Approved Judgment - EPLAW Patent Blog

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Dec 3, 2012 (4 years and 6 months ago)

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Neutral Citation Number:
[2012] EWHC 181 (Pat)


Case No:
HC11C01304

IN THE HIGH COURT OF JUSTICE

CHANCERY DIVISION

PATENTS COURT


Rolls Building, Fetter Lane, EC4A 1NL


Date:
10

February
2012


Before

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THE HON MR JUSTICE ARNOLD

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Between :



NOVARTIS PHARMACEUTICALS UK LIMITED

Claimant


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(1)

MEDIMMUNE LIMITED

(2)

MEDICAL RESEARCH COUNCIL

Defendant
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Simon Thorley QC
,

Justin Turner QC
and

Joe Delaney

(instructed by
Allen & Overy LLP
)
for the
Claimant


Richard Meade QC
,
Tom Mitcheson
and

James Whyte
(instructed by

Marks & Clerk
Solicitors LLP
) for the

Defendant
s


Hearing date:
3 February 2012

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Approved Judgment

I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this
Judgment and that copies of this version as handed down may be treated as authentic.



.............................


THE HON M
R JUSTICE ARNOLD



THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



MR JUSTICE ARNOLD

:


Introduction

1.

The
First Defendant

(“MedImmune

) and the Second Defendant (“the MRC”)

(collectively, “the Patentees”)

are joint proprietors of European Patent (UK) No. 2
055 777 (“
the Patent
”).
The Patentees

are

the holder
s

of Supplementary Protection
Certificate No. SPC/GB09/053 (“the SPC
”) granted in respect of the Patent. The
Claimant (“Novartis”) seeks a declaration that the SPC is invalid.
MedImmune is the
exclusive licensee of the MRC’s interest in the Patent and the SPC.
MedImmune
counterclaims for infringement of the SPC
by sales of

a pharmaceutical product
whose international non
-
proprietary name is ranibizumab and which is sold under the
trade mark Lucentis. Lucentis is approved for the treatment of an eye condition
known as wet age
-
related macular degeneration, which can lead to l
oss of vision.
Ranibizumab was developed by Genentech, Inc., which is not a party to the
proceedings
.

2.

In
MedImmune Ltd v Novartis Pharmaceuticals UK Ltd

[2011] EWHC 1669 (Pat)
(“the first judgment”)
I held that
(i)
the Patent was invalid and (ii) even if
valid, it had
not been infringed by Novartis because claim 1 on its true construction did not cover
the process by which ranibizumab had been produced. It is common ground that, if
either of these conclusions is correct, it follows that the SPC is invalid
.

I granted
MedImmune permission to appeal, however, and the hearing of the appeal has been
fixed for
9

July 2012. It is
also
common ground that I must approach the issues in the
present proceedings on the hypothesis that the Court of Appeal will conclude t
hat the
Patent is valid and has been infringed.

3.

In this judgment I will take the first judgment as read. The following sections of the
first judgment are particularly relevant:

i)

The technical background ([8]
-
[90]);

ii)

511 and 777 ([216]
-
[248]);

iii)

The development

of ranibizumab ([503]
-
[519]).

The Regulation

4.

European Parliament and Council Regulation 469/2009/EC of 6 May 2009 concerning
the supplementary protection certificate for medicinal products

(codified version)

(“the Regulation”)

enables the proprietor of a patent for a medicinal product to obtain
a supplementary protection certificate which extends the duration of the patent with
respect to th
at

product so as to compensate the proprietor for the effective loss of
patent term caus
ed by the need to obtain a marketing authorisation before the product
can be marketed.

5.

The Regulation
includes the following recitals:

“[
3
]

M
edicinal products, especially those that are the result of long, costly research
will not continue to be develope
d in the Community and in Europe unless they
THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



are covered by favourable rules that provide for sufficient protection to
encourage such research
.


[
4
]

A
t the moment the period that elapses between the filing of an application for
a patent for a new medicinal

product and authori
s
ation to place the medicinal
product on the market makes the period of effective protection under the
patent insufficient to cover the investment put into the research
.


[
5
]

T
his situation leads to a lack of protection which penali
s
es
pharmaceutical
research
.


[
6
]

There exists a

risk of research centres situated in the Member States relocating
to countries that offer greater protection
.


[
7
]

A

uniform solution at Community level should be provided for, thereby
preventing the heterogeneo
us development of national laws leading to further
disparities which would be likely to create obstacles to the free movement of
medicinal products within the Community and thus directly affect the
establishment and the functioning of the internal market
.


[
8
]

T
herefore, the creation of a supplementary protection certificate granted,
under the same conditions, by each of the Member States at the request of the
holder of a national or European patent relating to a medicinal product for
which marketing author
i
s
ation has been granted is necessary
. A

Regulation is
therefore the mo
st appropriate legal instrument.


6.

Articles 1
, 3,

4
and 5
of the Regulation provide:


Article 1


Definitions


For the purpose of this Regulation:


(a)

‘medicinal product’ means any
substance or combination of
substances presented for treating or preventing disease in human
beings or animals and any substance or combination of substances
which may be administered to human beings or animals with a view to
making a medical diagnosis or
to restoring, correcting or modifying
physiological functions in humans or in animals;


(b)

‘product’ means the active ingredient or combination of active
ingredients of a medicinal product;


(c)

‘basic patent’ means a patent which protects a product as de
fined in
(b) as such, a process to obtain a product or an application of a
product, and which is designated by its holder for the purpose of the
procedure for grant of a certificate;




THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC





Article 3


Conditions for obtaining a certificate


A certificate sha
ll be granted if, in the Member State in which the application
referred to in Article 7 is submitted and at the date of that application
-


(a)

the product is protected by a basic patent in force;


(b)

a valid authori
s
ation to place the product on the mark
et as a medicinal
product has been granted in accordance with Directive
2001
/
83
/EEC
or Directive
200
1/8
2
/EEC, as appropriate;


(c)

the product has not already been the subject of a certificate;


(d)

the authori
s
ation referred to in (b) is the first authori
s
ation to place the
product on the market as a medicinal product.


Article 4


Subject
-
matter of protection


Within the limits of the protection conferred by the basic patent, the protection
conferred by a certificate shall extend only to the product covere
d by the
authori
s
ation to place the corresponding medicinal product on the market and
for any use of the product as a medicinal product that has been authori
s
ed
before the expiry of the certificate.


Article
5


Effects of the certificate


Subject to the pr
ovisions of Article 4, the certificate shall confer the same
rights as conferred by the basic patent and shall be subject to the same
limitations and the same obligations.


The Patent

7.

I do not propose to repeat the description of the Patent given in the
first judgment.

In
brief summary, however, the Patent is directed to a method of producing
a
molecule
with specificity for a particular target co
mprising

two
key

steps:
(i) producing a
population of phage particles displaying at their surface binding molec
ules having a
range of binding
proper
ties wherein each particle contains nucleic acid encoding the
binding molecule; and (ii) selecting particles displaying a binding molecule with a
desired
binding property

by contacting the population of particles with a

target
epitope or antigen to which the binding molecule of interest binds.

In essence, what
the Patent discloses
and claims
is a technique for screening a library of
binding
molecules
(or, more specifically,
antibodies or
antibody fragments

or derivatives
)
to
THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



identify

one of interest.

Once the binding molecule has been isolated, it can be
produced by conventional recombinant techniques.

8.

The only claim of the
Patent

to which it is necessary to refer

is claim 1, which is as
follows
:

“[
1
]

A method for produc
ing a molecule with binding specificity for
a particular target, which method comprises:

[2]

producing a population of filamentous bacteriophage particles

displaying at their surface a population of binding molecules

having a range of
binding properties
,

[3]

wherein the binding molecules comprise
antibody antigen
binding domains

for complementary specific binding pair
members,

[4]

wherein the binding molecules are displayed at the surface of
the filamentous bacteriophage particles by
fusion with a gene
II
I protein

of the filamentous bacteriophage particles,

[5]

and wherein each filamentous bacteriophage particle contains
nucleic acid encoding the binding molecule expressed from the
nucleic acid and displayed by the particle at its surface;

[6]

selecting fo
r a filamentous bacteriophage particle displaying a
binding molecule with a desired binding property by contacting
the population of filamentous bacteriophage particles with a
particular target

[7]

so that individual binding molecules displayed on filament
ous
bacteriophage particles with the desired binding property bind
to said target;

[
8
]

separating bound filamentous bacteriophage particles from the
target;

[
9
]

recovering separated filamentous bacteriophage particles
displaying a binding molecule with the

desired binding
property;

[
10
]

isolating nucleic acid encoding the binding molecule from
separated filamentous bacteriophage particles;

[
11
]

inserting nucleic acid encoding the binding molecule, or a
fragment or derivative thereof with binding specificity

for the
target, in a recombinant system; and

[
12
]

producing in the recombinant system separate from
filamentous bacteriophage particles a molecule with binding
specificity for the target,

THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



[
13
]

wherein the molecule is said binding molecule or a fragment or

derivative thereof with binding specificity for the target
.”

Ranibizumab

9.

Age
-
related macular degeneration is caused by abnormal blood vessels proliferating
and damaging the retina. Human vascular endothelial growth factor (VEGF) promotes
endothelial cell
proliferation and neovascularisation, as well as vascular permeability.
Ranibizumab is an anti
-
VEGF antibody which reverses or at least halts these
processes.
I do not propose to repeat the description of the development of
ranibizumab given in the first j
udgment. In brief summary, however,

Genentech’s

starting point was a
mouse
monoclonal antibody
specific to
VEGF called
MAb
A4.6.1
, which was generated in hybridoma cells using monoclonal techniques
.

It is
common ground that this owed nothing to the inventi
on of the Patent. MAb
A4.6.1

was transformed into

a humanised antibody

ranibizumab in eleven steps. Three of
these steps involved phage display
. MedImmune contends that the method of claim 1
of the Patent was carried out in at least the third round of phag
e display (step 9). In
the first judgment, I held that the process carried out by Genentech did not fall within
claim

1 as I had construed it

(see [520]
-
[527])
, but that if the process fell within the
claim ranibizumab was obtained directly by means of it

within the meaning of section
60(1)(c) of the Patents Act 1977 (see [528]
-
[577])
. As related above, however, for
present purposes it must be assumed that the Court of Appeal will hold that
the
process did fall within the claim

on its true construction
.


The SPC

10.

The SPC was granted on 31 March 2011
,

came into force on 10 July 2011 when the
Patent expired

and

is due to expire on 9 July 2016
. It identifies the Patent as the basic
p
aten
t, authorisation EU/1/06/374/011 as the marketing authorisation and
ranibi
zumab as the product.
Although
the SPC

does not say so, authorisation
EU/1/06/374/011 was granted to Novartis

Europharm Ltd, a member of the same
group of companies as Novartis
.

Thus the SPC is based
up
on
a product obtained by
means of an allegedly infringing process
and upon a marketing authorisation obtained
by
an

alleged infringer

of the Patent
.

The issues

11.

Novartis contends that, even on the assumption that the Patent is

valid and that
ranibizumab is a p
roduct obtained directly
by
means of a process

falling within claim
1 of the Patent, the SPC is invalid for two reasons. First, ranibizumab is not protected
by the Patent within the meaning of Article 3(a) of the Regulation since it is not
specified or ide
ntified in the wording of the claims of the Patent. Secondly, the Patent
is not a basic patent within the meaning of Article 1(c) of the Regulation since it does
not protect a process to obtain a product.

12.

In support of the

first of the
se contentions Novart
is relies upon the judgment
s

of the
Court of Justice of the European Union in Case C
-
322
Medeva BV v Comptroller
-
General of Patents, Designs and Trade Marks

[2011] ECR I
-
000
0

(“
Medeva
”)
and
Case C
-
422/10
Georgetown University v
Comptroller
-
General of Paten
ts, Designs
and Trade Marks

[2011] ECR I
-
0000

(“
Georgetown
”)

and its reasoned orders in

Case
C
-
518/10
Yeda Research and Development Comptroller
-
General of Patents, Designs
THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



and Trade Marks

[2011] ECR I
-
0000

(“
Yeda
”)
,
Case C
-
630/10
University of
Queensland v

Comptroller
-
General of Patents, Designs and Trade Marks

[2011] ECR
I
-
0000
(“
Queensland
”)
and

Case C
-
6/11
Daiichi Sankyo Co v
Comptroller
-
General of
Patents, Designs and Trade Marks

[2011] ECR I
-
0000

(“
Daiichi
”)
.

13.

MedImmune’s position in a nutshell is that the law remains unclear in the light of
these decisions and a further reference to the Court of Justice is required to clarify it.

The background to
Medeva

and its progeny

14.

In order to explain the present situati
on it is necessary to begin by setting out the
background to
Medeva
and the other four cases referred to above.

15.

In Case C
-
392/97
Farmitalia Carlo Erba Srl
[1999] ECR I
-
5553 Farmitalia had
obtained a German patent for idarubicin. The claims specifically cov
ered idarubicin
hydrochloride. Farmitalia had also obtained a marketing authorization for idarubicin
hydrochloride. Farmitalia applied for an SPC for “idarubicin and salts thereof
including idarubicin hydrochloride”. The German Patent Office granted an SPC

for
idarubicin hydrochloride, but refused to grant one for “idarubicin and salts thereof
including idarubicin hydrochloride”. Farmitalia appealed first to the
Bundespatentsgericht and then the Bundesgerichtshof. The latter court referred two
questions con
cerning the interpretation of Article 3(b) and (a) respectively of
what
was then Council Regulation 1768/92/EEC
to the C
ourt of Justice
.

16.

With regard to the second question, the C
ourt

held:


23
.

By its second question, the Bundesgerichtshof is, in substance
,
asking what are the criteria, according to Regulation No
1768/92, and in particular Article 3(a) thereof, for determining
whether or not a product is protected by a basic patent.

24
.

In that connection, it should be noted that one of the conditions
for
obtaining a certificate is that the product should be
protected by a basic patent in force.

25
.

As indicated in the seventh recital in the preamble to
Regulation No 1768/92, the patent concerned may be either
national or European.

26
.

As Community law now stands, the provisions concerning
patents have not yet been made the subject of harmonisation at
Community level or of an approximation of laws.

27
.

Accordingly, in the absence of Community harmonisation of
patent law, the extent of p
atent protection can be determined
only in the light of the non
-
Community rules which govern
patents.

28
.

As is clear in particular from paragraph 21 of this judgment,
the protection conferred by the certificate cannot exceed the
scope of the protection c
onferred by the basic patent.

THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



29
.

The answer to be given to the second question must therefore
be that, in order to determine, in connection with the
application of Regulation No 1768/92 and, in particular,
Article 3(a) thereof, whether a product is prote
cted by a basic
patent, reference must be made to the rules which govern that
patent.


17.

In

Takeda Chemical Industries Ltd’s SPC Applications (No 3)
[2003] EWHC 649
(Pat),
[2004] RPC 3 Takeda

had obtained a patent, a marketing authorisation and an
SPC for the
anti
-
ulcer agent lansoprazole
. Subsequently Takeda obtained a patent for
the use of lansoprazole for the manufacture of a medicament for preventing or treating
infectious diseases caused b
y
Helicobacter pylori
.
It also obtained a variation to the
marketing authorization
adding the eradication of
Helicobacter pylori

as a new
therapeutic indication for lansoprazole when used in combination with appropriate
antibiotics
. It
filed six
applicatio
ns for SPCs

for
combinations of lansoprazole with
two antibiotics selected from clarithromycin, amoxycillin and metronidazole. Th
ree of
the applications
designated
the first patent, and the other three the second patent. The
hearing officer refused all the

applications for non
-
compliance with Article 3(a) and
(b) of the Regulation. Takeda appealed to the Patents Court.

18.

Jacob J
(as he then was)
dismissed the appeal. In relation to Article 3(a) he held as
follows:


7
.

Mr Alexander, for Takeda, submits that th
e combination of
lansoprazole with an antibiotic, if sold, would infringe the patent
(and for this purpose it matters not which). So, the combination
is protected by a basic patent which is in force. So, Takeda
comply with condition 3(a). Moreover, he subm
its, definition (b)
specifically contemplates that

product


may be a combination of
active ingredients. So it is clear that condition 3(a) contemplates
protection of a combination.



10
.

Mr Birss, for the Comptroller, submits Mr Alexander's argument
is fl
awed. I agree. The so
-
called

combination


of lansoprazole
and an antibiotic would only infringe because of the presence of
the lansoprazole. In truth, the combination is not as such

protected by a basic patent in force

. What is protected is only
the lan
soprazole element of that combination. It is sleight
-
of
-
hand to say that the combination is protected by the patent. The
sleight
-
of
-
hand is exposed when one realises that any patent in
Mr Alexander's sense protects the product of the patent with
anything e
lse in the world. But the patent is not of course for any
such

combination

.

11
.

I think the position is absolutely clear. I am not surprised to find
that the Swedish courts think so too. A/B Hassle sought an SPC
for a combination of two active ingredient
s. Only one of these
was covered by a patent. The Swedish Patent Office, the Patent
Appeal Court and the Supreme Administrative Court
THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



unanimously concluded that there was no compliance with
Art.3(a). (Case number 3248
-
1996).

12
.

The Swedish courts thought

the point was
acte clair

and refused
to make a reference to the Court of Justice. I think so too. The
SPC system is to provide supplementary protection to that
provided by the patent

to extend the relevant part of the patent
monopoly. It is not a system f
or providing protection for
different monopolies. Here, Takeda's monopoly is in
lansoprazole. The monopoly which they seek is a combination of
lansoprazole and an antibiotic. The fact that that combination
might infringe the monopoly given by the patent si
mply because
one component infringes is irrelevant. Accordingly, I uphold Mr
Walker's decision in relation to Art.3(a).


19.

In

Gilead Sciences Inc’s SPC Application
[2008] EWHC 1902 (Pat) Gilead

had
obtained a patent for a new class of antiretroviral compounds useful in the treatment
of HIV and other diseases, including tenofovir. Claim 1 of the patent was directed to
the class of compounds and claim 25 to tenofovir itself.

Paragraph [0047] of th
e
patent stated:


While it is possible for the active ingredients to be
administered as pure compounds it is preferable to present them
as pharmaceutical formulations. The formulations of the
present invention comprise at least one active ingredient, as
ab
ove defined, together with one or more acceptable carriers
and optionally other therapeutic ingredients.


Claim 27 of the patent was as follows:

“A
pharmaceutical composition comprising a compound
according to any one of claims 1
-
25 together with a
pharmac
eutically acceptable carrier and optionally other
therapeutic ingredients
.”

20.

Gilead obtained a marketing authorisation for a product co
ntaining

tenofovir and
another antiretroviral called emtricitabine
. It
appli
ed
for an SPC in respect of the
combination of

tenofovir and emtricitabine
.

The application was refused by the
United
Kingdom Intellectual Property O
ffice for non
-
compliance with Article 3(a) of the
Regulation. Gilead appealed to the Patents Court

on two grounds
.

The first was that
Takeda

was wrongly
decided, and that the correct test
wa
s the infringement test

which
Jacob J had rejected
. The second was that
Takeda

was distinguishable on the facts.

Kitchin J
(as he then was)
allowed the appeal on the second ground. Accordingly,
it
was not necessary for
him to come to a conclusion with regard to the first ground. He
nevertheless set out a number of considerations which might be said to support the
adoption of the infringement test
, and suggested that the issue merited consideration
by the Court of Appeal
and possibly the CJEU
.

21.

Kitchin J’s reasoning for allowing the appeal on the second ground was as follows:

THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



“31.

I come then to the narrower ground of appeal. Gilead says that
this is not a case where the basic patent only discloses and
claims the use of on
e of the active ingredients of the product.
Here claim 27 is specifically directed to a medicinal product
containing a
combination

of active ingredients and hence there
can be no doubt that the combination of tenofovir and
emtricitabine is protected as suc
h within the meaning of
Articles 1(c) and 3(a). So, it says, the facts of this case are
materially different from those in
Takeda

and, indeed, the
reasoning in that case should have led the Hearing Officer to
accept this application.



33.


I believe a t
est emerges from
Takeda
which is clear and can
be applied without difficulty to a product comprising a
combination of active ingredients. It is to identify the active
ingredients of the product which are relevant to a consideration
of whether the product f
alls within the scope of a claim of the
basic patent. It is those ingredients, and only those ingredients,
which can be said to be protected within the meaning of the
Regulation. So, in the case of a product consisting of a
combination of ingredients A and

B and a basic patent which
claims A, it is only A which brings the combination within the
scope of the monopoly. Hence it is A which is protected and
not the combination of A and B.

34.

Application of the test in the context of this appeal produces a
rea
dy answer. The product comprises two active ingredients,
tenofovir and emtricitabine. It falls within the scope of claims 1
and 25 of the basic patent, but only because of the presence of
tenofovir. Hence, on the
Takeda
test, claims 1 and 25 do not
protect

the product within the meaning of the Regulation.
However, claim 27 is directed to a composition comprising
tenofovir (amongst other compounds) together with a carrier
and optionally other active ingredients. The product falls
within this claim too and it

does so, in so far as the claim is
directed to a combination, as result of the presence of both
tenofovir and emtricitabine.

35.

The product comprising the combination of tenofovir and
emtricitabine is therefore protected by claim 27 within the
meaning o
f Articles 1(c) and 3(a) of the Regulation, and that is
so whether the infringement test or the
Takeda

test is adopted. I
feel some support for this conclusion because I understand that
an equivalent SPC has been granted in France, although I
recognise
from investigations kindly carried out at my request
by the Comptroller and supplied to me after the hearing that
practice is not consistent across all Member States.


THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



22.

In
Astellas Pharma Inc v Comptroller
-
General of Patents
[2009] EWHC 1916 (Pat)
Astellas
was the proprietor of a patent which covered

the anthelmintic
emodepside
.
Astellas
obtained a marketing authorization for a combination of
emodepside

and
another anthelmintic called
praziquantel
. Astellas

applied for an SPC in respect of the
combination of

emodepside

and
praziquantel
. The patent
d
id

not disclose or claim
praziquantel
. Nor did it
disclose or claim a combination of emodepside and
praziquantel.

Claim 19 of
the patent

was for:

“An anthelmintic agent which comprises a compound or a
pharmaceutically acceptable salt thereof of any of claims 1 to
11 and 14 as an active ingredient.”

23.

The UKIPO refused the application on the ground that it did not comply with Article
3(a) since
the patent

did not protect the combination.

Astellas appealed

to the Patents
Court

and advanced three arguments. Astellas’ first argument was that
the patent

protected the combination by virtue of Claim 19, relying on
Gilead
. Astellas’ second
argument was that
the patent

protected the combination because the combinat
ion
would infringe it, and
Takeda
was wrong. Astellas’ third argument was that paragraph
39 of the Commission’s Explanatory Memorandum when it proposed the Regulation
showed that the Regulation should be interpreted as permitting the grant of an SPC for
a
combination of active ingredients even if the basic patent only covered one of those
active ingredients.

24.

I
dismissed the appeal for the following reasons. First,
I

held that claim 19 covered
the combination of emodepside with another compound with anthelmi
ntic activity
such as praziquantel, but did not disclose it. Applying the test in
Gilead
, emodepside
was the only active ingredient which was relevant to deciding whether the product fell
within the scope of the
claim
. Secondly,
I

was not persuaded that
Ta
keda

was wrong,
but agreed with Kitchin J that the matter merited consideration by the CA and perhaps
the CJ
EU
. Thirdly,
I

held that paragraph 39 of the Explanatory Memorandum did not
support the grant of SPC for A plus B where the basic patent protected A

and the
marketing authorization was for A plus B. Moreover, Astellas’ interpretation of the
Regulation depended on the infringement test being correct.

Medeva

and its progeny
: the references

25.

In
Medeva
Medeva

was the proprietor of
a patent t
he specification
of which
disclose
d

that a combination of two antigens known as pertactin and filamentous
haemagglutinin (or FHA) produce
d

a synergistic effect such that a third antigen called
pertussis toxin (or LPF)
was

not required to produce a vaccine

against Bordella
pertussis (
which causes
whooping cough). The claims covered the combination of
pertactin and FHA. Medeva obtained four marketing authori
s
ations in respect of
vaccines each of which was for immunisation against a number of diseases in addit
ion
to pertussis and contained between 8 and 11 different antigens. Each of these included
pertactin, FHA and pertussis toxin. Medeva filed f
ive

applications for SPCs in respect
of the medicinal products the subject of the authori
s
ations. The UKIPO refused

four
of the
applications on the ground that they did not comply with Article 3(a) since
the
patent

did not protect the combinations of antigens which were the subject of the
authori
s
ations

and were specified in the applications
.

It also refused a fifth ap
plication
on the ground that it did not comply with Article 3(b)

since although the application
THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



specified the combination of antigens protected by the patent the authorisation was for
a combination product which included additional antigens
.

26.

Medeva appeale
d

to the Patents Court
. In relation to Article 3(a)
,

it

argu
ed

that
vaccines
we
re a special case in relation to which the infringement test should apply

for two reasons. F
irst
,

a combination vaccine
was

a medicinal product which
comprises a group of antige
ns directed at multiple diseases. They
we
re, in effect,
operating independently and in parallel. Accordingly, the product
wa
s indeed
protected by
the patent

within the meaning of Article 3(a).

S
econd
ly,
the
implementation of the invention by Medeva in the
form of combination vaccines
directed at multiple diseases ha
d

been driven by national health policy and, unless
vaccines
we
re treated as a special case, Medeva w
ould

be deprived of any opportunity
to secure an SPC in respect of any product covered by
the
patent
.

27.

Kitchin J
dismissed

the appeal

([2010] EWHC 68 (Pat), [2010] RPC 20)
. He held that
the first argument was
flawed both in law and in fact. In

the case of the first four
applications the product

as a whole
wa
s the medicinal product within the meaning

of
Article 1(a) and the
9

active ingredients together constitute
d

the relevant product
within the meaning of Article 1(b).
It was
impermissible to argue that the product
comprise
d

only the pertactin and FHA antigens for the purposes of Article 3(a). It
wa
s

plain that

product


must have the same meaning in Article 1(b) and Article 3(a). If
the product of Article 1(b)
wa
s the whole combination of active ingredients
,

then so it
remain
ed

for the purposes of Article 3(a). Turning to the facts, the evidence
sho
wed
that
the antigens of a vaccine combination
did not

necessarily operat
e

independently.
As to the second argument, the problem caused by
Takeda

was not

peculiar to
vaccines and it applie
d

with equal force to all combination products.
There was no
justif
i
cation for

treating
vaccines
as a special case. Moreover,
there was

no basis in
the Regulation for applying different qualifying criteria to different classes of
product
s
.

Finally, he held that the UKIPO had been right to refuse the fifth application
for n
on
-
compliance with Article 3(b).

28.

M
edeva appealed to the Court of Appeal
. In relation to Article 3(a), Medeva argued
that
Takeda

was wrong, alternatively should be distinguished for the reasons it had
advanced before Kitchin J. Medeva also argued that, if
T
akeda

was right and applied,
f
or the purposes of Art
icle
3(b) the product
could
be limited to that part of a multi
-
disease vaccine
which w
as protected by the basic patent in force
.

T
he Court of Appeal
decided to refer the following questions to the CJEU

([2010] EWCA Civ 700
, [2010]
RPC 27
)
:


1.

Regulation 469/2009 (

the Regulation

) recognises amongst the other purposes
identified in the recitals, the need for the grant of an SPC by each of the
Member States of the Community to holders of national or Eu
ropean patents
to be under the same conditions, as indicated in recitals 7 and 8. In the absence
of Community harmonisation of patent law, what is meant in Article 3(a) of
the Regulation by

the product is protected by a basic patent in force


and
what are

the criteria for deciding this?


2.

In a case like the present one involving a medicinal product comprising more
than one active ingredient, are there further or different criteria for
determining whether or not

the product is protected by a basic paten
t


THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



according to Article 3(a) of the Regulation and, if so, what are those further or
different criteria?


3.

In a case like the present one involving a multi
-
disease vaccine, are there
further or different criteria for determining whether or not

the prod
uct is
protected by a basic patent


according to Article 3(a) of the Regulation and, if
so, what are those further or different criteria?


4.

For the purposes of Article 3(a), is a multi
-
disease vaccine comprising
multiple antigens

protected by a basic p
atent


if one antigen of the vaccine is

protected by the basic patent in force

?


5.

For the purposes of Article 3(a), is a multi
-
disease vaccine comprising
multiple antigens

protected by a basic patent


if all antigens directed against
one disease are
“protected by the basic patent in force”?


6.

Does the Regulation and, in particular, Article 3(b), permit the grant of a
Supplementary Protection Certificate for a single active ingredient or
combination of active ingredients where:

(a)

a basic patent i
n force protects the single active ingredient or
combination of active ingredients within the meaning of Article 3(a) of
the Regulation; and

(b)

a medicinal product containing the single active ingredient or
combination of active ingredients together with

one or more other
active ingredients is the subject of a valid authorisation granted in
accordance with Directive 2001/83/EC or 2001/82/EC which is the
first marketing authorization that places the single active ingredient or
combination of active ingredi
ents on the market?



29.

In
Georgetown

Georgetown, Rochester and Loyola were the proprietors of three
patents.
Georgetown’s patent claimed a vaccine for the prevention of HPV infection
comprising L1 protein, or a fragment thereof, of HPV type 16 or type 18 or

type 16
and type 18 together. Rochester’s patent claimed a recombinant HPV
-
like particle
comprising type 16 L1 protein and a multivalent vaccine comprising a virus
-
like
particle from different HPV viruses. Loyola’s patent claimed recombinant HPV
-
like
part
icles in which one or more sections of the L1 protein were deleted.
GSK was
licensed under all three patents and had a marketing authorisation for Cervarix
vaccine which contained a combination of HPV type 16 and type 18 L1 proteins.
Sanofi Pasteur had a
marketing authorisation for Gardasil/Silgard which contained a
combination of HPV type 6, 11, 16 and 18 LI proteins. Georgetown, Rochester and
Loyola applied for SPCs

relying on the authorisations for Cervarix or
Gardasil/Silgard
. In each application the
product was defined as a single HPV L1
protein, variously of type 6, 11, 16 or 1
8
. The UKIPO refused the applications on the
ground that they did not comply with Article 3(b). Georgetown, Rochester and Loyola
appealed to the Patents Court. Kitchin J referr
ed a question to the CJEU which was
the same as question 6 in
Medeva
.

30.

In
Yeda

Yeda
was

the proprietor of
a patent
, claim 1 of which was as follows:

THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC




A therapeutic composition comprising:

(a)


a monoclonal antibody which inhibits the growth of
human
tumour cells by said antibody binding to the
extra
-
cellular domain of the human EGF receptors of
said tumour cells in an antigen
-
antibody complex, said
tumour cells being characterised by their expression of
human EGF receptors and mitogenic stimulation by

human EGF; and

(b)


an anti
-
neoplastic agen
t

wherein the antibody is not antibody 108 produced by
hybridoma cell line ATCC HB 9764 or antibody 96 produced
by hybridoma cell line ATCC HB 9763
.


31.

Yeda obtained a marketing authorisation for cetuximab

(a

monoclonal antibody
specific for the receptor of epidermal growth factor

or EGF
)
authorising its use in
combination with
irinotecan (an ant
i
-
neoplastic agent).

Yeda applied for an SPC for
cetuximab.

The
UKIPO refused the application on the ground that it
did not comply
with Article 3(a).

Yeda appealed

to the Patents Court
, arguing that cetuximab was
protected by the basic patent because sales of cetuximab would infringe pursuant to
section 60(2) of the Patents Act 1977. Lewison J
(as he then was)
dismissed

the
appeal, holding that it was not enough that there would be infringement under section
60(2)

([2010] EWHC 1733 (Pat), [2010] RPC 29)
. Yeda appealed to the Court of
Appeal which referred the following question to the CJEU:

“If

the criteria for de
ciding

that a product is

protected by a
basic patent in force


under Article 3(a) of the Regulation
include

or consist of an assessment of
whether
the

supply of
the

product would infringe the basic patent
, does it make any
difference to the analysis if infringem
ent is
by way of indirect
or contributory infringement based on Article 26 of the
Community Patent Convention
,

enacted as

s
60(2) of the Patents
Act

1977 in the UK, and the corresponding provisions in the
laws of other Member States of the Community?”


32.

In
Daiichi
Daiichi was the proprietor of
a patent,
Claim 5 was for
:


A pharmaceutical composition for the treatment or

prophylaxis of hypertension which comprises an

anti
-
hypertensive agent in admixture with a pharmaceutically

acceptable carrier or diluent, i
n which the anti
-
hypertensive

agent is at least one compound of formula (I) or

a
pharmaceutically acceptable salt or ester thereof, as claimed

in
any one of claims 1 to 4.



33.

Daiichi had obtained a marketing authorisation for
a combination of olmesartan
med
oxomil
, an anti
-
hypertensive agent of formula I,
and

hydrochlorothiazide
, a
different type of anti
-
hypertensive agent.

Daiichi applied for an SPC for
a
combination of olmesartan medoxomil and

THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



hydrochlorothiazide
.

The
UKIPO refused the application on the gr
ound that it did not
comply with Article 3(a). Daiichi appealed

to the Patents Court
, relying upon claim 5
and
Gilead
.

Floyd J held that claim 5 only covered a combination of
olmesartan
medoxomil

with another hypertensive agent where the other agent was al
so a
compound of formula I

([2010] EWHC 2897 (Pat))
.

He

nevertheless referred the
following questions to the CJEU:

“1.

Regulation 469/2009

(the Regulation) recognises amongst the
other purposes identified in the recitals, the need for the grant
of an SPC b
y each of the Member States of the Community to
holders of national or European patents to be under the same
conditions, as indicated in recitals 7 and 8. In the absence of
Community harmonisation of patent law, what is meant in
Article 3(a) of the Regulat
ion by

the product is protected by a
basic patent in force


and what are the criteria for deciding
this?

2.

In a case like the present one involving a medicinal product
comprising more than one active ingredient, are there further or
different criteria fo
r determining whether or not

the product is
protected by a basic patent


according to Art 3(a) of the
Regulation and, if so, what are those further or different
criteria?

3.

In order for a combination of active ingredients cited in an
authorisation for placing a medicinal product on the market to
be the subject of an SPC, and having regard to the wording to
Article 4 of the Regulation, is the condition that the product be

pro
tected by a basic patent


within the meaning of Articles 1
and 3 of the Regulation satisfied if the product infringes the
basic patent under national law?

4.

In order for a combination of active ingredients cited in an
authorisation for placing a medicinal

product on the market to
be the subject of an SPC, and having regard to the wording to
Article 4 of the Regulation, does satisfaction of the condition
that the product be

protected by a basic patent


within the
meaning of Articles 1 and 3 of the Regulati
on depend upon
whether the basic patent contains one (or more) claims which
specifically mention a combination of (1) a class of compounds
which includes one of the active ingredients in the said product
and (2) a class of further active ingredients which
may be
unspecified but which includes the other active ingredient in
the said product; or is it sufficient that the basic patent contains
one (or more) claims which (1) claim a class of compounds
which includes one of the active ingredients in the said pro
duct
and (2) use specific language which as a matter of national law
extends the scope of protection to include the presence of
further other unspecified active ingredients including the other
active ingredient in the said product?


THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



34.

In
Queensland

Queenslan
d was the proprietor of
three patents,
935, 211 and 156. 211
and 156 were divisionals from 935.

935 covered vaccines made from HPV type 6 or
11 L1 protein, 211 covered vaccines made from HPV type 18 L1 protein and 156
covered vaccines made from HPV type 16

L1 protein.

Claim 1 of 935 was a method
claim.
As noted above, GSK had obtained a marketing authorisation for Cervarix and
Sanofi Pasteur for Gardasil
/Silgard
.

Queensland applied for SPCs, filing applications
both for the two combination products and for
various products

defined as single
active ingredients
.

The
UKIPO refused the combination applications on the ground
that they did not comply with Article 3(a) and the single
active ingredient applic
ations
on the ground that they did not comply with Article

3(b). Queensland appealed

to the
Patents Court
.

I
referred the following questions to the CJEU:


1.

Regulation 469/2009 (the Regulation) recognises amongst the
other purposes identified in the recitals, the need for the grant
of an SPC by each of the Mem
ber States of the Community to
holders of national or European patents to be under the same
conditions, as indicated in recitals 7 and 8. In the absence of
Community harmonisation of patent law, what is meant in
Article 3(a) of the Regulation by

the prod
uct is protected by a
basic patent in force


and what are the criteria for deciding
this?

2.

In a case like the present one involving a medicinal product
comprising more than one active ingredient, are there further or
different criteria for determining wh
ether or not

the product is
protected by a basic patent


according to Article 3(a) of the
Regulation and, if so, what are those further or different
criteria?

3.

Is one of these further or different criteria whether the active
ingredients are admixed toge
ther rather than being delivered in
separate formulations but at the same time?

4.

For the purposes of Article 3(a), is a multi
-
disease vaccine
comprising multiple antigens

protected by a basic patent


if
one antigen of the vaccine is

protected by the b
asic patent in
force

?

5.

In a case like the present one involving a medicinal product
comprising more than one active ingredient, is it relevant to the
assessment of whether or not

the product is protected by a
basic patent


according to Article 3(a) tha
t the basic patent is
one of a family of patents based on the same original patent
application and comprising a parent patent and two divisional
patents which between them protect all the active ingredients in
the medicinal product?

6.

In a case like the p
resent one involving a basic patent with
claims to

a process to obtain a product


in the sense of Article
1(c), does the

product


of Article 3(a) have to be obtained
directly by means of that process?

THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



7.

Does the SPC Regulation and, in particular,
Article 3(b),
permit the grant of a Supplementary Protection Certificate for a
single active ingredient where:

(a)

a basic patent in force protects the single active
ingredient within the meaning of Article 3(a) of the
SPC Regulation; and

(b)

a medicinal p
roduct containing the single active
ingredient together with one or more other active
ingredients is the subject of a valid authorisation
granted in accordance with Directive 2001/83/EC or
2001/82/EC which is the first marketing authorization
that places t
he single active ingredient on the market?

8.

Does the answer to Question 7 differ depending on whether the
authorisation is for the single active ingredient admixed with
the one or more other active ingredients rather than being
delivered in separate
formulations but at the same time?


Medeva

and its progeny: the judgment
s

and the reasoned orders

35.

In
Medeva

the Court of Justice considered questions 1 to 5 together, beginning as
follows:


19.

By its first five questions, which it is appropriate to examin
e
together, the Court of Appeal asks, in essence, whether Article
3(a) of Regulation No

469/2009 must be interpreted as
precluding the competent industrial property office of a
Member State from granting a SPC where the active
ingredients specified in the
application include active
ingredients not mentioned in the wording of the claims of the
basic patent relied on in support of such an application.

20
.


While the Latvian, Lithuanian and Portuguese Governments
submit that only the wording of the claim
s is relevant for the
purpose of determining whether a product is protected by a
basic patent in force within the meaning of Article 3(a) of
Regulation No

469/2009, Medeva and the United Kingdom
Government maintain that the concept of a ‘product …
protecte
d by a basic patent in force’ within the meaning of that
provision corresponds to any combination of substances of a
medicinal product directly infringing the patent.


36.

The Court then rep
ea
ted what it had said in
Farmitalia

at [26]
-
[27] and continued:

“24.

It should be noted that Regulation No

469/2009 establishes a
uniform solution at European Union level by creating a SPC
which may be obtained by the holder of a national or European
patent under the same conditions in each Member State. It thus
aims to pre
vent the heterogeneous development of national
THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



laws leading to further disparities which would be likely to
create obstacles to the free movement of medicinal products
within the European Union and thus directly affect the
establishment and functioning of
the internal market (see Case
C
-
350/92
Spain
v
Council
[1995] ECR I
-
1985, paragraphs 34
and 35; Case C
-
127/00
Hässle
[2003] ECR I
-
14781, paragraph
37; and Case C
-
482/07
AHP Manufacturing
[2009] ECR
I
-
7295, paragraph 35).

25
.


Moreover, it should be r
ecalled that Article 5 of Regulation
No

469/2009 provides that any SPC confers the same rights as
conferred by the basic patent and is subject to the same
limitations and the same obligations. It follows that Article 3(a)
of the regulation precludes the gr
ant of a SPC relating to active
ingredients which are not specified in the wording of the
claims of the basic patent.

26
.


Similarly, if a patent claims that a product is composed of two
active ingredients but does not make any claim in relation to
one of those active ingredients individually, a SPC cannot be
granted on the basis of such a patent for the one active
ingredient
considered in isolation.

27
.


That approach is also borne out by the second subparagraph of
paragraph 20 of the explanatory memorandum to the proposal
for Council Regulation (EEC) of 11 April 1990 concerning the
creation of a supplementary protection

certificate for medicinal
products (COM(90) 101 final) (‘the explanatory
memorandum’), which, in so far as concerns what is ‘protected
by the basic patent’, refers expressly and solely to the wording
of the claims of the basic patent. That interpretation
also
accords with that given in recital 14 in the preamble to
Regulation (EC) No

1610/96 of the European Parliament and
of the Council of 23 July 1996 concerning the creation of a
supplementary protection certificate for plant protection
products (OJ 1996
L 198, p. 30), which refers to the need for
‘products’ to be ‘the subject of patents specifically covering
them’.

28
.


The answer to the first five questions is, therefore, that Article
3(a) of Regulation No 469/2009 must be interpreted as
precluding

the competent industrial property office of a
Member State from granting a SPC relating to active
ingredients which are not specified in the wording of the
claims of the basic patent relied on in support of the SPC
application.


37.

I am bound to say that I f
ind this reasoning difficult to follow.

The Court begins by
repeating its statement in
Farmitalia

that
“the extent of patent protection can be
determined only in the light of the non
-
European Union rules governing patents”.
THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



Neither in
Farmitalia

nor in
Med
eva
, however,
does the Court
clearly
identify the
rules to which it is referring.

38.

In countries such as the United Kingdom
, there are two sets of

rules
which might be
relevant
.
The first consists of

national laws which implement Article 69 of the
European P
atent Convention, which provides that:

“The extent of the protection conferred by a European patent …
shall be determined by the claims. Nonetheless, the description
and drawings shall be used to interpret the claims.”

Article 69 is
supplemented by the Pro
tocol on the Interpretation of Article 69. Both
are quoted by the Court in
Medeva
at [9] and [10]. They are
given effect to in the UK
by section 125(1)

and (3)

of the Patents Act 1977,
which the Court q
uoted

in
Medeva

at [12]. The second
set of rules
consi
sts of
national laws
that
we
re
intended
to
implement Articles 25 and 26 of the Community Patent Convention (
as revised in
1989), which never came into force.

In the UK, these are sections 60(1) and (2) of the
1977 Act, the first of which the Court quoted i
n part
in
Medeva

at [11].

Since the
Court refers to “the extent of patent protection”, it appears that at this stage of its
analysis it is referring to the first set of rules.

39.

The Court go
es

on to say at [24] that the Regulation establishes a uniform solution at
EU level, but does not explain how this
is
to be achieved if the extent of protection is
determined by non
-
EU rules.

In this regard, it should be borne in mind that all EU
Member Stat
es are party to the EPC, but not all EU Member States have implemented
the CPC.

40.

Next the Court notes in the first sentence of [25] that
(subject to Article 4)
Article 5 of
the Regulation
provides that an SPC “confers the same rights as conferred by the
bas
ic patent”. On its face, this means that an SPC is infringed by the same kinds of
acts as would infringe the basic patent. In other words, the Court is now referring to
the second set of rules mentioned above.

41.

The Court then says that “It follows that Arti
cle 3(a) … precludes the grant of a SPC
relating to active ingredients which are not specified in the wording of
the claims of
the basic patent”.

Leaving aside for now the question of what “specified in the
wording of the claims” actually means, how does t
his follow?
I cannot see that it
does.

42.

As
a
separate point, it will be noted that
the
Court did not actually answer question 1.
I have to say that, as the national judge who made one of the references before the
Court, I am disappointed by this. One of the

reasons for the multiplicity of references
was the need of the national courts for clear guidance as to the criteria to be applied in
deciding whether a product is “protected by a basic patent” within the meaning of
Article 3(a). As I shall discuss below,

not only has the Court not answered the
question referred, but also the guidance it has provided is not sufficiently clear

to
enable future disputes to be resolved
.



43.

As for question 6, t
he Court answered
this

as follows

at [42]
:

THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



“In view of the f
oregoing, the answer to Question 6 is that
Article 3(b) of Regulation No

469/2009 must be interpreted as
meaning that, provided the other requirements laid down in
Article 3 are also met, that provision does not preclude the
competent industrial property o
ffice of a Member State from
granting a SPC for a combination of two active ingredients,
corresponding to that specified in the wording of the claims of
the basic patent relied on, where the medicinal product for
which the MA is submitted in support of the

SPC application
contains not only that combination of the two active ingredients
but also other active ingredients.”

44.

In
Georgetown

the Court repeated this answer

supported by the same reasoning
.

45.

In
Yeda

the Court of Justice began by saying at [30]
-
[32] th
at the question referred in
this case was, for all essential purposes, similar to those referred in
Medeva
, and
accordingly could b
e

dealt with by way of reasoned order. It then stated

at [33]
:

“By its question, the Court of Appeal asks, in essence,
whether
Article 3(a) of Regulation No

469/2009 must be interpreted as
precluding the competent industrial property office of a
Member State from granting a SPC where the active ingredient
specified in the application, even though identified in the
wording
of the claims of the basic patent as an active ingredient
forming part of a combination in conjunction with another
active ingredient, is not the subject of any claim relating to that
active ingredient alone.”

46.

The Court went on
at

[
34]
-
[38] to repeat its r
easoning in
Medeva

at [22]
-
[26]. It
concluded at [39]:



In view of the foregoing considerations, the answer to the
question referred is that Article 3(a) of Regulation No 469/2009
must be interpreted as precluding the competent industrial
property office
of a Member State from granting a SPC where
the active ingredient specified in the application, even though
identified in the wording of the claims of the basic patent as an
active ingredient forming part of a combination in conjunction
with another active

ingredient, is not the subject of any claim
relating to that active ingredient alone.


47.

In
Daichii
the Court of Justice again began by saying at [21]
-
[24] that the question
s

referred in this case w
ere
, for all essential purposes, similar to those referred
in
Medeva
, and accordingly could b
e

dealt with by way of reasoned order. It then
repeated both its reasoning in
Medeva

and its ruling
,

except that its answer used the
word “identified” rather than the word “specified”
.

48.

In
Que
e
nsland

the Court of Justice be
gan by saying at [23]
-
[24] that the question
s

referred in this case w
ere
, for all essential purposes, similar to those referred in
Medeva

and
Geo
r
getown
, and accordingly could b
e

dealt with by way of reasoned
order. It then repeated both its reasoning in
M
edeva

and its answer
s

to questions 1
-
5

THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



and 6 in answer to questions 1
-
5 and 7
-
8
, except that its answer to questions 1
-
5 used
the word “identified” rather than the word “specified”
.

In relation to question 6, the
Court said:


37.

By Question 6, the referring court asks whether, in a case
involving a basic patent relating to a process by which a
product is obtained, it is necessary for the purpose of granting a
SPC, in the light in particular of Article 1(c) of Regulation
No

469/200
9, for it to be possible for the ‘product’ to be
obtained directly by means of that process.

38
.


It is sufficient to point out that a patent protecting the process
by which a ‘product’ within the meaning of Regulation
No

469/2009 is obtained may, in

accordance with Article 2 of
the regulation, enable a SPC to be granted and, in that case, in
accordance with Article 5 of the regulation, the SPC confers
the same rights as conferred by the basic patent as regards the
process by which the product is obta
ined (see
Medeva
,
paragraph 32).

39
.


If the law applicable to such a patent so provides, a SPC
granted on the basis of that patent will also extend the
protection of the process by which the product is obtained to
the product thus obtained (see, to
that effect,
Medeva
,
paragraph 32).

40
.


However, just as Article 3(a) of Regulation No

469/2009
precludes the grant of a SPC relating to active ingredients
which are not specified in the wording of the claims of the
basic patent
(Medeva
, paragraph 25
), where the basic patent
relied on in support of a SPC application relates to the process
by which a product is obtained, that provision also precludes a
SPC being granted for a product other than that identified in
the wording of the claims of that paten
t as the product deriving
from that process. The grant of a SPC is not conditional on
whether it is possible to obtain a product directly as a result of
the process by which the product is obtained, where that
process has been the subject of a patent.

41
.


The answer to Question 6 is therefore that, in the case of a
basic patent relating to a process by which a product is
obtained, Article 3(a) of Regulation No

469/2009 precludes a
SPC being granted for a product other than that identified in
the word
ing of the claims of that patent as the product deriving
from the process in question. Whether it is possible to obtain
the product directly as a result of that process is irrelevant in
that regard.


49.

Again I find this reasoning hard to follow. At [38] the
Court again refers to Article 5
.
It then says in [39] that, “if the applicable law so provides” an SPC “will also extend
the protection of the process by which the product is obtained to the product thus
THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



obtained”. Under the applicable law, namely section
60(1)(c) implementing Article
25(c), however, this is only the case if the product is obtained directly by means of the
process. Yet the Court goes on to say that this is “irrelevant”.

The first issue

50.

Novartis
contends

that

ranibizumab is not protected b
y the Patent within the meaning
of Article 3(a) of the Regulation since it is not specified in the wording of the claims
of the Patent
, nor is it identified in the wording of the claims of the Patent as the
product deriving from the claimed process
.

In sup
port of this contention counsel for
Novartis argued in summary as follows:

i)

As a result of the judgments in
Medeva

and
Georgetown
, it is no
w

settled law
that
, in order for an SPC to be granted in respect of a product, it is not
sufficient that the product i
nfringes the basic patent. Instead, the product must
be

“specified in the wording of the claims of the patent” or “identified in the
wording of the claims of the Patent as the product deriving from the process

in
question
”.

ii)

Even if there is some uncertaint
y as to what is meant by “specified (or
identified) in the wording of the claims”, it is clear that ranibizumab is not
“specified (or identified) in the wording of the claims” on any view.

Claim 1
of the Patent does not identify any particular product, sti
ll less ranibizumab
,
which was not developed until several years after the Patent was applied for
.
Indeed,
t
he Patent does not even mention macular degeneration or
the
treatment of
it
by
an
anti
-
VEGF antibod
y
.
Rather, it claims a general
technique

for use in pharmaceutical research
.

In support of this counsel relied
in
particular
upon what I had said in the first judgment at [491]:


In my judgment MedImmune is correct to characterise
the invention disclosed in the Patents as a principle of
general
application. At its core, it is a technique for
selecting a binding molecule of interest from amongst a
potentially large population of other binding molecules.
The technique does not depend on the precise identity
of the binding molecule. On the contrary,

part of the
usefulness of technique is that it can be applied to a
diverse range of binding molecules, fragments and
derivatives. Nor does the technique depend on the
precise application which the user has in mind.…


Counsel also pointed out that I had
fo
und

in the first judgment at [488] that
the screening carried out in the development of ranibizumab could readily
have been
achieved by the prior art technique of plaque lift.

51.

MedImmune contends that ranibizumab is protected by the Patent, but
accepts that

in
the present state of the law it is not clear that this is the case. Counsel for MedImmune
argued in summary as follows:

i)

Although the Court of Justice ha
s

clearly rejected the infringement
test
in the
context of issues as to whether an SPC for a combina
tion
of active ingredients

THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



A + B could be based on a patent with a claim to just A and whether an SPC
for
active ingredient

A could be based on a patent with a claim to the
combination A + B, it ha
s

not, or at least not clearly,
stated

the test to be
appli
ed to determine whether a
n

SPC for product can be based on a patent
claim where neither the product nor the claim involve a combination of active
ingredients.

In support of this, counsel relied upon comments from a
considerable number of commentators to th
e effect that the test stated by the
Court of Justice is unclear.

ii)

Where
neither the product nor the claim involve a combination of active
ingredients, it
remain
s at least a
rgu
abl
e that the correct

test is
to ask
whether
the product falls within the s
cope o
f
the
claim

interpreted in accordance with
national laws implementing Article 69 EPC and the Protocol on Interpretation.

In support of this counsel relied in particular upon the Court of Justice’s order
in
Yeda

at [33] and [39].

52.

I agree with c
ounsel for Me
dImmune that
Medeva

and its progeny were all concerned
with situations where either the patent claimed, or the product the subject of the
application for an SPC consisted of, a combination of active ingredients, and therefore
the present case is distinguishable

since it is c
oncerned with a single active ingredient
and a claimed method
by means of which it is alleged to have been

produc
ed
.

53.

In my view,
counsel for MedImmune is
also
correct

to say
that the test laid down by
the C
ourt of
J
ustice

in
Medeva

and its progeny is uncle
ar

save in its rejection of the
infringement test in combination cases
.

In particular, it is unclear precisely what is
meant by “specified (or identified) in the wording of the claims”. Does this mean that
it is sufficient for the product to fall within th
e
scope of the
claim on its true
construction, or is
something more required and if so what?
For example,
is

it

sufficient, say, for the claim to incorporate a Markush formula which covers a large
number of compounds one of which is the product in respect
of which an SPC is

sought
?

Is it sufficient for the product to be defined in functional terms?
Even in
combination cases,
it is not clear to me how

the test enunciated by the Court

should be
applied in a case like
Gilead
.
Regrettably,
therefore,
it is

inev
itable that there will
have to be further references to the CJEU to obtain clarification of the test.

54.

In my judgment, however,
ranibizumab is
not
“identified in the wording of” claim 1
of the Patent “as the product deriving from the process

in question


as

required by the
ruling in
Queensland
.

My reasons are as follows.

55.

First, it seems
clear
that the Court of Justice was intending in these cases to lay down
a
broad general rule. Thus the Court evidently did not consider it necessary to descend
into the deta
il of a number of the questions which had been referred.

56.

Secondly, the Court’s rulings do not merely require the product
to be
specified in the
claims

(
compare section 125(1) of the 1977 Act), but specified

or identified

in the
wording

of the claims.
It
appears to me that t
his points to a test which
is
more
demanding than merely requiring that the
product be within the scope of the claim
,
although it is not clear how much more demanding
.

57.

Thirdly, even if
Medeva

can be interpreted as leaving open the possibility that it is
sufficient for the product to be within the scope of the claim where the claim is a
THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



product claim, it seems to me that
Queensland

lays down a narrower rule in the case
of process claims.

The Co
urt of Justice require
s

the product to be
identified

in
the
wording

of the claim as
the product

deriving from the process in question.
Furthermore, it sa
ys
that it
i
s irrelevant whether or not it was possible to obtain the
product directly by means of that

product, which points away from an infringement
-
type test. In the present case, claim 1 merely identifies the product of the method as “a
molecule with binding specificity for a particular target”. This covers millions of
different molecules of various ki
nds. It is not even limited to antibodies. Although
ranibizumab falls within this extremely broad class of products, there is nothing

at all

in the wording of the claim, or even the lengthy specification of the Patent, to identify
ranibizumab as the produc
t of the process in question.

58.

Fourthly, I am not persuaded to the contrary

by
Yeda
.
Although it is fair to say that
the Court of Justice appears to have proceeded on the basis that cetuximab was
“identified in the wording of” integer (a) of claim 1 of the

patent in question, despite
not being
specifically referred to,

the degree of specificity required was simply not in
issue in that case. The question referred to the Court was solely about the effect of
section 60(2)
, and the Court’s answer was
only direc
ted to

reject
ing

the infringement
test
. In any event, claim 1
of the patent in question
was a product claim, not a process
claim, and
although
integer (a) de
fined

the agent in question
in functional terms
,

it did
so
considerably more specifically than inte
ger [1] of claim 1 of the Patent.

59.

Fifthly, I consider that this conclusion is in accordance with the policy underlying the
Regulation. The Patent is not in any sense a patent for ranibizumab.
I do not see that
an extension of the term of the Patent is just
ified by t
he
long period of time
which
was
required
first
to
develop
,

and then
to
obtain a marketing authorisation for
,

ranibizumab. Indeed, there is no reason to think that the Patentees were delayed in
reaping rewards from the Patent at all, since the pa
tented technique was of immediate
utility
in their own research
. It
was

also

licensed to
a
third part
y

for substantial
royalties

in 1993 (see
Cambridge Antibody Technology Ltd v Abbott Biotechnology Ltd

[2004] EWHC 2974 (Pat), [2005] FSR 27)
.










The second issue

60.

Although presented by Novartis as a separate argument, it seems to me that upon
analysis

the second issue is
the same as

the

first. A basic patent is defined
by Article
1(c) of the Regulation
as meaning
inter alia

“a patent which prot
ects … a process to
obtain a product”. This depends on whether the

patent protects the product obtained
by the process within Article 3(a).
I do not see that this gives rise to a different issue
.


A point not taken

61.

As noted above, in the present case the

SPC
is
based upon
a product obtained by
means of an allegedly infringing process and upon a marketing authorisation obtained
by an alleged infringer

of the Patent
.

It might be thought that it was not the purpose of
the Regulation to enable a patent owner
to obtain an SPC in such circumstances, since
the owner has not been delayed in getting
the

product to market by the need to get a
marketing authorisation, and therefore no extension to the term of the patent is needed
to compensate him for that delay. Counsel for MedImmune accepted that it was not
clear from the judgment of the C
ourt of Justice

in
Case C
-
181/95
Biogen Inc v
THE HON MR JUSTICE ARNOLD

Approved Judgment

Novartis v MedImmune SPC



SmithKline Biologicals SA

[1997] ECR I
-
386 that this was permissible. Nevertheless
,

counsel for Novartis made it clear that Novartis was not taking this point.



A reference

to the Court of Justice
?

62.

Counsel for Me
d
Immune sub
mitted that I should refer one or more question
s

to the
CJ
EU
to seek clarification of the law. Counsel for Novartis
resisted this. As I have
said, I consider it inevitable that there will have to be further references to the Court

of Justice
. It does not f
ollow, however, that the present case is an appropriate case in
which to refer questions, still less that I should
make a
refer
ence now

rather than
leaving the decision to the Court
of Appeal. Counsel for MedImmune submitted that it
was preferable for me t
o refer

questions
, since it would mean that they were answered
more quickly. As counsel for Novartis pointed out, however, if the Court of Appeal
uphold either of my conclusions in the first judgment that the Patent is invalid and
has
not
been
infringed, t
he issue considered in this judgment will be academic.

Counsel
for MedImmune replied that in that event the reference could be withdrawn.

63.

I
n my judgment I have to proceed on the basis of the current position. As matters
stand,
it is not necessary for me to

seek the guidance of the Court of Justice

since I
have held that the Patent is invalid and
has
not
been
infringed
.

Even if it is assumed
that the resolution of the issue of law discussed in this judgment is not
acte clair
, it
will only become necessary to

make a reference if both of those conclusions are
overturned by the Court of Appeal. In that event the Court of Appeal will be able to
consider
whether or not to make a reference. In my view it would not be right to
impose the burden of a reference on the

parties, the Court of Justice and the Member
States at this stage when the issue may well turn out to be academic. I am comforted
in this conclusion by the information provided to me by counsel for
MedImmune

that
the Bundespatentgericht in Germany will be

considering the validity of the German
counterpart to the SPC
at
a
hearing scheduled for

May 2012, and will be in a position
to make a reference
then
if it considers it appropriate to do so.


Conclusion

64.

For the reasons given above I conclude that the
SPC is invalid.