Novartis Pharmaceuticals UK Ltd v Medimmune Ltd & Anor

For a process claim, an SPC cannot be granted under Article 3(a) of the European Parliament and Council Regulation 469/2009/EC for a product merely because it falls within the broad scope of the claim or was obtained by a process falling within it. The product must be identified in the wording of the claims as the product deriving from the patented process. Whether it was obtained directly by that process is irrelevant. The question whether a patent is a basic patent protecting a process to obtain a product does not create a separate issue.

Novartis sought a declaration that an SPC for ranibizumab was invalid. The SPC was based on a patent jointly owned by MedImmune and the Medical Research Council and on a marketing authorisation for Lucentis. The court proceeded on the hypothesis that the patent was valid and infringed, although an earlier judgment had held otherwise. The central issues were whether ranibizumab was protected by the basic patent under Article 3(a) and whether the patent qualified under Article 1(c) as a patent protecting a process to obtain that product.

1. The SPC was invalid. Ranibizumab was not identified in the wording of claim 1 as the product deriving from the claimed process.
2. The decisions in Medeva BV v Comptroller-General of Patents, Designs and Trade Marks [2011] ECR I-0000 and its progeny rejected an infringement-based test in combination cases. The precise meaning of “specified” or “identified in the wording of the claims” remained unclear, but the present case concerned a single active ingredient and a process claim.
3. The claim identified only “a molecule with binding specificity for a particular target”. That covered millions of molecules and was not limited to antibodies. Neither the claim nor the specification identified ranibizumab as the product of the process.
4. University of Queensland v Comptroller-General of Patents, Designs and Trade Marks [2011] ECR I-0000 required identification of the product deriving from the process in the claim wording. Whether the product was obtained directly by the process was irrelevant.
5. Article 1(c) did not create a separate issue. Whether the patent was a basic patent depended on whether the product obtained by the process was protected under Article 3(a).
6. A further reference to the Court of Justice was premature because the issue might become academic if the earlier findings of invalidity or non-infringement were upheld on appeal.

The matter was decided at first instance. An earlier judgment, MedImmune Ltd v Novartis Pharmaceuticals UK Ltd [2011] EWHC 1669 (Pat), had held the patent invalid and not infringed. Permission to appeal had been granted, but the present judgment proceeded on the contrary hypothesis.