The CJEU has decided that there is no issue to be heard in this referral and has ruled it inadmissible.
The matter relates to a dispute between Genentech and Eli Lilly, where Genentech has applied for an SPC based on an Eli Lilly marketing authorisation.
The Genentech “basic” patent EP(UK) 1 641 822 relates to therapeutic peptides. Genentech does not hold a marketing authorisation for any product under this patent.
Eli Lilly markets ‘ixekizumab’, an antibody formulation to treat moderate to severe plaque psoriasis and psoriatic arthritis in adults. The formulation is marketed as Taltz, by virtue of marketing authorisation (MA) EU/1/15/1085. Genentech contends the antibody formulation falls within the scope of the basic patent.
Using the MA for ixekizumab, Genentech filed an application for an SPC on their “basic” patent.
In parallel proceedings, the English Courts had rule the basic patent invalid, however Eli Lilly also asked the English Court to confirm that if it was presumed the basic patent was valid any such SPC granted would still not be valid. The English Court referred the matter to the CJEU.
The position of Eli Lilly before the CJEU was that the SPC application does not comply with either Article 2 or Article 3(b) and (d) of SPC Regulation because the MA for ixekizumab is not a relevant MA, since it is owned by a third party (to the owner of the patent) and was relied upon without the consent of the third party.
On the 5th September 2019, the CJEU issued a preliminary ruling that the referral on this point is inadmissible. The CJEU have ruled that since the basic patent was found invalid by the English Court, the SPC will also be invalid and, therefore, there is no case to address regarding the validity of the SPC based on the MA being owned by a third party to the patent and relied upon without the consent of the third party.
The CJEU did not consider any of the factors submitted to it justifying the request for a judgement to be compelling enough for them to hear the case.
The outcome is undoubtedly frustrating for the industry in terms of the continuing level of uncertainty on this point. Patent owners will continue to seek SPC term on the basis of third party Marketing Authorisations, whether consent is given or not. This matter may reappear at the CJEU if, in one or more other EU country, the basic Genentech patent is found valid and the respective national Court refers the question to the CJEU or if Genentech wins an appeal on the invalidity finding at the English Court and the matter can be referred again to the CJEU.