Synthon BV v Merz Pharma GmbH & Company
| Jurisdiction | England & Wales |
| Judge | THE HON MR JUSTICE FLOYD,Mr Justice Floyd |
| Judgment Date | 02 April 2009 |
| Neutral Citation | [2009] EWHC 656 (Pat) |
| Court | Chancery Division (Patents Court) |
| Docket Number | Case No: HC 08 C 02210 |
| Date | 02 April 2009 |
[2009] EWHC 656 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Before : THE HON MR JUSTICE FLOYD
Case No: HC 08 C 02210
Michael Silverleaf QC (instructed by Bird & Bird LLP) for the Claimant
Andrew Waugh QC (instructed by Lovells LLP) for the Defendant
Hearing date: March 3 rd 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.
Mr Justice Floyd :
E.C. Council Regulation No. 1768/92 (“the SPC Regulation”) provides for a form of intellectual property protection known as a Supplementary Protection Certificate (SPC). An SPC provides, in defined circumstances, an extension of the life of a basic patent for a medicinal product. It does so in order to compensate the patentee for the lost period of monopoly caused by the time it takes to conduct the necessary safety and efficacy testing to obtain authorisation to place such a product on the market. The requirements for safety and efficacy testing were sought to be harmonised at Community level as long ago as 1965 in Council Directive 65/65/EEC (“65/65”). The question which arises in this action is: can one obtain an SPC in circumstances where the product has been placed on the market in the Community without the need to do safety and efficacy testing as prescribed in 65/65, or indeed at all? The defendant Merz Pharma GmbH & Co. KGaA (“Merz”) says that you can. The claimant Synthon B.V. (“Synthon”) says that you cannot.
Merz is the proprietor of SPC No GB 02/046 (“the SPC”) granted on 14 th August 2003 in respect of a compound called memantine. Although the SPC was granted on the basis of EU wide marketing authorisations granted in 2002, memantine had already been on the market in Germany (but not in the UK) for a quarter of a century. By this action Synthon seek revocation of the SPC on a number of grounds, or a declaration that it has zero term.
The SPC Regulation
The SPC Regulation recites the following, amongst other, matters:
“(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 research; …
(4) Whereas the situation leads to a lack of protection which penalizes pharmaceutical research;
(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; …
(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 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 by strictly confined to the product which obtained authorization to be placed on the market as a medicinal product.”
Article 1 of the Regulation defines a “medicinal product” as including “any substance or combination of substances for treating or preventing disease in human beings”, whereas the term “product” means the “active ingredient or combination of active ingredients of a medicinal product”. A “basic patent” means “a patent which protects a product [as defined] 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 [SPC].”
The following are the articles of the SPC Regulation of principal relevance to the dispute. Firstly, Article 2 defines the scope of the Regulation. This forms the basis for Synthon's argument that the present facts fall outside the scope of the Regulation altogether. It reads as follows:
“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 81/851/EEC may, under the terms and conditions of this Regulation be the subject of a certificate.”
Article 3 sets out the conditions for obtaining an SPC in a given member state. It is common ground that the words “in the Member State in which the application is submitted” qualify each of the following sub-paragraphs. It reads:
“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;
(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 7 requires the application for the SPC to be filed within 6 months of the date of the authorisation referred to in Article 3(b), i.e. the authorisation in that Member State, or within 6 months of the grant of the basic patent if that is after the authorisation.
Article 8 of the Regulation sets out what must be contained in the application for a certificate. Articles 8(1)(a)(iii) and (iv), (b) and (c) are as follows:
“ARTICLE 8
Content of the application for a certificate
1. The application shall contain:
(a) a request for the grant of a certificate, stating in particular:
(iii) the number of the basic patent and the title of the invention;
(iv) the number and date of the first authorization to place the product on the market, as referred to in Article 3(b), and, if this authorization is not the first authorization for placing the product on the market in the Community, the number and date of that authorization.
(b) a copy of the authorization to place the product on the market, as referred to in Article 3 (b), in which the product is identified, containing in particular the number and date of the authorization and the summary of the product characteristics listed in Article 4a of Directive 65/65/EEC or Article 5a of Directive 81/851/EEC;
(c) if the authorization referred to in (b) is not the first authorization for placing the product on the market as a medicinal product in the Community, information regarding the identity of the product thus authorized and the legal provision under which the authorization procedure took place, together with a copy of the notice publishing the authorization in the appropriate official publication.”
Article 13 is concerned with the duration of the certificate. The duration depends on the length of time between the date of the application for the basic patent and the date of the first marketing authorisation in the Community. This period, less 5 years, is the length of protection afforded by the certificate, subject to an overall maximum of 5 years. It is expressed in this way:
“ARTICLE 13
Duration of the certificate
1. The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorization to place the product on the market in the Community reduced by a period of 5 years.
2. Notwithstanding paragraph 1, the duration of the certificate may not exceed five years from the date on which it takes effect.”
Thus, if the first marketing authorisation in the Community is obtained 5 (or less) years after the date of application for the basic patent, the term will be zero. On the other hand if the authorisation is obtained 10 or more years after the application for the patent, the term will be the maximum of 5 years. It is important to note that, in this way, the objective of a maximum of 15 years exclusivity (referred to in recital 8) is obtained. That maximum period is based on an unspoken assumption that the product could not be on the market before the first authorisation is granted.
The need to calculate the duration of the certificate explains why, in Article 8, the applicant for an SPC is required to produce not only its marketing authorisation in the state where it is making the application, but also (if the application in the member state in question is not the first authorisation to place the product on the market in the Community) the first authorisation in the Community.
It might be thought that, as the duration of the certificate is determined by the period of time between the application for the basic...
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