COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
CHANCERY DIVISION (PATENTS COURT)
The Hon Mr Justice Arnold
Strand, London, WC2A 2LL
B e f o r e :
THE RT HON LORD JUSTICE JACOB
THE RT HON LORD JUSTICE PATTEN
| Neurim Pharmaceuticals (1991) Ltd
|- and -
|The Comptroller-General of Patents
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Miss Charlotte May (instructed by Treasury Solicitor) for the Respondent
Hearing date: 3 February 2011
Crown Copyright ©
Jacob LJ (giving the judgment of the court at the invitation of Smith LJ):
The essential facts
(1) Melatonin is a natural hormone. It is not and has not been patented by anyone.
(2) Neurim's research led them to discover that appropriate formulations of melatonin could be used as a medicine for insomnia. Their patent is for such formulations. Claim 1 reads as follows:A pharmaceutical formulation, for use in correcting a melatonin deficiency or distortion in the plasma melatonin level and profile in a human subject, which comprises melatonin in combination with at least one pharmaceutical carrier, diluent or coating, wherein the melatonin is present in the formulation in controlled-release form adapted to release melatonin following administration to a human patient, over substantially the whole of a single nocturnal period of at least about 9 hours, such that melatonin release occurs according to a profile which, taking into account the existing nocturnal profile simulates a normal human endogenous melatonin nocturnal profile in plasma, in that administration of the formulation at the beginning of said at least about 9 hour single nocturnal period causes melatonin to be detectable in the plasma in an amount which increases to a peak in the course of said period and subsequently decreases to a post-peak minimum essentially at the end of said period.There are also "Swiss-form" claims but nothing turns on these.
(3) No one suggests that the claims, even though only for formulations, are not novel or inventive. Or that Neurim's work has led to a highly beneficial and new medicine.
(4) Before Neurim could be allowed to sell their patented formulation (for which they use the trade mark Circadin) they of course had to get regulatory approval. They had applied for their patent on 23rd April 1992, but it took over 15 years before they got a marketing authorisation ("Neurim's MA"). This was granted by a Commission decision of 28h June 2007 pursuant to an opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency. The Committee had quite properly treated Circadin as a wholly new product so that it had to go through the full gamut of regulatory testing and procedures under Article 8(3) of Directive 2001/83/EC (formerly a full application under Article 4 of Directive 65/65/EEC).
(5) By the time of grant of the Neurim MA the Neurim patent had less than 5 years to run. Neurim accordingly applied for an SPC, basing their application on their June 2007 MA. This, they said, was the "first authorization to place the product on the market as a medicinal product" within the meaning of Art. 3(d) of the SPC Regulation EEC 1768/92. (This has since been replaced by EC 469/2009 but nothing turns on this.
(6) The terms of Neurim's MA are as follows:The marketing authorisation provided for in Article 3 of Regulation (EC) No 726/2004 is granted for the medicinal product "Circadin melatonin", the characteristics of which are summarised in Annex I to this Decision. "Circadin melatonin" shall be registered in the Community register of medicinal products under number(s)EU/1/07/392/001 Circadin 2 mg Prolonged-release tablets Oral use PVC/PVDC blister/alu 21 tablets
(7) The IPO objected to the application. It said that Neurim's MA was not the relevant first MA. It had identified an earlier MA. This was for melatonin for use in sheep. It had been granted to Ceva Animal Health between January and March 2001 by the UK Veterinary Medicines Directorate under Directive 81/851/EEC. The medicinal product was sold under the trade mark "Regulin." Subsequent enquiries by the IPO immediately before the appeal hearing revealed that the Regulin MA may have been first granted on 1st January 1993. However, it is the later Regulin MA upon which the IPO based its Article 3(d) objection.
(8) Neurim has disclosed that a further MA for a formulation of melatonin. This was granted in the Netherlands under number REG NL 7131 on 19th February 1992. This authorisation is to a formulation of melatonin for enhancing fur growth in mink; the trade mark of the medicinal product is "Prime-X". The scope of Neurim's patent would not extend to the product of the MA for Prime-X. It is not known whether there was ever a patent for Prime-X.
(9) Regulin was the subject of a quite different patent from Neurim's. It was owned by Hoechst. The Hoechst patent (EP 0 246 910) was applied for on 21st May 1987 and hence expired in May 2007. It was for a method of regulating the seasonal breeding activity of animals. It contained claims to the method and to "a coated veterinary implant made by granulation and compression" of a specified kind.
(10) The Regulin MA is for a yellow cylindrical implant whose active ingredient is melatonin and which also contains quinoline yellow lake. It is to be implanted near the base of the ear of a ewe.
The Parties' Contentions
The IPO's contentions
(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 [for human medicinal products] or Directive 81/851/EEC [for veterinary medicinal products], 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.
(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;
Lastly the product must not have been the subject of a certificate in the Member State concerned. The certificate is designed to encourage research into new medicinal products so the duration of protection it affords, together with the effective duration of the patent, is sufficient to enable the investment made in research to be recovered. However, it would not be acceptable, in view of the balance required between the interests concerned, for this total duration of protection for one and the same medicinal product to be exceeded. This might nevertheless be the case if one and the same product were able to be the subject of successive certificates.
Neurim say the present case does not fall within the vice contemplated here. The same product would not be the subject of successive certificates.
This calls for a strict definition of the product within the meaning of Article 2. If a certificate has already been granted for the active ingredient itself, a new certificate may not be granted for one and the same active ingredient whatever minor changes may have been made regarding other features of the medicinal product (use of a different salt, different excipients, different pharmaceutical presentation, etc.).
Neurim say the intention is clear. It is only minor changes which do not count. When the changes are enough to warrant a separate patent they are not minor as is confirmed by the recitals to the Plant Protection Regulation.
In conclusion, it should be noted that, although one and the same product may be the subject of several patents and several authorizations to be placed on the market in one and the same Member State, the supplementary protection certificate will only be granted for that product on the basis of a single patent and a single authorization to be placed on the market, namely the first chronologically given in the State concerned. .
Neurim says this shows a clear intention that there can be one, but only one, SPC for a particular patented product. The SPC now sought would indeed be the first SPC for its patented product and the first MA for that was in 2007.
The authorisation referred to in (b) is the first relevant authorisation (i.e. authorisation of a product within the scope of the basic patent) to place the product on the market as a medicinal product.
Why we are referring