Neurim Pharmaceuticals (1991) Ltd v The Comptroller-General of Patents
| Jurisdiction | England & Wales |
| Judgment Date | 08 March 2011 |
| Neutral Citation | [2011] EWCA Civ 228 |
| Date | 08 March 2011 |
| Court | Court of Appeal (Civil Division) |
| Docket Number | Case No: A3/2010/1351 |
[2011] EWCA Civ 228
[2010] EWHC 976 (Pat)
IN THE HIGH COURT OF JUSTICE
COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
CHANCERY DIVISION (PATENTS COURT)
The Hon Mr Justice Arnold
Before: The Rt Hon Lady Justice Smith
The Rt Hon Lord Justice Jacob
and
The Rt Hon Lord Justice Patten
Case No: A3/2010/1351
Andrew Waugh QC (instructed by Carpmaels & Ransford) for the Appellant
Miss Charlotte May (instructed by Treasury Solicitor) for the Respondent
Hearing date: 3 February 2011
Jacob LJ (giving the judgment of the court at the invitation of Smith LJ):
This appeal is from a judgment of Arnold J, [2010] EWHC 976 (Pat). He upheld the Intellectual Property Office's decision that Neurim are not entitled to a supplementary protection certificate (SPC) based on their patent EP (UK) No. 0 518 468 ("Neurim's patent"). In his judgment he thought the position acte clair but in giving permission to appeal he said there was a "tenable argument to the contrary which may lead to the matter being referred to the [Court of Justice of the European Union]."
Having heard the argument we indicated to the parties that we considered the matter was not acte clair and that accordingly we should refer questions to the CJEU. For the convenience of that court we here briefly set out the essential facts, and the rival arguments in outline. In case it may assist we also give our own views.
The essential facts
These can be stated shortly:
(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 23 rd 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 28 h 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 19 th 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 21 st 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.
So neither the scope of the Hoechst patent nor the subject matter of the Regulin MA fell within the scope of the Neurim Patent. Nor would any SPC granted to Neurim fall within the scope of either the Hoechst Patent or extend to the product authorised by the Regulin MA.
In short, commercially, medically and legally there is a vast expanse of clear blue water between the parties' products and legal rights. None of the work done by Hoechst helped Neurim at all – it may indeed have hindered them because the regulator would naturally have been concerned about possible side effects.
The Parties' Contentions
The IPO's contentions
The IPO says the case is simple and clearly covered by the wording of the Regulation. Moreover it is covered by existing ECJ case law.
As to the wording it says this. You can only get an SPC if you comply with all four of the Art. 3 conditions. These are that at the date of 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 [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.
The "first authorization to place the product on the market as a medicinal product" depends on the definitions of "product" and "medicinal product". Those are contained in Art. 1:
(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;
The active ingredient of both Circadin and Regulin is melatonin. So that is the "product". The first authorisation to place that "product" on the market as a medicinal product was for Regulin. So Neurim's MA was not the first. QED.
The IPO adds that Neurim could have applied for an SPC based on the Regulin...
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