Home > Insights > SPCs based on third party marketing authorisations – an undeserved advantage or a legitimate interpretation of the SPC Regulation?
23 April, 2019

As a result of a recent High Court decision in the UK (2019 EWHC 388), the following question is being referred 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?”

Facts of the main proceedings
The decision concerned Genentech’s European patent (UK) No. 1641822 entitled “IL-17A/F heterologous peptides and uses thereof”. Genentech have applied for an SPC (SPC/GB16/056) based on this patent (the “basic patent”). The SPC application attempts to rely upon a marketing authorisation (EU /1/15/1085) for an antibody called ixekizumab that binds to IL-17A/F and is used for the treatment of psoriasis and psoriatic arthritis. Importantly the marketing authorisation (MA) was obtained by Eli Lilly, and not by Genentech.

Eli Lilly have argued that the SPC application, if granted, would be invalid. Specifically, Eli Lilly contend that the authorisation relied upon is not a valid authorisation within the meaning of Articles 2, 3(b) or 3(d) of the SPC Regulation (EC/469/2009) because it is a third party MA relied upon without Eli Lilly’s consent.

Legal uncertainty
In the decision, Mr Justice Arnold summarises the relevant case law of the CJEU and UK court decisions relating to third party MAs, and notes that the differing opinions handed down over the years necessitate clarity on this issue.

In arguing that, for an SPC application, a basic patent and a MA cannot be held by different undertakings, Eli Lilly referred to statements of the CJEU in Lilly v HGS (C-493/12) and Teva CJEU (C-121/17) and to statements by the UK courts in Novartis v MedImmune ([2012] EWHC 181) and Sandoz v Searle ([2018] EWCA Civ 49). In each of these decisions the objective of the SPC Regulation was discussed, namely to award patent holders an extended term of protection as compensation for the period of exclusivity that was lost as a result of a delay in acquiring a MA. In view of this objective, the question arises as to whether a patent holder who has not necessarily been involved in taking a product to market (but is relying on a third party MA) is deserving of an extended term of protection.

In contrast, Genentech contend that it is implicit from Biogen v SKB (C-181/95) that a basic patent and a MA may be held by different and unconnected parties. In Biogen v SKB, the Court of Justice ruled that where the basic patent and the MA are held by different persons, the holder of the MA is not obliged to provide the patentee with a copy of the MA (i.e. does not have to provide consent). Furthermore, an application for an SPC cannot be refused solely on the grounds that the patentee was unable to obtain a copy of the MA. There is therefore a suggestion that consent from the third party is perhaps not required. Genentech also argued that it is consistent practice of the national offices to grant SPCs on the basis of third party MAs.

It was however noted in Biogen v SKB that the SPC Regulation is silent on the relationship between the holder of a basic patent and the holder of a related MA. It is readily apparent that clarity on the issue of third party MAs is needed and we hope that the CJEU will be able to provide a solution

Authors

Joanna Peak Partner Biotechnology Patents Firm

Joanna Peak
Partner

Phone this number +44 (0)20 7430 7500

Email this address jpeak@boult.com

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Nadia Tyler Rubinstein Patent Assistant

Nadia Tyler-Rubinstein
Patent Assistant

Phone this number +44 (0)20 7430 7500

Email this address ntyler-rubinstein@boult.com

Salisbury Square House
8 Salisbury Square
London
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