Eli Lilly And Company v Genentech, Inc

For Article 3(a) of the SPC Regulation, a product must necessarily fall under the invention covered by the basic patent and be specifically identifiable by the skilled person, assessed using the patent and the prior art available at the filing or priority date. Later research cannot establish those requirements.

Functional patent claims may identify an antibody specifically. The outcome may differ between claims where one claim is directed to an antibody and another requires a therapeutic effect that was not plausible at the priority date. Where the law on reliance upon a third-party marketing authorisation is unclear, a reference to the CJEU may be necessary even though the patent has separately been held invalid, particularly in exceptional circumstances.

Genentech sought a supplementary protection certificate based on its patent concerning IL-17A/F antibodies and Lilly’s marketing authorisation for ixekizumab. Lilly sought a declaration that an SPC granted on that basis would be invalid.

Lilly challenged the application under Articles 2, 3(a), 3(b) and 3(d) of the SPC Regulation. The principal issues were whether ixekizumab was protected by the patent and whether an SPC could rely on a marketing authorisation held by a third party without that party’s consent. The court had separately concluded that the patent claims defended by Genentech were invalid, but considered whether the third-party marketing-authorisation question should nevertheless be referred to the CJEU.

1. Article 3(a). The court applied the two-limb test in Teva UK Ltd v Gilead Sciences Inc [EU:C:2018:585]: the product must necessarily fall under the invention covered by the basic patent, and each relevant active ingredient or product must be specifically identifiable from the patent and the prior art at the filing or priority date.
2. Claim 1. Ixekizumab fell within the scope of claim 1. The skilled team would understand it to embody the claim’s technical contribution, and it was specifically identifiable by the functional characteristics stated in the claim. Its later creation was irrelevant to that assessment. An SPC based on claim 1 would therefore satisfy Article 3(a) (paras [22]-[26]).
3. Claim 12. Claim 12 required a discernible therapeutic effect on psoriasis and a contribution by inhibition of IL-17A/F to that effect. At the priority date the skilled team would not have regarded such an effect as plausible. The later clinical and scientific research establishing efficacy could not be used. Ixekizumab therefore did not necessarily fall under, or become specifically identifiable as covered by, claim 12 (paras [27]-[29]).
4. Third-party marketing authorisation. The law was not clear on whether the SPC Regulation precluded an SPC for the proprietor of a basic patent where the relevant marketing authorisation was held by a third party without consent. The competing arguments could not be resolved with sufficient certainty at first instance (paras [30]-[44]).
5. Reference. Despite the separate conclusion that the patent was invalid, the court considered a reference necessary. The possibility of a successful appeal, the possible loss of UK jurisdiction to refer questions to the CJEU, the EU-wide nature of the dispute and the wider significance of the issue constituted exceptional circumstances. The question was referred in the terms set out at paragraph [44], subject to submissions on its precise wording (paras [45]-[51]).

First-instance decision. The judgment records that the court’s separate Patent Judgment concluded that the claims defended by Genentech were invalid. This judgment nevertheless referred the third-party marketing-authorisation question to the CJEU.