In Eli Lilly And Co v Human Genome Sciences Inc  EWHC 2404(the Judgment), the High Court has interpreted and applied the decision of the Court of Justice of the European Union (CJEU) in case C-493/12 concerning Article 3(a) of Regulation (EC) 469/2009 (SPC Regulation).
The judgment confirms that supplementary protection certificates (SPCs) can be granted for products where only functional, not structural, language is included in the claims of the basic patent. It also provides some insight on how the CJEU's comments concerning Article 3(a) of the SPC Regulation should be interpreted. However, the judgment recognises that there may be errors in the approach adopted by the High Court and, like others before it, criticises the CJEU for failing to provide clear guidance in respect of the questions referred to it. On this basis, it seems the frequency of SPC references to the CJEU from the English Courts is set to continue unabated.
This case centres on Human Genome Sciences, Inc's. (HGS) European Patent concerning Neutrokine-α (a novel protein) and its specific antibodies (the Patent). Specifically, claim 13 of the Patent is for: “An isolated antibody or portion thereof that binds specifically to (a) the full length Neutrokine-… polypeptide … or (b) the extracellular domain of the Neutrokine-… polypeptide …”.
Eli Lilly and Company Ltd (Eli Lilly) intends to market a Neutrokine-α specific antibody (termed tabalumab), which it accepts infringes the Patent. Eli Lilly is currently pursuing marketing authorisation for tabalumab and sought to clear the way for launch. Despite a number of validity attacks advanced by Eli Lilly (including matters of industrial application and sufficiency), both the English Courts and European Patent Office determined that the Patent is valid.
In addition, Eli Lilly sought a declaration from the English Courts that no valid SPC could be granted to HGS, based upon a marketing authorisation for tabalumab and the Patent.
Eli Lilly argued that tabalumab is not “protected by” the Patent for the purposes of Article 3(a) of the SPC Regulation, seeing as the Patent claims do not include a structural definition of tabalumab.
Article 3(a) of the SPC Regulation provides that one criteria for the grant of a SPC is that "the product is protected by a basic patent". The issue of what the word "protected" means in that context has been addressed by a number of cases. In Case C-322/10 Medeva BV v Comptroller General of Patents, Designs and Trade Marks, a combination drug case, the CJEU held that Article 3(a) of the SPC Regulation "precludes the grant of a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent" [emphasis added] and rejected the idea that products "protected by a basic patent" included any combination of substances which directly infringed that patent (referred to as the "infringement test").
To assist in the determination of the issues the English High Court referred questions to the CJEU in October 2012 regarding the interpretation of Article 3(a) of the SPC Regulation. In December 2013 the CJEU published its decision, reformulating the questions referred and finding, in a 45 paragraph decision, that in order for an active ingredient to be regarded as "protected by a basic patent": (i) "it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula"; and (ii) where a functional, rather than structural, formula appears in patent claims, Article 3(a) of the SPC Regulation does not preclude the grant of a SPC "on condition that it is possible to reach the conclusion on the basis … that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question", interpreting the claim in accordance with Article 69 of the European Patent Convention (EPC) and the Protocol associated with that provision.
High Court Judgment
Following the CJEU's decision, both Eli Lilly and HGS applied to the High Court for judgment in their favour. This goes some way to show the ambiguity of guidance received from the CJEU.
Eli Lilly claimed that the CJEU's use of the word "identified" in its decision, means that a patent must contain a description or definition of the active ingredient in question which provides particulars from which it can be ascertained. Consequently, the second limb of the test outlined by the CJEU must require a similar level of detail. On the other hand, HGS argued that claim 13 of the Patent did relate “implicitly but necessarily and specifically” to tabalumab, following European rules of patent interpretation.
Ultimately, the High Court dismissed Eli Lilly's claim for a declaration of invalidity. The Court held that the CJEU has clearly indicated that an active ingredient can, in principle, be brought within the protection of a basic patent by a functional definition in a claim. However, there is a proviso: the functional claim must relate "implicitly but necessarily and specifically, to the active ingredient in question". The Court noted that this language was entirely new addition to the case law relating to Article 3(a).
Setting out the correct approach to adopt, the Court held that the CJEU’s decision first required the application of Article 69 EPC to construe the claims (i.e. to determine the limit of the invention). Should the active ingredient be covered by the properly construed claims, protection of any given product, in respect of Article 3(a) of the SPC Regulation, is conditional on the proviso. The proviso operates so that a product is not protected within the meaning of Article 3(a) of the SPC Regulation as a result of a claim containing general wording (such as “comprises” or "including") that extends the claim. In this regard the Court found HGS' counsel's explanation, that the aim is to discover what the patent is "really about", attractive: "Where a patent expressly identifies an active ingredient, that is what the patent is really about; the fact that the patent would be infringed because (and only because) that active ingredient is used in a combination of active ingredients does not mean that the patent is really about the combination or really about any other active ingredient in the combination".
In this case no extending words appear in claim 13 of the Patent. Consequently the proviso did not bite. The Court held that claim 13 had a focused scope, meaning that all that needed to be determined was whether a product fell within the scope of the claim. As it was common ground between the parties that tabalumab fells within the scope of claim 13 of the Patent, the Court held that tabalumab was “protected by” the Patent within the meaning of Article 3(a) of the SPC Regulation.
The Court also made a number of comments on paragraph 43 of the CJEU’s ruling, concerning the issue of research steps taken by patentees towards achieving marketing authorisations. The Court found this factor likely related more to Eli Lilly's abandoned third party issue, than to the Article 3(a) analysis. However, the Court deemed the approach taken by the CJEU unsatisfactory and emphasised that the grant of SPCs is not meant to be available only to certain levels of research. The objective of the regime is to reward any research leading to a qualifying product with a qualifying marketing authorisation and protected by a patent. Further, it was the Court's view that the CJEU overstepped its jurisdiction by making assumptions about whether HGS carried out research to identify a commercial product. This is a factual matter, which the Court determined the CJEU should leave to the national courts.
The judgment confirms that SPCs can be granted for products where only functional, not structural, language is included in the claims of the basic patent. It also provides some insight on how the CJEU's comments concerning Article 3(a) of the SPC Regulation should be interpreted. However, the judgment recognises that there may be errors in the approach adopted by the High Court, particularly in respect of the implications of the CJEU's comments on patentee research in respect of marketing authorisations. In fact, the High Court expressly notes that a further reference to the CJEU may be necessary on that point, once the facts of HGS's investment activities are known.
The Court has permitted Eli Lilly leave to appeal, so further judicial consideration of the issues is on the horizon.