Daiichi Sankyo Co Ltd v Comptroller General of Patents [2010] EWHC 2897

Neutral Citation Number: [2010] EWHC 2897 (Pat)
Case No: CH 2010 APP 107
IN THE HIGH COURT OF JUSTICE, CHANCERY DIVISION
PATENTS COURT

Date: 05/11/2010
Before:
MR. JUSTICE FLOYD
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Between:
 DAIICHI SANKYO COMPANY LIMITED Appellant
 - and -
 COMPTROLLER GENERAL OF PATENTS Respondent
 - - - - - - - - - - - - - - - - - - - - -
 - - - - - - - - - - - - - - - - - - - - -
MR. MICHAEL TAPPIN QC (instructed by Marks & Clerk ) appeared for the Appellant.
MR. THOMAS MITCHESON (instructed by The Treasury Solicitor) appeared
for the Comptroller General of Patents
MISS CHARLOTTE MAY (instructed by Messrs. Bristows) appeared
for Novartis AG.


Approved Judgment


1. This is an appeal from a decision of the 5th February 2010 of Dr. Lawrence Cullen,
a Deputy Director acting for the Comptroller, refusing the grant of a supplementary
protection certificate ("SPC") to the appellant, Daiichi Sankyo Company Limited,
("Daiichi") in relation to a combination of olmesartan medoxomil and
hydrochlorothiazide.  I shall call these ingredients OM and HTC respectively.
2. OM is one of a range of compounds disclosed in Daiichi's European patent UK 0 503
785, which I shall refer to as the basic patent.  It is one of the compounds specifically
named in claim 4.  HTC is a diuretic which is used as an anti-hypertensive agent
which is not one of the claimed agents.  The application for the SPC was refused by
the UKIPO on the basis that it did not comply with Article 3(a) of Council Regulation
EC 469/2009, which is the codified version of the original SPC regulation, Council
Regulation EEC 1768/92.  I shall call codified version "the Regulation".
3. The UKIPO relied on the decision of Jacob J (as he then was) in Takeda Chemical
Industries Limited SPC Applications (No. 3) [2003] EWHC 649 (Pat).
4. The relevant provisions of the regulation are Articles 1, 3 and 4:
"Article 1.
"Definitions.
"For the purposes of this Regulation, the following definitions
shall apply:
"(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
such, a proc ess 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;
"(d) 'certificate' means the supplementary protection certificate;
"(e) 'application for an extension of the duration' means an
application for an extension of the duration of the certificate
pursuant to Article 13(3) of this Regulation and Article 36 of
Regulation (EC) No 1901/2006 of the European Parliament and
of the Council of 12 December 2006 on medicinal products for
paediatric use."
"Article 3.
"Conditions for obtaining a certificate.
"A certificate shall be granted if, kin 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 authorisation to place the product on the market as
a medicinal product has been granted in accordance with
Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;
"(c) the product has not already been the subject of a certificate;
"(d) the authorisation referred to in point (b) is the first
authorisation 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 covered by the authorisation to place the
corresponding medicinal product on the market and for any use
of the product as a medicinal product that has been authorised
before the expiry of the certificate."
5. The critical provision is that in Article 3(a), that the product is "protected by a basic
patent in force".  There is, to say the least, a lack of uniformity amongst the courts of
the European Union Member States as to the test which is to be applied to determine
whether a product is protected by a basic patent.  The test is currently the subject of
a reference from the Court of Appeal in England to the Court of Justice in Medeva
BV's SPC application [2010] EWHC 68 (Pat).
6. It is common ground that the outcome of that reference may have an impact on this
appeal.  For present purposes, I must first follow the English decisions unless I were
to be convinced, which I am not, that they are clearly wrong.  
7. I turn therefore to consider those decisions.  Three decisions at first instance have
considered the test to apply to determine whether a product is protected by a basic
patent in force under Article 3(a) of the regulation.  
8. The first is Takeda.  The SPC was sought for a combination of the drug lansoprazole
with an antibiotic.  None of the nominated patents contained any disclosure or claims
relating to a combination of that drug with any other active ingredient.  The rival
arguments were (a) that the combination would if sold infringe the patent, and so it
was for that reason "protected" and (b) that as the combination would only infringe
because of the presence of lansoprazole, the combination with an antibiotic was not
protected.  
9. Jacob J said at paragraph 12:  
"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 for 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
simply because one component infringes is irrelevant."
10. The second case is a decision of Kitchin J in Gilead Sciences Inc's SPC Application
[2008] EWHC 1902 (Pat).  The drug in question was tenofovir.  Claim 27 was to
a pharmaceutical formulation comprising a compound according to any one of claims
1 to 25 together with a pharmaceutically acceptable carrier and optionally other
therapeutic ingredients.  The SPC was sought for a combination of tenofovir and
another drug, emtricitabine.  
11. Kitchin J characterised the  Takeda test as "to identify the active ingredients of the
product which are relevant to a consideration of whether the product falls within the
scope of a claim of the basic patent".  
12. At paragraph 34, Kitchin J applied the test in Takeda in this way:
"Application of the test in the context of this appeal produces a
ready 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 a result of the presence of both
tenofovir and emtricitabine."
13. The third case is Astellas Pharma Inc's SPC Application, a decision of Arnold J.  The
basic patent disclosed and claimed the drug emodepside but not a combination of
emodepside with other active ingredients.  Claim 19 was to an anthelmintic agent
which comprised a compound or a pharmaceutically acceptable salt thereof of any of
claims 1 to 11 and 14 as an active ingredient.  
14. Arnold J accepted that this claim covered products which included active ingredients
other than those of claims 1 to 11 and 14, but not that it disclosed such combination.
He held that it was only emodepside which was relevant to a determination of whether
the product fell within claim 19.  
15. With those cases in mind, I turn to the circumstances of the present case.  For this
purpose, it is sufficient to set out paragraph 8 of the specification and claim 5.  
16. Paragraph 8 reads:
"The invention also provides a pharmaceutical composition for
the treatment or prophylaxis of hypertension, which comprises
an effective amount of an anti-hypertensive agent in admixture
with a pharmaceutically acceptable carrier or diluent, in which
the anti-hypertensive agent is at least one compound of formula
(1) or a pharmaceutically acceptable salt or ester thereof."
Claim 5 is to:  
"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, in 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."  
17. It is not in dispute that AM is one of the compounds identified in the claim and is the
sixth compound, the general formula of which is set out in claim 4.
18. Mr. Tappin QC submits for the appellants that claim 5 requires the presence of an
anti-hypertensive agent and further that the anti-hypertensive agent can be
a combination of more than one compound.  Further, at least one of the compounds
making up the anti-hypertensive agent must be a compound of formula I.
Accordingly, he submits, just as in Gilead, that the claim is in part to a combination of
active ingredients.  He says that in so far as the claim is directed to a combination, it
falls within the claim as a result of the presence of both OM and HTC.  The appeal on
this basis therefore resolves itself into a simple question of construction of the claim.
19. I think the flaw in Mr. Tappin's argument is that, properly understood, claim 5 is not
in part to a combination of OM with any other active ingredient as in Gilead.  It is in
part to a combination of anti-hypertensive agents all falling within the class of
formula I.  There is no disclosure in the specification of any combination of the
anti-hypertensive agents claimed with other agents.  I am equally unable to read any
part of claim 5 as requiring the presence  of an anti-hypertensive agent not falling
within formula I.  
20. It follows, in my judgment, that the presence of HTC is not relevant to a consideration
of whether the product falls within the basic patent.  It follows that if I am applying
the law as set out in the cases which I have cited, I would have been disposed to
dismiss this appeal.  
21. However, as I have already indicated, the law on this topic is by no means acte claire.
In Gilead, Kitchin J said this, having reviewed arguments both for and against the
infringement test and the test set out in Takeda:  
"These are difficult questions and they raise a serious issue as
to whether the decision in  Takeda is correct.  I believe they
merit further consideration by a higher court and perhaps even
the Court of Justice.  In that latter regard, it is my
understanding the Court of Justice has not yet considered how
the requirements of the Regulation are to be interpreted in the
case of a medicinal product consisting of a combination of
active ingredients where only one is claimed in the basic patent.
It may require a development of the reasoning in Farmitialia.
But in this case and in the light of my conclusion on the second
submission advanced by Gilead, it is not necessary for me to
express a final conclusion and, in the circumstances, I prefer
not to do so."
22. As I have said, the law is currently the subject of the reference in Medeva.  In that
reference, a number of questions have been put to the CJEU including the following
questions on Art. 3(a):
"1.  Regulation 469/2009 (the Regulation) recognises 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 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
Art.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 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 patent' according to Art.3(a) of the
Regulation and, if so, what are those further or different
criteria?
"3.  In a case like the present case involving a multi-disease
vaccine, are there further or different criteria for 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?
"4.  For the purposes of Art.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 basic patent in force'?
"5.  For the purposes of Art.3(a) is a multi-disease vaccine
comprising multiple antigens 'protect ed by a basic patent' if all
antigens directed against one disease are 'protected by the basic
patent in force'?
23. In the present case, the appellants seek  an order referring the following questions.
The first two questions are the same as the questions referred in Medeva, but the third
and fourth questions are these:  
"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 of
Article 4 of the regulation, is the condition that the product be
protected 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 of
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 regulation depend on
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 product
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."
24. Question 3 is designed to characterise the infringement test.  Question 4 is designed to
pick up the distinction between the decisions in Gilead and Astellas and to help to
resolve that dilemma.  
25. If a simple infringement test is to be applied under Article 3(a), then it is tolerably
clear to me that the problems represented by Gilead and Astellas will go away.  But if
it is some other test, then it seems to me that one will have to place under the spotlight
the precise alternative test which is to be applied.
26. The dispute between the appellants and the Comptroller on this aspect of the case is
not that a reference would not help to resolve the issues on this appeal but that the
existence of the Medeva reference makes it unnecessary to refer the questions again.
The appellants contend that a further reference is desirable for a number of reasons.
The Comptroller, whilst content that the fate of the appeal should await the outcome
of the Medeva reference, submits that the appeal should simply be stayed without any
further reference being made.
27. I have come to the conclusion that it is desirable to refer the questions posed by
Daiichi to the CJEU.  First, there is no doubt that the questions referred are necessary
in order for me to reach a result in the present appeal.  They concern the precise test
which it is necessary to apply in order to decide whether to grant an SPC to Daiichi
for their combination product.  As I have said, those questions are far from clear.  
28. However, I am not persuaded that justice  can be fully done to the appellants by
merely staying the appeal until the outcome of the Medeva reference is known.  First,
the  Medeva case was concerned with multi-disease vaccines and the subsidiary
questions which are asked in that case are directed to treating vaccines as a special
case.  
29. Mr. Tappin realistically accepts that logically the CJEU should consider the first two
questions before coming on to those vaccine-specific questions thereafter.
Nevertheless, he says that there is a real danger that the questions may come back
answered wholly or partly in terms which relate to multi-disease vaccines.  I agree.
30. Secondly, the additional questions proposed to be asked by the appellants here, while
not necessary if the CJEU were to give comprehensive answers to the first two
questions, may, by being more specific, ultimately provide a more convenient vehicle
for the CJEU to provide the guidance which national courts require.  
31. Thirdly, the claim in Medeva is a process claim.  Although that should not make any
difference in principle, the fact that the protection available under the patent and
hence under the SPC is more limited may be a concrete reason why Medeva might
wish to focus their arguments more on the exception rather than the rule.  
32. Fourthly, there was always a possibility that, for commercial reasons, Medeva may
withdraw its reference.  Whilst I accept that this is not a case where the Comptroller
and Medeva are likely to reach a commercial settlement, it remains a factor to take
into account.  Of course, if this case is not joined with Medeva and the decision in
Medeva does turn out to resolve the matters in dispute in this case, then Daiichi could
and should withdraw its reference.
33. I am, of course, aware of the obligation of the national court not to overburden the
CJEU with references.  However, as I cannot be wholly confident that the Medeva
reference will necessarily produce an answer to the present appeal, I think it is right to
allow a reference in the present case.
34. There was some debate about whether it is now too late for this reference to catch up
with Medeva so as to enable it to be dealt with on a consolidated basis.  A further
case,  Yeda, has been referred with a recommendation that it should be heard with
Medeva as recently as one month ago.  Ultimately, whether this case is consolidated
with Medeva and/or Yeda is a matter for the CJEU to decide.
35. Other questions were debated in argument before me, including whether this is a case
of so-called evergreening rather more than or less than Medeva.  It does not seem to
me that those questions ultimately assist with the question of whether I should make
a reference.  I would propose in due course to make an order for reference in the terms
sought.