OPINION OF ADVOCATE GENERAL
FENNELLY
delivered on 3 June 1999 (1)
Case C-392/97
Farmitalia Carlo Erba S.r.l.
v
Patentamt
I Introduction
- 1.
- This case raises the question of the terms in which a supplementary
protection certificate should be granted under Council Regulation (EEC)
No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection
certificate for medicinal products (2) (hereinafter 'the SPC Regulation or 'the
Regulation) where the necessary 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 where it is argued that the
scope of protection of the basic patent extends by implication to all such salts.
II Legal and factual context
(i) Community legislation and other instruments
- 2.
- The extended period of protection provided by a certificate granted
pursuant to the SPC Regulation is designed to compensate the holder of a basic
patent for the delay necessarily attendant on the grant of an authorisation to
market a medicinal product (hereinafter a 'marketing authorisation) whose active
ingredient is covered by that patent. It is inherent in this scheme that, as the ninth
recital states, 'the protection granted should furthermore be strictly confined to the
product which obtained authorisation to be placed on the market as a medicinal
product.
- 3.
- The principal relevant provisions of the SPC Regulation are as follows:
Article 1
'For the purpose of this regulation:
(a) medicinal product means any substance or combination of substances
presented for treating or preventing disease in human beings or animals and
any substance or combination of substances which may be administered to
human beings or animals with a view to making a medical diagnosis or to
restoring, correcting or modifying physiological functions in humans or in
animals;
(b) product means the active ingredient or combination of active ingredients
of a medicinal product;
(c) basic patent means a patent which protects a product as defined in (b)
as such, a process to obtain a product or an application of a product, and
which is designated by its holder for the purpose of the procedure for grant
of a certificate;
... .
Article 3
'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 65/65/EEC [(3)] or
Directive 81/851/EEC, [(4)] as appropriate;
(c) the product has not already been the subject of a certificate;
... .
Article 4
'Within the limits of the protection conferred by the basic patent, the protection
conferred by a certificate shall extend only to the product covered by the
authorisation to place the corresponding medicinal product on the market and for
any use of the product as a medicinal product that has been authorised before the
expiry of the certificate.
Article 5
'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.
- 4.
- The 17th recital in the preamble to Regulation (EC) No 1610/96 of the
European Parliament and of the Council of 23 July 1996 concerning the creation
of a supplementary protection certificate for plant protection products (5)
(hereinafter 'the 1996 Regulation) states that 'the detailed rules in recitals 12, 13
and 14 ... are also valid, mutatis mutandis, for the interpretation in particular of
recital 9 ... of [the SPC Regulation]. The 13th and 14th recitals state, respectively:
'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 certificate confers the same
protection;
Whereas the issue of a certificate for a product consisting of an active substance
does not prejudice the issue of other certificates for derivatives (salts and esters)
of the substance, provided that the derivatives are the subject of patents specifically
covering them.
- 5.
- Article 69(1) of the European Patent Convention, done at Munich on 5
October 1973, provides:
'The extent of the protection conferred by a European patent or a European
patent application shall be determined by the terms of the claims. Nevertheless,
the description and drawings shall be used to interpret the claims.
The Protocol on the interpretation of Article 69 of the Convention, which is an
integral part thereof, states:
'Article 69 should not be interpreted in the 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 an ambiguity found in the claims.
Neither should it be interpreted in the sense that the claims serve only as a
guideline and that the actual protection conferred may extend to what, from a
consideration of the description and drawings by a person skilled in the art, the
patentee has contemplated. On the 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.
(ii) Factual background and national proceedings
- 6.
- The appellant in the main proceedings, Farmitalia Carlo Erba S.r.l.
(hereinafter 'Farmitalia), holds a German patent notified on 9 June 1975 for
alpha-anomer of 4-Demethoxydaunomycin, its manufacturing process and the
medicament containing that substance. The short designation recommended by the
World Health Organisation for chemical compositions so structured is idarubicin.
The patent claims mention the salt idarubicin hydrochloride as an embodiment of
the invention.
- 7.
- Farmitalia subsequently obtained an authorisation to market the products
'Zavedos 5 mg and 'Zavedos 10 mg in Germany as medicinal products for
treatment of acute myelitic leukaemias. These products contain the salt idarubicin
hydrochloride and, as an ancillary ingredient, dehydrated lactose.
- 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. (6)
However, on 9 June 1993, the defendant in the main proceedings, the Patentamt
(German Patent Office, hereinafter 'the defendant), granted a German certificate
only in respect of 'the medicament Zavedos containing as its active ingredient
idarubicin hydrochloride.
- 9.
- Farmitalia commenced complaint proceedings before the
Bundespatentgericht (Federal Patents Court) seeking a certificate in the terms
initially requested or, in the alternative, for 'idarubicin and idarubicin
hydrochloride. That court rejected both the main and the subsidiary applications.
- 10.
- The Bundespatentgericht took the view that neither the main nor the
subsidiary application satisfied Article 3(b) of the SPC Regulation, as an SPC could
only be granted to a product stated to be an active ingredient of a medicinal
product in the relevant marketing authorisation. In the present case, idarubicin
hydrochloride was the named active ingredient of the two authorised Zavedos
products, so that an SPC could not be granted in wider terms.
- 11.
- Furthermore, in the view of the Bundespatentgericht, the main application
did not satisfy Article 3(a) of the SPC Regulation, because not all the salts of
idarubicin were protected by the basic patent. In addition to the free base
idarubicin itself, only one salt, idarubicin hydrochloride, was mentioned in the
patent. The Bundespatentgericht considered that the protection by a basic patent
required by Article 3(a) did not refer to the effective scope of patent protection in
any notional infringement proceedings, but, rather, to the technical doctrine
protected 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 indispensable in regard to the patented
discovery without the need for special mention to be made of them, or which the
person skilled in the art on an attentive reading of the patent papers can recognise
and follow in his own thought processes. This was not the case regarding idarubicin
salts as, owing to their different chemical composition in comparison with idarubicin
and idarubicin hydrochloride, the expert could at least consider it possible that
there might be differences in their therapeutic effectiveness.
- 12.
- On appeal to the Bundesgerichtshof (Federal Court of Justice, hereinafter
'the national court), Farmitalia argued, in respect of Article 3(b) of the SPC
Regulation, that the term 'active ingredient should be understood as designating
the pharmacologically active base including its derivatives (salts and esters).
Article 3(b) did not, therefore, require a marketing authorisation in respect of every
possible variant of the active ingredient, provided it had been authorised in one of
its possible forms. Regarding Article 3(a) of the Regulation, Farmitalia submitted
that the Bundespatentgericht had erred, as a matter of German law, concerning the
scope of the protection conferred by the basic German patent, as a person skilled
in the art would have known that other pharmaceutically consistent salts of
idarubicin would have been equally as suitable as idarubicin hydrochloride as a
means of dispensing the active ingredient idarubicin.
- 13.
- The national court observed that, on the one hand, it would be difficult for
the national authorities responsible for issuing SPCs to determine the
pharmaceutical equivalence of salts in the abstract. On the other hand, it felt that
it would be unsatisfactory if an SPC could not be obtained for a variant of a
patented pharmaceutical invention for which a marketing 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 respect of the
substance identified in the marketing authorisation but the scope of the protection
conferred by that certificate would extend, in accordance with the criteria
applicable to the basic patent, to pharmaceutically acceptable equivalent
substances. In the light of the dispute regarding the proper interpretation of the
SPC Regulation, the national court has referred the following questions to the
Court for a preliminary ruling pursuant to Article 177 of the EC Treaty:
'1 Does Article 3(b) presuppose that the product in respect of which the grant
of a protection certificate is sought is described as an active constituent
in the authorisation for marketing as a medicinal product?
Is, then, Article 3(b) not complied with where a single individual salt of an
active ingredient is stated in the notice of authorisation to be an active
constituent, but the issue of a protection certificate is sought for the free
base and/or for other salts of the active ingredient?
2. If the questions at 1. are answered in the negative:
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
including any of its salts, but the basic patent in its patent claims mentions
only the free base of that ingredient and, moreover, mentions in an
embodiment a single salt of this free base? Is the wording of the claim for
the basic patent or the latter's scope of protection the determining
criterion?
III Observations
- 14.
- Written and oral observations have been submitted by Farmitalia, the
French Republic, the Kingdom of the Netherlands and the Commission. Written
observations were also submitted by the Federal Republic of Germany and the
United Kingdom of Great Britain and Northern Ireland.
- 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 as an active constituent in the marketing 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:
Article 3(b) of the Regulation does not require that the product be
mentioned in the marketing authorisation, but, rather, that the marketing
of the product as a medicinal product has been authorised;
the pharmaceutical effects of a free base, its salts and its esters are normally
equivalent. Exceptional cases would not have to be specifically identified
when an SPC is granted, as this could be done when the scope of protection
of the certificate is determined, for example in infringement proceedings
regarding such a salt or ester;
the certificate is granted in respect of an active ingredient as such, and not
in respect of any particular mode of administration; in this regard, the
definition of a product in Article 1(b) of the Regulation, based on the
concept of the active ingredient, may be linked to that of a medicinal
product in Article 1(a), which emphasises its therapeutic or diagnostic
properties rather than its form;
the Commission's Explanatory Memorandum (7) for the proposed SPC
Regulation indicates that a new certificate cannot be issued in respect of an
active ingredient which already benefits from one simply because of minorchanges in the related medicinal product, such as the use of different salts;
this implies that the active ingredient is understood as being the relevant
free base or parent compound;
the minutes to the Council meeting at which it reached a common position
on the proposed SPC Regulation state that the Commission and the Council
considered that the definition of a 'product in Article 1(b) of the
Regulation did not exclude salts and esters from the protection of a
certificate and did not prevent the issue of a new certificate for those which
could be qualified as new active ingredients. This point of view was
accepted by all but two delegations at a subsequent meeting of national
experts on industrial property hosted by the Commission on 3 February
1995;
the same view is expressed in the 13th, 14th and 17th recitals in the
preamble to Regulation No 1610/96. Although these cannot modify the
SPC Regulation, they serve to clarify its interpretation. Thus, the ninth
recital in the preamble to the SPC Regulation serves only to exclude the
grant of an SPC in respect of non-medicinal uses of a product covered by
the basic patent. Although the national court does not consider this to
affect the interpretation of Article 3(b) of the Regulation, it is argued that
the fact that a single certificate can confer protection on a 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;
the objective of the SPC Regulation would not be achieved if a certificate
could only be granted in respect of the particular salt of an active ingredient
mentioned in a marketing authorisation, because, once the basic patent
expired, generic manufacturers would then be free to obtain marketing
authorisations for medicinal products using other salts of the same free
base, with equivalent therapeutic or diagnostic effects, simply by conducting
a small number of bio-equivalence tests, which could be carried out in
advance outside the Community, in the light of the known literature. The
intermediate approach suggested by the national court would oblige SPC
holders to establish the equivalence of the generic medicinal product with
the protected product in lengthy, costly and unsatisfactory infringement
proceedings. Furthermore, the scope of protection of national patents
differs, so that this approach would not achieve the uniform solution, by way
of a certificate granted under the same conditions, referred to in the sixth
and seventh recitals in the preamble to the Regulation; (8)
reference has been made to guidelines issued by the competent authorities
in Denmark (9) and the United Kingdom (10) and to appellate decisions in
France (11) and the Netherlands. (12) These all interpret the reference in
Article 3(b) of the Regulation to 'the product in a broad fashion,
distinguishing it from the pharmaceutical speciality in respect of which the
marketing authorisation is expressly granted and construing the term 'active
ingredient to include derivatives such as salts and esters in addition to the
free base. This reflects international practice, which normally treats bases
and their salts as being interchangeable.
- 16.
- Regarding the second question, Farmitalia, Germany and the Commission
argue that, for the purposes of Article 3(a) of the SPC Regulation, the relevant
criterion for determining whether a product is protected by a patent is the effective
scope of the protection conferred by that patent in national law, as determined by
the national courts, and not the literal text of the claims in the patent itself.
Exclusive reliance on the patent claims would be too formalistic and there is no
reference to them in the text of Article 3(a). The importance of the scope of
protection of the patent is confirmed by the recitals in the preamble to Regulation
No 1610/96 and by the conclusions of the 1995 meeting of national experts referred
to above. Administrative difficulties cannot be permitted to dictate a reduction in
protection. In practical terms, the pharmaceutical equivalence of the free base and
its salts can be presumed when a certificate is awarded. It would be necessary for
the competent national authority simply to check that the variant in respect of
which a marketing authorisation has been granted is covered by the patent.
Disputes regarding whether other variants are in fact covered by the patent and,
thus, by the SPC could be determined in the course of any subsequent infringement
proceedings. However, the Commission stated in response to a question at the oral
hearing that it would be sufficient to mention only the free base or parent
compound when granting the SPC; Farmitalia, on the other hand, persisted in its
argument that the certificate should expressly refer to idarubicin and its salts in
order to avoid having to establish equivalence in infringement proceedings.
- 17.
- The Netherlands submits, on the contrary, that, as Article 18(2) of the
Regulation rules out an opposition procedure, compliance with Article 3(a) should
be determined on the basis of the basic patent claims, as clarified by the
description. This objective, easily verified criterion would result in a simple,
transparent award system. It adds that, by virtue of Article 4 of the Regulation, the
national courts could determine that the protection afforded by a certificate granted
in such terms could extend to the ensemble of pharmaceutically equivalent variants
of the protected compound in the same way as would that afforded by the basic
patent.
- 18.
- France also proposes that compliance with Article 3(a) of the Regulation
be judged by reference to the basic patent claims, interpreted in the light of the
accompanying description. It derives this interpretative approach from Article 69
of the European Patent Convention, which prescribes the extent of the protection
conferred by a European patent. However, France alone also proposes that the
extent of the protection conferred by the SPC be determined in the same fashion.
As an exceptional extension of patent holders' monopoly rights, the SPC should be
strictly construed. The reference in the ninth recital in the preamble to the SPC
Regulation to the interest in public health requires that account be taken of the
national health policy of favouring the commercialisation of generic drugs.
Furthermore, a uniform approach, on the basis of the European Patent
Convention, to the grant of SPCs and to the extent of the protection conferred by
them would be consistent with the Regulation's sixth and seventh recitals and with
the judgment in Spain v Council. (13)
IV Analysis
- 19.
- I wish to make a number of general observations at the outset of my
analysis of the present case. First, both of the questions referred by the national
court relate to the conditions for the grant of an SPC set out in Article 3 of the
SPC Regulation. What is at issue is not whether or not a certificate should be
granted, but its terms. The criteria for the grant of a certificate are procedurally
and substantively distinct from those which determine the effective scope of the
protection it confers. The latter are applied when it is sought to enforce the SPC
in infringement proceedings, whereas the former are considered by the competent
national industrial property office at the time of application for the award of a
certificate.
- 20.
- Secondly, and in spite of this distinction, the conditions for the grant of an
SPC cannot be construed in isolation from the general scheme established by the
Regulation and, in particular, from the provisions governing the scope and effect
of the protection it encompasses. These two elements of the scheme combine to
determine in practice the extent to which patentees can recover investment in
research, which is the essential purpose of the Regulation.
- 21.
- Thirdly, although the SPC regime creates a distinct, new form of intellectual
property right, rather than simply extending the period of protection guaranteed
by existing patents, it is, none the less, closely connected with the national systems
under which pharmaceutical patent rights are initially granted and protected. Thus,
in substantive terms, a certificate can only be granted if a product is protected by
a basic patent and the protection conferred by a certificate must be within the
limits of that conferred by the basic patent. The certificate holder enjoys the same
rights and is subject to the same limitations and obligations as affected the basic
patent. The Regulation replicates the basic procedural model of distinct phases for
the administrative grant and judicial enforcement of patents which is common to
all the Member States.
- 22.
- Fourthly, the first question referred by the national court turns entirely, and
the second substantially, on the interpretation to be given to the term 'product
in Article 3(a) and (b) of the Regulation, which is defined in Article 1(b) by
reference to the concept of an 'active ingredient. Thus, in the first question, the
national court essentially asks whether the product can be understood in wider
terms than those used to describe the medicinal product in the relevant marketing
authorisation. 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) and (d) also employs the term 'product; Article 3(c) in particular
may be of relevance to the interpretation of the term.
- 23.
- Furthermore, by virtue of Article 4 of the Regulation, the concept of a
'product is also central to the determination of the protection conferred by a
certificate. As it is defined only once, in Article 1(b), in the absence of a contrary
indication, the term should, normally, be given a uniform interpretation in the
different contexts in which it is used in the Regulation. In particular, the
Regulation's provisions on the grant and enforcement, respectively, of SPCs cannot
be construed in isolation one from the other.
- 24.
- Therefore, I will first examine the underlying question of the proper
construction of the definition of a product in Article 1(b) of the Regulation and will
then indicate how this affects the application of Article 3(a) and (b).
- 25.
- The term 'product is open to a number of possible interpretations, none
of which can be excluded on purely textual grounds. (14) 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 marketing
authorisation. (15) An alternative approach is to interpret the term 'product as
referring, broadly speaking, either exclusively to the parent compound or variants
expressly referred to in the patent claims, or to the ensemble of the parent
compound and its pharmaceutically acceptable derivatives for which patent
protection can be secured in infringement proceedings. The number of possible
options increases when one takes into account the fact that the effective scope of
protection of the basic patent can vary according to whether it is granted pursuant
to the European Patent Convention and is subject, thus, to Article 69 of that
Convention, or is granted under the national patent regime, as the national rules
on the extent of the protection conferred by the patent are not identical in all
Member States to those established by Article 69 of the Convention.
- 26.
- Each of these alternative approaches can be reconciled in a practical way
with the terms of the Regulation. The first approach (which is that favoured by the
defendant) offers a relatively straightforward means of establishing whether a
product is protected by a basic patent in force, especially if it is actually mentioned
in the description accompanying the patent claims for the free base. The 'one
certificate per product rule set out in Article 3(c) of the Regulation could be easily
applied; it does not exclude the admittedly improbable grant of further certificates
for other variants of the patented free base which have benefited from separate
marketing authorisations. It is open to question whether 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 intermediate approach,
as the concept of the 'product is also central to that question, (16) but it would, at
the very least, secure a level of protection regarded as adequate by the defendant,
the Bundespatentgericht and two delegations to the meeting of national experts on
industrial property of 3 February 1995.
- 27.
- Moving to the other extreme, if the product were taken to be a patented
free base together with all its pharmaceutically acceptable salts and esters, one
variant of 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 usually more restricted terms of the claims. In such a case, the 'one
certificate per product rule in Article 3(c) would, in effect, become one of 'one
certificate per patent. Furthermore, as the certificate would itself expressly
contemplate any pharmaceutically acceptable variant of the authorised medicinal
product and could not have a scope of protection wider than that conferred by the
basic patent, Article 4 would give rise to, at most, factual disputes regarding the
pharmaceutical properties of certain variants. (17)
- 28.
- How is one to choose between these different possible constructions? As
I have already observed, the possible textual arguments do not appear to me to be
decisive. The most that can be said is that they are not inconsistent with certain
outcomes. The fact that a 'medicinal product is defined in Article 1(a) of the
Regulation by reference 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 ingredient
includes any variant of a patented substance which displays those properties, rather
than the single variant which has in fact been authorised to be marketed as a
medicinal product. To observe that Article 3(b) does not state that the product
should itself be mentioned in the marketing authorisation, or that Article 3(a) does
not refer to the patent claims, is, I think, simply to beg the question. The argument
that the use of the terms 'protected or 'protection implicitly refers to the scope
of protection of the basic patent, although plausible, hardly determines the termsof the certificate. It refers, in any event, to a question which is posterior to that of
the interpretation of the term 'product if 'active ingredient and, thus,
'product are narrowly construed, the debate over the meaning of Article 3(a)
would be largely pointless, because the product, so construed, would, in the
circumstances of the present case at least, fall clearly within even the terms of the
patent claims, read in the light of the description. It has been suggested that the
implicit distinction between an active ingredient and an active moiety in Council
Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member
States relating to analytical, pharmaco-toxicological and clinical standards and
protocols in respect of the testing of proprietary medicinal products (18) 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. (19)
- 29.
- It is necessary, therefore, to look to the scheme and objectives of the SPC
Regulation for further assistance. In this regard, the following considerations
appear to me to be crucial. First, the SPC Regulation is intended, as I observed
in paragraph 2 above, to confer an additional compensatory period of protection
for pharmaceutical inventions. The Regulation would not achieve this aim if it
were interpreted as providing for SPC protection limited to the narrow category of
authorised medicinal products, or to the invention set out in the patent claims; that
interpretation would permit other manufacturers to produce pharmaceutically
equivalent medicinal products, on the basis of other derivatives of the patented
invention, which could have been prohibited pursuant to national infringement
proceedings during the life of the patent itself. (20) The argument of France
regarding the public-health interest in the availability of generic drugs does not
convince me in this regard, because it is inconsistent with the principal objective of
the Regulation; that interest can, perhaps, be understood as having been addressed
by the temporal limits imposed on SPCs. (21)
- 30.
- Secondly, as is clear from Article 5, the SPC can never afford greater
protection than is afforded by the patent itself. To my mind, this limitation has a
procedural as well as a substantive component. Thus, the Regulation should not
be interpreted in such a fashion that the certificate holder has greater procedural
advantages than he enjoyed qua patent holder. This could arise, for example, if an
SPC were granted in terms much wider than those used in the original patent, thus
potentially affecting the relative burdens of evidence and proof borne by the
certificate holder and another manufacturer in subsequent infringement
proceedings. More generally, the supplementary protection regime should, in the
absence of contrary indications, mirror the procedural steps typical to the national
and European patent systems on which it is dependent and, to a large extent,
modelled. Thus, to the greatest extent possible, the respective roles of the
administrative authorities responsible for granting patents and the judicial bodies
responsible for enforcing them should be replicated under the SPC Regulation. (22)
- 31.
- Thirdly, as stated in the seventh recital in the preamble, the SPC must be
'granted under the same conditions by each of the Member States. However, the
conditions for the grant of a certificate must be distinguished from those governing
the protection it confers. The extent of this protection, and the rights, limitations
and obligations ensuing therefrom, are chiefly determined by reference to the basic
patent (subject, of course, to it being confined to the product which is the subject
of the relevant marketing authorisation) and, thus, by national patent law. (23)
Although the sixth recital in the preamble to Regulation indicates that it was
designed to provide for 'a uniform Community solution and to prevent 'the
heterogenous development of national laws leading to further disparities (24) which
would directly affect the internal market, it is clear to me that this refers primarily
to the development, before the Regulation's adoption, of diverse national
supplementary protection regimes. (25) The Regulation does not seek to harmonise
the underlying national patent rules, upon which the supplementary protection
regime is grafted. As a result, in spite of the significance of Article 69 of the
European Patent Convention both for the application of that Convention and in
the purely national patent systems of a number 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.
- 32.
- Fourthly, regard may be had to a variety of sources of evidence of the
objectives of the Commission in proposing and of the Council in adopting the SPC
Regulation. It is clear from the Explanatory Memorandum that the Commission
understood an active ingredient as being a pharmaceutically active basic compound,
of which several variants could exist, so that the use, for example, of a different salt
would be regarded as a minor change which could not give rise to a new
certificate. (26) Consistently with this view, it refers to the possibility of a product
being the subject of several marketing authorisations in different pharmaceutical
forms, (27) implying, therefore, that the product is not simply the substance which
is the subject of any given marketing authorisation, but may be more widely
defined. (28)
- 33.
- The statement in the Council minutes 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 provision being interpreted. (29) However,
reference is occasionally made to such material where it is consistent with an
interpretation of the legislative text in question already favoured by the Court on
other grounds. (30) In the present case, the statement is a little ambiguous.
Although it clearly indicates that salts and esters should normally fall within the
effective scope of protection of an SPC, it does not state that they should be
considered to be within the definition of the 'product, which determines the terms
in which the SPC is granted. The statement that that definition would not prevent
the issue of a new certificate for salts and esters which could be qualified as new
active ingredients implies, however, that this is the case. Without prejudice to the
question whether the Community legislature is entitled to seek to influence the
judicial interpretation of a legislative measure through the inclusion of
interpretative 'rules in later legislation 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 statement in the Council minutes. (31)
- 34.
- The Commission's statement to the meeting of national experts in 1995,
assented to by several delegations and opposed by two, that the certificate 'covered
both the compound (the base) and its pharmaceutically acceptable salts and esters
and its further statement that a salt or ester with a distinct activity profile could be
considered to be a new product and could, thus, benefit from a further certificate
are consistent with the foregoing interpretative material. However, while the
minutes of such meetings illustrate the (not entirely uniform) views of the
Commission and the Member States acting in their administrative capacities, they
cannot, in my view, be treated as shedding light, ex post facto, on the objectives of
the Community legislator when it adopted the SPC Regulation.
- 35.
- All of these statements are, in themselves, inconclusive. However, they
recognise that, as pointed out by the United Kingdom in its observations, the
marketing authorisation, being principally concerned with clinical use, will almost
inevitably name the active constituent by reference not to the parent compound but
to its salt or ester. In the light of all of the foregoing factors, I would construe an
active ingredient as being the pharmacologically active free base or parent
compound underlying a medicinal product which is subject to a marketing
authorisation. Different salts and esters can normally be understood as being
simply variants of the active ingredient and, thus, of the product, rather than as
being either products in their own right or distinct elements of the product. As a
result, and in view of the fact that the patent claims will normally be phrased, as
in the present case, in terms of the free base, these can be taken as defining the
product and, therefore, as dictating the terms in which a subsequent SPC is
granted. In my view, therefore, the certificate should be granted in the same terms
as the patent claims. This would have the advantage of establishing a uniform
criterion for the grant of a certificate, which could not easily be arrived at on the
basis of the scope of protection of the basic patent, and of permitting national
competent authorities to grant certificates without having to engage in an inquiry
into the likely additional scope of protection of the patent and of the certificate,
which is alien to their normal function. Furthermore, it would preserve the normal
division of functions between those authorities and the national courts, permitting
the latter to decide the ultimate scope of protection of a certificate worded in
terms of the patent claims on the basis of the same principles of national law as are
applied to the patent itself (subject always to the caveat required by Article 4 that
the certificate's scope be limited to authorised medicinal uses of the product).
Thus, manufacturers of generic pharmaceutical products would enjoy no greater
freedom than under the basic patent, and infringement proceedings could be
conducted on broadly the same procedural lines as those in respect of a patent,
with the same balance of advantage between the parties.
- 36.
- To return to the questions referred by the national court, my recommended
approach to the definition of the product would result in a negative answer to both
parts of the first question regarding the definition of the active ingredient and, as
should already be clear, in the second question being answered in favour of the use
of the wording of the patent claims rather than the use of the scope of protection
of the basic patent to define the product in question and, thus, to determine
whether it is protected by a basic patent.
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.
1: Original language: English.
2:
OJ 1992 L 182, p. 1.
3:
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.
4:
Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of
the Member States relating to veterinary medicinal products, OJ 1981 L 317, p. 1.
5:
OJ 1996 L 198, p. 30.
6:
It appears that an SPC was granted in these terms in the United Kingdom.
7:
COM(90) 101 final SYN 255, 11 April 1990, paragraph 36.
8:
See Case C-350/92 Spain v Council [1995] ECR I-1985, paragraphs 35 and 36.
9:
Guidelines P 3.4-2, September 1994.
10:
The Patent Office, Supplementary Protection Certificates for Medicinal Products: A Guide
for Applicants (Newport, 1992), paragraph 1.6.
11:
Fisons plc v Le Directeur de l'Institut National de la Propriété Industrielle, Cour d'Appel de
Paris, judgment of 7 July 1994. However, this case appears to deal with the French SPC
legislation which preceded the adoption of the SPC Regulation.
12:
SPC Application No. 930006, Merck & Co., Inc., Patent Office Board of Appeal, decision
of 12 July 1995.
13:
Case C-350/92, loc. cit.
14:
Some textual arguments are discussed below, but, in my view, none is in itself conclusive.
15:
Nor is any consistent guidance furnished by Council Directive 65/65/EEC, loc. cit. The
English version uses the term 'active constituent. The German text of
Directive 65/65/EEC also uses a distinct term, 'wirksamer Bestandteil, rather than the
term 'Wirkstoff employed in the SPC Regulation. On the other hand, however, the
French versions of both measures employ the term 'principe actif.
16:
This depends, of course, on the construction of Article 4 of the Regulation, which is notat issue in the present case, but which it is necessary to consider in order to assess the
overall impact of any given approach to the interpretation of the definition of a 'product
in Article 1(b).
17:
Disputes could arise either where it is alleged that a particular variant does not have any
therapeutic or diagnostic effect, or where the marketing of a variant as a medicinal product
has been separately authorised because of its substantially different therapeutic or
diagnostic effect.
18:
OJ 1975 L 147, p. 1.
19:
See J.N. Adams, 'Supplementary Protection Certificates: The Salt Problem (1995) 6,
European Intellectual Property Review 277, at p. 279.
20:
See the second to fourth recitals in the preamble to the SPC Regulation. The ninth recital
does not afford any great assistance in this regard, as it uses the term 'product in a
manner similar to its use in Article 4.
21:
See the ninth recital in the preamble to the SPC Regulation.
22:
This is, I think, implicit in Articles 5, 9(1), 17 and 18(1) of the SPC Regulation.
23:
Article 4 of the SPC Regulation would seem to dictate that Article 69 of the European
Patent Convention be applied by analogy when determining the scope of a certificate
founded upon a patent granted under the Convention.
24:
Emphasis added.
25:
See Spain v Council, loc. cit., paragraphs 34 and 35.
26:
Explanatory Memorandum, loc. cit., paragraph 36. See Case 131/86 United Kingdom v
Council [1988] ECR 905, paragraphs 26 and 27, regarding the use of preparatory
documents to assist in construing legislative measures.
27:
Ibid., paragraph 35.
28:
It follows from the judgment in Case C-181/95 Biogen v Smithkline Beecham Biologicals
[1997] ECR I-357 that the product may also be more narrowly defined than the medicinal
product referred to in a marketing authorisation, where the latter is the subject of a
number of patents.
29:
Case C-292/89 Antonissen [1991] ECR I-745, paragraph 18; Case C-368/96 The Queen v
Licensing Authority established by the Medicines Act 1968, ex parte Generics (UK) Ltd [1998]
ECR I-0000.
30:
Case C-106/96 United Kingdom v Commission [1998] ECR I-2729, paragraph 29.
31:
The use of the term 'active substance in the recitals in the English version of the
preamble to the 1996 Regulation, as opposed to the term 'active ingredient, does not
appear to me to indicate a material distinction. The term 'substance is also used in the
definition of a medicinal product in Article 1(a) of the SPC Regulation. Although the
term 'substance might be thought in the latter context to indicate a finished medicinal
product, including, for example, an excipient, such a construction is clearly not intended
in the case of the 1996 Regulation. Furthermore, the use of distinct terms is not
consistent in the different language versions of the two Regulations. For example, the
French versions of the two Regulations use the terms 'substance active, 'principe actif
and 'substance in the same fashion as in the English, whereas the German versions of
both Article 1(b) of the SPC Regulation and of the 13th and 14th recitals in the preamble
to the 1996 Regulation employ the term 'Wirkstoff, while the term 'Stoff is confined
to Article 1(a) of the SPC Regulation.