Lifesciences AG and Edwards Lifesciences LLC v Corevale Valve, Inc
and Medtronic Corevalve, LLC
2011 WL 446203 (D. Del).
40
The
prices have all been rounded to the nearest Rand.