Medeva BV v The Comptroller General of Patents
| Jurisdiction | England & Wales |
| Judgment Date | 24 June 2010 |
| Neutral Citation | [2010] EWCA Civ 700 |
| Date | 24 June 2010 |
| Court | Court of Appeal (Civil Division) |
| Docket Number | Case No: A3/2010/0295 |
[2010] EWCA Civ 700
IN THE HIGH COURT OF JUSTICE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE CHANCERY DIVISION (PATENTS COURT)
IN THE COURT OF APPEAL
ON APPEAL FROM THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Mr Justice Kitchin
Before: The Chancellor of the High Court
Lord Justice Etherton
and
Lord Justice Elias
BEFORE
THE CHANCELLOR OF THE HIGH COURT
LORD JUSTICE ETHERTON
And
LORD JUSTICE ELIAS
Case No: A3/2010/0295
COURT 16
Appeal No.
A3/2010/0295
CH/2009/APP/0493
Mr Colin Birss Qc & Mr Miles Copeland (instructed by Rouse Legal) for the Appellant
Mr Tom Mitcheson (instructed by Treasury Solicitors) for the Respondent
Hearing date: 28 April 2010
The Chancellor giving the judgment of the Court
Introduction
Council Regulation (EC) No.469/2009 (“the Regulation”) enables the competent industrial property office of a member state (in the United Kingdom the Intellectual Property Office) to grant a certificate called a supplementary protection certificate (“SPC”) to the holder of a patent or his successor in title extending the rights conferred by his patent but subject to the same limitations and obligations for a period. That period, not exceeding five years, is equal to the period which elapsed between the date on which the application for the patent was lodged and the first authorisation to place on the market in the European Union a medicinal product, as defined, protected by the patent less five years. The purpose of such a certificate, as recorded in recital (4), is to extend the period of protection conferred by the patent so as to enable the patentee to cover the cost of the necessary research.
On 20th April 1990 the appellant, Medeva BV (“Medeva”), filed an application for a patent for a method of making acellular vaccine compositions against whooping cough (bordetella pertussis) by combining two antigens, pertactin (69kDa protein) and filamentous haemagglutinin (FHA), to produce a synergistic effect such that a third antigen, pertussis toxin (LPF) is not required. The patent was granted on 18th February 2009 and expired on 26th April 2010. It is not suggested that its expiry affects the issues with which we are concerned.
Medicinal products must be approved in accordance with The Medicines for Human Use (Marketing Authorisations etc.) Regulations 1994, made under s.2(2) European Communities Act 1972, before they are put on the market in any member state of the European Union. The first commercial vaccine made in accordance with the invention and duly authorised comprised all three antigens but was combined with diphtheria toxoid and tetanus toxoid so as to be effective against whooping cough, diphtheria and tetanus. It was launched in 1996. In and after 2000 larger combinations, similarly approved, were launched comprising vaccines against whooping cough, diphtheria, tetanus, meningitis (haemophilus influenzae type b) and polio. By 2004 the combined vaccine against all five diseases, DTPa-IPV/Hib, was routinely recommended as the primary immunisation for babies.
On 17th April 2009 Medeva filed five applications for SPCs. Three of them relate to vaccines against all five diseases (DTPa-IPV/Hib). The other two omitted the vaccine against meningitis (Hib). These applications came before Dr Cullen, the Hearing Officer acting for the Comptroller General of Patents, following an examination by Dr Patrick Purcell. In his decision dated 16th November 2009 Dr Cullen rejected all five applications. In the case of four of them he concluded that the active ingredients included some, namely the vaccines against diseases other than whooping cough, which are not protected by Medeva's patent. In the case of the fifth, though the active ingredients were limited to those protected by Medeva's patent the market authorisation covered a combination vaccine which included vaccines against the other four diseases. In other words, in the case of all five there was a mismatch between the active ingredients protected by the patent and the active ingredients in the vaccine or medicinal product for which the relevant market authorisations had been given.
Medeva appealed. The principal ground (at least with respect to the four applications) was that the Comptroller had wrongly construed the meaning of a “product protected by a basic patent” in Article 3(a). This should, it was submitted, extend to any product which could be subject to successful proceedings for infringement of the patent (“the infringement test.”). For the reasons given in his judgment dated 27th January 2010 Kitchin J dismissed Medeva's appeal but gave Medeva permission to appeal to this court. In considering the papers before the hearing commenced on 28th April 2010 it appeared to us that there might be a need for a reference of certain questions on the interpretation of the Regulation to the Court of Justice of the European Union. Accordingly we invited counsel to confine their arguments, in the first instance, to that issue. Having heard that argument we concluded that such a reference should be made. We indicated that we would give our reasons in our judgments to be handed down in due course and invited counsel to revise the draft questions they had helpfully provided in advance of the hearing. We were informed that counsel acting for other interested parties were attending the hearing. We asked counsel for the parties before us to take account of the views of the latter in considering the form of the questions and let us have their revised draft on or before Friday 7th May.
What follows are our reasons for considering that this court should refer to the Court of Justice the questions mentioned in paragraph 34 below. To explain them it is necessary to set out the relevant Articles of the Regulation, consider further certain parts of the basic patent and refer to some of the decided cases both in this jurisdiction and in the EU.
The Regulation
The Regulation came into force on 20th July 2009. It was a consolidation of the previous Regulation 1768/92 and all subsequent amendments. Accordingly cases decided on the earlier regulation are equally applicable to this one. It recites that pharmaceutical research plays a decisive role in the continuing improvement in public health (recital 2) but that (recital 4) the period between the filing of a patent application for a new medicinal product and the grant of the requisite authority to put it on the market “makes the period of effective protection under the patent insufficient to cover the investment put into the research”.
Articles 1, 3, 4 and 5 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 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 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 (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.
Article 5
Effects of the certificate
Subject to the provisions 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.”
Article 7 imposes time limits on applying for an SPC. They are six months from the date of the marketing authorisation referred to in Article 3(b) or, where such authorisation precedes the grant of the patent referred to in Article 3(a), six months from the date the patent is granted. Article 13 provides for the SPC to take effect from the end of the term of the basic patent and to be effective for a period equal to that which elapsed from the application for the basic patent and the date of the first authorisation less five years. The duration of the SPC may not exceed five years.
The issues with which we are concerned relate to the proper interpretation and application of Articles 3(a) and (b). To explain them it...
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