C-392/97

FARMITALIA

OPINION OF ADVOCATE GENERAL FENNELLY delivered on 3 June 1999 *

I — Introduction the SPC Regulation is designed to compen- sate the holder of a basic patent for the delay necessarily attendant on the grant of an authorisation to market a medicinal 1. This case raises the question of the terms product (hereinafter a 'marketing autho- in which a supplementary protection certi- risation') whose active ingredient is covered ficate should be granted under Council by that patent. It is inherent in this scheme Regulation (EEC) No 1768/92 of 18 June that, as the ninth recital states, 'the protec- 1992 concerning the creation of a supple- tion granted should furthermore be strictly mentary protection certificate for medicinal confined to the product which obtained products 1 (hereinafter 'the SPC Regulation' authorisation to be placed on the market as or 'the Regulation') where the necessary a medicinal product'. authorisation to place a medicinal product on the market relates only to a single salt of a free base protected by the basic patent, where a medicinal product with equivalent properties could probably be manufactured from different salts of this free base and 3. The principal relevant provisions of the where it is argued that the scope of SPC Regulation are as follows: protection of the basic patent extends by implication to all such salts.

Article 1 II — Legal and factual context

'For the purpose of this regulation:

(i) Community legislation and other instru- ments

Article 4

'Within the limits of the protection con- ferred by the basic patent, the protection Article 3 conferred by a certificate shall extend only to the product covered by the authorisation to place the corresponding medicinal pro- duct on the market and for any use of the 'A certificate shall be granted if, in the product as a medicinal product that has Member State in which the application been authorised before the expiry of the referred to in Article 7 is submitted and at certificate.' the date of that application:

2 — 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, OJ, English Special Edition 1965-66 (I), p. 20. (a) the product is protected by a basic 3 — Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to patent in force; veterinary medicinal products, OJ 1981 L 317, p. 1.

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Article 5 does not prejudice the issue of other certificates for derivatives (salts and esters) of the substance, provided that the deriva- tives are the subject of patents specifically covering them.' 'Subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.' 5. Article 69(1) of the European Patent Convention, done at Munich on 5 October 1973, provides:

The Protocol on the interpretation of Article 69 of the Convention, which is an integral part thereof, states: 'Whereas the certificate confers the same rights as those conferred by the basic patent; whereas, consequently, where the basic patent covers an active substance and its various derivatives (salts and esters), the 'Article 69 should not be interpreted in the certificate confers the same protection; sense that the extent of the protection conferred by a European patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving Whereas the issue of a certificate for a an ambiguity found in the claims. Neither product consisting of an active substance should it be interpreted in the sense that the claims serve only as a guideline and that the actual protection conferred may extend to 4 — OJ 19% L 198, p. 30. what, from a consideration of the descrip-

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tion and drawings by a person skilled in the chloride and, as an ancillary ingredient, art, the patentee has contemplated. On the dehydrated lactose. contrary, it is to be interpreted as defining a position between these extremes which combines a fair protection for the patentee with a reasonable degree of certainty for third parties.' 8. The original patent has since expired. Farmitalia applied for a supplementary protection certificate (hereinafter 'SPC' or 'certificate') for the free base 'idarubicin and salts thereof including idarubicin hydrochloride'. 5 However, on 9 June 1993, the defendant in the main proceed- ings, the Patentamt (German Patent Office, hereinafter 'the defendant'), granted a Ger- (ii) Factual background and national pro- man certificate only in respect of 'the ceedings medicament Zavedos containing as its active ingredient idarubicin hydrochloride'.

the named active ingredient of the two tion, that the term 'active ingredient' should authorised Zavedos products, so that an be understood as designating the pharma- SPC could not be granted in wider terms. cologically active base including its deriva- tives (salts and esters). Article 3(b) did not, therefore, require a marketing authorisa- tion in respect of every possible variant of the active ingredient, provided it had been authorised in one of its possible forms. 11. Furthermore, in the view of the Bundes- Regarding Article 3(a) of the Regulation, patentgericht, the main application did not Farmitalia submitted that the Bundespa- satisfy Article 3(a) of the SPC Regulation, tentgericht had erred, as a matter of Ger- because not all the salts of idarubicin were man law, concerning the scope of the protected by the basic patent. In addition to protection conferred by the basic German the free base idarubicin itself, only one salt, patent, as a person skilled in the art would idarubicin hydrochloride, was mentioned have known that other pharmaceutically in the patent. The Bundespatentgericht consistent salts of idarubicin would have considered that the protection by a basic been equally as suitable as idarubicin patent required by Article 3(a) did not refer hydrochloride as a means of dispensing to the effective scope of patent protection the active ingredient idarubicin. in any notional infringement proceedings, but, rather, to the technical doctrine pro- tected by the basic patent, that is, in addition to the matters mentioned expressly in the patent, such other matters which, in the view of a person skilled in the art, are self-explanatory or all but indis- pensable in regard to the patented discov- ery without the need for special mention to be made of them, or which the person skilled in the art on an attentive reading of 13. The national court observed that, on the patent papers can recognise and follow the one hand, it would be difficult for the in his own thought processes. This was not national authorities responsible for issuing the case regarding idarubicin salts as, SPCs to determine the pharmaceutical owing to their different chemical composi- equivalence of salts in the abstract. On tion in comparison with idarubicin and the other hand, it felt that it would be idarubicin hydrochloride, the expert could unsatisfactory if an SPC could not be at least consider it possible that there might obtained for a variant of a patented phar- be differences in their therapeutic effective- maceutical invention for which a marketing ness. authorisation was obtained and which, although falling within the effective scope of protection of the basic patent, was not expressly mentioned therein. The national court proposed an intermediate approach, whereby an SPC could only be granted in 12. On appeal to the Bundesgerichtshof respect of the substance identified in the (Federal Court of Justice, hereinafter 'the marketing authorisation but the scope of national court'), Farmitalia argued, in the protection conferred by that certificate respect of Article 3(b) of the SPC Regula- would extend, in accordance with the

'1 Does Article 3(b) presuppose that the product in respect of which the grant of ΠΙ — Observations a protection certificate is sought is described as an "active constituent" in the authorisation for marketing as a medicinal product? 14. Written and oral observations have been submitted by Farmitalia, the French Republic, the Kingdom of the Netherlands and the Commission. Written observations Is, then, Article 3(b) not complied with were also submitted by the Federal Repub­ where a single individual salt of an lic of Germany and the United Kingdom of active ingredient is stated in the notice Great Britain and Northern Ireland. of authorisation to be an "active con­ stituent", but the issue of a protection certificate is sought for the free base and/or for other salts of the active ingredient ? 15. Regarding the first question, all those submitting observations have argued that a certificate may be granted in respect of a product which is not expressly mentioned 2. If the questions at 1. are answered in as an active constituent in the marketing the negative: authorisation referred to in Article 3(b) of the SPC Regulation, provided that that authorisation relates to a salt of that product. A number of arguments have been put forward in support of this conclusion: According to which criteria is it to be determined whether the product, as referred to in Article 3(a), is protected by a basic patent where the issue of a protection certificate is sought for the free base of an active ingredient includ­ — Article 3(b) of the Regulation does not ing any of its salts, but the basic patent require that the product be mentioned

— the same view is expressed in the 13th, 14th and 17th recitals in the preamble to Regulation No 1610/96. Although — the Commission's Explanatory Mem- these cannot modify the SPC Regula- orandum 6 for the proposed SPC Reg- tion, they serve to clarify its interpreta- ulation indicates that a new certificate tion. Thus, the ninth recital in the cannot be issued in respect of an active preamble to the SPC Regulation serves ingredient which already benefits from only to exclude the grant of an SPC in one simply because of minor changes in respect of non-medicinal uses of a product covered by the basic patent. Although the national court does not 6 — COM(90) 101 final — SYN 255, 11 April 1990, para- consider this to affect the interpretation graph 36. of Article 3(b) of the Regulation, it is

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argued that the fact that a single recitals in the preamble to the Regula­ certificate can confer protection on a tion; 7 base, its salts and its esters, pursuant to Article 4, implies that Article 3(b) can be satisfied, in respect of such a range of variants, by a single marketing authorisation in respect of just one form of administration of a product;

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ferred by them would be consistent with protection it encompasses. These two ele­ the Regulation's sixth and seventh recitals ments of the scheme combine to determine and with the judgment in Spain ν Coun­ in practice the extent to which patentees cil. 12 can recover investment in research, which is the essential purpose of the Regulation.

TV — Analysis 21. Thirdly, although the SPC regime cre­ ates a distinct, new form of intellectual property right, rather than simply extend­ ing the period of protection guaranteed by existing patents, it is, none the less, closely 19. I wish to make a number of general connected with the national systems under observations at the outset of my analysis of which pharmaceutical patent rights are the present case. First, both of the questions initially granted and protected. Thus, in referred by the national court relate to the substantive terms, a certificate can only be conditions for the grant of an SPC set out in granted if a product is protected by a basic Article 3 of the SPC Regulation. What is at patent and the protection conferred by a issue is not whether or not a certificate certificate must be within the limits of that should be granted, but its terms. The conferred by the basic patent. The certifi­ criteria for the grant of a certificate are cate holder enjoys the same rights and is procedurally and substantively distinct subject to the same limitations and obliga­ from those which determine the effective tions as affected the basic patent. The scope of the protection it confers. The latter Regulation replicates the basic procedural are applied when it is sought to enforce the model of distinct phases for the adminis­ SPC in infringement proceedings, whereas trative grant and judicial enforcement of the former are considered by the competent patents which is common to all the Mem­ national industrial property office at the ber States. time of application for the award of a certificate.

can be understood in wider terms than indicate how this affects the application of those used to describe the medicinal pro- Article 3(a) and (b). duct in the relevant marketing authorisa- tion. In the second question, the issue whether the protection of a product by a basic patent is determined in accordance with the patent claims or on the basis of the effective scope of protection of the patent only arises if it is at least possible to conceive of the product in terms wider than those used in the claims. Article 3(c) 25. The term 'product' is open to a number and (d) also employs the term 'product'; of possible interpretations, none of which Article 3(c) in particular may be of rele- can be excluded on purely textual vance to the interpretation of the term. grounds. 13 The term 'active ingredient... of a medicinal product' is not defined in the SPC Regulation. On the one hand, it would be possible to construe the term 'product' as being the particular form of a patented pharmaceutical, for example the particular salt of a free base which is the 'active constituent' referred to in a market- ing authorisation. 14 An alternative approach is to interpret the term 'product' 23. Furthermore, by virtue of Article 4 of as referring, broadly speaking, either exclu- the Regulation, the concept of a 'product' is sively to the parent compound or variants also central to the determination of the expressly referred to in the patent claims, protection conferred by a certificate. As it is or to the ensemble of the parent compound defined only once, in Article 1(b), in the and its pharmaceutically acceptable deriva- absence of a contrary indication, the term tives for which patent protection can be should, normally, be given a uniform secured in infringement proceedings. The interpretation in the different contexts in number of possible options increases when which it is used in the Regulation. In one takes into account the fact that the particular, the Regulation's provisions on effective scope of protection of the basic the grant and enforcement, respectively, of patent can vary according to whether it is SPCs cannot be construed in isolation one granted pursuant to the European Patent from the other. Convention and is subject, thus, to Arti- cle 69 of that Convention, or is granted under the national patent regime, as the national rules on the extent of the protec- tion conferred by the patent are not iden-

tical in all Member States to those esta- acceptable salts and esters, one variant of blished by Article 69 of the Convention. which was the subject of a marketing authorisation, then it would only be logical to construe the requirement in Article 3(a) that it be protected by a basic patent as referring to the extent of the protection conferred by the patent rather than to the 26. Each of these alternative approaches usually more restricted terms of the claims. can be reconciled in a practical way with In such a case, the 'one certificate per the terms of the Regulation. The first product' rule in Article 3(c) would, in approach (which is that favoured by the effect, become one of 'one certificate per defendant) offers a relatively straightfor- patent'. Furthermore, as the certificate ward means of establishing whether a would itself expressly contemplate any product is protected by a basic patent in force, especially if it is actually mentioned pharmaceutically acceptable variant of the in the description accompanying the patent authorised medicinal product and could claims for the free base. The 'one certificate not have a scope of protection wider than per product' rule set out in Article 3(c) of that conferred by the basic patent, Article 4 the Regulation could be easily applied; it would give rise to, at most, factual disputes does not exclude the admittedly improb- regarding the pharmaceutical properties of able grant of further certificates for other certain variants. 16 variants of the patented free base which have benefited from separate marketing authorisations. It is open to question whe- ther an SPC issued in these restricted terms could, none the less, secure for its holder the wide scope of protection suggested by the national court in its proposed inter- 28. How is one to choose between these mediate approach, as the concept of the different possible constructions? As I have 'product' is also central to that question, 15 already observed, the possible textual argu- but it would, at the very least, secure a level ments do not appear to me to be decisive. of protection regarded as adequate by the The most that can be said is that they are defendant, the Bundespatentgericht and not inconsistent with certain outcomes. The two delegations to the meeting of national fact that a 'medicinal product' is defined in experts on industrial property of 3 Febru- Article 1(a) of the Regulation by reference ary 1995. to its properties does not seem to me to be sufficient on its own to establish that, when one looks at Article 1(b), its active ingre- dient includes any variant of a patented substance which displays those properties, rather than the single variant which has in 27. Moving to the other extreme, if the fact been authorised to be marketed as a product were taken to be a patented free medicinal product. To observe that Arti- base together with all its pharmaceutically

cle 3(b) does not state that the product tion for further assistance. In this regard, should itself be mentioned in the marketing the following considerations appear to me authorisation, or that Article 3(a) does not to be crucial. First, the SPC Regulation is refer to the patent claims, is, I think, simply intended, as I observed in paragraph 2 to beg the question. The argument that the above, to confer an additional compensa- use of the terms 'protected' or 'protection' tory period of protection for pharmaceuti- implicitly refers to the scope of protection cal inventions. The Regulation would not of the basic patent, although plausible, achieve this aim if it were interpreted as hardly determines the terms of the certifi- providing for SPC protection limited to the cate. It refers, in any event, to a question narrow category of authorised medicinal which is posterior to that of the interpreta- products, or to the invention set out in the tion of the term 'product' — if 'active patent claims; that interpretation would ingredient' and, thus, 'product' are nar- permit other manufacturers to produce rowly construed, the debate over the mean- pharmaceutically equivalent medicinal pro- ing of Article 3(a) would be largely point- ducts, on the basis of other derivatives of less, because the product, so construed, the patented invention, which could have would, in the circumstances of the present been prohibited pursuant to national infrin- case at least, fall clearly within even the gement proceedings during the life of the terms of the patent claims, read in the light patent itself.19 The argument of France of the description. It has been suggested regarding the public-health interest in the that the implicit distinction between an availability of generic drugs does not con- active ingredient and an active moiety in vince me in this regard, because it is Council Directive 75/318/EEC of 20 May inconsistent with the principal objective of 1975 on the approximation of the laws of the Regulation; that interest can, perhaps, Member States relating to analytical, phar- be understood as having been addressed by maco-toxicological and clinical standards the temporal limits imposed on SPCs. 20 and protocols in respect of the testing of proprietary medicinal products 17 points towards a narrow interpretation of the former term, confined to variants which are actually the subject of a marketing authorisation, but this is in the context of a different regulatory regime. 18

such a fashion that the certificate holder relevant marketing authorisation) and, has greater procedural advantages than he thus, by national patent law. 22 Although enjoyed qua patent holder. This could arise, the sixth recital in the preamble to Regula­ for example, if an SPC were granted in tion indicates that it was designed to terms much wider than those used in the provide for 'a uniform Community solu­ original patent, thus potentially affecting tion' and to prevent 'the heterogenous the relative burdens of evidence and proof development of national laws leading to borne by the certificate holder and another further disparities' 2 3 which would directly manufacturer in subsequent infringement affect the internal market, it is clear to me proceedings. More generally, the supple­ that this refers primarily to the develop­ mentary protection regime should, in the ment, before the Regulation's adoption, of absence of contrary indications, mirror the diverse national supplementary protection procedural steps typical to the national and regimes. 24 The Regulation does not seek to European patent systems on which it is harmonise the underlying national patent dependent and, to a large extent, modelled. rules, upon which the supplementary pro­ Thus, to the greatest extent possible, the tection regime is grafted. As a result, in respective roles of the administrative autho­ spite of the significance of Article 69 of the rities responsible for granting patents and European Patent Convention both for the the judicial bodies responsible for enforcing application of that Convention and in the them should be replicated under the SPC purely national patent systems of a number Regulation. 21 of Member States, there are no grounds for concluding that the Regulation requires a uniform approach to the question of the extent of the protection conferred by an SPC.

of which several variants could exist, so normally fall within the effective scope of that the use, for example, of a different salt protection of an SPC, it does not state that would be regarded as a minor change they should be considered to be within the which could not give rise to a new certifi­ definition of the 'product', which deter­ cate. 2 5 Consistently with this view, it refers mines the terms in which the SPC is to the possibility of a product being the granted. The statement that that definition subject of several marketing authorisations would not prevent the issue of a new in different pharmaceutical forms, 2 6 imply­ certificate for salts and esters which could ing, therefore, that the product is not be qualified as new active ingredients simply the substance which is the subject implies, however, that this is the case. of any given marketing authorisation, but Without prejudice to the question whether may be more widely defined. 27 the Community legislature is entitled to seek to influence the judicial interpretation of a legislative measure through the inclu­ sion of interpretative 'rules' in later legisla­ tion which does not purport to amend the earlier measure, it is also clear that the 13th and 14th recitals in the preamble to the 1996 Regulation are consistent with the 33. The statement in the Council minutes statement in the Council minutes. 3 0 that 'the Council and Commission consider that the definition of "product" does not mean that salts and esters are excluded from the protection' is of more doubtful interpretative value in the light of the consistent view of the Court that such material should not be used unless its content is reflected in the wording of the 34. The Commission's statement to the provision being interpreted. 2 8 However, meeting of national experts in 1995, reference is occasionally made to such assented to by several delegations and material where it is consistent with an opposed by two, that the certificate 'cov­ interpretation of the legislative text in ered both the compound (the base) and its question already favoured by the Court pharmaceutically acceptable salts and on other grounds. 2 9 In the present case, the esters' and its further statement that a salt statement is a little ambiguous. Although it or ester with a distinct activity profile could clearly indicates that salts and esters should

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35. All of these statements are, in them- Thus, manufacturers of generic pharma- selves, inconclusive. However, they recog- ceutical products would enjoy no greater nise that, as pointed out by the United freedom than under the basic patent, and Kingdom in its observations, the marketing infringement proceedings could be con- authorisation, being principally concerned ducted on broadly the same procedural with clinical use, will almost inevitably lines as those in respect of a patent, with name the active constituent by reference the same balance of advantage between the not to the parent compound but to its salt parties.

distinct elements of the product. As a the national court, my recommended result, and in view of the fact that the approach to the definition of the product patent claims will normally be phrased, as would result in a negative answer to both in the present case, in terms of the free base, parts of the first question regarding the these can be taken as defining the product definition of the active ingredient and, as and, therefore, as dictating the terms in should already be clear, in the second which a subsequent SPC is granted. In my question being answered in favour of the view, therefore, the certificate should be use of the wording of the patent claims granted in the same terms as the patent rather than the use of the scope of protec-

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V — Conclusion

37. In conclusion, I recommend that the Court answer the questions referred by the Bundesgerichtshof as follows:

(1) It is not necessary for the purposes of the application of Article 3(b) of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products that the product in respect of which the grant of a supplementary protection certificate is sought is described as an active constituent in the relevant authorisation to place a medicinal product on the market, provided that that authorisation relates to a pharmaceutically equivalent variant of the product in question;

(2) For the purposes of the application of Article 3(a) of Regulation No 1768/92, the product, defined by reference to the pharmacologically active free base or parent compound underlying the medicinal product which is subject to a marketing authorisation, should be deemed to be protected by a basic patent in force where it comes within the terms of the claims of the relevant patent.