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January 2014

Introduction

Just one month after its ruling in GlaxoSmithKline Biologicals SA (C-210/13) on the application of the supplementary protection certificate Regulation 469/2009/EC ("SPC Regulation") to vaccine adjuvants, the CJEU delivered three more important rulings on the same regulation on the same day, 12 December 2013. All the rulings follow from referrals made by national courts, seeking clarification of issues that had arisen as a result of the Court of Justice of the European Union's (CJEU's) rulings in Neurim Pharmaceuticals (C-130/11)and Medeva (C-322/10).

The issues raised are acutely important to understanding the circumstances in which a patent can support the valid grant of an SPC for a product, and what constitutes a product in the first place. The issues are these:

• Is an adjuvant an active ingredient, and therefore capable of constituting a "product" protectable by an SPC (under Article 1(b) SPC Regulation);
• Can more than one SPC be granted on the basis of the same "basic patent in force" (under Article 3(a) SPC Regulation); and
• What does it mean to say that a product, or a process for making that product, must be "specified" or "identified" by a basic patent in force in order to be "protected by" that patent (under Article 3(a)).

As discussed below, whilst the answers to these issues have dealt with the particular factual scenarios in which the references were made, they have also muddied the waters considerably for anyone trying to draw out principles that can be applied more generally. This inevitably means that new questions will need to be addressed by the CJEU in due course.  Unless, of course, the Commission takes Arnold J's advice and re-casts the SPC Regulation.

The context for the latest decisions

As noted above, the latest decisions from the CJEU concerning SPCs address issues that have either directly or indirectly arisen from the earlier cases Neurim and Medeva. In order to understand the new developments, it is first necessary to look back briefly to what happened in those cases:

The Neurim case – leading to issue 1

Neurim concerns an application for an SPC on the basis of a marketing authorisation (MA) and a patent for use of the active ingredient “circadin-melatonin” in the treatment of insomnia in humans. The same active ingredient had previously been authorised for improving the reproductive activity of sheep in the veterinary product Regulin.  The question therefore arose of whether the MA for Regulin meant that the product was the subject of an earlier MA thereby preventing the grant of an SPC for circadin-melatonin for the new use (under Articles 3(b) and 3(d) SPC Regulation).  At first instance, the English Patents Court held that, consistent with the earlier CJEU decisions, the SPC was not permissible on this basis. However, the English Court of Appeal was concerned that investment in valuable pharmaceutical research, particularly into second medical uses, would not be adequately rewarded if such SPCs were not permitted. It therefore referred the matter to the CJEU for a preliminary ruling. The CJEU subsequently ruled that:

…if a patent protects a therapeutic application of a known active ingredient which has already been marketed as a medicinal product, for veterinary or human use, for other therapeutic indications, whether or not protected by an earlier patent, the placement on the market of a new medicinal product commercially exploiting the new therapeutic application of the same active ingredient, as protected by the new patent, may enable its proprietor to obtain an SPC, the scope of which, in any event, could cover, not the active ingredient, but only the new use of that product.

Hence, the Neurim ruling appeared to open up the possibility of obtaining SPC protection for second medical use products even when the active ingredient at issue had already been the subject of an earlier MA. The reasoning of the decision was based largely on the understanding that the SPC Regulation is intended to protect the investment made in pharmaceutical research to discover new therapeutic uses of products and so should be interpreted to provide such protection.  Interpreting a regulation in order to give effect to its purpose is called the 'teleological approach' but the scope of such an approach is unclear.  For instance, how should one judge whether valuable research that warrants protection under the SPC Regulation has been conducted?  If applied in its broadest form, the investment based approach of the CJEU in Neurim might open up new categories of product to SPC protection.  Since Neurim was decided, it has been used in the courts as a justification by patent owners for a number of SPCs that, at first sight at least, appear contrary to the wording of the SPC Regulation.

The Medeva case – leading to issues 2 and 3

In the Medeva judgment, the CJEU made two particular statements that are significant for current purposes:

Firstly, leading to issue 2, the following line of the ruling suggests that only one SPC is allowed per basic patent in force:

…where a patent protects a product, in accordance with Article 3(c) of Regulation No 469/2009, only one certificate may be granted for that basic patent.

Prior to this, it was commonly accepted practice in many national intellectual property offices to grant more that one SPC per basic patent, providing they were for different products covered by the claims of that patent. Hence, after Medeva, the matter urgently needed to be referred to the CJEU for clarification. This happened in Georgetown University (C-484/12).

Secondly, the following statement from the case has also caused confusion, leading to issue 3:

Article 3(a)…must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate. (underline added)

The CJEU then essentially repeated the Medeva ruling in two further decisions that followed shortly afterwards, from parallel referrals in Daiichi Sankyo Company¹ and University of Queensland². However, in Queensland, the CJEU echoed the above statement, but in language that differed slightly from that in the Medeva ruling. The context of the decision was that of products obtained from a patented process. The CJEU stated:

…where the basic patent relied on in support of a SPC application relates to the process by which a product is obtained, that provision also precludes a SPC being granted for a product other than that identified in the wording of the claims of that patent as the product deriving from that process. (underline added)

As the underlined words show, between the Medeva and University of Queensland cases there is a difference in language³: Medeva refers to the active ingredients being “specified” in the wording of the claims, whereas, University of Queensland refers to products being “identified” as the product of a process in the wording of the claims. Although it is generally thought that these terms are meant to be synonymous, it is far from clear what they mean.

The CJEU has thus introduced the question of what it means for a product to be identified or specified in the basic patent in force – must a product be identified explicitly by name or specific formula, or is it sufficient for the product to be referred to generically or by function? Or, is the answer somewhere in between these two extremes? The distinction is important, as the cases below demonstrate.

Addressing the first issue – adjuvants

The first issue is dealt with in the GlaxoSmithKline Biologicals SA (C-210/13) case, which arose in the aftermath of the controversial Neurim decision.

It is the scope of application of the approach in Neurim that has now been tested in GlaxoSmithKline. In GlaxoSmithKline the CJEU had to decide whether to refuse two SPC applications: one for an adjuvant called AS03; and, one for an influenza vaccine combined with adjuvant AS03. Again, the strict interpretation of a "product" as an active ingredient or combination of active ingredients that is followed in earlier CJEU cases would, on the face of it, seem to suggest that an adjuvant is not capable of being an active ingredient and cannot support an SPC. However, the investment/teleological approach in Neurim had brought this strict interpretation into doubt, by suggesting that the commercial investment made in developing the adjuvant may be a factor in deciding whether an SPC is warranted.

The CJEU has now gone some way to clearing this matter up. In its 'reasoned order' in GlaxoSmithKline, the court has decided that an adjuvant to a vaccine, having no therapeutic effect of its own, is not an active ingredient capable of protection by an SPC, either alone or as a combination of active ingredients with a vaccine. The decision thus abides strictly by previous rulings from the CJEU that limit SPC protection to products which contain an active ingredient or combination of active ingredients.

So, how does this affect the decision in Neurim?  In its reasoned order, the CJEU expressly supports the controversial decision in Neurim that an SPC may be granted for a new medicinal application of a new or known product but, in doing so may have been trying to draw a line around the investment/teleological approach adopted in Neurim.

Addressing the second issue – number of SPCs allowed per patent

Georgetown University v Octrooicentrum Nederland (C-484/12)

Georgetown University v Octrooicentrum Nederland (C-484/12) concerns vaccines against HPV.  Georgetown owns a basic patent entitled "Vaccine against HPV", covering the combination of four active ingredients as well as one active ingredient individually.  On the basis of this patent and two authorised vaccines, Georgetown applied for eight SPCs.  Two SPCs were issued - one naming HPV-6, -11, -16 and -18 and another naming HPV-16 and -18. Five SPCs remain pending.  This reference relates to a further application for a single active (HPV-16) which had been rejected on the basis that only one SPC per patent may be granted.

According to the CJEU's ruling, it is possible, in principle, on the basis of a patent which protects several different products, to obtain several SPCs in relation to each of those different products. Each of those products should, however, be protected as such by that basic patent in accordance with article 3(a) and be contained in a medicinal product and subject to a marketing authorisation.  In the case of the vaccine component in this case (HPV-16), it was protected as such by the basic patent in force and so the grant of SPCs to separate combinations of products did not preclude the grant of a further SPC for HPV-16.

Actavis Group v Sanofi (C-443/12)

The dispute in Actavis Group v Sanofi (C-443/12) relates to irbesartan, an antihypertensive drug. Irbesartan was first authorised as a single product and later authorised in a fixed-dose combination with hydrochlorothiazide (HCTZ), a diuretic. Sanofi owned a patent covering irbesartan, including a claim to the combination of irbesartan and a diuretic, and obtained two SPCs on this patent on the basis of its two MAs: an SPC for irbesartan alone and a later-expiring SPC for irbesartan in combination with HCTZ.

One basis on which Actavis challenged the validity of the combination SPC was that irbesartan had already been the subject of an SPC and a marketing authorisation, for irbesartan alone, contrary to Article 3(c) of the SPC Regulation. Upon referral, the CJEU held that, where the patentee has already obtained an SPC on the basis of an MA for a single product, the patent holder is precluded from obtaining a second SPC on the basis of the same patent for a combination product which includes another active ingredient which is not protected as such by the patent (i.e. an active ingredient that is not protected by a basic patent in force in accordance with Article 3(a)).  In Actavis, HCTZ was not part of the invention and was not protected as such by the basic patent and so the combination SPC was not permitted.  Actavis is therefore distinct from Georgetown University (above), where all active ingredients were protected as such by the basic patent in force.

The third issue – what do “specified” and “identified” mean?

Actavis Group v Sanofi (C-443/12)

A second question was referred to the CJEU in Actavis, namely whether a combination of irbesartan and HCTZ was not "protected by" the patent because HCTZ was not specified (or identified) in the wording of the claim. As discussed above, the CJEU decided that Sanofi's combination SPC was invalid because it was not entitled to more than one SPC on the same patent so did not need to consider the second question.  Although the CJEU did not formally address this question and so throws little light on the matter, it impliedly held that the expression "diuretic" does not "specify" or "identify" HCTZ because the SPC for the combination would have been allowed if each of the products was protected as such by the basic patent within the meaning of Article 3(a) of the SPC Regulation⁴.  The meaning of identified or specified was addressed expressly in Eli Lilly v HGS.

Eli Lilly v HGS (C-493/12)

The issue of the meaning of specified / identified in the wording of the claim was addressed in Eli Lilly v HGS (C-493/12), which relates to therapeutic antibodies to neutrokine-α. HGS owns a patent covering such antibodies and has approval for Benlysta (belimumab), an anti-neutrokine-α antibody, to treat SLE which it developed with its partner GSK.

Eli Lilly has also developed an anti-neutrokine-α antibody (tabalumab) which is in clinical trials but has not yet been approved. When it is approved, HGS will have the opportunity to apply for an SPC for tabalumab (relying on Eli Lilly's MA) which it could enforce against Eli Lilly. In an attempt to avoid this, Eli Lilly sought a declaration that any such SPC would be invalid at least because Eli Lilly's antibody was not specified in the claim - the claim being worded generally to cover any antibody to neutrokine-α. Mr Justice Warren referred questions to the CJEU from the English Patents Court about the correct interpretation of article 3(a) of the SPC Regulation and, in particular, the meaning of protected by a basic patent in force.

The judgment from the CJEU explains that it is not necessary for the product to be identified by a structural formula (in this context the amino acid sequence of the antibody) but that a functional definition may be acceptable if:

…the claims relate, implicitly but necessarily and specifically, to the active ingredient in question.

The CJEU adds that the claims should be construed in accordance with Article 69 EPC and as the CJEU does not have jurisdiction to interpret these provisions, it is for the referring court to do so.

The test is notably different to the test set out in Medeva.  It is also inconsistent with Medeva in putting the onus onto the national courts and the EU Member States.  The infringement test was rejected in Medeva because it might lead to differing decisions across the EU.  Whilst the infringement test is not re-introduced by Eli Lilly, the test set out requires the national patent offices to construe the claim in accordance with Article 69 EPC and the Protocol on its interpretation.  These provisions are applied in differing ways across the national courts, and so it would seem that inconsistent decisions on SPCs on this issue are likely to appear in the foreseeable future.

Once the claim has been construed, it appears that, rather than applying an infringement test which would be the usual approach taken by the national courts, it will be necessary to consider whether the claims relate,implicitly but necessarily and specifically, to the active ingredient in question.  This is not the infringement test and it is far from clear how it should be applied.

One of the questions referred to the CJEU was whether or not the position was different to that with combination products.  This question was not answered directly by the CJEU.  The distinction between the tests may, therefore, be on the basis that Medeva related to a combination SPC whereas this case concerns a single agent defined by a functional claim. Hence, it is now possible that the CJEU has initiated another line of authority for such cases, although whether this was the intention of the CJEU or will be the effect of the decision is, once again, far from clear.

Conclusion

The four SPC decisions that have emerged from the CJEU since November 2013 have failed to provide the clarification needed to the application of the SPC Regulation.

Georgetown University will provide considerable relief for SPC owners, who prior to the ruling were facing the possibility that they would have to forfeit second and subsequent SPCs on the same basic patent. However, whilst the decision of Actavis is consistent with Georgetown, does this mean that it is now clear in what situation it is possible to obtain more than one SPC per patent in the context of Article 3(c) of the SPC Regulation?  We think not.  The CJEU has introduced a test which is, in effect, whether or not a product is protected as such within the meaning of Article 3(a) of the SPC Regulation.  The meaning of this term and its application to situations that are distinct from the facts of Georgetown and Actavis is unclear.  For instance, does a Markush formula protect every chemical falling within it as such or does a claim to an antibody to neutrokine-α (as per Eli Lilly v HGS) protect every possible antibody as such?  It is also unclear whether the meaning of Article 3(a) is to be construed differently in the context of Article 3(c).  In any event, the wording of this decision will likely require further references to address how the test should be applied in different circumstances.

The test in relation to whether a product is protected by a basic patent in accordance with Article 3(a) was considered in Eli Lilly, in the context of a claim with a functional definition to antibodies to neutrokine-α.  The answer provided by the CJEU is different to both the test in Medeva and to the tests set out in Georgetown and Actavis.  The test in Eli Lilly is whether the claims relate "implicitly but necessarily and specifically, to the active ingredient in question"  It is unclear whether or not the new test is intended to replace the Medeva test and to apply to single agents, combinations and functionally defined claims alike or whether it applies only to single agents.  It is also unclear how the test should be applied.  In our opinion, it is only clear that asking the national courts to apply such a test will lead to diverging decisions and further references to the CJEU.

It may not be what the CJEU intended but, depending on the context in which the question is asked, it appears that there may now be three different tests to apply to decide whether a product is protected by a basic patent within the meaning of Article 3(a) – specified / identified in the wording of the claim (Medeva) when considering combination products; protected as such (Georgetown / Actavis) in the context of whether a second SPC can be granted in relation to a basic patent; and related implicitly but necessarily and specifically, to the active ingredient in question (Eli Lilly) in the context of a single active ingredient.

In addition, the basis of the factual decision in Eli Lilly, as set out in paragraph 43, is that HGS did not carry out more in-depth research and did not identify the invention (by which they mean tabalumab) specifically.  In essence, this applies the teleological approach from Neurim, or something very close to it, and asks "does the patentee deserve an SPC?"  So while GlaxoSmithKline may have appeared to draw a line around Neurim, it is possible that Eli Lilly has simultaneously erased that line or at least blurred it.  Indeed, it is unlikely that the comments in GlaxoSmithKline will prevent further reliance on the principles set out in Neurim to justify the grant of SPCs in the future.  So, while the position in relation to adjuvants has been clarified by GlaxoSmithKline, we fear that the application of Neurim has not been.

All in all, the much observed ability of one ruling by the CJEU to generate the need for another, continues…

Read our latest article for an update on SPC protection.

If you have any questions on this article or would like to propose a subject to be addressed by Synapse please contact us.

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