19 March 2019
In a recent High Court decision (Eli Lilly & Company vs Genentech, Inc), Mr Justice Arnold referred the following question to the CJEU: “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 referral arises in the context of Genentech’s European Patent EP1641822 B1 and Lilly’s marketing authorisation (MA) EU1/15/1085 for Taltz® (ixekizumab) – Genentech pursued a supplementary protection certificate (SPC) based on its EP patent and with reference to Lilly’s MA.
The referral in this case may come as a surprise to many, since the practice of applying for ‘third party SPCs’ is now relatively common, and is usually accepted by national patent offices. This practice follows an earlier CJEU decision (C-181/95 – Biogen) which indicated that the SPC Regulation did not require there to be a relationship between the holder of the basic patent and the holder of a related MA.
However, the practice of applying for ‘third party SPCs’ without the consent of the MA holder can be problematic – the MA holder must then either take a licence under the SPC, or seek to invalidate the SPC, in order to commercialise the product for which they have obtained the MA. In view of this, the practice is not without criticism and, moreover, comments from both the CJEU and the Advocate General (in C-493/12 – Lilly and Teva v Gilead, respectively) have implied that an SPC should only be granted to a party investing in research relating to the authorised product.
Parties will now discuss the wording of the question before a final referral is made to the CJEU.
The outcome of this referral will be of significant interest to the biotech community and may have an impact on patent proprietors seeking ‘third party SPCs’, particularly if no legal relationship between the parties exists and/or if consent from the MA holder has not been obtained. We also note that the referral question has interesting parallels to the paediatric extension provisions recently enacted in Switzerland, which appear to suggest that the documentation required in order to apply for a paediatric extension of a Swiss SPC may only be requested from Swissmedic by the MA holder.
If you have any questions about this article, please contact Jonathan Israel for more information.
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