Astellas Pharma Inc. v Comptroller General of Patents

JurisdictionEngland & Wales
CourtChancery Division (Patents Court)
JudgeTHE HON MR JUSTICE ARNOLD,MR JUSTICE ARNOLD
Judgment Date31 Jul 2009
Neutral Citation[2009] EWHC 1916 (Pat)
Docket NumberCase No: CH/2009/APP/0160

[2009] EWHC 1916 (Pat)

IN THE HIGH COURT OF JUSTICE

CHANCERY DIVISION

PATENTS COURT

Royal Courts of Justice

Strand, London, WC2A 2LL

Before:

The Hon Mr Justice Arnold

Case No: CH/2009/APP/0160

Between
Astellas Pharma Inc
Appellant
and
Comptroller-general of Patents
Respondent

Phillip Johnson (instructed by Stevens Hewlett & Perkins) for the Appellant

Charlotte May (instructed by the Treasury Solicitor) for the Respondent

Dr Gordon Wright of Elkington & Fife LLP submitted written third party observations

Hearing date: 21 July 2009

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 MR JUSTICE ARNOLD MR JUSTICE ARNOLD

MR JUSTICE ARNOLD:

Introduction

1

This is an appeal by Astellas Pharma Inc (“Astellas”) from a decision of Dr Lawrence Cullen on behalf of the Comptroller-General of Patents dated 20 February 2009 ( BL O/052/09). By his decision the hearing officer refused Astellas' application for the grant of a Supplementary Protection Certificate (“SPC”) in respect of its European Patent (UK) No. 0634408B1 entitled “Depsipeptide Derivative, Production Thereof and Use Thereof” (“the Basic Patent”) pursuant to Council Regulation 1768/92/EEC of 18 June 1992 concerning the creation of a supplementary protection certificate (“the Regulation”). The Regulation has subsequently been repealed and replaced by a codified version, Council and European Parliament Regulation 469/2009/EC of 6 May 2009, the relevant provisions of which are identical to those in the Regulation (although the codified version includes an additional recital before those quoted below).

The Regulation

2

The first nine recitals of the Regulation state (with numbering added for ease of identification):

“[1] Whereas pharmaceutical research plays a decisive role in the continuing improvement in public health;

[2] Whereas medicinal products, especially those that are the result of long, costly research will not continue to be developed in the Community and in Europe unless they are covered by favourable rules that provide for sufficient protection to encourage such research;

[3] Whereas at the moment the period that elapses between the filing of an application for a patent for a new medicinal product and authorization 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;

[4] Whereas this situation leads to a lack of protection which penalizes pharmaceutical research;

[5] Whereas the current situation is creating the risk of research centres situated in the Member States relocating to countries that already offer greater protection;

[6] Whereas a uniform solution at Community level should be provided for, thereby preventing the heterogeneous 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;

[7] Whereas, therefore, 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 authorization has been granted is necessary; whereas a Regulation is therefore the most appropriate legal instrument;

[8] Whereas the duration of the protection granted by the certificate should be such as to provide adequate effective protection; whereas, for this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of fifteen years of exclusivity from the time the medicinal product in question first obtains authorization to be placed on the market in the Community;

[9] Whereas all the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector must nevertheless be taken into account, whereas, for this purpose, the certificate cannot be granted for a period exceeding five years; whereas the protection granted should furthermore be strictly confined to the product which obtained authorization to be placed on the market as a medicinal product.”

3

Articles 1 to 4 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 defined 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;

(d) 'certificate' means the supplementary protection certificate.

Article 2

Scope

Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorization procedure as laid down in Council Directive 65/65/EEC or Directive 81/851/EEC may, under the terms and conditions provided for in this Regulation, be the subject of a certificate.

Article 3

Conditions for obtaining a certificate

A certificate shall 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 authorization to place the product on the market as a medicinal product has been granted in accordance with Directive 65/65/EEC or Directive 81/851/EEC, as appropriate. For the purpose of Article 19(1), an authorization to place the product on the market granted in accordance with the national legislation of Austria, Finland or Sweden is treated as an authorization granted in accordance with Directive 65/65/EEC or Directive 81/851/EEC, as appropriate;

(c) the product has not already been the subject of a certificate;

(d) the authorization referred to in (b) is the first authorization 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 authorization to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorized before the expiry of the certificate.”

The Application

4

On 13 January 2006 Astellas filed application SPC/GB/06/002 for an SPC in respect of the Basic Patent (“the Application”). The Application identified the product which Astellas wanted to protect as “emodepside/praziquantel (Profender)”. The Application identified Commission decision EU/2/05/054/001–007 (EMEA/V/C/097) dated 27 July 2005 which granted a marketing authorization for the veterinary medical product Profender as the first authorization to place the product on the market in the UK.

5

Profender is an anti-parasitic product for cats. It contains two active ingredients, emodepside and praziquantel. Emodepside is a depsipeptide. It is active against roundworms (ascarids and hookworms). In Profender, emodepside is responsible for efficacy against Toxocara cati, Toxacaris leonina and Ancyclostoma tubaeforme. Praziquantel is a pyrazineisoquinoline derivative. It is active against tapeworms such as Dipylidium caninum, Echinococcus multilocularis and Taenia taeniaeformis. Profender also contains butylhydroxyanisole (“BHA”), an antioxidant, as an excipient.

6

It is common ground that:

i) emodepside is the compound claimed in claim 9 of the Basic Patent;

ii) the Basic Patent does not disclose or claim praziquantel;

iii) the Basic Patent does not disclose or claim a combination of emodepside and praziquantel.

7

The examiner objected to the Application on the ground that it did not comply with Article 3(a) of the Regulation. The examiner also pointed out that the product should not be referred to by its trade mark, Profender. Astellas accepted the latter point, and it is common ground that this could easily be dealt with by deleting the reference to Profender. Nevertheless, for convenience I shall use the trade mark to refer to the combination of empodepside and praziquantel which is the subject of the marketing authorization.

8

In response to the objection Astellas requested amendment of the definition of the product to “a product comprising emodepside”. The examiner declined to make this amendment and maintained the objection under Article 3(a). Accordingly Astellas requested a hearing.

The hearing officer's decision

9

In his decision the hearing officer held that the Application as originally filed did not comply with Article 3(a) since the Basic Patent did not protect the product in question, namely Profender.

10

The hearing officer also held that, if the Application were to be amended in the manner sought by Astellas, it would not comply with Article 3(b) since the authorization relied on was not an authorization for “a product comprising emodepside”. This point is no longer in issue since Astellas does not pursue its application to amend the Application in that way.

Existing case law

11

Before turning to consider Astellas' grounds of appeal, it is convenient to put them in context by referring to three earlier cases.

12

In ...

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1 firm's commentaries
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