England and Wales Court of Appeal (Civil Division) Decisions

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
[2010] EWHC 976 (Pat)

		Royal Courts of Justice Strand, London, WC2A 2LL
		08/03/2011

Jacob LJ (giving the judgment of the court at the invitation of Smith LJ):

1. 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]."
2. 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

3. 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.

4. 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.
5. 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

6. 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.
7. 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.

8. 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;

9. 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.
10. The IPO adds that Neurim could have applied for an SPC based on the Regulin MA. It would have got one. Initially it would have been one of "zero scope" since the SPC would not have protected the subject matter of the Regulin MA under Article 4 because this is not within the limits of the protection conferred by Neurim's Patent. The IPO contends that there is no difficulty in granting an SPC of "zero scope." It argues that a distinction must be made between the conditions for grant (provided under Article 3) and the effect of grant, including scope (provided under Articles 4 and 5). Furthermore, it points out that Article 4 of the Regulation contemplates that the scope of the SPC may change to cover any use of the product as a medicinal product authorised before expiry of the certificate (subject to the limits of the basic patent). Hence the IPO says that a certificate which initially has "zero scope" is still of value to a patentee.
11. As to case law, the IPO relies upon a number of cases, but particularly Case C-31/03 Pharmacia [2004] ECR I-10001, Case C-431/04 MIT [2006] ECR I-4089 and Case C-202/05 Yissum [2007] ECR I-2839.
12. It says that Pharmacia makes it clear that it makes no difference whether the first MA was for a human or veterinary use. MIT makes it clear that only the active ingredient is a "product" and Yissum emphasises that, by saying that the concept of "product" is to be interpreted strictly to mean "active substance". It says that Yissum also confirms the broad application of the reasoning in Pharmacia to cases with different facts. Moreover it says that MIT clearly involves a rejection of an appeal to the general purposes or objectives of the legislation relied upon by Neurim in this case, because the Court did not follow the opinion of Advocate-General Léger which was based on that.
13. Furthermore, says the IPO, the new point that emerged in the course of argument does not help Neurim. The point is based on Case C-181/95 Biogen. That decided that there if there is more than one patent holder covering a product each patent holder can have an SPC for it. However, says the IPO, each of those SPCs must be based on the first MA for the product, which will be the same for all the SPCs granted. The IPO argues that the same point is confirmed by Case C-482/07 AHP in which it is clear that each patentee relied upon the same MA for the purposes of its SPC application, being the first MA in time granted in respect of the product in question. The IPO points out that no consideration was given in either of those cases as to whether the use of the product as authorised by the MA fell within the scope of the basic patent, something it says the Court would have addressed if it had been relevant. The consequence of these cases is that each patentee must rely on the first authorisation for the product chronologically given, and that this may result in a certificate of zero scope.
14. Finally the IPO submits that on the facts of this case, the SPC would have had no duration under Article 13(1) of the Regulation, based on the Prime-X MA referred to above.

Neurim's contentions

15. The heart of Neurim's contentions is that an SPC is just that: protection supplementing the protection of the basic patent. An MA for a product never protected by the basic patent is irrelevant. The very title says it all.
16. Neurim say that the Court's case-law makes it clear that instruments such as this Regulation should be construed teleologically. In particular the Court has made it clear, for instance in AHP, that the "fundamental objective" of the Regulation is set out in the first and second recitals, namely to ensure sufficient protection to encourage pharmaceutical research and that the third and fourth recitals make it clear that the loss of time caused by the need for a MA penalises pharmaceutical research.
17. They say the cases relied upon by the IPO must all be seen in the context of their own facts and the nature of the questions referred to the ECJ. What the court said should not be taken wholly out of context so as to apply to a case such as the present when there are two patents of non-overlapping scope. Their argument is that the basic principle is one SPC for one patent.
18. That is reinforced by Recitals (13) and (14) of the Plant Protection Regulation EC No. 1610/96 which, by Recital (17) are to be used to interpret Art. 3 of the medicinal product SPC Regulation. These make it clear that there can be a further SPC for derivatives of an active substance if the derivatives are the subject of patents specifically covering them. This shows that what matters is the existence of a second patent, a second invention. It may well be that the active moiety of the first patent is the same as in the second patent, but for some reason (e.g., better delivery), the derivative is enough to warrant a second patent. If so that patent can have its own SPC. That, by analogy, is the position here. Each patent can have its own SPC, but only one. And the relevant MA for that patent is an MA for a product falling within the scope of that patent.
19. Neurim say Case C-229/09 Hogan Lovells supports that. There the Court said at [17] "the SPC establishes a link between the basic patent and the first MA". There is no realistic link between Neurim's patent and the MA for Regulin.
20. Neurim also rely on the passage about the product in the Commission's Explanatory Memorandum for the Regulation (COM(90) 101 final – SYN 255). Paragraph 36 of this says:

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.

21. Going on with paragraph 36:

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.

22. Paragraph 36 concludes:

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.

23. As to the wording of the Regulation, Neurim say the condition of Art. 3(d) should accordingly be read in the following sense:

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.

24. Only such a reading could fulfil the basic purpose of the Regulation. It is implicit that the MA must be within the scope of the basic patent. Moreover, in none of the cases relied on by the Comptroller (in particular, MIT and Yissum) was the Court asked to consider the meaning of "authorisation" within the context of Article 3(d).
25. As to the SPC with zero scope suggestion of the IPO, Neurim say the concept is absurd and serves to illustrate why the IPO is wrong. They contend that a system that grants zero scope SPCs has no basis (legally or logically), and also that it requires patent holders to have unreasonable prescience in that they must monitor for MAs granted to third parties in totally unrelated fields, possibly years before they can expect to receive their own MA. They also say that zero scope SPCs place interested third parties under an obligation to watch for subsequent MAs that "activate" the scope of the SPC (under Article 4) throughout the life of the patent and the SPC. They add that an analogy with "zero term" SPCs does not help the IPO, not least because "zero term" SPCs are the subject of a separate CJEU referral (Case C-125/10 Merck).
26. Finally and alternatively Neurim rely on Biogen. That decides that two or more parties can each have an SPC for a product covered by their respective patents. It follows, they say, that the relevant MA for each SPC is the MA relating to a product covered by that patent. The logic of Biogen requires that the position of each patent holder is regarded independently.
27. Neurim contend that the interpretation it applies to Article 3(d) must also apply to Article 13 such that the duration of the certificate cannot be calculated by reference to the Prime-X MA referred to above.

Why we are referring

28. We consider that Neurim's arguments are not only tenable: in our view they are right. Many kinds of valuable pharmaceutical research will not get the encouragement or reward they deserve if they are not. Pharmaceutical research is not confined to looking for new active compounds. New formulations of old active substances are often sought. Most are unpatentable but from time to time a real invention is made and patented.
29. Moreover there is much endeavour to find new uses for known active ingredients. The European Patent Convention 2000 has indeed made the patenting of inventions in this area clearer. Its effect is that a patent for a known substance or composition for use in a method of treatment is not to be regarded as old (and hence unpatentable) unless use for that method is known. It would be most unfortunate if second medical use patents could not get the benefit of an SPC.
30. In short, if Neurim are wrong, then the Regulation will not have achieved its key objects for large areas of pharmaceutical research: it will not be fit for purpose. Whether that is so or not is clearly a matter for the EU's highest court.