Eli Lilly And Co v Human Genome Sciences Inc [2014] EWHC 2404 (Pat) (18 July 2014)

Parties

Procedural Posture

Patent Dispute / Reference for Interpretation of EU Law (spc Regulation) / Post Preliminary Reference; Application of CJEU Ruling to National Proceedings

Legal Issues

1. 1 Whether an active ingredient must be identified in the claims of a patent by a structural formula, or whether a functional formula suffices for SPC purposes under Article 3(a) of Regulation No 469/2009
2. 2 Whether tabalumab is 'protected by a basic patent in force' within the meaning of Article 3(a)

Ratio Decidendi

An active ingredient does not need to be identified in the claims of a basic patent by a structural formula for the purposes of Article 3(a) of Regulation No 469/2009. A functional definition may suffice, provided that, interpreted in light of the description and as required by Article 69 EPC and the Protocol, the claims relate, implicitly but necessarily and specifically, to the active ingredient in question. The national court must determine, applying these principles, whether the product is protected by the basic patent. The infringement test is not the correct standard; the focus is on what is specified or identified in the claims, not what would infringe the patent.

Court Disposition

Guidance provided for national court to determine whether tabalumab is protected by HGS's patent under Article 3(a) of Regulation No 469/2009; no final order granting or refusing SPC in this judgment.