Skip to content

Eli Lilly and Company v Human Genome Sciences Inc, Patents Court, 18 July 2014, [2014] EWHC 2404 (Pat), Warren J

The unenviable task of implementing the CJEU ruling in Eli Lilly v HGS (C-493/12 here, on the meaning of “protected” by a basic patent, and reported in the EPLAW Patent Blog here) fell to Warren J (who is not a patent specialist but hears the occasional patents case). Following a hearing which 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 has refused to grant the declaration sought by Lilly that any SPC granted to HGS for Lilly’s antibody, tabalumab, (based on HGS’ patent) 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: (i) paragraph [32] where 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) paragraph [33] where the CJEU had again expressly rejected the infringement test.


The judge also considered that the assessment using the “extent of the invention” test should be subject to one proviso – namely that where the claims contain some general word or words extending their extent 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 directed 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. Thus, Arnold J’s decision in Astellas would still be correct although Kitchin J’s decision in Gilead may not be depending on whether “…and optionally other therapeutic ingredients” came within the definition of “general words”.

In a very English manner, 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 noted that the purpose of the SPC Regulation is to encourage all kinds of pharmaceutical research, drawing support from the Explanatory Memorandum and the Opinion of AG Fennelly in the Biogen case. 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 at paragraph [43] 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 so-called “Third Party Issue” (i.e. whether HGS could obtain an SPC by relying on Lilly’s MA) 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 is inevitable Warren J’s judgment will be appealed and it will be interesting to see what the Court of Appeal makes of this unsatisfactory situation. In the meantime, the Third Party Issue remains ripe for a further reference.

Read the decision here.

Headnote: Laura Reynolds