Novartis (AG) v Ivax Pharmaceuticals UK Ltd

Patent claims are construed by asking what the skilled person would understand the patentee to mean, read in the context and purpose of the patent. For a claim to an oil-in-water microemulsion pre-concentrate, the cyclosporin active ingredient had to be carried by the microemulsion. The presence of some microemulsion-sized particles was insufficient where most of the drug was carried by larger emulsion-sized particles. A claimed lipophilic phase also had to perform its functional role of carrying the insoluble drug and forming the oil phase; an amphiphilic surfactant could not satisfy that requirement. The appeal was dismissed.

Novartis appealed Pumfrey J’s decision, reported at [2006] EWHC 2506 (Pat), which held its UK patent valid but found that Ivax’s Equoral cyclosporin formulation did not infringe it. The appeal concerned the construction of claim 1, particularly whether a product containing both microemulsion-sized and larger particles could be an oil-in-water microemulsion pre-concentrate when most of the active ingredient was in the larger particles. It also concerned whether an amphiphilic component could constitute the claimed lipophilic phase. Ivax’s contingent cross-appeal on validity did not arise after non-infringement was upheld.

Lord Justice Jacob gave the reasons, with Lord Justices Buxton and Hughes agreeing.

1. Disposition. The appeal was dismissed after the court concluded that Equoral did not infringe. The contingent cross-appeal on validity therefore did not require determination.
2. Claim construction. The court applied the approach referred to in Amgen: the fundamental question was what the skilled person would understand the patentee to mean. The claim had to be read as a whole, in the context and purpose of the patent. The patent’s fundamental teaching was to carry cyclosporin in microemulsion-sized particles so as to avoid the problems of the prior-art emulsion formulation.
3. Microemulsion requirement. Claim 1 required the active ingredient to be carried by the oil-in-water microemulsion. It was insufficient that some particles were below 2,000 angstroms when more than 86% of the active ingredient was carried by larger particles. The principle discussed in Henriksen v Tallon [1965] RPC 434 concerning an inefficient product was distinguishable: this was not merely an inefficient commercial product, but one which was substantially what the patent sought to avoid. Expert evidence about the word in isolation, optical cloudiness, and Austrian product information did not alter the construction.
4. Lipophilic phase. The claimed lipophilic phase had to carry the insoluble cyclosporin and form the oil phase. Polyglycerol (3) oleate was amphiphilic and had a surfactant function, so it could not perform that role. The word include did not remove the functional requirement, and the patent’s discussion of a surfactant as an additional carrier or co-solvent did not permit it to replace the lipophilic phase. The late reliance on patent examples not put to witnesses or argued below was also inappropriate.

• Court of Appeal (Civil Division) dismissed Novartis’s appeal on 18 October 2007. The contingent cross-appeal was unnecessary.
• High Court of Justice, Chancery Division (Patents Court) held the patent valid but found no infringement by Equoral: [2006] EWHC 2506 (Pat).