Eli Lilly and Company v Human Genome Sciences Inc, Patents Court, 3 August 2012,  EWHC 2290 (Pat)
This decision concerned supplementary protection certificates (SPCs) and specifically the questions of (i) whether a person is permitted to obtain an SPC based upon a marketing authorisation (MA) obtained by another, and (ii) whether the relevant patent claim sufficiently identified or specified a particular antibody in order for an SPC to be obtained in the light of the CJEU ruling in Medeva, Queensland and related cases.
Eli Lilly’s concern was that if it obtained an MA for its antibody before the Patent expired, HGS might then seek an SPC based on Eli Lilly’s MA. Eli Lilly therefore commenced proceedings seeking a declaration from the court that HGS was not entitled to obtain a valid SPC. Eli Lilly then brought an application requesting the court to make an immediate reference to the CJEU in order to enable the above questions to be determined. HGS applied for Eli Lilly’s claim for a declaration to be struck out, on the basis that it had been made prematurely and could not be resolved whilst the factual position was unclear.
The relevant patent was HGS’s EP (UK) No. 0 939 804. The Patent has already been heavily litigated in proceedings between Eli Lilly and HGS, including a leading decision of the UK Supreme Court reversing the earlier findings of the Patent Court and Court of Appeal that the Patent was invalid for insufficiency. The Supreme Court remitted certain outstanding validity issues back to the Court of Appeal. Validity of the Patent was therefore the subject of other proceedings and still to be determined.
The judge (Warren J) held as follows:
1. Eli Lilly’s claim for declaratory relief should not be struck out but allowed to proceed. However, the claim should be stayed until the ongoing validity proceedings had been concluded.
2. The question of whether Lilly’s antibody was “specified” or “identified” in the relevant claim of the Patent was a matter of EU law to which the answer was unclear from the guidance so far given by the CJEU on the meaning of the SPC regulation (Council Regulation No. 469/2009). A reference to the CJEU would be required. Claim 13 covered: “An isolated antibody or portion thereof that binds specifically to: (a) the full length Neutrokine-α polypeptide …; or (b) the extracellular domain of the Neutrokine-α polypeptide …”. It is clear from Medeva et al that the “infringement test” should not apply to combination vaccine cases but what is the correct approach to cases such as this one, where no combination is involved?
3. It was permissible for a person (HGS in this case) to apply for an SPC based on an MA obtained by another person. But although HGS was correct on this point, if a reference to the CJEU was to be made on question of whether the Patent specified or identified the Eli Lilly antibody, then it would be sensible to include a reference on this point too.
4. A reference to the CJEU should only be made once validity had been determined and (if the patent were found to be valid) the stay lifted, and should only be made on the basis of established facts, which might mean not until after a trial. A reference at this stage was too early.
Read the decision (in English) here.
Head note: Graham Burnett-Hall