Astrazeneca AB v Comptroller-General of Patents, Designs and Trade Marks

On 11 December 2009 the Appellant (“AstraZeneca”) applied for a supplementary protection certificate for the product gefitinib, which is the active ingredient in a medicinal product marketed by AstraZeneca under the trade mark Iressa that is used to treat non-small-cell lung cancer, under European Patent (UK) 0 832 900 (“the Patent”), which will expire on 22 April 2016. By a decision dated 2 April 2012 (BL O/146/12, “the Decision”), Dr Lawrence Cullen, the Deputy Director of the UK Intellectual Property Office, acting on behalf of the Comptroller, decided that an SPC should be granted with an expiry date of 1 March 2019. The Deputy Director held that the duration of the SPC should be calculated by reference to a marketing authorisation granted by the Swiss regulatory authority on 2 March 2004 (“the Swiss MA”). AstraZeneca has appealed against that decision, contending that the correct expiry date is 22 April 2021. AstraZeneca argues that the duration of the SPC should be calculated by reference to a marketing authorisation granted by the European Medicines Agency (“EMA”) on 24 June 2009 (“the European MA”). It is common ground that the resolution of the appeal depends on two issues of interpretation of European Parliament and Council Regulation 469/2009/EC of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) (“the SPC Regulation”) upon which a preliminary ruling from the Court of Justice of the European Union is required.

The first European legislation concerning marketing authorisations for medicinal products was Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products. Directive 65/65/EECwas repealed and replaced by European Parliament and Council Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use, which has subsequently been amended, in particular by European Parliament and Council Directive 2004/27/EC of 31 March 2004. Article 6(1) of Directive 2001/83, as amended, provides in part:

“No medicinal product may be placed on the market of a Member State unless a marketing authorization has been issued by the competent authorities of that Member State in accordancewith this Directive or an authorization has been granted in accordance with Regulation (EC) No 726/2004….”

Council Regulation 2309/93/EEC of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products established a centralised procedure for obtaining a Community-wide authorisation. This was repealed and replaced byEuropean Parliament and Council Regulation 726/2004/EC of 31 March 2004, which has subsequently been amended. Regulation 726/2004 includes the following provisions:

“Article 3

1.

No medicinal product appearing in the Annex may be placed on the market within the Community unless a marketing authorisation has been granted by the Community in accordance with the provisions of this Regulation.

…

Article 4

1.

Applications for the marketing authorisations referred to in Article 3 shall be submitted to the Agency.

2.

The Community shall grant and supervise marketing authorisations for medicinal products for human use in accordance with Title II.

…

Article 13

1.

Without prejudice to Article 4(4) of Directive 2001/83/EC, a marketing authorisation which has been granted in accordance with this Regulation shall be valid throughout the Community. It shall confer the same rights and obligations in each of the Member States as a marketing authorisation granted by that Member States in accordance with Article 6 of Directive 2001/83/EC.

…”

The Annex includes the following paragraph:

“3.

Medicinal products for human use containing a new active substance which, on the date of entry into force of this Regulation, was not authorised in the Community, for which the therapeutic indication is the treatment of any of the following diseases:

…

- cancer,

…”

The SPC Regulation includes the following recitals:

“(3)

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.

(4)

At the moment, the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation 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.

(5)

This situation leads to a lack of protection which penalises pharmaceutical research.

(6)

There exists a risk of research centres situated in the Member States relocating to countries that offer greater protection.

(7)

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.

(8)

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 authorisation has been granted is necessary. A regulation is therefore the most appropriate legal instrument.

(9)

The duration of the protection granted by the certificate should be such as to provide adequate effective protection. For this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains authorisation to be placed on the market in the Community.

(10)

All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector should nevertheless be taken into account. For this purpose, the certificate cannot be granted for a period exceeding five years. The protection granted should furthermore be strictly confined to the product which obtained authorisation to be placed on the market as a medicinal product.”

Articles 2, 3 and 13(1) and (2) of the SPC Regulation provide:

“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 authorisation procedure as laid down in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use or Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products 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 authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;

(c)

the product has not already been the subject of a certificate;

(d)

the authorisation referred to in (b) is the first authorisation to place the product on the market as a medicinal product.

Article 13

Duration of the certificate

1.

The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community, reduced by a period of five years.

2.

Notwithstanding paragraph 1, the duration of the certificate may not exceed five years from the date on which it takes effect.”

The SPC Regulation repealed and replaced Council Regulation 1768/92/EEC (as amended by the Act of Accession of Austria, Sweden and Finland), Article 19(1) of which provided in part:

“Any product which on the date of accession is protected by a valid patent and for which the first authorization to place it on the market as a medicinal product in the Community or within the territories of Austria, Finland or Sweden was obtained after 1 January 1985 may be granted a certificate.

In the case of certificates to be granted in Denmark, in Germany and in Finland, the date of 1 January 1985 shall be replaced by that of 1 January 1988.

…”

The Principality of Liechtenstein is one of the Contracting Parties to the EEA Agreement, as are all of the Member States of the European Union. The EEA Agreement includes the following provisions:

“Article 7

Acts referred to or contained in the Annexes to this Agreement or in decisions of the EEA Joint Committee shall be binding upon the Contracting Parties and be, or be made, part of their internal legal order….

Article 23

Specific provisions and arrangements are laid down in:

(a)

Protocol 12 and Annex II in relation to technical regulations, standards, testing and certification;

…

Article 65

…

2.

Protocol 28 and Annex XVII contain specific provisions and arrangements concerning intellectual, industrial and commercial property, which, unless otherwise specified, shall apply to all products and services.”

Chapter XIII of Annex II to the EEA Agreement, as amended by Decisions 82/2002 and 61/2009 of the EEA Joint Committee, refers to Directive 2001/83 and Regulation 726/2004.

Point 6 of Annex XVII to the EEA Agreement, as amended by Annex 15 to Decision 7/94 of the EEA Joint Committee, refers to Regulation 1768/92. It also provides that Regulation 1768/92 should, for the purposes of the EEA Agreement, be read with certain adaptations.

Point 8 of Protocol 1 to the EEA Agreement provides, that, whenever the acts referred to in the Annexes to the EEA Agreement:

“contain references to the territory of the ‘Community’ or of the ‘common market’ the references shall for the purposes of the Agreement be understood to be references to the territories of the Contracting Parties as defined in Article 126 of the Agreement.”

It follows that, for the purposes of the EEA Agreement, Articles 2 and 13 of the SPC Regulation are to be read as if the references to “the Community” were replaced by “the EEA”, while Article 3(b) is to be read with the following adaptation (in bold):

“a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate; for the purposes of this subparagraph and the Articles which refer to it, an authorization to place the product on the market granted in accordance with the national legislation of the EFTA State shall be treated as an authorization granted in accordance with Directive 65/65/EEC [now 2001/83/EC] or Directive 81/851/EEC [now 2001/82/EC] as appropriate”.

There has been a customs union between Switzerland and Liechtenstein since 1924. Since 1980, this has extended to patents, a sphere in which a single patent office (the Swiss one) operates, which grants patents effective in both territories. Furthermore, in 2004 marketing authorisations for medicinal products granted by one country were automatically recognised in the other. (Since 2006, a so-called “negative list” procedure has been in force for marketing authorisations in Switzerland and Liechtenstein, which means that medicinal products approved in Switzerland may not be approved for use in Liechtenstein until up to 12 months later.)

Annex II to the EEA Agreement, as amended by Annex 2A to Decision 1/95 of the EEA Council of 10 March 1995, establishes the “principle of parallel marketability”, as follows:

“For products covered by the acts referred to in this Annex, Liechtenstein may apply Swiss technical regulations and standards deriving from its regional union with Switzerland on the Liechtenstein market in parallel with the legislation implementing the acts referred to in this Annex. Provisions on free movement of goods contained in this Agreement or in acts referred to shall be applicable to exports from Liechtenstein to the other Contracting Parties only to products in conformity with the acts referred to in this Annex.”

Annex 10 to Decision No 1/95 of the EEA Council provides:

“In view of the patent union between Liechtenstein and Switzerland, Liechtenstein shall not deliver any supplementary protection certificates for medicinal products as laid down in this Regulation.”

The factual background is set out in the Decision at [31]-[42]. It may be summarised as follows. In July 2002 AstraZeneca submitted an application to the Swiss Institute for Medicinal Products (known as SwissMedic) for a marketing authorisation for Iressa in Switzerland. The application was based upon the data from two Phase II studies. The Swiss MA was granted under a “fast-track” procedure on 2 March 2004. The authorisation was, however, conditional on the provision of further clinical data to demonstrate the effects of Iressa.

By virtue of the customs and patent union between Switzerland and Liechtenstein, under the Liechtenstein legislation as it stood in 2004, the Swiss MA was automatically recognised in Liechtenstein. As a consequence, the first authorisation to put gefitinib on the market as a medicinal product in Liechtenstein was the Swiss MA on 2 March 2004. Whilst there is no direct evidence that any sales of Iressa in Liechtenstein were actually made during the following period, indirect sales via wholesalers cannot be ruled out.

The Swiss MA was suspended by SwissMedic on 24 October 2005. From that date, it was no longer possible to market Iressa in Switzerland or Liechtenstein (save for supply to individual patients specifically approved by SwissMedic).

In January 2003 AstraZeneca submitted an application to the EMA for a European marketing authorisation for Iressa under Regulation 2309/93. The Committee for Proprietary Medicinal Products (now the Committee for Medicinal Products for Human Use or CHMP) was not willing to grant a marketing authorisation on the basis of the Phase II studies. Furthermore, the data generated by a Phase III study did not enable AstraZeneca to answer questions which had been raised by the CHMP, and so AstraZeneca withdrew the application in January 2005.

In May 2008 AstraZeneca re-submitted its application to the EMA with a refined therapeutic indication, supported by further studies which had been undertaken to address the CHMP’s concerns with the original application. On the basis of all the data, the European MA was granted on 24 June 2009.

In June 2008 AstraZeneca applied to SwissMedic to lift the suspension of the Swiss MA and to amend the indications for Iressa, relying upon the further studies. The suspension was lifted on 8 December 2010, after which it was permissible for AstraZeneca to put Iressa back on the market in Switzerland and Liechtenstein.

The duration of an SPC in accordance with Article 13(1) of the SPC Regulation can be calculated using the following formula:

The Comptroller contends that in the present case the first authorisation was the Swiss MA. Using the formula above, the duration is calculated as follows:

AstraZeneca contends that the first authorisation was the European MA, and hence the duration is calculated as follows:

The issues arising on this appeal involve consideration of a number of decisions of the Court of Justice of the European Union, which I shall take in chronological order.

In Case C-110/95 Yamanouchi Pharmaceutical Co Ltd v Comptroller-General of Patents, Designs and Trade Marks [1997] ECR I-3266 Yamanouchi applied to the UK Patent Office on 15 January 1993 for an SPC relying upon a UK patent and marketing authorisation obtained by its licensee Ciba-Geigy in France on 29 June 1990. The UK regulatory authority did not grant a marketing authorisation until 17 August 1995. The application was refused, and Yamanouchi appealed to the Patents Court. The Patents Court referred to the Court of Justice a question the essence of which was whether the grant of an SPC pursuant to Article 19 of Regulation 1768/92 was conditional upon a marketing authorisation having been obtained in the Member State in which the application was submitted at the date of the application in accordance with Article 3(b). The Court of Justice answered that question in the affirmative.

In reaching this conclusion, the Court held:

“23.

As is apparent from Article 13, the condition imposed by Article 19(1) in respect of the first marketing authorization in the Community is necessary only for the purposes of determining the duration of the certificate. Thus, Article 8(l)(a)(iv) and (c) and Article 9(2)(e) of the regulation lay down an obligation to provide information concerning that first marketing authorization in support of an application for a certificate, in order to ensure that the competent industrial property authority receiving the application has available to it the information needed in order to determine the duration of the certificate. Article 11(l)(e) provides that that information is to appear in the notification of the grant of the certificate which is published for the information of the public.

24.

However, the effect of Articles 8(l)(a)(iv) and (b), 9(2)(d) and 11(l)(d) is that the first marketing authorization in the Community is not intended to take the place of the marketing authorization provided for in Article 3(b) of the regulation, that is to say, the authorization granted by the Member State in which the application is submitted; instead, it constitutes a further condition applying in the event that the latter authorization is not the first authorization to place the product on the market as a medicinal product in the Community. The first marketing authorization in the Community therefore serves a purely temporal purpose.

25.

By referring to the first marketing authorization in the Community, the regulation is designed to exclude the possibility that, in Member States in which there has been significant delay in the grant of authorization to place a given product on the market, a certificate can still be granted even though that is no longer possible in the other Member States in which the authorization in question has been granted before expiry of the deadline. The regulation is thus intended to prevent the grant of certificates whose duration varies from one Member State to another. In those circumstances, Article 19(1) cannot be construed as meaning that the existence of an authorization in the Member State in which the certificate is sought is of no relevance.

26.

On the contrary, it is the authorization referred to in Article 3(b) of the regulation which confers entitlement to the certificate. That principle is borne out by Article 4, according to which the protection conferred by the certificate extends only to the product covered by the marketing authorization in respect of the corresponding medicinal product. Entitlement to the certificate is strictly linked, therefore, to the existence of a marketing authorization granted in the Member State in which the application is submitted and to the date of that application.”

In Case C-127/00 Hässle AB v Ratiopharm GmbH [2003] ECR I-14814 Hässle was the proprietor of a European patent which covered omeprazole. Companies in the Hässle group obtained marketing authorisations for medicinal products having omeprazole as their active ingredient in accordance with Directive 65/65 in France, Luxembourg and Germany on 15 April 1987, 11 November 1987 and 6 October 1989 respectively. In order for the medicinal products to be marketed in Luxembourg, they also had to receive authorisation under pricing legislation, which was granted on 17 December 1987, and to be included a list of medicinal products authorised for sale in the Grand Duchy, which occurred on 21 March 1988. In France, omeprazole was included in the list of products eligible for reimbursement under the social security scheme on 22 November 1989. On 9 June 1993 Hässle applied to the German Patent Office for an SPC for omeprazole, giving 21 March 1998 and Luxembourg as the date and place of the first authorisation to place the product on the market in the Community. The German Patent Office granted the SPC. Ratiopharm applied for a declaration that the SPC was invalid on the ground that the first authorisation to place medicinal products containing omeprazole on the market in the Community had already been granted before the relevant transitional date, which under Article 19(1) of Regulation 1768/92 was 1 January 1988 for Germany. The Bundesgerichtshof referred four questions of interpretation of Regulation 1768/92 to the Court of Justice.

The Court interpreted the first part of the first question as asking whether the words “first authorisation to place … on the market” in Article 19(1) referred solely to a marketing authorisation in accordance with Directive 65/65 or whether it could also include authorisations required under national legislation on the pricing of, or reimbursement for, medicinal products. The Court ruled that they referred solely to a marketing authorisation in accordance with Directive 65/65. Part of the Court’s reasoning was as follows:

“56.

First, neither Article 19 of Regulation No 1768/92, nor any other provision of that regulation, nor the recitals therein mentions, whether expressly or by implication, any authorisation other than that relating to provisions on medicinal products in accordance with Directive 65/65, and in particular no mention is made of any authorisation issued by the competent national authorities with regard to the fixing of prices or reimbursement for medicinal products. The scope of Regulation No 1768/92 is specifically defined, in Article 2 thereof, as extending to products protected by a patent which are subject, prior to being placed on the market as medicinal products, to an administrative authorisation procedure as laid down in Council Directive 65/65.

57.

There is thus nothing to justify the words ‘authorisation to place ... on the market’ being interpreted differently depending on which provision of Regulation No 1768/92 they appear in. In particular, those words cannot be construed as having a different meaning according to whether they appear in Article 3 or Article 19, especially when it is apparent from Article 8(1)(a)(iv) and (c) that the marketing authorisation referred to in Article 3(b) may also be the first marketing authorisation in the Community.

58.

It follows therefrom that the ‘first authorisation to place ... on the market ... in the Community’, mentioned in, among others, Article 19(1) of Regulation No 1768/92, must, like the ‘authorisation to place ... on the market’ mentioned in Article 3 of that regulation, be a marketing authorisation issued in accordance with Directive 65/65.”

The Court interpreted the second part of the first question as asking whetherthe words “first authorisation to place … on the market … in the Community ” in Article 19(1) referred to the first marketing authorisation in the Member State in which the application was submitted or the first marketing authorisation in any of the Member States. The Court ruled that they referred to the first marketing authorisation granted in any of the Member States. Part of the Court’s reasoning was as follows:

“ 72. In that connection, as stated in paragraph 57 of the present judgment, the words ‘first authorisation to place ... on the market’ must not be interpreted differently depending on the provision of Regulation No 1768/92 in which they appear. The same is particularly true of the words ‘first authorisation to place ... on the market ... in the Community’ (see, to that effect, Yamanouchi Pharmaceutical, cited above, paragraphs 23 and 24).”

The Court went on to answer the third question by ruling that an SPC issued where the first marketing authorisation in the Community was obtained prior to the relevant date fixed by Article 19 was invalid: see [84]-[92].

As Floyd J pointed out in Synthon BV v Merz Pharma GmbH & Co KgaA [2009] EWHC 656 (Pat), [2009] RPC 20 at [33], it is important to note that the issue in Hässle was whether something additional to a Directive 65/65-compliant authorisation was required, and that is different from the question of whether something less will do.

In Joined Cases C-207/03 and C-252/03 Novartis AG v Comptroller-General of Patents, Designs and Trade Marks [2005] ECR I-3209 Novartis AG and University College London applied to the UK Patent Office for an SPC for basiliximab and Novartis and the Institute of Microbiology and Epidemiology applied for an SPC for a combination of artemether and lumefantrin. On 7 April 1998 and 22 January 1999 respectively, the Swiss authority granted marketing authorisations for basiliximab and for the combination of artemether and lumefantrin. Those authorisations were automatically recognised in Liechtenstein. Basiliximab and the combination of artemether and lumefantrin were granted marketing authorisations in the UK on 9 October 1998 and 30 November 1999 respectively.

In a decision dated 12 February 2003 (BL O/44/03) R. J. Walker, the Deputy Director of the Patent Office, acting for the Comptroller, held that the duration of the SPCs should be calculated by reference to the dates when the Swiss marketing authorisations were granted. The applicants appealed to the Patents Court, contending that the duration of the SPCs should have been calculated by reference to the first marketing authorisations granted within the Community i.e. the UK authorisations. The Patents Court referred the following question to the Court of Justice:

       “Is the date of the granting of a marketing authorisation in Switzerland, which is automatically recognised in Liechtenstein, to be considered as the first authorisation to place a medicinal product on the market, for the purpose of calculating the duration of a supplementary protection certificate as provided in Article 13 of Regulation No 1768/92 (as amended by the EEA Agreement)?”

A similar question was also referred by Cour administrative of Luxembourg in a parallel case.

The Court ruled that, in so far as a Swiss marketing authorisation automatically recognised in Liechtenstein under that State’s legislation is the first authorisation to place the product on the market in a State of the EEA, it constituted the first authorisation to place the product on the market within the meaning of Article 13 of Regulation 1768/92, as it was to be read for the purposes of the EEA Agreement.

AstraZeneca contends that this decision is inconsistent with the Court’s earlier judgment in Hässle, with its later judgment in Synthon (as to which, see below) and with the primary purpose of the SPC Regulation. It is therefore necessary to consider the reasoning supporting the ruling with some care.

In his Opinion Advocate General Ruiz-Jarabo Colomer explained in footnote 4 why Swiss marketing authorisations were automatically recognised in Liechtenstein even though Liechtenstein had established its own system of marketing authorisations:

“Since 1973, by virtue of an exchange of notes (LGBl. 1973 No 20/1), Liechtenstein has automatically recognised authorisations granted by the Interkantonale Kontrollstelle (Swiss Institute for the Control of Medicinal Products), a body which is regulated in the Interkantonale Vereinbarung (Amtliche Sammlung des Bundesrechts – ‘AS’ – 1972, 1026; LGBl. 1973 No 20/2). Between 1990 and 2001, it applied the Heilmittelgesetz (Law on medicinal products) of 24 October 1990 (LGBl. 1990, No 75), Article 7(2) of which merely provided that a medicinal product could be marketed once it was registered at the abovementioned Swiss body. By virtue of the Arzneimittelgesetz-EEE (Law on the marketing of pharmaceutical products in the EEA), of 18 December 1997 (LGBl. 1998 No 45), Liechtenstein established, with effect from 1 May 1998, a system of authorisations in keeping with Community requirements, as a result of the obligations deriving from its membership of the EEA. On 15 December 2000, in order for it to enter into force on 1 January 2001, Switzerland adopted the Heilmittelgesetz (Systematische Sammlung des Bundesrechts – ‘SR’ – 812.21), which replaced the Interkantonale Vereinbarung and set up a new body (the Schweizerisches Heilmittelinstitut – Swiss Institute for Medicinal Products), which was the successor to the Interkantonale Kontrollstelle. The result of these two pieces of legislation and the exchange of notes of 11 December 2001 (AS 2002, 2788) is that two sets of rules on authorisation coexist in Liechtenstein: the Swiss rules, which are effective in the customs union with Switzerland, and Liechtenstein’s own rules, which comply with the requirements of the EEA.”

The Advocate General began his legal analysis by considering the position concerning medicinal products in Liechtenstein as follows (footnote omitted):

“39.

The principle of parallel marketability, enunciated in Annex II to the EEA Agreement, derives from Liechtenstein’s involvement in distinct economic areas, which are governed by different, irreconcilable sets of rules. Two legal systems meet in one place: one governs relations between Switzerland and Liechtenstein, the other regulates the latter’s membership of the EEA. If there is no conflict between the systems, they are permeable; as a general rule, nothing prevents a product from Switzerland moving from the territory of its partner to that of another EEA member, and vice versa. If, on the other hand, there is conflict, the barriers are raised and the markets are sealed, so that goods authorised in Liechtenstein can be exported to the other Contracting Parties to the Agreement only if they comply with EAA [sic] rules.  In conclusion, goods which enjoy unimpeded freedom of movement within the customs union do not, merely because of that, enjoy the same freedom within the EEA.

40.

As a consequence, both medicinal products authorised under EEA law and others covered by the Swiss system are found on the Liechtenstein market but, because of the principle of parallel marketability referred to above, the Swiss authorisations, which are automatically effective in the framework of the agreement with Liechtenstein, only allow the medicine to enter other States party to the Agreement if it satisfies the requirements laid down by the applicable legislation: Directives 65/65 and 81/851 (now Directive 2001/83, as amended by Directives 2004/27 and 2004/24). Therefore, it is quite clear that medicinal products originating in Switzerland cannot be automatically marketed within the EEA. As I explained in note 4, since 1 May 1998 and as a result of the Arzneimittelgesetz-EEE, Liechtenstein has been granting marketing authorisations in accordance with Community law, which confirms that the authorisations granted by Switzerland are of no relevance outside the boundaries of the customs union between the two countries.

41.

However, does this non-conformity on which all the parties submitting observations are agreed, make it possible to disregard the authorisations when calculating how long supplementary protection is to last? The answer must be sought in the objective of the regulation.”

The Advocate General next considered the purpose of Regulation 1768/92 at [42]-[46]. In this context he stated:

“43.

There can be no question that, for the purpose of replying to the referring courts, it is irrelevant that the marketing authorisations granted in Switzerland do not enable the medicinal products which they protect to be traded within EEA territory, other than Liechtenstein. That is also shown by the fact that authorisations conferred by the Member States under Directives 65/65 and 75/319 and the new Directive 2001/83, as recently amended, do not make it lawful for the product to be freely marketed in other Member States.”

The Advocate General then considered the effect of marketing a medicinal product in a part of the EEA. Having pointed out at [47]-[48] that the SPC Regulation extended the protection afforded to medicinal products in a uniform manner, citing Yamanouchi at [25], he went on (footnotes omitted):

“49.

The purpose of the regulation is not to standardise marketing authorisations but to set up a single system of extended protection and, as regards ensuring that the period of exclusive use lasts for the same time throughout the EEA, the decisive factor is the date on which that use commences, namely the date from which the drug can be lawfully marketed in a part of the EEA,  regardless of where, and regardless of the enabling document – it could be a national authorisation issued by a Member State under the directives referred to above, it could be a centralised authorisation granted under Council Regulation No 2309/93 (now Regulation (EC) No 726/2004), or it could be another document which, under the legislation in force, enables it to be lawfully marketed.

50.

The latter category includes … both authorisations granted by the EFTA States under their various national laws, which are not in conformity with the sectoral directives, and authorisations granted by the Swiss authorities, which clearly do not comply with the requirements of Community law either, because both types of authorisation allow the medicinal products to be marketed in a part of the EEA. … The reference point is the fact – the legally relevant fact – that the medicines can lawfully be marketed in a part of the EEA, and it is irrelevant whether that occurs by virtue of a document which permits free movement throughout the EEA. 

51.

The risk, mentioned by one of the interveners, of the consequences of an agreement – the customs union between Liechtenstein and Switzerland – being extended beyond its strict limits – to the other EEA States – in breach of the principles which prevail in international law, is thereby avoided, because it is not a rule of an external legal order which is rendered effective but rather an event with legal significance which occurs in its own legal order. ”

The Advocate General then considered and rejected a number of arguments to the contrary at [53]-[61]. In this context he said:

“53.

The Court of Justice acknowledged in its judgment in Hässle that the ‘first authorisation to place [a product] on the market as a medicinal product in the Community’ must be a marketing authorisation issued in accordance with Directive 65/65 in any of the Member States (paragraphs 58 and 78 and the second paragraph of the operative part). However, this finding must not be taken out of context: it shows, first, that the intention was to exclude other types of authorisations from the matters covered, such as authorisations relating to prices of, or reimbursement for, medicinal products; second, in Hässle, no Member State of the EEA which was not also a Member of the European Union was involved in the facts of the case before the national courts and consequently it was not necessary to refer to the text of Regulation No 1768/92, as varied by the EEA Agreement and the protocols and annexes thereto and by the decisions adopted by the decision-making bodies of the EEA.

54.

As the Court observed in its judgment in Hässle (paragraph 72), the terms ‘first authorisation to place … on the market’ or ‘first authorisation to place … on the market as a medicinal product in the Community’ must not be interpreted differently depending on the provision of Regulation No 1768/92 in which they appear. In conclusion, when Article 13 refers to that notion, it also includes authorisations granted under the national law of the EFTA States because that is how Article 3(b) and Article 19(1) read in the wording attributed to them by Annex XVII (point 6) to the EEA Agreement, as adopted by Decision No 7/94 of the Joint Committee….

55.

Further, Liechtenstein cannot issue supplementary protection certificates, something which, as the Commission reasons, is the logical consequence of not awarding patents and which has no significance for the purpose of answering the question referred, since the cardinal point, as I have already stated, is the time from when a medicinal product can be lawfully marketed in a part of the EEA, a fact which allows the final day of the period to be fixed when calculating the extended protection. …

…

57.

What is more, [the approach advocated by Novartis and others] would disregard Regulation No 1768/92’s objective of recognising that the holder of a patent and a certificate should be able to enjoy a maximum of 15 years of exclusivity in the Community (8th recital). Following the scheme of the regulation for basiliximab, for example, Novartis and others would enjoy that exclusivity until 8 October 2013 (see note 29), having been able to market the product in the EEA since 7 April 1998 by virtue of the authorisation granted on that date by the Swiss authorities, which was valid in Liechtenstein.

…

61.

… I have already argued that it was clearly the intention of the framers of [Decision 7/94] to take account of authorisations issued by the EFTA States regardless of the Community rules: that is clearly also the case as regards the Swiss authorisations, which, by reason of the agreement with Liechtenstein, are automatically effective in Liechtenstein, an integral part of the EEA. Furthermore, the EEA Council, in its Decision 1/95 (Annex 10), stated, after referring to Decision No 7/94 of the Joint Committee, that Liechtenstein would not issue any supplementary protection certificates but did not deem it necessary to introduce the qualification that, wherever reference was made to authorisations granted in accordance with the national legislation of the EFTA States, authorisations were not to be included which, issued by a member (Switzerland), facilitated the marketing of medicinal products in Liechtenstein.”

It can be seen from these passages that the key points in the Advocate General’s reasoning were as follows:

The Court’s judgment is much terser. Although the Court set out the adaptation to Article 3(b) of the SPC Regulation for the purposes of the EEA Agreement in its judgment at [5], it did not explicitly refer to this in its reasoning. Rather, it reasoned as follows:

“28.

In that regard, it is clear from Annex II to the EEA Agreement, as amended by Annex 2 to the Decision of the EEA Council No 1/95, that Liechtenstein may, as regards inter alia the medicinal products to which Directive 65/65 refers, apply Swiss technical regulations and standards deriving from its regional union with Switzerland on the Liechtenstein market in parallel with the legislation implementing that directive.

29.

The EEA Agreement recognises therefore that two types of marketing authorisation may co-exist in the principality of Liechtenstein, namely marketing authorisations issued by the Swiss authorities, which because of the regional union between Switzerland and that State are automatically recognised in the latter, and marketing authorisations issued in Liechtenstein in accordance with Directive 65/65.

30.

Thus, under Article 13 of Regulation No 1768/92, in conjunction with Annex II to the EEA Agreement, as amended by Annex 2 to the Decision of the EEA Council No 1/95, a marketing authorisation issued by the Swiss authorities and automatically recognised in Liechtenstein in the context of its regional union with Switzerland must be regarded as a first marketing authorisation for the purposes of the said Article 13.

31.

Such an interpretation of that provision is, moreover, consistent with the purpose of Regulation No 1768/92, set out in the eighth recital in the preamble thereto, as it is to be read for the purposes of the application of the EEA Agreement and according to which the holder of both a patent and an SPC should not be able to enjoy more than 15 years of exclusivity from the time the medicinal product concerned first obtains authorisation to be placed on the market in the EEA. Indeed, if a marketing authorisation issued by the Swiss authorities and automatically recognised by the Principality of Liechtenstein under that State’s legislation were precluded from constituting a first marketing authorisation for the purposes of Article 13 of Regulation No 1768/92, the duration of SPCs would have to be calculated by reference to a marketing authorisation issued subsequently in the EEA. Thus, there would be a risk of the period of 15 years of exclusivity being exceeded in the EEA.”

Of the six key points in the Advocate General’s reasoning, the only one which the Court explicitly repeated was point (vi), although the point made by the Court at [29]-[30] is very similar to point (ii) and point (i) appears to be implicit in the Court’s reasoning.

In Case C-195/09 Synthon BV v Merz Pharma GmbH & Co KGaA [2011] ECR I-0000, Merz had marketed memantine as a medicinal product in Germany for the treatment of Parkinson’s disease and other indications since prior to September 1976. This was covered by an authorisation issued in accordance with German legislation dating from 1961 which did not provide for medicinal products to be tested for efficacy or safety. Under transitional provisions in German legislation of 1976, memantine was treated as authorised under Directive 65/65. This deemed authorisation remained in force until January 1990. Luxembourg implemented Directive 65/65 in April 1983. On 19 September 1983 Merz was granted a marketing authorisation in Luxembourg under the implementing legislation. The Luxembourg authority did not investigate the safety or efficacy of memantine, however, but simply relied on the existence of the German authorisation.

In 1989 Merz applied for a patent in respect of a second medical use of memantine, namely the prevention and treatment of cerebral ischemia. The patent was subsequently granted. As Floyd J pointed out in his judgment (cited above) at [24], because the patent was for a second medical use, the earlier commercial availability of memantine was not a bar to the grant of it. On 15 May 2002 Merz obtained a series of Community authorisations in respect of memantine. These were the first authorisations to be granted following an assessment of the efficacy and safety of memantine. On 13 November 2002 Merz applied to the UK Patent Office for an SPC relying upon the patent and the 2002 authorisations, which was duly granted. Synthon applied for the SPC to be revoked. The Patents Court referred the following questions to the Court of Justice:

“‘(1)  For the purposes of Articles 13 and 19 of [Regulation No 1768/92], is an authorisation a ‘first authorisation to place … on the market in the Community’ if it is granted in pursuance of a national law which is compliant with [Directive 65/65], or is it necessary that it be established in addition that, in granting the authorisation in question, the national authority followed an assessment of data as required by the administrative procedure laid down in that directive?

(2)

For the purposes of Articles 13 and 19 of [Regulation No 1768/92], does the expression ‘first authorisation to place … on the market in the Community’ include authorisations which had been permitted by national law to co-exist with an authorisation regime which complies with [Directive 65/65]?

(3)

Is a product which is authorised to be placed on the market for the first time in the EEC without going through the administrative procedure laid down in [Directive 65/65] within the scope of [Regulation No 1768/92] as defined by Article 2?

(4)

If not, is an SPC granted in respect of such a product invalid?”

The Court of Justice ruled upon the third and fourth questions, but in the light of its answer to those questions held that it was not necessary to answer the first and second questions. In answer to the third question, the Court held that Article 2 was to be interpreted as meaning that a product which was placed on the market in the Community as a medicinal product for human use before obtaining a marketing authorisation in accordance with Directive 65/65, and in particular without undergoing safety and efficacy testing, was not within the scope of Regulation 1768/92 and was not therefore eligible for an SPC ([44], [49]-[51]). In answer to the fourth question, the Court held that an SPC granted for a product outside the scope of the Regulation as defined in Article 2 was invalid ([56]-[57]).

The Court gave a similar ruling in a parallel case, Case C-427/09 Generics (UK) Ltd v Synaptech Inc [2011] ECR I-0000.

In Case C-130/11 Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents [2012] ECR I-0000 melatonin, a naturally occurring hormone, had been marketed by Hoechst under the trade mark Regulin for regulating the seasonal breeding activity of sheep pursuant to a patent applied for in 1987 and a marketing authorisation granted in 2001 (“the Regulin MA”). Neurim marketed melatonin under the trade mark Circadin for the treatment of insomnia in humans pursuant to a patent applied for in 1992 and a marketing authorisation granted on 28 June 2007 (“the Circadin MA”). Neurim applied to the UK Intellectual Property Office for an SPC in respect of Circadin. The IPO refused the application on the ground that it did not comply with Article 3(d) of the SPC Regulation since the Circadin MA was not the first authorisation to place melatonin on the market, the Regulin MA was. Neurim’s appeal to the Patents Court was dismissed, but the Court of Appeal referred five questions to the Court of Justice.

The Court interpreted the third and fourth questions as asking, in essence, whether Articles 3 and 4 of the SPC Regulation were to be interpreted as meaning that the existence of an earlier marketing authorisation for a veterinary medicinal product precluded the grant of an SPC for a different use of the same product. The Court ruled (at [27]) that the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product did not preclude the grant of an SPC for a different use of the same product for which a marketing authorisation had been granted, provided that the use was within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC.

It appears to me that, in so ruling the Court was intending to depart from its earlier judgments in Case C-31/03 Pharmacia Italia SpA [2004] ECR I-10001, Case C-431/04 Massachusetts Institute of Technology [2006] ECR I-4089 and Case C-202/05 Yissum Research and Development Company of the Hebrew University of Jerusalem v Comptroller-General of Patents [2007] ECR I-2839. This is not clear, however, since it did not refer to those decisions. Thus one does not know if those decisions are to be regarded as having been overruled, or as qualified in some unspecified manner.

It does not appear that the Court was intending to depart from its earlier judgments in Synthon and Generics, since it cited Synthon at [20]. It is not clear to me, however, how Neurim is to be reconciled with those decisions. The reasoning which the Court relied on in Neurim, namely that the research required to obtain a patent and marketing authorisation for a second medical use of an active ingredient justifies the grant of an SPC for the second medical use despite the fact that the same active ingredient has already been lawfully marketed as a medicinal product, seems to me to be equally applicable to Generics and Synthon.

Be that as it may, the Court interpreted the second question as asking, in essence, whether Article 13(1) of the SPC Regulation was to be interpreted as meaning that it refers to the authorisation of a product which is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC. The Court answered this as follows:

“29.

It must be pointed out that the MA in the European Union referred to in Article 13(1) of the SPC Regulation is not intended to take the place of the MA provided for in Article 3(b) of that regulation, that is to say, the authorisation granted by the Member State in which the application is submitted; instead, it constitutes a further condition applying in the event that the latter authorisation is not the first authorisation to place the product on the market as a medicinal product in the European Union (see, to that effect, Case C-127/00 Hässle [2003] ECR I-14781, paragraph 73).

30.

However, although those two provisions of the SPC Regulation thus refer to the two different territorial areas of the authorisations in question in defining the duration of the protection conferred by the SPC in a particular situation, there is no reason why, as regards the assessment of the very nature of those authorisations, it is necessary to use different criteria according to which the article is applicable. Therefore, the MA referred to in Article 13(1) of the SPC Regulation is the authorisation of a product which is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC.

31.

It follows from the above that the answer to the second question is that Article 13(1) of the SPC Regulation is to be interpreted as meaning that it refers to the MA of a product which is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC.”

It is common ground that, having regard to point 8 of Protocol 1 to the EEA Agreement and the Court of Justice’s ruling in Hässle, Article 13(1) of the SPC Regulation must be interpreted as meaning that the duration of an SPC should be calculated by reference to the date of the first authorisation to place the product on the market in the EEA in accordance with Directive 2001/83. The first issue is whether this extends to a Swiss authorisation which is automatically recognised in Liechtenstein in a case such as the present.

The Comptroller contends that, as the Deputy Director held, this issue is covered by the ruling in Novartis. Counsel for the Comptroller submitted that Novartis could be understood in one of two ways. The first way, which is apparent from the Advocate General’s Opinion but not the judgment of the Court, is that, by virtue of the adaptation to Article 3(b) of the SPC Regulation by the EEA Agreement, such an authorisation is deemed to be in accordance with Directive 2001/83. The second way, which is apparent from both the Opinion and the judgment, is that it is sufficient for this purpose that the authorisation is permitted to co-exist with authorisations that comply with Directive 2001/83. Either way, it follows that Article 13 should be interpreted in a case such as the present as meaning that the duration of the SPC is to be calculated from the date of the Swiss authorisation.

AstraZeneca contends that Novartis was either wrongly decided or should be confined to its own facts. As noted above, AstraZeneca argues that Novartis is inconsistent with Hässle, with Synthon and with the primary purpose of the SPC Regulation, as follows. It is inconsistent with Hässle because Hässle decides that “first authorisation to place … on the market” means a marketing authorisation in accordance with Directive 65/65, now Directive 2001/83 or Regulation 726/2004: nothing less will do. It is inconsistent with Synthon because Synthon decides that a product which is placed on the market pursuant to a marketing authorisation which does not comply with Directive 2001/83 or Regulation 726/2004 is outside the scope of the SPC Regulation. Above all, it is inconsistent with the primary purpose of the SPC Regulation, as reflected in recitals (3)-(6). Given that the primary purpose of the SPC Regulation is to compensate patentees for the loss of effective protection caused by the need to obtain a marketing authorisation which complies with Directive 2001/83 or Regulation 726/2004, the duration of the SPC should be calculated from the date on which such a marketing authorisation is granted.

So far as the adaptation to Article 3(b) by the EEA Agreement is concerned, AstraZeneca contends that it is clear from its wording that this does not apply to Article 13. Furthermore, AstraZeneca argues that there is no reason to interpret the adaptation as applying to Article 13 since Article 3(b) and Article 13 serve different purposes: Article 3(b) lays down one of the fundamental conditions for the grant of an SPC, whereas Article 13 is purely concerned with the duration of the SPC.

As to the position of Liechtenstein specifically, AstraZeneca contends that the amendment to Annex II of the EEA Agreement made by Annex 2 to Decision 1/95 and Annex 10 to Decision 1/95 show that actions taken within the context of the Switzerland-Liechtenstein customs union, and in particular the recognition by Liechtenstein of Swiss marketing authorisations, are not intended to produce any effect within the EEA legal order.

As noted above, the parties are agreed that this issue should be referred to the Court of Justice for a preliminary ruling. I also agree that this is necessary, for two reasons. First, in the light of the arguments summarised above, I do not consider that the answer is acte clair. Secondly, it is clear that there is a divergence of interpretation between the different national authorities on this point. Thus the patent offices in the Czech Republic, Latvia, Portugal, Spain, Sweden and the UK have all granted AstraZeneca SPCs the duration of which has been calculated on the basis that the Swiss MA is the “first authorisation” for the purposes of Article 13(1) of the SPC Regulation, while the patent offices in Bulgaria, Denmark, Estonia, Greece, Italy, Lithuania, Luxembourg, Norway, Slovenia, Romania and Slovakia have all granted SPCs the duration of which has been calculated on the basis that the European MA is the “first authorisation”.

Accordingly, I shall refer the following questions to the Court of Justice:

“1.

Is a Swiss marketing authorisation not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, but automatically recognised by Liechtenstein, capable of constituting the ‘first authorisation to place the product on the market’ for the purposes of Article 13(1) of Regulation 469/2009/EC?

2.

Does it make a difference to the answer to the first question if:

(a)

the set of clinical data upon which the Swiss authority granted the marketing authorisation was considered by the European Medicines Agency as not satisfying the conditions for the grant of a marketing authorisation pursuant to Regulation 726/2004/EC; and/or

(b)

the Swiss marketing authorisation was suspended after grant and was only reinstated following the submission of additional data?”

In case it assists, I shall offer my own view. AstraZeneca’s arguments rely heavily on the primary purpose of the SPC Regulation, which was described by the Court of Justice in Case C-482/07 AHP Manufacturing BV v Bureau voor de Industriële Eigendom[2009] ECR I-7295 at [30] as follows:

“Regarding the objectives of Regulation No 1768/92, firstly, it must be noted that the fundamental objective of the Regulation, as set out in the first and second recitals in the preamble thereto, is to ensure sufficient protection to encourage pharmaceutical research, which plays a decisive role in the continuing improvement in public health (Case C-392/97 Farmitalia [1999] ECR I-5553, paragraph 19). In that regard, the third and fourth recitals in the preamble give as a reason for the adoption of the Regulation the fact that the period of effective protection under the patent is insufficient to cover the investment put into the pharmaceutical research. Regulation No 1768/92 thus seeks to make up for that insufficiency by creating an SPC for medicinal products. It seeks, in addition, to confer supplementary protection on the holders of national or European patents, without instituting any preferential ranking amongst them (Biogen, paragraphs 26 and 27).”

As counsel for the Comptroller pointed out, however, the SPC Regulation has at least two other objectives, reflected in recitals (7)-(10), which the Court of Justice described in AHP as follows:

“35.

Second, Regulation No 1768/92, which was adopted on the basis of Article 100a of the EEC Treaty (subsequently Article 100a of the EC Treaty, and now, after amendment, Article 95 EC), establishes, as is apparent from the sixth and seventh recitals in the preamble thereto, a uniform solution at Community level by creating an SPC which may be obtained by the holder of a national or European patent under the same conditions in each Member State. It thus aims to prevent 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 (see Case C-350/92 Spain v Council [1995] ECR I-1985, paragraphs 34 and 35, and Case C-127/00 Hässle [2003] ECR I-14781, paragraph 37).

…

39.

Thirdly, apart from the objective of adequate protection to encourage research, Regulation No 1768/92 recognises, as is apparent from the ninth recital in its preamble, the necessity, in a sector as complex as the pharmaceutical sector, to take into account all the interests at stake, including those of public health (see Spain v Council, paragraph 38). For that purpose, the SPC may not be granted for a period exceeding five years. Similarly, the eighth recital in the preamble states that the holder of both a patent and an SPC should be able to enjoy an overall maximum of fifteen years of exclusivity from the time the medicinal product in question first obtains authorisation to be placed on the market in the Community.”

Having regard to all these objectives, I find the reasoning of Advocate General Colomer in Novartis which I have summarised in paragraph 43 above persuasive. If the adaptation of Article 3(b) of the SPC Regulation for the purposes of the EEA Agreement is interpreted as applying to Article 13, there is no inconsistency between Novartis and Hässle. It is true that the adaptation does not refer to Article 13, but that does not prevent a teleological interpretation of it, just as the Court of Justice interpreted “first authorisation to place … on the market” in Article 19 of Regulation 1768/92 as meaning an authorisation in accordance with Directive 65/65 even though those words did not appear in Article 19. It is immaterial that Article 3(b) and Article 13 serve different purposes: as the Court’s judgment in Neurim recognises, the nature of the marketing authorisation referred to (but not its territorial extent) must be the same in both provisions. Nor is there is any inconsistency between Novartis and Synthon, since the adaptation says that a Swiss marketing authorisation recognised in Liechtenstein shall be treated as an authorisation in accordance with Directive 2001/83. I agree with the Advocate General that it is immaterial that the product is not in free circulation in the rest of the EEA and that Liechtenstein cannot grant SPCs.

In my opinion the factual circumstances mentioned in question 2 do not provide any cogent basis for distinguishing Novartis. The fact remains that in the present case Iressa was authorised to be placed on the market in Liechtenstein during the period from 2 March 2004 to 24 October 2005.

If, however, the Court of Justice decides to overrule or qualify Novartis, I would request that it says so in clear and unambiguous terms, in order to avoid the need for yet another reference on this issue.

The Comptroller contends that, if AstraZeneca is correct to say that a product placed on the market in the EEA pursuant to an authorisation which is not in accordance with Directive 2001/83 or Regulation 726/2004 is outside the scope of the SPC Regulation, it follows that in the present case gefitinib is ineligible for an SPC in accordance with the rulings in Synthon and Generics. AstraZeneca contends that, for the reasons outlined above, a Swiss marketing authorisation which was automatically recognised in Liechtenstein only has legal effect in the context of the Switzerland-Liechtenstein customs union and not for the purposes of the EEA legal order.

The parties are agreed that the Court of Justice should be asked to rule upon this issue as well. Again, I agree that it is necessary to seek the Court’s guidance. Accordingly, I shall refer the following question:

“3.

If Article 13(1) of Regulation 469/2009 refers solely to marketing authorisations granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, does the fact that a medicinal product was first placed on the market within the EEA pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein which was not granted pursuant to Directive 2001/83/EC render that product ineligible for the grant of a supplementary protection certificate pursuant to Article 2 of Regulation 469/2009?”

Again, I will offer my own view in case it assists. As discussed above, Synthon and Generics suggest that the answer to this question is “yes”, while Neurim suggests that the answer is “no”. I prefer the reasoning in Synthon and Generics to that in Neurim. The reasoning in Synthon and Generics has the advantage that it is consistent with Pharmacia, MIT and Yissum. Neurim is not only inconsistent with all those earlier decisions, but also appears to me to place undue emphasis on the SPC Regulation’s first objective and to give insufficient weight to its second and third objectives and the actual wording of the Regulation.

For the reasons given above, I will refer the questions set out in paragraphs 61 and 68 to the Court of Justice for a preliminary ruling.