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Medeva BV v The Comptroller General of Patents

Judgment Business Law Reports Cited authorities 10 Cited in 8 Precedent Map Related
Vincent
JurisdictionEngland & Wales
JudgeTHE HONOURABLE MR. JUSTICE KITCHIN,MR. JUSTICE KITCHIN
Judgment Date27 January 2010
Neutral Citation[2010] EWHC 68 (Pat)
CourtChancery Division (Patents Court)
Docket NumberCase No: CH/2009/APP/0493
Date27 January 2010
Categories

[2010] EWHC 68 (Pat)

IN THE HIGH COURT OF JUSTICE

CHANCERY DIVISION

PATENTS COURT

ON APPEAL FROM The UK Intellectual Property Office

IN THE MATTER OF Medeva BV's SPC Applications Nos. SPC/GB/09/015–019

AND IN THE MATTER OF Council Regulation (EC) NO. 469/2009

Before: The Honourable Mr. Justice Kitchin

Case No: CH/2009/APP/0493

Between
Medeva Bv
Appellant
and
The Comptroller General of Patents
Respondent

Mr. Colin Birss QC and Mr. Miles Copeland (Instructed by Rouse Legal) for the Appellant

Mr. Thomas Mitcheson (Instructed by The Treasury Solicitor) for the Respondent

Hearing dates: 12 th January 2010

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 HONOURABLE MR. JUSTICE KITCHIN MR. JUSTICE KITCHIN

MR. JUSTICE KITCHIN:

1

This is an appeal by Medeva BV (“Medeva”) against the decision of Dr Cullen, the Deputy Director acting on behalf of the Comptroller, dated 16 November 2009, whereby he refused five applications for supplementary protection certificates (“SPCs”) relating to EP (UK) 1 666 057 B1 (“the Patent”).

2

The Deputy Director decided that the product the subject of four of the applications was not “protected” by the Patent within the meaning of Article 3(a) of Council Regulation (EC) No 469/2009 (“the SPC Regulation”). In the case of the fifth application he decided that the marketing authorisation relied upon was not a valid authorisation to place the product on the market as required by Article 3(b) of the SPC Regulation. It is against these findings that Medeva now appeals. I am also invited to decide a procedural point as to whether Medeva filed its appeal prematurely and before any decision of the Comptroller had been made. This is a point of some importance to the Comptroller for reasons I shall explain.

Background

3

The Patent was filed on 20 April 1990, with a priority date of 8 May 1989, and it was granted on 18 February 2009, that is to say just over one year before it was due to expire.

4

The Patent describes and claims a method of making acellular vaccine compositions against Bordetella pertussis, more commonly known as whooping cough. The specification discloses that a combination of two particular antigens known as pertactin (or the 69kDa protein) and filamentous haemagglutinin (or FHA) produces, surprisingly, a synergistic effect which is such that a third antigen called pertussis toxin (or LPF) is not required to produce an effective dose of vaccine.

5

This, explains the specification, was an important discovery. Prior to the invention there was a general understanding that pertussis toxin was an essential part of any acellular vaccine. But it was also believed that some of the adverse effects associated with pertussis vaccination were related to this antigen. Accordingly, the synergistic combination of pertactin and FHA meant that pertussis toxin need no longer be used, and consequently the risk of adverse reactions could be reduced. Additionally, a bivalent vaccine containing only pertactin and FHA would be cheaper to produce.

6

The relevant claims reflect the disclosure in the specification. Claim 1 is directed to a method of making the synergistic combination of the pertactin and FHA antigens and reads:

A method for the preparation of an acellular vaccine, which method comprises preparing the 69kDa antigen of Bordetella pertussis as an individual component, preparing the filamentous haemagglutinin antigen of Bordetella pertussis as an individual component, and mixing the 69kDa antigen and the filamentous haemagglutinin antigen in amounts that provide the 69kDa antigen and the filamentous haemagglutinin antigen in a weight ratio of between 1:10 and 1:1 so as to provide a synergistic effect in vaccine potency.

7

And claim 2 is directed to a vaccine which does not contain pertussis toxin:

A method according to claim 1 wherein the vaccine is devoid of the B. pertussis toxin.

8

Despite the teaching in the specification, no vaccine containing only pertactin and FHA has ever been produced. The first commercial vaccine made in accordance with the invention contained pertactin, FHA and pertussis toxin. It was launched in 1996 as a combination with diphtheria toxoid and tetanus toxoid (DTPa) and was effective against the three diseases: pertussis, diphtheria and tetanus.

9

The desirability of combining vaccines against different diseases was something that had been appreciated for many years, so it was natural to develop even larger vaccine combinations from DTPa. But each time a new antigen is built into a combined vaccine there is a risk of an increase in the frequency of existing side effects or of a reduction in the immune response to certain antigens. So extensive clinical testing is required.

10

It was therefore not until 2000 that the first such larger combination (DTPaP-Hib) was approved. This included antigens against haemophilus influenzae type b, an agent which causes meningitis. It was followed in 2001 by the approval of a combination which included inactivated polio virus vaccine (DTPa-IPV) and then, in 2002, by the approval of the ultimate goal in the UK for childhood vaccines, namely DTPa-IPV/Hib, which provides a measure of protection against pertussis, diphtheria, tetanus, polio and meningitis. By 2004, DTPa-IPV/Hib was routinely recommended as the primary immunisation for babies.

11

On 17 April 2009, Medeva filed the five applications for SPCs the subject of this appeal. They were accorded the numbers SPC/GB/09/015, 09/016, 09/017, 09/018 and 09/019. Three of them (09/015, 09/016 and 09/018) relate to DTPa-IPV/Hib. The other two (09/017 and 09/019) relate to the combination DTPa-IPV (that is to say, without Hib) which is the primary booster vaccine used in the UK. At the hearing of the appeal, counsel for the Comptroller helpfully produced a table setting out details of each application, including the relevant marketing authorisation (MA), trade name of the relevant medicinal product, the combination of active ingredients sought to be protected and the combination of active ingredients actually approved. I reproduce it with gratitude below:

Combination of Active Ingredients

SPC/GB

/09/015

/09/016

/09/017

/09/018

/09/019

Marketing Authorisation PL

10592/0216

06745/0120

06745/0121

06745/0120

10592/0209

Medicinal Product relied upon

Infanrix- IPV+Hib (DTPa/IPV/

Hib)

Pediacel

(DTPa/IPV/

Hib)

Repevax

(DTPa/IPV)

Pediacel

(DTPa/IPV/

Hib)

Infanrix IPV

(DTPa/IPV)

Marketed by

GSK

Sanofi

Sanofi

Sanofi

GSK

Current UK use

1 º vaccine

1 º vaccine

Booster

1 º vaccine

Booster

Expiry of SPC

26.06.12

25.04.15

25.04.15

25.04.15

06.08.11

# of active components for SPC

9

9

9

2

8

# of active components in Medicinal Product

9

11

9

11

8

SPC

MA

SPC

MA

SPC

MA

SPC

MA

SPC

MA

Filamentous

Haemagglutinin

P

P

P

P

P

P

P

P

P

P

Pertactin

P

P

P

P

P

P

P

P

P

P

Pertussis toxoid

P

P

P

P

P

P

-

P

P

P

Pertussis Fimbrial Agglutinogens 2 and 3

-

-

-

P

P

P

-

P

-

-

Diphtheria toxoid

P

P

P

P

P

P

-

P

P

P

Tetanus toxoid

P

P

P

P

P

P

-

P

P

P

Inactivated poliovirus type 1

P

P

P

P

P

P

-

P

P

P

Inactivated poliovirus type 2

P

P

P

P

P

P

-

P

P

P

Inactivated poliovirus type 3

P

P

P

P

P

P

-

P

P

P

Haemophilus influenzae type b capsular polysaccharide-Tt conjugate

P

P

P

P

-

-

-

P

-

-

Haemophilus influenzae type b polyribosylribitol phosphate

-

-

-

P

-

-

-

P

-

-

12

As I have mentioned, the Deputy Director concluded that the Patent did not protect the product the subject of applications 09/015, 09/016, 09/ 017 or 09/019 for the purposes of Article 3(a) of the SPC Regulation. Further, he concluded that marketing authorisation PL 06745/0120 for Pediacel was not, for the purposes of Article 3(b) of the SPC Regulation, a valid authorisation to place the product the subject of application 09/018 on the market as a medicinal product. On this appeal Medeva contends that he fell into error in so doing. Before assessing the merits of that contention I must set out the relevant parts of the SPC Regulation.

Legal framework

13

The SPC Regulation came into effect on 6 July 2009 and codified various amendments made to Council Regulation (EEC) No 1768/92 of 18 June 1992. It recognises in its recitals that medicinal products will not continue to be developed in the Community unless they are covered by rules that provide for sufficient protection to encourage research. Further, the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation to place the product on the market makes the period of effective protection under the patent itself insufficient to cover the investment put into research. The scheme of the SPC Regulation is therefore to provide for an additional period of protection by means of an SPC. The duration of protection is a maximum of 15 years from the time the medicinal product first obtains marketing authorisation, as explained in Recital (9):

“The duration of the protection granted by the certificate should be such as to provide adequate effective protection. For this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains authorisation to be placed on the market in the Community.”

14

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