UK: A Bumper Crop Of SPC Rulings From The CJEU - Part 2: The Latest Rulings On Article 3

Last Updated: 12 August 2014
Article by Mike Snodin

1. Introduction

This article, the second in a series of three, discusses the latest rulings from the CJEU in connection with Article 3 of the Supplementary Protection Certificate (SPC) legislation.

As will be discussed below, although much remains uncertain, there may be some patent drafting and SPC filing strategies that applicants can adopt in order to avoid some of the risks generated by the recent case law.

2. SPCs

SPCs provide additional protection for a "product", which is a (combination of) active ingredient(s).

For both medicines (human or veterinary) and plant protection products (agrochemicals and the like), Article 3 of the SPC legislation defines key criteria that must be satisfied in order for supplementary protection to be awarded. In essence, that Article demands that, on the date that the SPC application is filed, the following must all be true in the country where protection is sought:

a) the "product" must be protected by an in-force patent;

b) the "product" must be the subject of a valid Marketing Authorisation (MA);

c) the patentee cannot already have been granted an SPC for the same "product"; and

d) the MA mentioned in (b) must be the first in the country for the "product".

3. The Cases

On 12 December 2013, the CJEU provided rulings in the following 3 cases:

1. C-443/12 (Actavis v Sanofi);

2. C-484/12 (Georgetown University v Octrooicentrum Nederland); and

3. C-493/12 (Eli Lilly v HGS).

The provisions upon which these cases touched were Article 3(a) (at issue in both Actavis and Eli Lilly) and Article 3(c) (which was at issue in both Actavis and Georgetown).

In order to understand the context in which questions were referred to the CJEU in these cases, it is necessary to outline certain facts from those cases.

1. Actavis v Sanofi

In 1997, Sanofi obtained authorisation from the European Commission to market the compound irbesartan, which was the sole active ingredient in the medicinal product Aprovel®.

Upon the basis of the MA for Aprovel® and a patent protecting irbesartan (EP 0 454 511 B1), Sanofi obtained an SPC in the UK, for which the "product" was irbesartan.

Sanofi subsequently sought and obtained a centralised MA for CoAprovel®, a medicinal product containing both irbesartan and hydrochlorothiazide (HCTZ, a diuretic) as active ingredients.

The patent protecting irbesartan (EP 0 454 511 B1) also contained claims to a composition comprising irbesartan in association with "a diuretic". Pointing to those claims as providing protection for the "product" consisting of the combination of irbesartan and HCTZ, Sanofi then obtained a second SPC in the UK based upon EP 0 454 511 B1 (SPC/GB99/008).

Subsequent to expiry of the SPC to irbesartan alone, Actavis sought to clear the way for the marketing of a generic version of CoAprovel® by challenging the validity of SPC/GB99/008. In essence, the grounds for their challenge included allegations that:

a) Article 3(a) was not satisfied, as EP 0 454 511 B1 did not "protect" the combination of irbesartan and HCTZ; and

b) the provisions of Article 3(c) were not met, as comments made in connection with prior CJEU cases indicated that it was not possible to obtain more than 1 SPC per patent.

2. Georgetown University

A patent was granted to Georgetown University (EP 0 647 140 B1) that contained claims directed towards vaccines based upon certain human papilloma virus (HPV) L1 proteins.

Vaccines containing such HPV L1 proteins and designed to prevent HPV infections were authorised for sale in the EU. These vaccines were:

  • Gardasil® (containing HPV-6, HPV-11, HPV-16 and HPV-18 L1 proteins); and
  • Cervarix® (containing HPV-16 and HPV-18 L1 proteins).

Upon the basis of EP 0 647 140 B1 and the MAs for Gardasil® and Cervarix®, Georgetown University filed a number of SPC applications in the Netherlands.

Two of Georgetown's SPC applications, directed towards the combinations of HPV proteins present in Gardasil® and Cervarix®, were granted in 2008. However, based upon comments made in connection with CJEU cases decided subsequent to 2008 (which comments suggested that no more than 1 SPC can be granted per patent), the Dutch patent office rejected an application to a single antigen, HPV-16 L1 protein.

When handling an appeal against the rejection of Georgetown's application, the Court of the Hague was uncertain as to whether it really was impermissible to obtain more than 1 SPC per patent (and, if so, whether the SPC application in question could be allowed to proceed if Georgetown surrendered the two granted SPCs based upon the same patent). The court therefore referred questions to the CJEU on these points.

3. Eli Lilly v HGS

Eli Lilly, the developer of an antibody (tabalumab) to the protein Neutrokine-α, has for some time been in dispute with HGS, the proprietor of a patent (EP 0 939 804 B2) directed towards the protein Neutrokine-α, and antibodies thereto. The antibodies were claimed using functional terms only, i.e. by reference to the antigen to which they bind.

The dispute between the two parties has so far included challenges by Eli Lilly (at the EPO and at the UK courts) to the validity of HGS's patent. After the patent survived these challenges, Eli Lilly were faced with a freedom-to-operate issue for tabalumab, as it was common ground between the parties that marketing of tabalumab in the UK would infringe Claim 13 of HGS's patent.

Based upon current practice in Europe, is it possible for a third party to base an SPC application upon a combination of their patent and a Marketing Authorisation issued to another (unconnected) entity. Thus, there was nothing stopping HGS from eventually obtaining (upon the basis of an MA issued to Eli Lilly) an SPC to tabalumab, thus significantly prolonging the period during which Eli Lilly would not have freedom-to-operate for that antibody.

In order to prevent this happening, Eli Lilly sought a declaration from the UK High Court that any SPC based upon HGS's patent and an MA for tabalumab (if and when such an MA was granted) would be invalid. This allegation of invalidity was based upon the assertion that the broad, functional definition of antibodies in Claim 13 of HGS's patent was not sufficiently precise for compliance with Article 3(a). In particular, Eli Lilly alleged that, with respect to the antibody tabalumab, Claim 13 of the patent did not satisfy the "specified in the wording of the claims" test from Medeva (C-322/10).

4. The questions answered by the CJEU

In the three cases mentioned above, the national courts referred a total of 8 distinct questions. However, the CJEU essentially provided answers to only two questions, which can be summarised as follows.

(1) Under the provisions of Article 3(c), can one patent be used as the basis for more than one SPC?

Comments made by Advocate-General Verica Trstenjak in joined cases C-322/10 (Medeva) and C-422/10 (Georgetown University et al.) suggested that the answer to this question was "no". However, this contrasted with common practice of patent offices across the EU, which had interpreted earlier case law of the CJEU (C-181/95, Biogen v SKB) to permit the grant of one SPC per patent per product.

(2) What are the criteria for deciding whether Article 3(a) of Regulation No 469/2009 (which requires that "the product is protected by a basic patent in force") has been satisfied?

The practices of different national authorities have been far from harmonised over recent years. Moreover, prior rulings of the CJEU on this very point (e.g. in Medeva) have failed to provide a sufficiently clear test that can be routinely (and harmoniously) applied in all cases. In particular, the national courts and patent offices have struggled in some cases (such as Eli Lilly v HGS) to determine whether the active ingredient(s) in question meet the requirement of being "specified" (or "identified") in the wording of the claims of the basic patent.

4.1 The CJEU's answers

Question 1

Despite superficially similar fact patterns, the CJEU essentially answered question 1 in the affirmative in Georgetown University, but in the negative in Actavis v Sanofi.

Thus, Georgetown are free to obtain grant of an SPC to HPV-16 L1 protein, despite the prior grant of two SPCs (directed to the combinations of HPV L1 proteins present in Gardasil® and Cervarix®, respectively) that are based upon the same patent.

By way of contrast, the ruling of the CJEU appears to indicate that Sanofi's prior SPC to irbesartan is prejudicial to the validity of their later SPC (to the combination of irbesartan and HCTZ) that is based upon the same patent.

Question 2

Question 2 was posed to the CJEU in Actavis v Sanofi, but not (directly) answered by the Court. Nevertheless, there is perhaps a tacit admission by the Court that the claim to a composition comprising irbesartan and "a diuretic" does satisfy Article 3(a) with respect to a product defined as the combination of irbesartan and HCTZ. This is because point 28 of the reasons for the decision in Actavis v Sanofi states:

"However, the main proceedings concern a different situation. They entail a situation in which the same patent may be regarded as protecting a number of products within the meaning of Article 3(a)" (emphasis added)

Thus, it appears from the above-quoted passage that the CJEU in Actavis v Sanofi was prepared (in principle) to accept that the functional term "diuretic" could satisfy the provisions of Article 3(a) in respect of the active ingredient HCTZ.

The potential for functional definitions of active ingredients to satisfy the provisions of Article 3(a) is a point that emerges much more clearly from the decision in Eli Lilly v HGS. In that case, the Court conducted an analysis that began by concluding that, when determining whether a patent "protects" an active ingredient:

a) reference must be made to the claims of the patent (and to national or European provisions governing interpretation of the claims);

b) but there must not be any recourse to the rules governing infringement proceedings.

Whilst they must be read in the context of this general approach, the CJEU's further comments can essentially be interpreted to mean that, so long as the claims contain an integer that reads on to the active ingredient in question, then that integer may be expressed in either structural or functional terms and still satisfy the requirements of Article 3(a).

However, the CJEU added a proviso to this conclusion, namely:

"on condition that it is possible to reach the conclusion on the basis of those claims, interpreted inter alia in the light of the description of the invention, as required by Article 69 of the EPC and Protocol on the interpretation of that provision, that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question" (emphasis added).

The Court did not expand upon the meaning of the phrase "implicitly but necessarily and specifically". However, subsequent comments in the judgment provide an insight into the Court's thinking in connection with that phrase. That is, despite it being clear that HGS's claims contained a (potentially permissible) functional definition of the antibody in question, the CJEU nevertheless indicated that:

"the refusal of an SPC application for an active ingredient which is not specifically referred to by a patent issued by the EPO relied on in support of such an application may be justified ... where the holder of the patent in question has failed to take any steps to carry out more in-depth research and identify his invention specifically, making it possible to ascertain clearly the active ingredient which may be commercially exploited in a medicinal product corresponding to the needs of certain patients" (emphasis added).

The answer to whether or not a functional definition of an active ingredient will satisfy Article 3(a) may therefore depend upon the level of involvement of the SPC applicant in the research leading to identification of the specific active ingredient concerned.

5. Commentary

Article 3(c)

If just the operative parts of the judgments relating to Article 3(c) are compared and contrasted, a notable difference emerges between the key criteria cited.

In Actavis v Sanofi, the key criterion cited in the (unfavourable) ruling is the absence of patent protection for the "secondary" ingredient of a combination product. However, that criterion was not mentioned at all in the judgment in Georgetown University (though it does appear to have been satisfied by the claims of the Georgetown patent).

This key difference poses a number of questions. For example, was it really the presence of patent protection for each individual component of the combination (as well as for the combination itself) that won the day for Georgetown? Or were there other factors at play?

Analysis of the reasons for the decisions in both Actavis v Sanofi and Georgetown University suggests that other factors were indeed influential, if not decisive.

The first potentially relevant factor is duration of SPC protection. Whereas Sanofi's second SPC endured beyond the expiry date of their first SPC, the projected expiry dates for Georgetown's SPCs were all the same. The CJEU appears to have taken this into account when reaching their decisions. For example, at point 35 of the reasons for the decision in Georgetown University, the Court commented as follows.

"Therefore, Article 3(c) of that regulation does not, in principle, preclude Georgetown University being granted, on the basis of that patent and the same MA, namely the marketing authorisation for Gardasil, an SPC both for the combination of active ingredients (HPV-6, HPV-11, HPV-16 and HPV-18) and for the active ingredient HPV- 16 individually. Even if the protection conferred by two such SPCs were to overlap, they would, in principle, expire on the same date" (emphasis added).

This contrasts with comments in Actavis v Sanofi, where the Court stated the following (in point 36 of the reasons for the decision).

"In such a situation, Article 13 of Regulation No 469/2009 dictates that, upon expiry of the initial SPC, the holder thereof may no longer, in connection with the basic patent used as the basis for the grant of the SPC, oppose the marketing by third parties of the active ingredient which was the subject of the protection conferred by that SPC. This means that, after that date, it must be possible for third parties to place on the market not only medicinal products consisting of the formerly protected active ingredient but also any medicinal product containing that active ingredient in combination with another active ingredient that is not protected as such by the basic patent or any other patent".

In other words, the Court felt that, in the circumstances, Sanofi should not be able to enjoy any period of supplementary protection for the combination of irbesartan and HCTZ that extended beyond the period of supplementary protection awarded to irbesartan.

Likely reasons behind the Court's feelings on this point lead to the second factor that is potentially relevant to the different conclusions reached in Actavis v Sanofi and Georgetown University. Thus, in Actavis v Sanofi, it is clear (from points 41 and 42 of the reasons for the decision) that the CJEU did not consider the combination of irbesartan and HCTZ to represent an inventive advance that was distinct from irbesartan alone. As a result, the Court appears to have viewed irbesartan and the combination as representing the same "product" (see below).

"41. It should be recalled that the basic objective of Regulation No 469/2009 is to compensate for the delay to the marketing of what constitutes the core inventive advance that is the subject of the basic patent, namely, in the main proceedings, irbesartan....

42. It follows that, in such a situation, Article 3(c) of Regulation No 469/2009 precludes a patent holder from obtaining, on the basis of one and the same basic patent, more than one SPC in connection with irbesartan, since such SPCs would in fact be connected, wholly or in part, with the same product" (emphasis added).

This immediately poses the question of whether it is possible to argue that a single patent relates to more than one "core inventive advance". Although there is not a direct answer to this question, point 42 of the reasons for the decision in Actavis v Sanofi states the following.

"...if a combination consisting of an innovative active ingredient in respect of which an SPC has already been granted and another active ingredient, which is not protected as such by the patent in question, is the subject of a new basic patent within the meaning of Article 1(c) of that regulation, the new patent could, in so far as it covered a totally separate innovation, confer entitlement to an SPC for that new combination that is subsequently placed on the market" (emphasis added).

Thus, we know that a "new" patent protecting a "totally separate innovation" can effectively be viewed as relating to a different inventive advance. However, there is no reason in logic why the same patent cannot also be capable of protecting such a "totally separate innovation". This is because it is perfectly possible for a single patent to cover more than one innovation (e.g. in the circumstances where multiple innovations share a sub-set of features that provide a common distinction over the prior art).

At this stage, it is impossible to say whether or not the additional factors discussed above really did influence the CJEU's decisions. However, when tackling further cases having different fact patterns, it is almost inevitable that national patent offices and courts will at some point need to consider the relevance (if any) of those factors.

Article 3(a)

It will be a relief to many that the CJEU has clarified that functional definitions of active ingredients are, in principle, capable of satisfying the provisions of Article 3(a). This is not least because it is now appears almost certain that generic structural definitions of active ingredients will also be deemed capable of satisfying those provisions.

Nevertheless, the criteria for satisfying Article 3(a) are still far from clear for those active ingredients that are not, or cannot be, defined in (fully) structural terms. This is because of the apparent need for the claims to relate "implicitly but necessarily and specifically" to the active ingredient in question. At this time, it is not at all clear how the national patent offices and courts can apply this test to cases having different fact patterns from that in Eli Lilly v HGS (nor is it in fact clear yet how the UK Court will apply the ruling in the case giving rise to this CJEU judgment). Indeed, it appears that particular problems will arise if, as implied in Eli Lilly v HGS, assessing compliance with this test will necessarily include determining the level of involvement of the applicant in "in depth research" into the authorised active ingredient.

For many marketed medicinal products, there will be complex relationships between the owner(s) of the patents protecting the active ingredient(s), the entity or entities conducting the (pre-)clinical research and the owner(s) of the MA. With this in mind, it is almost impossible to see how the national patent offices and courts can develop a simple, clear and consistent approach to determining whether the patent holder has "failed to take any steps to carry out more in-depth research and identify his invention specifically". As a result, some patent offices may ignore this additional test for functionally-defined active ingredients (e.g. by applying to those active ingredients the same Article 3(a) standard as the CJEU has outlined for structurally-defined active ingredients).

6. Summary and Practice Points

The lack of clarity in the judgments of the CJEU will provide ample room for interpretation by the national patent offices and courts. Thus, it is possible, perhaps even likely, that different practices will emerge in different countries. If this happens, further references to the CJEU will be necessary in order to enhance harmonisation of practices across Europe. Nevertheless, practice points that emerge at this time are as follows.

Article 3(c)

  • The full reasons for the contrasting decisions in Actavis v Sanofi and Georgetown University are not yet clear. This is because of significant differences in the key criteria cited by the CJEU in the operative parts of the judgments.
  • Factors favouring the grant of an SPC application that is based upon a patent already serving as the basis for one or more granted SPCs would appear to include:

a) the provisions of Article 3(a) being satisfied for each active ingredient forming (part of) the definition of the product in the SPC application;

b) the granted SPC(s) not providing any protection for the product defined in respect of the SPC application;

c) the SPC granted on the new application having a theoretical duration that would not extend beyond that of the already-granted SPC(s); and/or

d) the product defined in respect of the SPC application representing a "totally separate innovation" to the product(s) for the granted SPC(s).

  • Unless and until the relative importance of these (or other) factors are clarified by the courts, devising a strategy for filing multiple SPCs based upon a single patent will prove to be a challenging task in situations where the factual scenario differs significantly from that in Georgetown University.
  • A significant difference from the facts in Georgetown University could be the absence of any one or more of factors (1) to (4) above.
  • In order to protect against uncertainties as to how the case law will develop on this point, the owners of patents that protect more than one "product" may wish to consider a "safety first" SPC filing strategy, wherein:

a) the first SPC protection to be sought (and granted) is for each individual active ingredient (or each non-overlapping sub-combination of active ingredients) that is both protected by the basic patent and present in the medicinal product that has received marketing authorisation; and

b) protection for (larger) combinations containing that (or those) same active ingredient(s) is only pursued in earnest after the grant of the protection mentioned in a) above.

  • A relative disadvantage for such a strategy is a potentially shorter term of protection for the (larger) combination, in circumstances where that combination has a later authorisation date than the single active(s).
    • However, it has the relative advantage of ensuring, through the SPC(s) to the or each single active, at least some supplementary protection for all medicinal products containing that or those actives.
  • Of course, more aggressive SPC filing strategies may be perfectly appropriate in some circumstances, depending, for example, upon the level of risk that is acceptable in view of the potential (additional) reward that might be obtainable.
    • We therefore strongly recommend that, before proceeding, patentees seek expert advice that takes into account the technical, commercial and legal facts pertaining to their individual situation.
    • Our SPC experts are ideally placed to offer such advice.

Article 3(a)

  • When determining whether a claim "protects" an active ingredient (or combination of active ingredients), the approach adopted by the CJEU is to:

(i) refer to the claims (as interpreted by European or national rules governing claim interpretation); and

(ii) seek to identify structural or functional definitions in the claims that relate to the active ingredient.

  • In instances where the active ingredient(s) are identified in the claims by way of a functional definition, the further criterion of requiring the claims to relate "implicitly but necessarily and specifically" to the active ingredient in question apparently applies.
  • It is currently unclear what the national patent offices and courts will make of this additional criterion and how they will apply it in practice.
    • This may be a highly relevant factor for patents defining active ingredients only in very broad, functional terms.
  • On the other hand, patents defining active ingredients in purely structural terms would appear to stand a high chance of satisfying the provisions of Article 3(a).
  • These observations imply that eligibility for SPC protection can perhaps be maximised by drafting patent applications that include (preferred) definitions of the relevant active ingredient(s) that:

(a) are capable of being included in the claims;

(b) rely upon at least some structural (as opposed to functional) features; and

(c) read as closely as possible onto the active ingredient(s) that are (or are likely to be) included in authorised medicinal products.

In any event, please contact us for advice if you have any queries about the eligibility for SPC protection in respect of a substance that is protected by a patent in which you have an interest.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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