In January 2014 we reported on the CJEU ruling in Eli Lilly v HGS (C-493/12). This dealt with the requirement, arising from the earlier Medeva case (C-322/10), that a product must be "specified" / "identified" in the wording of a claim of a basic patent already in force in order to be capable of supporting an SPC. The case has now been referred back to Warren J in the Patents Court of England & Wales to interpret the meaning of the CJEU ruling and apply it to the facts of the case. The resulting judgment goes some way to clarifying the approach to be taken to such claims, at least in the UK.

The case 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.

The CJEU ruling explained 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.

However, this ruling, and in particular the wording above, has created further confusion – what does it mean?

Warren J has interpreted the CJEU's ruling as meaning that functional definitions can, in principle, bring an active ingredient within the protection of a basic patent. He also states that the CJEU's requirement that the "claims relate implicitly but necessarily and specifically" to the active ingredient means that the court should use the conventional rules of interpretation of claims to establish whether the claim protects the active ingredient in question. That is, Article 69 of the European Patent Convention (EPC) and its accompanying Protocol must be applied to ascertain the extent of the invention and what the claims relate to. If the active ingredient in question is covered by the claims, it is protected for the purposes of Article 3(a).  If this is what the CJEU intended, it is unfortunate that they chose to use the wording that they did because it implies something different to asking simply whether the active ingredient is covered by the scope of the claims.

However,  Warren J did make a proviso, which is necessary to reflect the CJEU's approach inMedeva, in relation to products containing combinations of active ingredients. A product is not protected within the meaning of Article 3(a) solely because a claim contains general wording that extends the claim to potentially encompass it (such as the word "comprises", which is used in patent claims to denote that something is included or contained non-exclusively). However, in the absence of such extending words, the judge held that "the claims have a focused scope and the question is simply whether the product falls within the scope of the claims". It has been conceded during the course of these proceedings that tabalumab falls within the scope of claim 13 of the patent, and the proviso did not apply since there were no extending words. Tabalumab was therefore "protected by" the patent within the meaning of Article 3(a).

This decision therefore puts the issue of whether a product is specified or identified by a claim for the purpose of SPC protection, into the familiar terms of claim construction under the provisions of the EPC.  This is essentially the infringement test that was rejected by Medeva in the context of combination products and so highlights the divergence between the test for a single active and combinations of actives.  It remains unclear whether this is what the CJEU intended in Eli Lilly v HGS because it did not expressly respond to the question of whether the position is different for combination products.  Ultimately, this is only a judgment of a first instance UK court, which has been appealed and will be considered by the Court of Appeal in February 2015. It remains to be seen whether the Court of Appeal will agree with Warren J's understanding of the Eli Lilly v HGS CJEU ruling, how the courts of other Member State countries will understand it, and how the CJEU might interpret it in any future references.

The decision