20 September 2019
The referral from the UK High Court to the CJEU regarding ‘third party SPCs’ represented a matter of significant interest to the biotech community. Our earlier commentary regarding this referral can be found here.
The referred question was as follows: “Does the SPC Regulation preclude the grant of an SPC to the proprietor of a basic patent in respect of a product which is the subject of a marketing authorisation held by a third party without that party’s consent?”
The CJEU has now provided a response to the referral (C-239/19) – unfortunately without providing an answer to the referred question.
The CJEU comments that the referral from the UK High Court was “manifestly inadmissible”, particularly as the question referred was hypothetical in the context of the UK proceedings which gave rise to the referral.
In particular, the CJEU noted that the justification provided for the referral was based on the following purely hypothetical set of circumstances: Genentech would appeal the decision declaring the claims of the basic patent to be invalid; the Court of Appeal would overturn that first instance decision; the Court of Appeal would then find it necessary to refer a question to the CJEU; and the Court of Appeal might, by that point, have lost its jurisdiction to refer such a question to the CJEU because of the UK’s planned withdrawal from the EU.
The CJEU decided that these circumstances did not justify the request for a ruling on the referred question. Specifically, the CJEU comments that its ruling was not “necessary for the effective resolution” of the dispute.
Disappointingly the UK High Court’s question regarding ‘third party SPCs’ therefore remains unanswered for now. However, given the level of interest in this issue, and the possibility of MA holders utilising the arguments put forward by Eli Lilly in future SPC revocation actions, it seems likely that a referral to the CJEU along similar lines will be made in the future. As noted in the referral, there are ongoing contentious proceedings between Eli Lilly and Genentech in other EU jurisdictions – a future referral could therefore even originate from the same parties.
If you have any questions about this update or SPCs in general, please visit our specialist SPC page.
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