Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents
| Jurisdiction | England & Wales |
| Judge | THE HON MR JUSTICE ARNOLD |
| Judgment Date | 06 May 2010 |
| Neutral Citation | [2010] EWHC 976 (Pat) |
| Docket Number | Case No: CH/2010/APP/0020 |
| Court | Chancery Division (Patents Court) |
| Date | 06 May 2010 |
[2010] EWHC 976 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Before: The Hon Mr Justice Arnold
Case No: CH/2010/APP/0020
Andrew Waugh Q.C. (instructed by Carpmaels & Ransford) for the Appellant
Charlotte May (instructed by the Treasury Solicitor) for the Respondent
Hearing date: 27 April 2010
Approved Judgment
MR. JUSTICE ARNOLD :
Introduction
This is an appeal by Neurim Pharmaceuticals (1991) Ltd (“Neurim”) from a decision of Dr C. L. Davies on behalf of the Comptroller-General of Patents dated 15 December 2009 ( BL O/384/09). By her decision the hearing officer refused Neurim's application for the grant of a Supplementary Protection Certificate (“SPC”) in respect of its European Patent (UK) No. 0 518 468 B1 entitled “Melatonin containing compositions” (“the Circadin Patent”) pursuant to Council Regulation 1768/92/EEC of 18 June 1992 concerning the creation of a supplementary protection certificate (“the Regulation”). By the time of the hearing officer's decision, the Regulation had been repealed and replaced by a codified version, Council and European Parliament Regulation 469/2009/EC of 6 May 2009, the relevant provisions of which are identical to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). Nevertheless I shall continue to refer to the Regulation, since that was the legislation in force when the application was made.
The Regulation
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.”
Articles 1 to 4 and 7 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.
Article 7
Application for a certificate
1. The application for a certificate shall be lodged within six months of the date on which the authorisation referred to in Article 3(b) to place the product on the market as a medicinal product was granted.
2. Notwithstanding paragraph 1, where the authorisation to place the product on the market is granted before the basic patent is granted, the application for a certificate shall be lodged within six months of the date on which the patent is granted.
….”
The Application
On 26 September 2007 Neurim filed application SPC/GB/07/051 for an SPC in respect of the Basic Patent (“the Application”). The Application identified the product which Neurim wanted to protect as “melatonin”. The Application identified Commission decision EU/1/07/392/001–007 dated 29 June 2007, which granted a marketing authorization for a medicinal product for human use identified as “Circadin – melatonin” (“the Circadin Authorization”), as the first authorization to place the product on the market in the UK. The medicinal product to which the Circadin Authorization relates is Circadin 2 mg prolonged release tablets, which comprise melatonin as the active ingredient and various excipients. The therapeutic indication of Circadin 2 mg prolonged release tablets is as monotherapy for the short-term treatment of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over.
The examiner objected to the Application on the ground that it did not comply with Article 3(d) of the Regulation since the Circadin Authorization was not the first authorization to place melatonin on the market as a medicinal product. An earlier authorization to place melatonin on the market was granted between 1 January 2001 and 22 March 2001 (“the Regulin Authorization”). The Regulin Authorization, which was granted to CEVA Animal Health Ltd, relates to the veterinary medicinal product Regulin 18 mg implant, which comprises melatonin as the active ingredient and various excipients. Regulin is indicated for administration to sheep, more specifically ewes, to improve the reproductive performance of pure bred and cross bred lowland sheep which are to be mated early in the season before the usual peak of reproductive activity. When used as directed, it stimulates the early onset of natural reproductive activity. Regulin is protected by European Patent 0 246 910 B1 (“the Regulin Patent”).
Although Neurim endeavoured to persuade the examiner that the Application did comply with Article 3(d), he maintained the objection. Accordingly Neurim requested a hearing.
The hearing officer's decision
In her decision the hearing officer upheld the objection that the Application did not comply with Article 3(d). Her reasoning in short was that she interpreted Article 3(d) as requiring the...
To continue reading
Request your trial
-
Supplementary Protection Certificates For New Uses - ECJ Clarifies 'First Authorization Of The Product'
...was previously approved in 2001. The UK IPO's decision was initially upheld by Justice Arnold of the English High Court of Justice ([2010] EWHC 976 (Pat)), holding that article 3(d) requires the authorization in Article 3(b) to be the first authorization to place the product on the market a......