Astellas Pharma Inc v Comptroller-General of Patents

This is an appeal by Astellas Pharma Inc (“Astellas”) from a decision of Dr Lawrence Cullen on behalf of the Comptroller-General of Patents dated 20 February 2009 (BL O/052/09). By his decision the hearing officer refused Astellas’ application for the grant of a Supplementary Protection Certificate (“SPC”) in respect of its European Patent (UK) No. 0634408B1 entitled “Depsipeptide Derivative, Production Thereof and Use Thereof” (“the Basic Patent”) pursuant to Council Regulation 1768/92/EEC of 18 June 1992 concerning the creation of a supplementary protection certificate (“the Regulation”). The Regulation has subsequently been repealed and replaced by a codified version, Council and European Parliament Regulation 469/2009/EC of 6 May 2009, the relevant provisions of which are identical to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).

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 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.”

On 13 January 2006 Astellas filed application SPC/GB/06/002 for an SPC in respect of the Basic Patent (“the Application”). The Application identified the product which Astellas wanted to protect as “emodepside/praziquantel (Profender)”. The Application identified Commission decision EU/2/05/054/001-007 (EMEA/V/C/097) dated 27 July 2005 which granted a marketing authorization for the veterinary medical product Profender as the first authorization to place the product on the market in the UK.

Profender is an anti-parasitic product for cats. It contains two active ingredients, emodepside and praziquantel. Emodepside is a depsipeptide. It is active against roundworms (ascarids and hookworms). In Profender, emodepside is responsible for efficacy against Toxocara cati, Toxacaris leonina and Ancyclostoma tubaeforme. Praziquantel is a pyrazineisoquinoline derivative. It is active against tapeworms such as Dipylidium caninum, Echinococcus multilocularis and Taenia taeniaeformis. Profender also contains butylhydroxyanisole (“BHA”), an antioxidant, as an excipient.

It is common ground that:

The examiner objected to the Application on the ground that it did not comply with Article 3(a) of the Regulation. The examiner also pointed out that the product should not be referred to by its trade mark, Profender. Astellas accepted the latter point, and it is common ground that this could easily be dealt with by deleting the reference to Profender. Nevertheless, for convenience I shall use the trade mark to refer to the combination of empodepside and praziquantel which is the subject of the marketing authorization.

In response to the objection Astellas requested amendment of the definition of the product to “a product comprising emodepside”. The examiner declined to make this amendment and maintained the objection under Article 3(a). Accordingly Astellas requested a hearing.

In his decision the hearing officer held that the Application as originally filed did not comply with Article 3(a) since the Basic Patent did not protect the product in question, namely Profender.

The hearing officer also held that, if the Application were to be amended in the manner sought by Astellas, it would not comply with Article 3(b) since the authorization relied on was not an authorization for “a product comprising emodepside”. This point is no longer in issue since Astellas does not pursue its application to amend the Application in that way.

Before turning to consider Astellas’ grounds of appeal, it is convenient to put them in context by referring to three earlier cases.

In Case C-392/97 Farmitalia Carlo Erba Srl [1999] ECR I-5553 Farmitalia had obtained a German patent for idarubicin. The claims specifically covered idarubicin hydrochloride. Farmitalia had also obtained a marketing authorization for idarubicin hydrochloride. Farmitalia applied for an SPC for “idarubicin and salts thereof including idarubicin hydrochloride”. The German Patent Office granted an SPC for idarubicin hydrochloride, but refused to grant one for “idarubicin and salts thereof including idarubicin hydrochloride”. Farmitalia appealed first to the Bundespatentsgericht and then the Bundesgerichtshof. The latter court referred two questions concerning the interpretation of Article 3(b) and (a) respectively of the Regulation to the Court of Justice of the European Communities.

With regard to the second question, the ECJ held:

“23.

By its second question, the Bundesgerichtshof is, in substance, asking what are the criteria, according to Regulation No 1768/92, and in particular Article 3(a) thereof, for determining whether or not a product is protected by a basic patent.

24.

In that connection, it should be noted that one of the conditions for obtaining a certificate is that the product should be protected by a basic patent in force.

25.

As indicated in the seventh recital in the preamble to Regulation No 1768/92, the patent concerned may be either national or European.

26.

As Community law now stands, the provisions concerning patents have not yet been made the subject of harmonisation at Community level or of an approximation of laws.

27.

Accordingly, in the absence of Community harmonisation of patent law, the extent of patent protection can be determined only in the light of the non-Community rules which govern patents.

28.

As is clear in particular from paragraph 21 of this judgment, the protection conferred by the certificate cannot exceed the scope of the protection conferred by the basic patent.

29.

The answer to be given to the second question must therefore be that, in order to determine, in connection with the application of Regulation No 1768/92 and, in particular, Article 3(a) thereof, whether a product is protected by a basic patent, reference must be made to the rules which govern that patent.”

In Takeda Chemical Industries Ltd’s SPC Applications (No 3) [2003] EWHC 649 (Pat), [2004] RPC 3 Takeda had obtained a patent, a marketing authorisation and an SPC for the anti-ulcer agent lansoprazole. Subsequently Takeda obtained a patent for the use of lansoprazole for the manufacture of a medicament for preventing or treating infectious diseases caused by Helicobacter pylori. It also obtained a variation to the marketing authorization adding the eradication of Helicobacter pylori as a new therapeutic indication for lansoprazole when used in combination with appropriate antibiotics. It filed six applications for SPCs for combinations of lansoprazole with two antibiotics selected from clarithromycin, amoxycillin and metronidazole. Three of the applications designated the first patent, and the other three the second patent. The hearing officer refused all the applications for non-compliance with Article 3(a) and (b) of the Regulation. Takeda appealed to the Patents Court.

Jacob J (as he then was) dismissed the appeal. In relation to Article 3(a) he held as follows:

“7.

Mr Alexander, for Takeda, submits that the combination of lansoprazole with an antibiotic, if sold, would infringe the patent (and for this purpose it matters not which). So, the combination is protected by a basic patent which is in force. So, Takeda comply with condition 3(a). Moreover, he submits, definition (b) specifically contemplates that ‘product’ may be a combination of active ingredients. So it is clear that condition 3(a) contemplates protection of a combination.

…

10.

Mr Birss, for the Comptroller, submits Mr Alexander's argument is flawed. I agree. The so-called ‘combination’ of lansoprazole and an antibiotic would only infringe because of the presence of the lansoprazole. In truth, the combination is not as such ‘protected by a basic patent in force’. What is protected is only the lansoprazole element of that combination. It is sleight-of-hand to say that the combination is protected by the patent. The sleight-of-hand is exposed when one realises that any patent in Mr Alexander's sense protects the product of the patent with anything else in the world. But the patent is not of course for any such ‘combination’.

11.

I think the position is absolutely clear. I am not surprised to find that the Swedish courts think so too. A/B Hassle sought an SPC for a combination of two active ingredients. Only one of these was covered by a patent. The Swedish Patent Office, the Patent Appeal Court and the Supreme Administrative Court unanimously concluded that there was no compliance with Art.3(a). (Case number 3248-1996).

12.

The Swedish courts thought the point was acte clair and refused to make a reference to the Court of Justice. I think so too. The SPC system is to provide supplementary protection to that provided by the patent—to extend the relevant part of the patent monopoly. It is not a system for providing protection for different monopolies. Here, Takeda's monopoly is in lansoprazole. The monopoly which they seek is a combination of lansoprazole and an antibiotic. The fact that that combination might infringe the monopoly given by the patent simply because one component infringes is irrelevant. Accordingly, I uphold Mr Walker's decision in relation to Art.3(a).”

In Gilead Sciences Inc’s SPC Application [2008] EWHC 1902 (Pat) Gilead had obtained a patent for a new class of antiretroviral compounds useful in the treatment of HIV and other diseases, including tenofovir. Claim 1 of the patent was directed to the class of compounds and claim 25 to tenofovir itself.

Paragraph [0047] of the patent stated:

“While it is possible for the active ingredients to be administered as pure compounds it is preferable to present them as pharmaceutical formulations. The formulations of the present invention comprise at least one active ingredient, as above defined, together with one or more acceptable carriers and optionally other therapeutic ingredients.”

Claim 27 of the patent was as follows:

“A pharmaceutical composition comprising a compound according to any one of claims 1-25 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients.”

Gilead obtained a marketing authorisation for a product containing tenofovir and another antiretroviral called emtricitabine. It applied for an SPC in respect of the combination of tenofovir and emtricitabine. The application was refused by the hearing officer for non-compliance with Article 3(a) of the Regulation. Gilead appealed to the Patents Court on two grounds. The first was that Takeda was wrongly decided, and that the correct test is the infringement test. The second was that Takeda was distinguishable on the facts.

Kitchin J allowed the appeal on the second ground. Accordingly, the part of his judgment dealing with the first ground is obiter. Since it was relied upon by Astellas before me, however, I shall set it out:

“23.

I would begin by noting that if Gilead's first submission is correct then the product is protected not just by claim 27 but also by claims 1 and 25, and that is precisely the argument rejected by Jacob J in Takeda. It would mean that the holder of a basic patent could first obtain an SPC for the active ingredient the subject of the patent, so giving him perhaps one or two years of protection beyond the life of the patent, and then, some years later, obtain another SPC for a combination of the same ingredient together with another active ingredient and so gain protection for a full five years beyond the life of the patent. That, it may be said, is contrary to the purpose of the Regulation which is to provide an effective period of protection for the invention the subject of the patent and so encourage research, and not to provide an extension of protection based upon the adoption of another, possibly quite different, ingredient. I believe this reasoning underpins the decision in Takeda and it plainly provides powerful support for the Comptroller's position.

24.

There are, however, other matters which bear on this issue and which do not appear to have been explored in argument before the court in Takeda. The first is the decision of the European Court of Justice in Case C-392/97 Farmitalia Carlo Erba Srl's Supplementary Protection Certificate [2000] RPC 580. This primarily concerned the question whether the Regulation requires an SPC to be restricted to the particular form of the active ingredient described in the medicinal authorisation. The Court held it does not and that an SPC is capable of covering the product, as a medicinal product, in any of the forms enjoying the protection of the basic patent. As a secondary question the Court was asked, in substance, what are the criteria for determining whether or not a product is protected by a basic patent? The Court answered that, in the absence of Community harmonisation of patent law, the extent of patent protection can be determined only in the light of non-Community rules which govern patents. As both parties before me were disposed to accept, this ruling suggests I must determine whether the product is protected as a matter of English law.

25.

Second, s.125 of the Patents Act 1977 defines the extent of protection of a patent as being that specified in a claim as interpreted in the light of the specification. For this purpose the Protocol on the Interpretation of Article 69 of the EPC applies and this too refers to the extent of protection conferred by a patent and how it is to be understood. These two provisions make it clear that a product is protected by a patent within the meaning of the Act if it falls within the scope of a claim.

26.

Third, no other provision of domestic law addresses the issue of protection of a product by a patent. This suggests the Court of Justice in Farmitalia must have had the infringement test and, for Contracting States to the EPC, Article 69 in mind. Anything less would have required the Court to interpret the term "protected" in the context of the Regulation as having a particular and different meaning, and that was something it declined to do. Certainly that appears to be the understanding of a number of other Member States, including Germany, as illustrated by the decision of the Federal Supreme Court in Case X ZB 12/00 of March 12, 2002.

27.

Fourth, it must be remembered that the monopoly conferred by an SPC for a product consisting of both tenofovir and emtricitabine would be narrower and comprised wholly within a monopoly for tenofovir alone. It would be, in effect, a monopoly for tenofovir only when used with emtricitabine.

28.

Fifth, I can envisage circumstances where the application of the Takeda test may produce a harsh result. For example, the holder of a patent for a new pharmaceutical may have chosen to market it only in combination with another active ingredient and duly secured a marketing authorisation for the medicinal product containing those ingredients. In such a case the product would appear to be the combination of active ingredients (Article 1(b)) for which authorisation has been obtained (Article 3(b)). Yet, upon an application of the Takeda test, it would not be protected by the basic patent and hence the inventor would be deprived of an opportunity to secure any SPC at all.

29.

A possible answer, canvassed briefly before me in argument, is to regard such a medicine as containing, effectively, three products, that is to say the two active ingredients separately and in combination. In such a case an SPC could then be granted for the ingredient claimed by the basic patent. This solution has its attractions and would permit the holder of the basic patent claiming only one of two active ingredients to secure an SPC for that particular ingredient, assuming, of course, it is not already the subject of a certificate (Article 3(c)) and the authorisation is the first authorisation to place that ingredient on the market in a medicinal product (Article 3(d)). However, it must depend upon the proper interpretation of, at least, Articles 1(b) and 4 and it is my initial impression that it is hard to reconcile with the words of Article 4 which specify that protection shall extend only to the product covered by the marketing authorisation.

30.

These are difficult questions and they raise a serious issue as to whether the decision in Takeda is correct. I believe they merit further consideration by a higher court and perhaps even the Court of Justice. In that latter regard, it is my understanding the Court of Justice has not yet considered how the requirements of the Regulation are to be interpreted in the case of a medicinal product consisting of a combination of active ingredients where only one is claimed in the basic patent. It may require a development of the reasoning in Farmitalia. But in this case and in the light of my conclusion on the second submission advanced by Gilead, it is not necessary for me to express a final conclusion and, in the circumstances, I prefer not to do so.”

Kitchin J’s reasoning for allowing the appeal on the second ground was as follows:

“31.

I come then to the narrower ground of appeal. Gilead says that this is not a case where the basic patent only discloses and claims the use of one of the active ingredients of the product. Here claim 27 is specifically directed to a medicinal product containing a combination of active ingredients and hence there can be no doubt that the combination of tenofovir and emtricitabine is protected as such within the meaning of Articles 1(c) and 3(a). So, it says, the facts of this case are materially different from those in Takeda and, indeed, the reasoning in that case should have led the Hearing Officer to accept this application.

…

33.

… I believe a test emerges from Takeda which is clear and can be applied without difficulty to a product comprising a combination of active ingredients. It is to identify the active ingredients of the product which are relevant to a consideration of whether the product falls within the scope of a claim of the basic patent. It is those ingredients, and only those ingredients, which can be said to be protected within the meaning of the Regulation. So, in the case of a product consisting of a combination of ingredients A and B and a basic patent which claims A, it is only A which brings the combination within the scope of the monopoly. Hence it is A which is protected and not the combination of A and B.

34.

Application of the test in the context of this appeal produces a ready answer. The product comprises two active ingredients, tenofovir and emtricitabine. It falls within the scope of claims 1 and 25 of the basic patent, but only because of the presence of tenofovir. Hence, on the Takeda test, claims 1 and 25 do not protect the product within the meaning of the Regulation. However, claim 27 is directed to a composition comprising tenofovir (amongst other compounds) together with a carrier and optionally other active ingredients. The product falls within this claim too and it does so, in so far as the claim is directed to a combination, as result of the presence of both tenofovir and emtricitabine.

35.

The product comprising the combination of tenofovir and emtricitabine is therefore protected by claim 27 within the meaning of Articles 1(c) and 3(a) of the Regulation, and that is so whether the infringement test or the Takeda test is adopted. I feel some support for this conclusion because I understand that an equivalent SPC has been granted in France, although I recognise from investigations kindly carried out at my request by the Comptroller and supplied to me after the hearing that practice is not consistent across all Member States.”

Astellas’ first ground of appeal is that the reasoning of Kitchin J in Gilead with regard to the second ground of appeal in that case is applicable to the present case.

The basis for this contention is claim 19 of the Basic Patent, which is as follows:

“An anthelmintic agent which comprises a compound or a pharmaceutically acceptable salt thereof of any of claims 1 to 11 and 14 as an active ingredient.”

Astellas accepts that the specification of the Basic Patent does not disclose the use of any of the claimed compounds with any other active ingredient. Nevertheless, Astellas contends that claim 19 implicitly claims a combination of one of the claimed compounds such as emodepside with another active ingredient such as praziquantel. The basis for this contention is that, on its true construction, claim 19 is for an anthelmintic (i.e. anti-worm) agent which “comprises” (that is to say, includes) one of the claimed compounds as “an” (not “the”) active ingredient, and thus can include another active ingredient if it has anthelmintic activity.

I agree that the word “comprises” in a patent claim normally means “includes” and not “consists” of: see the European Patent Office’s Guidelines for Examination (April 2009 edition), Part C Chapter III paragraph 4.13. There is nothing in claim 19 or the specification of the Basic Patent to suggest that it should bear a different meaning in the context of claim 19.

I therefore accept that the effect of the word “comprises” is that claim 19 on its true construction covers products which include substances other than the compounds of claims 1-11 and 14. These may include an excipient, but they may also include another compound with anthelmintic activity. This conclusion is supported by the use of the wording “an active ingredient”.

I do not accept that it follows that claim 19 discloses a combination of a compound of claims 1-11 and 14 with another compound with anthelmintic activity. A claim may cover a product without disclosing it: see A.C. Edwards Ltd v Acme Signs & Displays Ltd [1992] RPC 131.

Accordingly, I accept that Profender is covered by claim 19. If one asks oneself what brings Profender within the scope of claim 19, however, it is clear that it is the presence of the empodepside. It is not the presence of the praziquantel, any more than it is the presence of the BHA.

Applying the test articulated by Kitchin J in Gilead at [33], namely “to identify the active ingredients which are relevant to a consideration of whether the product falls within the scope of a claim of the basic patent”, I consider that the answer in the present case is that it is only empodepside which is relevant. Accordingly, Profender is not protected by claim 19 of the Basic Patent within the meaning of Article 3(a) of the Regulation as interpreted in Gilead.

To put the same point another way, the present case is to be distinguished from Gilead. In that case the basic patent specifically disclosed and claimed a combination of active ingredients, whereas in this case the Basic Patent does not.

Astellas’ second ground of appeal is the same as the first ground in Gilead. Astellas contends that Takeda was wrongly decided and that the correct test to apply under Article 3(a) of the Regulation is the infringement test.

Counsel for Astellas supported the five reasons given by Kitchin J in Gilead for questioning the correctness of Takeda. In particular, he submitted that Takeda is inconsistent with the ECJ’s ruling on the second question in Farmitalia that to determine whether a product is protected by a basic patent reference must be made to the national law governing the patent. He argued that this must mean determining whether the product falls within the scope of protection of the patent in accordance with section 125 of the Patents Act 1977 and Article 69, and the Protocol on the Interpretation of Article 69, of the European Patents Convention. He also submitted that, in the light of Kitchin J’s judgment, it could not be said that it was acte clair that the infringement test was wrong and that this question should be referred to the ECJ.

Counsel for the Comptroller submitted that none of the five points identified by Kitchin J justified the conclusion that the infringement test was the right test. In particular, she submitted that there is a distinction between the scope of protection of a patent and infringement: the scope of protection is limited to that specified in the relevant claim properly construed, whereas infringement is not so limited. A product which includes all the elements of the claim infringes, but so does a product which also includes additional elements which are not specified in the claim at all. Accordingly, she argued, it is the scope of protection which matters, not whether a product infringes. She also submitted that consideration of the Opinion of Advocate General Fennelly in Farmitalia leads to the conclusion that the ECJ rejected the infringement test in that case. Finally, she submitted that the matter remained acte clair. She acknowledged, however, that it is the Comptroller’s understanding that at least one Member State of the Community, namely Norway, applies the infringement test.

I am not convinced that Takeda is wrong. To my mind, Jacob J’s reasoning remains persuasive. Furthermore, I agree that there is a distinction between the scope of protection and the question of infringement. As to Farmitalia, it is not clear to me that the ECJ either endorsed or rejected the infringement test in that case. Nevertheless, I agree with Kitchin J that there are arguments in favour of the infringement test which do not appear to have been considered in Takeda and which merit consideration by a higher court and perhaps the ECJ.

I have considered whether it is appropriate to refer this question to the ECJ. If I were confident that the Court of Appeal would refer it, I would avoid delay by making a reference now. I am not confident that the Court of Appeal will refer it, however. I conclude that the decision whether to refer should be left to that Court.

Astellas’ third ground of appeal is one which does not appear to have been advanced in Gilead. Astellas contends that, where a marketing authorization is granted for a product containing a combination of active ingredients, an SPC can be obtained for that product even if the basic patent only covers one of those active ingredients.

This contention has been supported, albeit with slightly different arguments, in third party observations filed by Dr Gordon Wright, an experienced pharmaceutical patent attorney with a long-standing interest in SPCs. Dr Wright filed his observations under section 21 of the Patents Act 1977, which is applicable to SPCs by virtue of Schedule 4A paragraph 1. The Comptroller is bound to consider such observations, and accordingly counsel for the Comptroller did not object to my considering them. I should not be taken to accept that this is an appropriate method for filing what in substance amount to the submissions of an amicus curiae. Nevertheless, in the present case I have found them of assistance.

As a matter of the construction of the Regulation, this contention can I think be analysed as follows:

Counsel for Astellas submitted that this interpretation of the Regulation was supported by consideration of the purpose of the Regulation as identified in recitals 1, 2 and 4, namely to provide protection to encourage pharmaceutical research and thereby improve public health.

In addition, both counsel for Astellas and Dr Wright drew attention to the Commission’s Explanatory Memorandum COM(90) 101 final dated 11 April 1990 setting out the Proposal which led to the Regulation, and in particular the following paragraphs in the commentary to Article 4:

“38.

The supplementary protection certificate is a protection certificate sui generis inasmuch as it is linked to both an authorisation to place the product on the market (the first chronologically given in the State concerned) and to a previous patent (the basic patent). This is already evident from the conditions for obtaining a certificate, which require both that the basic patent is in force and that the authorisation is valid, failing which the certificate is void.

39.

The delimitation of the subject protected by the certificate also illustrates this duality since the protection given by the certificate is limited in two ways.

It is thus often the case in the chemical and pharmaceutical field that a patent protects a series of products based on the same formula. However, only some of these products will subsequently be developed and possibly only one may be put on the market. In such a case, the certificate will only protect the product covered by the authorisation and not all the products protected by the patent.

At the same time, the product authorised will itself be limited by the subject protected by the basic patent. If the basic patent protects a compound x, where the product authorised consists of a combination of compound x and another active ingredient only compound x will be protected by the certificate.

Furthermore, the certificate will protect only the product covered by the authorization, namely the product within the strict meaning of Article 2.”

Both counsel for Astellas and Dr Wright submitted that, particularly in the light of this passage, it is not acte clair that no SPC can be granted for the combination in such circumstances and that a question should be referred to the ECJ.

Counsel for the Comptroller submitted that it is clear from Article 3(a) and (b) that the one and the same product must be the subject of the marketing authorisation, protected by the basic patent and the subject of the SPC.

So far as the purpose of the Regulation is concerned, she submitted that its purpose is to provide an extension to the protection provided by the basic patent due to the delay in obtaining a marketing authorisation and not to protect or reward pharmaceutical research more widely, as shown by recital 3; and to ensure that the SPC system is transparent and certain, as shown by recital 9, and uniform, as shown by recitals 6 and 7.

As to paragraph 39 of the Explanatory Memorandum, she submitted that this is not relevant since it was not concerned with Article 3 at all. To the extent that it is relevant, she submitted that it supports the Comptroller’s position, since it makes it clear that, if the basic patent protects x, it is only x that can be the subject of an SPC even if the marketing authorisation is for x plus y.

Counsel for the Comptroller acknowledged, however, that, as Kitchin J noted in Gilead at [35], the practice of the Member States in this regard does not appear to be uniform. She drew to my attention the following passage in the record of the Second Meeting of National SPC Experts held in Brussels on 9 October 2006:

“Article 3.a) If an active substance A is protected by a patent and is permitted, within the active substance combination A-E-C-D, as a medicinal product (not separately as A). Should a patent office grant a SPC for the active substance A?

Practice is inconsistent between Member states. Some NPOs grant a SPC (one delegation pointed out paragraph 39 of the explanatory memorandum of the SPC Regulation). However, other NPOs follow a different practice on the ground that the basic patent does not cover the combination of the MA. Furthermore, the courts of certain MS have ruled in opposing ways on this matter.

More specifically, some MS will not grant a SPC if the patent does not cover the combination, if there is a combination of substances (i.e. antibiotics, with for example one named specifically and others only generically) claimed in the patent and the MA is for a product consisting of the specific antibiotic and a member of this generic class that can be identified with this patented combination, then the SPC could be granted.

The European Commission argued that it could be desirable to reach a common practice. This could also help to identify the relevant MA for cases in which the subject matter of the patent is ‘A’ and there is a MA for the product ‘A’ and also a MA for the combination ‘A+ B’ with different dates of granting.”

In my judgment the main problem with the third ground of appeal is that the crucial step in the argument, step (iii), is a disguised version of the infringement test, as I think Dr Wright recognised in his observations. If Takeda is correct in holding that the test under Article 3(a) is not the infringement test, then the argument breaks down at that point.

Moreover, so far as paragraph 39 of the Explanatory Memorandum is concerned, I agree with counsel for the Comptroller that, at best, this supports the grant of an SPC for A where the basic patent protects A and the marketing authorization is for A plus B. It does not support the grant of an SPC for A plus B.

This leads me to Astellas’ fall-back position, which is to contend that, if no SPC can be granted for the combination of emodepside and praziquantel, then it should be entitled to an SPC for emodepside, and accordingly it should be permitted to amend the Application to define the product as “emodepside”. In my judgment Astellas is not entitled to an SPC for emodepside. An application for such an SPC would not comply with Article 3(b) of the Regulation since Astellas has not been granted a marketing authorization for emodepside as opposed to Profender: see the recent decision of the Court of Appeal in Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd [2009] EWCA Civ 646, in particular at [57]-[58].

I have considered whether to refer a question about the correct treatment of applications for SPCs for combination products to the ECJ, but for the reasons given above I consider that this should be left to the Court of Appeal to decide.

For the reasons given above, I consider that the hearing officer’s decision was correct. The appeal is dismissed.