This summer the Eli Lilly v HGS case came back before the High Court, following the CJEU’s ruling that SPCs could be granted for patents which defined the active ingredient by reference to a functional formula.
It is perhaps a poor reflection on the CJEU that it regularly issues rulings that, when the case is restored before the referring court, lead both parties to an action to claim victory. However, this happened yet again when Warren J was given the unenviable task of implementing the Eli Lilly v HGS CJEU decision, which was one of the trio of references decided by the CJEU last December in the world of SPCs.
HGS has a patent directed to Neutrokine-alpha which includes a claim to antibodies which bind to this protein. This claim is drawn at a fairly broad level – anything that binds specifically to the full length Neutrokine-alpha polypeptide or the extracellular domain of this polypeptide falls within the claim. This patent has survived numerous challenges in the UK and at the EPO. Lilly has developed an antibody, tabalumab, which was accepted for the purposes of the present proceedings to fall within the claims of the HGS patent. Lilly were concerned that HGS would seek an SPC for tabalumab based on HGS’ patent and Lilly’s MA, if the MA was granted before HGS’ patent expired. They therefore sought a declaration from the English Patents Court that any such SPC would be invalid. Originally, there were two grounds of objection – (i) that tabalumab was not “protected” by a basic patent for the purpose of Article 3(a) of the SPC Regulation as interpreted in Medeva and subsequent cases (the “Specified Issue”) and (ii) that HGS should not be able to file for an SPC based on a competitor’s MA (the “Third Party Issue”) Eventually, the Specified Issue but not the Third Party Issue was referred to the CJEU by the English Patents Court.
The CJEU issued its ruling in December 2013 on the same day as its decisions in Actavis v Sanofi and Georgetown II. The case was then restored before the English Patents Court and a hearing took place over two days in May and June 2014 (in which both parties argued strenuously the CJEU had found in their favour). In a judgment dated 18 July 2014, Warren J refused to grant Eli Lilly’s declaration that any SPC filed by HGS for tabalumab would be invalid.
Warren J considered that the CJEU ruling was unclear and unsatisfactory in many respects. However, in his view, the most important parts of the decision were that: (i) the CJEU had held that the protection conferred by a basic patent was to be assessed with reference to the extent of the invention covered by the patent as provided for by Section 125 UK Patents Act and Article 69 EPC; and (ii) the CJEU had confirmed that the infringement test was not the correct approach.
The Judge also considered that an assessment following the extent of protection test should be subject to one proviso – namely that where the claims contain some general wording extending their scope beyond the principal wording of the claims, a product would not be considered to be specified unless it fell within the claim absent the general words. In other words, if a patent is direct to “A” but contains a claim “A pharmaceutical composition comprising A”, A+B would not be protected by this patent even though “comprises” means “contains but is not limited to” under EPC drafting conventions. In a very English turn of phrase, Warren J set out that the task of the Court is to consider “what a patent is and is not ‘really about’” and noted that, although this is not the (rejected) infringement test, it will give the same result as the infringement test “in many cases”.
Warren J also noted that the purpose of the SPC Regulation is to encourage all kinds of pharmaceutical research. On this basis, the Judge thought it was not right in principle that the satisfaction of Article 3(a) depended on who carried out the research leading to the MA for the product for which the SPC had been sought. He noted the comment from the CJEU that “the refusal of an SPC for an active ingredient which is not specifically referred to by a patent… may be justified – in circumstances such as those in the main proceedings and as observed by Eli Lilly – 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…”. However, the Judge considered that: (i) this was more apposite to the Third Party Issue which had been formally abandoned and (ii) the CJEU had exceeded its jurisdiction insofar as it had found as a fact that HGS had failed to carry out the research to identify its invention specifically.
It is disappointing that another ruling from the CJEU was so unclear that both sides could credibly claim victory when the case was recommenced before the English Court. It will be interesting to see what the Court of Appeal makes of this unsatisfactory situation when the appeal comes before it in February next year. In the meantime, the Third Party Issue remains ripe for a further reference.