C-127/00

OPINION OF MRS STIX-HACKL — CASE C-127/00

O P I N I O N O F ADVOCATE GENERAL STIX-HACKL delivered on 26 February 2002 1

I — Introduction I I — Facts of the case and main proceed- ings

2. These questions have arisen in a dispute between Ratiopharm GmbH ('Ratioph- arm') and Aktiebolaget Hassle ('Hassle') concerning the grant to Hassle of a supple- 1. The issue in this case is whether the mentary protection certificate for the active establishment of relevant dates differing by substance omeprazol. Member State in the transitional provision in Article 19(1) of Council Regulation (EEC) No 1768/92 of 18 June 1992 con- cerning the creation of a supplementary protection certificate for medicinal prod- ucts, 2 as amended by the Acts of Accession of Austria, Finland and Sweden 3 ('Regu- lation No 1768/92'), infringes higher-rank- 3. Hässle was the holder of a European ing Community law and is consequently patent for the active substance omeprazol. invalid. If that is not the case, the referring That patent, valid inter alia in Germany, court (the Bundesgerichtshof (Federal was granted to Hassle with effect from Court of Justice)) (Germany) applies for 3 April 1979 and expired on 3 April 1999 an interpretation of the notion of 'first at the end of its 20-year period of validity. authorisation to place... on the market... in the Community' as it appears in the transitional provision and seeks a ruling on the legal consequences of an infringe- ment of that provision.

1 — Original language: German. 4. In France and Luxembourg authori- 2 — OJ 1992 L 182, p. 1. sations for the purposes of the law on 3 — Act concerning the conditions of accession of the Kingdom medicinal products were granted in respect of Norway, the Republic of Austria, the Republic of Finland and the Kingdom of Sweden and the adjustments to the of proprietary medicinal products based on Treaties on which the European Union is founded, Annex I — List referred to in Article 29 of the Act of omeprazol, in accordance with Council Accession — XI. Internal market and financial services — Directive 65/65/EEC of 26 January 1965 F. Intellectual property and product liability — I. Patents (OJ 1994 C 241, p. 233). on the approximation of provisions laid I - 14784

6. On 9 June 1993 Hassle applied to the Deutsches Patentamt for a protection cer- tificate for the active substance Omeprazol. A — Regulation No 1768/92 It stated 'March 1988 Luxembourg' as the time and place of the first authorisation to place Omeprazol on the market as a 9. The third and fourth recitals read: medicinal product in the European Com- munity and attached a copy of the above- mentioned list containing the entry dated 21 March 1988. 'Whereas at the moment the period that elapses between the filing of an application 4 — OJ, English Special Edition 1965-1966, p. 20, in the version established by Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products (OJ 1993 L 214, p. 22). 5 — Regulation No 1768/92, Article 19(1), second sentence.

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OPINION OF MRS STIX-HACKL — CASE C-I 27/00

for a patent for a new medicinal product fore the most appropriate legal instru- and authorisation to place the medicinal ment;'. product on the market makes the period of effective protection under the patent insuf- ficient to cover the investment put into the research;

11. The 10th recital reads:

Whereas this situation leads to a lack of protection which penalises pharmaceutical research;'. 'Whereas a fair balance should also be struck with regard to the determination of the transitional arrangements; whereas such arrangements should enable the Com- munity pharmaceutical industry to catch up to some extent with its main competitors who, for a number of years, have been 10. The sixth and seventh recitals read, in covered by laws guaranteeing them more extract: adequate protection, while making sure that the arrangements do not compromise the achievement of other legitimate objec- tives concerning the health policies pursued both at national and Community level;'.

(b) a valid authorisation to place the product on the market as a medicinal (d) "certificate" means the supplementary product has been granted in accord- protection certificate.' ance with Directive 65/65/EEC or Directive 81/851/EEC, as appropriate. For the purpose of Article 19(1), 6an authorisation to place the product on the market granted in accordance with the national legislation of Austria, Fin- land or Sweden is treated as an auth- orisation granted in accordance with 13. Article 2 reads: Directive 65/65/EEC or Directive 81/851/EEC, as appropriate;...

'Any product protected by a patent in the (d) the authorisation referred to in (b) is territory of a Member State and subject, the first authorisation to place the prior to being placed on the market as a product on the market as a medicinal medicinal product, to an administrative product.' authorisation procedure as laid down in Council Directive 65/65/EEC or Directive 6 — In what is clearly an editorial error, the German version 81/851/EEC may, under the terms and refers to Article 19(2). All other language versions refer at conditions provided for in this regulation, this point to Article 19(1). The erroneous reference has therefore been corrected hereinafter, without further be the subject of a certificate.' explicit mention.

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15. Article 5 reads: (iv) the number and date of the first authorisation to place the product on the market, as referred to in Article 3(b) and, if this authori- sation is not the first authorisation for placing the product on the 'Subject to the provisions of Article 4, the market in the Community, the certificate shall confer the same rights as number and date of that authori- conferred by the basic patent and shall be sation; subject to the same limitations and the same obligations.'

'The certificate shall be invalid if:

In the case of certificates to be granted in (a) it was granted contrary to the provi- Belgium, in Italy and in Austria, the date of sions of Article 3; 1 January 1985 shall be replaced by that of 1 January 1982.'

(b) the basic patent has lapsed before its lawful term expires;

B — Directive 65/65

(c) the basic patent is revoked or limited to the extent that the product for which the certificate was granted would no 21. Article 1 reads, in extract: longer be protected by the claims of the basic patent or, after the basic patent has expired, grounds for revocation exist which would have justified such revocation or limitation.' 'For the purposes of this Directive, the following shall have the meanings hereby assigned to them:

20. Article 19(1) reads:

23. Recital 17 reads, in extract:

1. (a) For the purpose of applying the t r a n s i t i o n a l p r o v i s i o n in Article 19(1) of the Regulation, in so far as that provision refers to the 'Whereas the detailed rules in... Article... 'first authorisation to place... on 17(2) of this Regulation are also valid, the market... in the Community' mutatis mutandis, for the interpretation in before a specified relevant date, particular of... Article 17 of Council Regu- does that refer exclusively to an lation (EEC) No 1768/92,'. authorisation within the meaning of Directive 65/65/EEC or Direc- tive 81/851/EEC as the case may 7 — For the purposes of Directive 65/65, 'medicinal products' be, or may another authorisation requiring authorisation means 'proprietary medicinal prod- granted later (after the relevant ucts' within the meaning of Article 1(1) thereof and other 'commercially prepared medicinal products...' that do not date) relating in particular to the correspond to the definition of a proprietary medicinal product (see Article 2(2) of Directive 65/65). prices of the medicinal product 8 — OJ 1996 L 198, p. 30. also be material in this respect, if

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HÄSSLE

(aa) without such a further authori- 2. Is there doubt as to the validity of the sation, for example one for price- transitional provision in Article 19(1) law purposes, marketing of the of the Regulation in so far as it lays medicinal product is not permis- down different relevant dates for dif- sible under the law of the ferent Member States? Member State concerned, or

3. Is the list of grounds of invalidity in Article 15(1) of the Regulation exhaus- tive?

May and must national law provide, as under Article 17(2) of Regulation (EC) No 1610/96 of the European Parlia- ment and of the Council of 23 June 1996 concerning the creation of a supplementary protection certificate 26. Medicinal products, 13 based on such for plant protection products, for an active ingredients, for treating or prevent- appeal aimed at rectifying the duration ing disease in human beings require, in the of the protection certificate for a Community, authorisation for the purposes medicinal product in the event of a of the law on medicinal products; 14 auth- breach of the transitional provision in orisation is then granted on successful A r t i c l e 1 9 ( 1 ) of R e g u l a t i o n completion of a national procedure based No 1768/92? on the corresponding national measure(s) for implementing Directive 65/65 ('pro- cedure under Directive 65/65'). Such auth- orisation is not granted in respect of a medicinal product as such but is granted separately for each presentational form, dosage etc. in which the medicinal product concerned is to be placed on the market under a special name and in a special pack V — Preliminary remarks on the concepts (proprietary medicinal product). 15 underlying, and the aims of, patent pro- tection for the purposes of the law on medicinal products and on the underlying reconciliation of interests 9

27. In the Member States a number of other authorisation procedures are to some 25. Patent protection for the purposes of extent also in operation which are generally the law on medicinal products affords an initiated only when the procedure under exclusive right. It allows the holder of a Directive 65/65 has been completed but basic patent 10 to exploit economically the which are often also, under national law, a

28. A number of Member States also have social security regulations under which the social security system will bear the cost of a 31. Extending the exclusive right consti- proprietary medicinal product only if the tutes, in economic terms, 18 a prolongation product has been authorised by that system of the period during which scientific or has been entered in a list of proprietary research results are available for economic medicinal products eligible for reimburse- exploitation on an exclusive basis. This ment. While placing on the market a benefits those firms which, by virtue of proprietary medicinal product that has their research, are the holders of the not been so authorised or listed is not a certificates concerned. To the extent that bar to economic exploitation of the basic the firms concerned reinvest the additional patent, its exploitation is a substantially profits so earned in further research, grant more attractive proposition if reimburse- of the certificates directly benefits research ment by social security authorities is poss- and hence also contributes to the availabil- ible. ity of new products. The grant of certifi- cates is however also of benefit to firms which produce proprietary medicinal prod- ucts under licence to certificate holders.

would have been in a position to use and the Danish, Netherlands, French and products that were no longer protected to, Spanish Governments, have stated their in particular, develop their own medicinal positions. In view of the length of those products or to place known medicinal statements, the views expressed will, in products on the market in the form of what follows, be ordered according to basic proprietary medicinal products. These so- lines of argument. 19 called 'generic' medicines are generally cheaper to produce, if only because, with the use of products that are no longer protected, no or only modest research costs are incurred. It follows that the production of economical generic medicines is of strong interest above all to the national 35. As the answers to the other questions health systems and the Member States that depend on the answer to the second ques- support them financially. tion referred, that question will be addressed first in what follows.

VI — Consideration of the questions referred by the national court A — The second question: compatibility of Article 19(1) of Regulation No 1768/92 with higher-ranking Community law (vary- ing relevant dates)

38. Ratiopharm, the Commission and the Danish and Netherlands Governments con- sider the transitional provision in Article 19(1) to be valid. They argue that, Arguments of the parties according to the principles underlying the Court's decisions, the standards applying to the statement of reasons for a regulation of general application are not very high. The 10th recital can thus be regarded as adequately explaining the purpose of the 37. Hassle argues that providing for dif- transitional provision, that of achieving a fering relevant dates by Member States is balance of interests, as considered above. 20 invalid because it infringes higher-ranking As the question of costs is of varying Community law and in particular the significance in the public health policies of principle of equal treatment, the obligation individual Member States, providing for to state reasons and 'harmonisation of the differing relevant dates is justified in objec- internal market'. There is discrimination tive terms. because medicinal products for which an authorisation to place on the market in Germany has been obtained could not be granted a certificate for Germany if auth- orisation occurred prior to 1 January 1988. In contrast, a certificate for other Member States could still be obtained even if an authorisation to place on the market in those countries lay six years further into the Assessment past. An objective justification for the differing relevant dates cannot be dis- cerned. The Community legislature has moreover failed fully to comply with the 39. The question of the validity of the obligation to state reasons, as convincing transitional provisions at issue clearly turns grounds for the differing relevant dates on the following points: incompatibility of assigned to Member States are to be found Article 19(1) of Regulation No 1768/92 neither in the legislative materials nor in the with the legal basis of that regulation, recitals. The whole of Regulation namely Article 100a of the EC Treaty No 1768/92 is, in Hassle's view, solely (now, after amendment, Article 95 EC); concerned with the harmonisation of pat- ent protection in accordance with the legal basis of the Regulation in Article 100a of 20 — See point 31 et seq. above.

infringement of the general principle of 41. That ruling is not however, in my equality; and at all events — if that prin- opinion, of general application. In particu- ciple is ruled to have been observed — lar, the present case does not concern a non-compliance with the obligation to state coordinating provision, that is to say a reasons for acts of Community law in provision serving the realisation of a fun- accordance with Article 190 of the EC damental freedom and hence dictated by Treaty (now Article 253 EC). p r i m a r y law. R a t h e r , R e g u l a t i o n No 1768/92 rests on Article 100a of the EC Treaty (now, after amendment, Article 95 EC) and is intended to bring about a Community-wide harmonisation 2 3 of particular elements of intangible prop- erty law in furtherance of more effective exercise of fundamental rights. The Court has already found that harmonisation as an aim of Community secondary law does not in itself conflict with the fact that the 40. The Court has already, in its judgment application of Community law has varying in Pinna, 21 addressed the question of the consequences for those subject to the validity of a provision of secondary law provisions concerned in the various that differentiated between Member States. Member States. 24 At issue then had been an exemption provision in a regulation, according to which one of the provisions of that regu- lation would not 22 be applicable in one Member State. The Court, in that judg- 42. It follows that incompatibility can be ment, refers to the objective of the primary considered to obtain only if the general law concerned (freedom of movement for principle of equal treatment has been workers, Articles 48 and 51 of the EEC infringed. 25This is always the case, where Treaty (now, after amendment, Articles 39 provisions of Community law introduce EC and 42 EC) and finds that '... that differential treatment, if there is no objec- objective... will be imperilled... if unnecess- tive justification for the differentiation so ary differences in the social security rules introduced. are introduced by Community law. It follows that the Community rules on social security introduced pursuant to Article 51 of the Treaty must refrain from adding to the disparities which already stem from the absence of harmonisation of national legis- 43. The entire Regulation serves the recon- lation.' ciliation of interests described earlier. 26It

45. In the light of these considerations it need only be observed, as regards alleged non-compliance with the obligation to state reasons in accordance with Article 190 of the EC Treaty (now Article 253 EC), that the Court has consistently held it to be unnecessary, 28 particularly in the case of regulations, which are of general appli- cation, to specify all relevant factual or legal aspects. It is sufficient to present — even succinctly — the overall situation that led to their adoption and to state the 4 4 . The retrospective provision in overall objective pursued. Regulation Article 19(1) of Regulation No 1768/92 No 1768/92 meets these requirements in determines, through the time-periods spe- its preamble. cific to the Member States concerned, the number of 'established' medicines qual- ifying for conferment of extended exclusive patent rights. 27 A relatively long retro- spective period has advantages for under- takings that are holders of the basic patents or are manufacturers under licence to those undertakings. A short retrospective period represents a decision in favour of the availability of more economical generic medicines and in favour of those undertak- 46. This analysis has thus brought out ings that manufacture them. Bearing in nothing to indicate that the establishment mind, as described earlier, the many layers of varying relevant dates in Article 19(1) of of interests at play in the framework of Regulation No 1768/92 is incompatible patent protection for the purposes of the with higher-ranking Community law. law on medicinal products and given that this constellation of interests is clearly not 28 — See, for example, its judgments in Case 108/81 Amylum [1982] ECR 3107, Case 3/83 Abrias [198J] ECR 199J, Case C-350/88 Société Française des biscuits Delacre v Commission [1990] ECR 1-395, Case C-122/94 Commis- 27 — Sec also the Opinion of Advocate General Fennelly in Case sion v Council [1996] ECR 1-881, and Case C-183/95 C-110/95 Yamanouchi [1997] ECR 1-3251. Affish [1997] ECR 1-4315.

47. Hassle argues that, under the terms of the first subparagraph of Article 19(1) of Regulation No 1768/92 and in the absence 49. Hassle argues further that this inter- of any explicit reference therein to Direc- pretation is consistent with the purpose of tive 65/65, the 'first authorisation to place Regulation No 1768/92. It follows in par- on the market' means those national legal ticular from the third and seventh recitals, or administrative acts on which effective from the Commission's explanations con- economic exploitation of the product as a cerning the Regulation when submitted as a medicinal product depends. Such acts proposal, and from the history of the include price-law authorisations and auth- Regulation in general, that its purpose is orisations by the social security authorities to extend patent protection to compensate recognising proprietary medicinal products for the time taken up with authorisation as eligible for reimbursement. The absence procedures of all kinds. In the absence of a of such authorisations would make effec- certificate, the 'real' duration of the patent tive exploitation more difficult, or even protection, that is to say the period of impossible, to achieve. In so arguing, effective exploitation of the basic patent, Hassle relies essentially on the wording would be limited to the time remaining and purpose of the Regulation. between the last authorisation required and I - 14798

HÄSSLE

expiry of the basic patent. If the first Article 19(1) that the product obtains subparagraph of Article 19(1) were taken authorisation 'as a medicinal product'. This to refer only to authorisations for the can only mean authorisation for the pur- purposes of the law on medicinal products poses of the law on medicinal products, within the meaning of Directive 65/65, the within the meaning of Directive 65/65. The compensation which Regulation additions made to the first subparagraph of No 1768/92 seeks to provide would not Article 19(1) and to Article 3(b) of Regu- be secured. lation No 1768/92 with the accession of the new Member States make no difference in this respect.

OPINION OF MRS STIX-HACKL — CASE C-127/00

for the purposes of the law on medicinal apart from the Kingdom of Denmark — products within the meaning of Directive that, in the first subparagraph of 65/65. It is also argued, with reference to Article 19(1), the 'first authorisation to the judgment in the Yamanouchi case, 29 place on the market' does not always have that as a transitional provision Article 19 to be the first authorisation in the Member is, technically, modelled on the main body State of application, a further uncertainty of the Regulation, such that Article 19(2) arises. For the authorities of the Member corresponds to the provision concerning State of application would then have to time-limits for application (Article 7) and consider whether, and if so what, other Article 19(1) to the provision concerning authorisation procedures exist in other the conditions for obtaining a certificate Member States, and would have also to (Article 3(b)). assess whether, in individual cases, effective economic exploitation depends on receipt of such authorisation. The possibility could not be ruled out therefore of different authorities arriving at different con- clusions.

HÄSSLE

first subparagraph of Article 19(1) the necessarily provide a basis for concluding Community legislature wished to allow that in this context other national auth- for an authorisation to place on the market orisations could (also) be material with other than the authorisation within the regard to placing on the market. Neither meaning of Directive 65/65. It is true that the recitals nor the legislative materials the German and other language versions of indicate at any point with sufficient clarity this provision are ambiguous on this point that Regulation No 1768/92, in extending because they use the indefinite article 'a'. In the period during which a product can be the Danish and English language versions, marketed under the protection of exclusive however, the definite article 'the' is used, patent rights, seeks to provide compen- while other versions (in the Greek and sation for delays in placing a product on Finnish languages for example) use neither the market resulting from national auth- the definite nor the indefinite article. orisation procedures additional to the pro- cedure under Directive 65/65, even less do they suggest which authorisations might thereby be referred to.

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Article 13 and the transitional provision in Member State concerned, a certificate can Article 19(1). In any case the position of be, or as the case may be has been Article 19 at the end of the Regulation and wrongfully, granted for 'established' medi- its — explicit — status as a transitional cines. It would, furthermore, be unclear in rule do not suggest a compelling need for those circumstances which authorisations, such an express reference. This is borne out other than authorisation for the purposes by the considerations below. of the law on medicinal products within the meaning of Directive 65/65, were supposed to be material, in the various Member States, to placing on the market. 30

2. The question whether the 'first auth- orisation to place... on the market... in the Community' means the first authorisation in the Member State of application or in 63. The reservations concerning legal any Member State uncertainty are also convincing. If the transitional provision were taken to refer also to other authorisation procedures that 30 — In addition to the price-law authorisation referred to in the were not harmonised under Community main proceedings and inclusion in the lists of medicaments eligible for reimbursement maintained by the social law, then neither the holder of a basic security authorities — the latter not so much an 'auth- patent nor a competitor interested in orisation' perhaps as a measure to boost sales volumes — other national authorisations relevant to placing on the exploiting the product could tell from market could also be imagined, in furtherance for example of consumer protection, environmental protection or fair Regulation No 1768/92 whether, in the competition.

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Arguments of the parties 68. The words 'in the Community' do not, in their view, conflict with this interpre- tation, the Community being the sum of all the Member States and one of those States being the Member State of application. They consider it to be clear from the use, in the German and also in other language 65. Hassle and the Danish Government are versions, of the indefinite article in 'a first of the view that the material authorisation authorisation' that there can be more than is the first authorisation in the Member one 'first' authorisation in the Community. State of application. It follows that in Article 19(1), as in Article 3(c), of the Regulation, 'first auth- orisation' means the first of several auth- orisations that may be granted in one and the same Member State.

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moreover that, in a number of provisions, Yamanouchi 32 addressed a different ques- Regulation No 1768/92 even uses the tion 33 in relation to Article 19 of Regu- concepts 'authorisation in the Member lation No 1768/92. The Court ruled on that State of application' and 'in the Commu- occasion that the condition laid down in nity' in juxtaposition (in Articles 8(1)(a)(iv), Article 3(b), namely that for a supplemen- 9(1)(d) and (e) and 11(1)(d) and (e)). It can tary protection certificate to be granted in a be concluded from this that Regulation Member State an authorisation for the No 1768/92 makes this distinction deliber- purposes of the law on medicinal products ately. And it follows that, where a provi- must previously have been granted for that sion such as the first subparagraph of Member State (the State of application), Article 19(1) speaks of 'in the Community', applies also to 'established' medicines this can only be taken to refer to an within the scope of Article 19(2). authorisation in any Member State.

73. The Court established rather that, as 71. The reference to the first authorisation regards the material conditions attaching to in the Community is important above all in the grant of a certificate, Article 3 of relation to the duration of the certificate. If, Regulation No 1768/92 assumes the pro- in contrast, the reference were to the first cedure concerning authorisation for the authorisation in the Member State of purposes of the law on medicinal products application, the duration of the certificate in the Member State of application and that could, for example, be extended at will. this must therefore also be the case for the conditions attaching to the grant of certifi- cates within the scope of the transitional provision ('established' medicines).

76. The concepts 'first authorisation in the Member State of application' and 'first authorisation in the Community' are used not only in the first subparagraph of Article 19(1) but also in a number of other provisions in Regulation No 1768/92. The various references are taken in turn below and the sense in which the concepts are The wording of the first subparagraph of used is analysed in each case. It can be Article 19(1) of Regulation No 1768/92 shown that the reference to the first auth- orisation in the Member State of appli- cation on the one hand and to the first authorisation in the Community on the other, or again the use of both concepts in one and the same article, are by no means fortuitous. In each instance particular requirements are attached to, or effects produced on, the grant of certificates and these, taken together, allow a specific overall purpose to be discerned in Regu- lation No 1768/92. I propose to ascertain that purpose and then proceed, on that 75. A first point to be made concerning the basis, to interpret the first subparagraph of wording of the first subparagraph of Article 19(1) of the Regulation. Article 19(1) of Regulation No 1768/92 is that the text refers unequivocally to 'first authorisation in the Community' (emphasis added). As regards the line of argument relying on the reference in the German and some other language versions to 'a' first authorisation, I refer to the points devel- oped above 34 concerning the lack of uni- formity in the various language versions of 77. Article 3(d) of Regulation No 1768/92 this provision. refers to the first authorisation in the Member State of application. The back- ground to this provision is considered 34 — See point 57. below. I - 14805

79. The reference to obtaining such a first authorisation in the Member State of application is of importance for the begin- ning of the period during which appli- 81. To sum up, the holder of a basic patent cations may not be lodged for certificates, thus has only one opportunity to apply for which — as will be shown — have very a certificate for its product. It has only a restrictive effects for the holders of a basic short period of time in which to do so and patent. that period begins at the earliest possible point in time, namely when it is established that, in the Member State of application, the product is eligible for authorisation, for the purposes of the law on medicinal products, in the form of at least one proprietary medicinal product. It can be seen therefore that the reference to the 80. In accordance with Article 3(d) in Member State of application in Article 3(d) conjunction with Article 7(1) of the Regu- of Regulation No 1768/92 serves a restrict- lation, a certificate may be granted only if ive application of the Regulation. the application is lodged within six months of the successful completion, in the Member State of application, of the first procedure for authorisation, for the pur-

35 — It can also occur that medicinal products are produced on the basis of products that are protected by more than one basic patent. Although Regulation No 1768/92 does not offer unequivocal guidance on this point, the Court holds 82. A reference to the first authorisation in that several certificates (one for each basic patent) may be granted in such cases. This was the tenor of the judgment the Community is to be found — apart in Case C-181/95 Biogen (cited in footnote 9). from the occurrence in the provision at I - 14806

i s s u e , the first s u b p a r a g r a p h of lation takes as the starting point for the Article 19(1) — in the provision concern- calculations the duration of the procedure ing the duration of the certificate (Article 13 on whose completion the first authorisation of Regulation No 1768/92). The back- for the purposes of the law on medicinal ground to this provision is considered products was granted in the Community. below. Where the application for the basic patents and the procedures under Directive 65/65 are set in motion at the same time, the basis for calculating the duration of the certifi- cate in the Member State of application thus becomes the shortest procedure in any Member State and hence is not necessarily the duration of the procedure that in practice shortened the period of economic 83. The purpose of Regulation No 1768/92 exploitation of the basic patent in the being to compensate, by means of the Member State of application. 36 certificates, for the shortening of the period of economic exploitation of the exclusive right resulting from the procedures under Directive 65/65, it follows that the duration of a certificate must in principle be calcu- lated by reference to the duration of those procedures. Generally speaking, procedures under Directive 65/65 are set in motion at the same time as the application for the basic patent and come to an end upon 85. Article 13(1) of Regulation No 1768/92 successful completion of the process. From contains a further restriction of the dur- that period, five years are deducted as ation of the certificate, again through a standard and a maximum certificate dur- deliberate reference to the 'first authori- ation of five years can be obtained from the sation... in the Community'. Calculation time remaining. thereof is not based on the overall duration of this first procedure to be successfully completed in any Member State of the Community. It is based rather on the period from the time of application for the basic patent in the State of application to the date of completion of the first procedure for the purposes of the law on medicinal products in any Member State. 37 The effect of this 84. If the duration were calculated solely calculation is that the certificates — on the basis of the duration of the first successfully completed procedure in the Member State of application, the duration 36 — Basis for the Commission proposal (cited in footnote 18). of the national certificate concerned would 37 — If for example, in any Member State, the procedure under Directive 65/65 was only successfully completed first in principle — because of the standard because the basic patent was applied for earlier and hence Community-wide curtailments — be the procedure for the purposes of the law on medicinal products could also be initiated and completed earlier, the longer, the longer the duration of the basis for calculating the duration of the certificate is limited to the period from expiry of the basic patent to procedure itself. That is clearly not the completion of the procedure under Directive 65/65 in any intention, since Article 13(1) of the Regu- Member State.

86. It can be concluded from the foregoing that a certificate under Regulation 88. These occurrences do not in them- No 1768/92, because of the limitation selves, however, allow any particular con- placed on its duration by Article 13(1), clusions to be drawn in answer to the rarely has the same duration as the cor- questions referred. If the two concepts are responding national procedure under used in juxtaposition, this is solely because Directive 65/65. The primary consider- (a) where application for a certificate, and ations would seem rather to be acceleration more particularly examination of the of the procedures under Directive 65/65 associated conditions and time-limits and the legal certainty afforded by simulta- (Articles 3 and 7 of R e g u l a t i o n neously expiring certificates. This outcome No 1768/92), are concerned, and for the is to be obtained by means of the reference purposes also of lodging an application and to 'the first authorisation to place the notifying the fact that a certificate has been product on the market in the Community'. granted, the relevant date is that of the first authorisation in the Member State of application, while (b) in calculating the 38 — Example: an application for a basic patent was filed in duration of the certificate, the relevant date Member State A in 1979. The basic patent in A expired in 1999 after a 20-year life. The procedure under Directive is that of the first authorisation in the 65/65 was initiated in A in 1979 and lasted, say, 8 years. Community. 39 According to the formula contained in Article 13 of Regulation No 1768/92, the duration of a certificate for Member State A is: 8 years — 5 years = 3 years. In Member State A, the duration of the certificate thus comes to an end in 2002. In Member State B the basic patent was applied for a year later, in 1980, and lapsed in 2000. The duration of the certificate for which an application has been made for Member State B is calculated on the basis of the period from expiry of the basic patent in B to completion of the procedure in the first Member State in the Community, i.e. Member State A. The procedure in A, having taken 8 years, was completed in 1987. For the purpose of the calculation account is not however taken of the entire duration of the procedure but only of the residual period as from the application for a basic patent in B, i.e. 1980 — 1987 = 7 years. According to the formula Conclusions regarding the use of the con- i nArticle 13 of Regulation No 1768/92, the duration of a cept 'first authorisation in the Community' certificate for Member State B is thus: 7 years — 5 years = 2 years. The period of validity of the certificate commences on expiry of the basic patent in B, i.e. in 2000. This means that the period of validity in B ends in 2002 — at the same time then as the certificate in A. 39 — See also the Opinion of Advocate General Fennelly in the Yamanouchi case (cited in footnote 27).

in the first subparagraph of Article 19(1) of procedure under Directive 65/65 was com- Regulation No 1768/92 pleted by the grant of an authorisation. That date has to be later than one of the dates specified in the first, second and third subparagraphs (1 January 1982, 1985 and 1988). If the relevant date was determined 89. With the transitional provision in by the first authorisation in the Member Article 19(1) it becomes possible to apply State of application, it would be all the for certificates for products in respect of more easily exceeded, the longer the dur- which the authorisation procedures for the ation of the procedure for the purposes of purposes of the law on medicinal products the law on medicinal products in the had already been successfully completed Member State concerned. some years before the Regulation entered into force and which, therefore, would not ordinarily have fallen within the scope of t h a t R e g u l a t i o n . As d i s c u s s e d , 40 92. In contrast, where relevant dates are Article 19(1) constitutes a deviation from governed by uniform, Community-wide the general rules applying to the temporal provisions hinging on the earliest possible scope of a Regulation and should, if only point in time (the 'first' authorisation in the for that reason, be interpreted restrictively. Community), the effect is for Regulation No 1768/92 to be applied to 'established' medicines in a uniform manner across the Community. This is because all products are disqualified where the medicinal prod- 90. But this provision should also, in my ucts based on them were granted auth- opinion, be construed narrowly in keeping orisation for the purposes of the law on with the generally restrictive nature — a medicinal products later than the earliest point developed earlier 41 — of Regulation possible point in time. The earliest possible No 1768/92. It is not however possible point in time is however the time when it is with a restrictive interpretation to estab- established that a proprietary medicinal lish, on the basis of the corresponding first product based on the product qualifying successfully completed procedure under for a certificate is in principle eligible for Directive 65/65 in the Member State of authorisation — this being the time when application, the relevant date for determin- an authorisation for the purposes of the law ing whether 'established' medicines are on medicinal products within the meaning eligible for certificates. This assertion is of Directive 65/65 was granted in any supported by the considerations set out Member State. below.

96. Hassle and the Danish Government contend that the response to a breach of Article 19(1) should not be invalidation of Arguments of the parties the certificate but rather a recalculation of its duration. They point out that Article 17(2) of Regulation No 1610/96 provides expressly for such recalculation where the date of the first authorisation to place on the market was incorrectly given. 95. Hassle and the Danish and Netherlands This legal consequence is also, in accord- Governments take the view that the grant ance with Recital 17 in Regulation of a certificate in breach of Article 19(1) of No 1610/96, applicable in the framework Regulation No 1768/92 does not invalidate of Regulation No 1768/92. The expression the certificate. They argue essentially that 'mutatis mutandis' also allows such appli- Article 15(1) of the Regulation gives an cation in connection with provisions that exhaustive list of the grounds of invalidity are not expressly mentioned in that recital. ('shall be invalid if...') but makes no reference to Article 19(1). Article 15(1) contributes in this way to the legal certainty that is necessary in patent law. They observe further that Regulation No 1610/96 concerning the creation of a supplementary protection certificate for 97. The Netherlands Government, without plant protection products is to a large expressly registering a preference for recal- extent identical to Regulation No 1768/92 culation of duration, takes the general view but that here again the Community legis- that the legal consequence of an infringe- lature — in full awareness of the issues — ment of Article 19(1) should, in accordance has nowhere provided for breaches of the with Article 17 of Regulation No 1768/92, transitional provision to be treated as a be determined by national law. I - 14810

99. The Commission takes the view in principle that Article 19(1) is concerned with defining the practical scope of appli- cation of Regulation No 1768/92 and that a recalculation of duration is inconsistent 102. If a supplementary protection certifi- therefore with the delimiting function of a cate is granted pursuant to Article 10(1) of provision concerning relevant dates. In the Regulation No 1768/92 even though the alternative, it does however consider — conditions laid down in Article 19(1) have with reference to Recital 17 in Regulation not been fulfilled, the certificate has necess- No 1610/96 — recalculation of duration arily been granted outside the area of under national law in accordance with application of the Regulation. That being Article 17 of that Regulation to be possible. the case, a ground of invalidity within the meaning of Article 15(1) cannot be envis- aged as a legal consequence — whether through further interpretation of, or by analogy to, the grounds of invalidity spec- ified in that article. A certificate granted outside the scope of Regulation No 1768/92 100. Ratiopharm objects to the reference to cannot be regarded as a 'supplementary Article 17(2) of Regulation No 1610/96 on protection certificate' within the meaning the ground that, while Recital 17 thereof of Regulation No 1768/92 and, by the same refers to various provisions in Regulation token, cannot lay claim to the protective No 1768/92, it fails precisely to refer to effects of Article 5 thereof.

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OPINION OF MRS STIX-HACKL — CASE C-127/00

103. In the light of the points just made, No 1768/92, say because the relevant date there is again, in my view, no need to for the purpose of this calculation was consider a recalculation of duration on the given incorrectly in the application for the basis of Article 17(2) of Regulation certificate. No 1610/96. In case that view is not shared by the Court, I would nevertheless like, with all due brevity, to take a position on the fourth question referred.

I-14812

HÄSSLE

VII — Conclusion

108. In the light of the foregoing, I propose that the questions referred for a preliminary ruling be answered as follows:

(1) Examination of the transitional provision in Article 19(1) of Regulation (EEC) No 1768/92 with regard to its establishment of varying relevant dates has disclosed no factor capable of calling into question its compatibility with higher-ranking Community law.

(2) The concept of 'first authorisation for placing on the market in the Community' as it appears in Article 19(1) of Regulation No 1768/92 must be interpreted as meaning exclusively the first authorisation for the purposes of the law on medicinal products, within the meaning of Directive 65/65/EEC or Directive 81/851/EEC as the case may be, granted in any Member State of the Community.