31 August 2018
Article 3(a) of Regulation (EC) No 469/2009 (SPC Regulation) requires that in order for a product to be capable of protection by a supplementary protection certificate (SPC) it must be "protected by a basic patent in force". How exactly is protection by a basic patent in force to be determined? This question has been the subject of a number of rulings by the CJEU in recent years.
The latest ruling of the CJEU, dated 25 July, in the case Teva UK Ltd & Others v Gilead Sciences Inc (Case C‑121/17 – the Truvada Case), concerns an SPC protecting Gilead's HIV treatment, Truvada, consisting of a combination of tenofovir disoproxil fumarate and emtricitabine in a fixed dose tablet.
The relevant claim of the patent, claim 27, does not expressly identify the emtricitabine ingredient, but merely talks of the optional combination with "other therapeutic ingredients".
To establish whether this combination is protected by the basic patent in force, the CJEU has now ruled that the correct question to ask is whether, "from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:
The CJEU states that it is for the referring court to check whether this test, which places the emphasis on construction of the claim at issue, is satisfied in this case.
However, the court expresses its own view that it 'does not seem possible' that a person skilled in the art would be able to understand that the combination of emtricitabine with TD necessarily falls under the invention covered by the patent.
The Truvada Case has its background in a number of earlier decisions of the CJEU. These attempted to define an approach to determining whether a product covered by an SPC is "protected by a basic patent in force" for the purpose of Article 3(a) SPC Regulation.
These cases start with Medeva (Case C-322/10), which rejected the notion that protection could be determined on the basis of an infringement test alone (that is, merely whether the product falls within the scope of the claim as construed). It held instead that Article 3(a) precludes an SPC being issued where it relates to active ingredients which are "not specified in the wording of the claims in that basic patent".
Further cases have attempted to elaborate on the degree of specificity that this requires: does it include functional definitions and generic structural definitions, or must products be named individually and expressly by the patent claim? These have tended to confuse the issue instead.
Most recently, in Eli Lilly v Human Genome Sciences (Case C-493/12), which is concerned with a patent for therapeutic antibodies to neutrokine-α, rather than a combination of the kind in Truvada, the CJEU explained that protection by a basic patent in force does not require a product to be identified by a structural formula (in this context, the amino acid sequence of the antibody).
Instead, a functional definition may be acceptable if, once construed "the claims relate, implicitly but necessarily and specifically, to the active ingredient in question".
In this case, the CJEU placed the onus back on Warren J in the English Patents Court, from where the reference was made. But what did its ruling mean?
Warren J's interpretation was that functional definitions could, in principle, bring an active ingredient within the protection of a basic patent. Determining whether the claims "relate implicitly but necessarily and specifically" to the active ingredient means, in his judgment, that if the active ingredient is covered by the claims, according to conventional methods of claim interpretation, it is protected for the purposes of Article 3(a) of the SPC Regulation.
On the facts of the case, tabalumab, the active ingredient at issue and one of many thousands of antibodies covered by the basic patent, fell within the scope of claim 13 of the patent, even though it was not individually identified. Tabalumab was therefore protected by the patent within the meaning of Article 3(a).
The approach here was a relatively liberal one and appeared to resemble the infringement test, which Medeva had ruled out. Other national courts have had different understandings of the Eli Lilly decision. This brings us to the Truvada case.
In nullity proceedings concerning the Truvada SPC in Germany, a qualified notice of the German Federal Patent Court expressed the preliminary view that the SPC for the combination of tenofovir disoproxil fumarate and emtricitabine is not valid.
This was on the basis that, applying the CJEU case law, and in particular the Eli Lilly ruling, emtricitabine was not identified in a sufficiently specific way in the wording of claim 27 of the basic patent in force (see above).
In a request before the Regional Court of Munich for a preliminary injunction based on the Truvada SPC, the Regional Court agreed with the preliminary view of the Federal Patent Court that the requirement of Article 3(a) of the SPC Regulation can only be considered fulfilled if, in respect of combinations of active ingredients:
The Truvada SPC in the Regional Court's view did not meet these requirements because the basic patent only disclosed the tenofovir disoproxil component explicitly. Consequently, the application for the grant of a preliminary injunction based on the Truvada SPC was rejected.
On 15 May 2018, the German Federal Patent Court declared the Truvada SPC invalid. The reasons for the judgment are not yet published, but obviously, the Federal Patent Court saw itself in a position to decide on the validity of the Truvada SPC based on the case-law already available from the CJEU.
In the absence of clear criteria in the earlier CJEU decisions and the resultant diverging national applications of Article 3(a), the English Patents Court in its Truvada Case requested a preliminary opinion from the CJEU on the following simple question: "What are the criteria for deciding whether "the product is protected by a basic patent in force" in Article 3(a) of the SPC Regulation?"
Pending the preliminary ruling, Arnold J suggested that the answer should be to consider the 'inventive advance' or technical contribution of the basic patent. According to this approach, a product would satisfy Article 3(a) if "it contains an active ingredient, or a combination of active ingredients, which embodies the inventive advance (or technical contribution) of the basic patent".
When applied to the facts of the case, the combination of agents comprising Truvada would not, the judge suggested, embody the 'inventive advance' of the basic patent.
On 25 April 2018, however, Advocate General (AG) Wathelet delivered his Opinion on the question, stating as follows:
"A product is protected by a patent within the meaning of Article 3(a) of that regulation if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the claims of the basic patent. In the case of a combination of active ingredients, each active ingredient in that combination must be specifically, precisely and individually identifiable in the wording of the claims of the basic patent." (emphasis added)
The use of the wording "specifically, precisely and individually identifiable" appeared to be intended by the AG to advise the CJEU to take a stricter approach, more akin to that in Germany. It is also a different test to those previously set by the CJEU.
What the AG's Opinion perhaps lacked was sufficient guidance on how specific, precise and individual identification was to be determined. Would it mean that compounds need to be expressly claimed? In its ruling, the CJEU goes some way to addressing this:
"[Article 3(a)] must be interpreted as meaning that a product composed of several active ingredients with a combined effect is 'protected by a basic patent in force' within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:
This approach appears at first blush to be a synthesis of aspects of the Eli Lilly ruling (the product must be covered necessarily and specifically, if not expressly), the German decisions in Truvada (the product must be specifically identified) and Arnold J in his referring decision (the product must embody the inventive advance of the basic patent).
However, in the absence of express mention of an ingredient, what the CJEU appears to intend is that the ingredient is identified necessarily and specifically by the claim if this is how it is understood from the "…point of view of a person skilled in the art" on the basis of "…the prior art at the filing date or priority date of the basic patent… in the light of the description and drawings of that patent… [and] all the information disclosed by that patent".
In other words, the court is emphasising that reliance should be placed on the skilled person's understanding of what the claim means in the context of the patent as a whole and its prior art, and (the judgment suggests) using their general knowledge. The skilled person might find a particular product necessarily and specifically covered by a claim, given the overall context, even if it is not expressly mentioned. This is a form of claim construction.
For claims giving functional definitions, for example, the court explains the earlier Eli Lilly ruling as meaning that a product cannot be considered to be protected by a basic patent in force unless the product which is the subject of the SPC is either expressly mentioned in the claims of that patent or those claims relate to that product necessarily and specifically, as a matter of construction, using the description and drawings of the basic patent as stipulated in Article 69 EPC and the Protocol.
Using this approach, the CJEU states, claims cannot allow the holder of the basic patent to enjoy, by obtaining an SPC, protection which goes beyond that granted for the invention covered by that patent.
Given that claim construction is a matter of the national courts applying Article 69 EPC and the Protocol, which are not EU law, the CJEU admits that there has been a tension when interpreting the SPC Regulation, which is EU law. However, the skilled person's interpretation of the claim according to this ruling should not be confused with the normal national approaches to claim construction.
For example, the exercise requires consideration of the prior art and must not take into account results from research which took place after the filing date or priority date of the basic patent – which would potentially enable the SPC holder unduly to enjoy protection for results not yet known at the priority date or filing date of the basic patent – which is not the normal approach to construction of some national courts..
Interestingly and contrary to the position the AG stated in his Opinion, the CJEU does not explicitly reject the criterion that the product has to embody the inventive advance of the basic patent. Instead, the CJEU explicitly refers to its decisions C-577/13 (Actavis Group PTC EHF and Actavis UK Ltd v Boehringer Ingelheim Pharma GmbH & Co. KG), and, as a result, C-443/12 (Actavis Group PTC EHF and Actavis UK Ltd v Sanofi), which mainly led to the discussion whether the CJEU had established an "inventive advance" criterion in the past.
The decision in the Truvada Case therefore does, at last, go some way to providing useful guidance on how to deal with the difficult issue of determining when a product is protected by a patent under Article 3(a), albeit in the limited context of combination claims.
In practice, it is however to be expected that disputes will only be shifted to the question what the person skilled in the art would have taken from the basic patent necessarily and specifically identifiable on the basis of the prior art at the filing or priority date. It also cannot be excluded that there will be another referral raising the question whether the "inventive advance" criterion has to be considered under Article 3(a) SPC Regulation.
There are two other references pending before the CJEU on the subject of Article 3(a), concerning functional claims and Markush claims, respectively. As previous rulings have demonstrated, these may not provide more clarity.
by multiple authors