Validity - Novelty - Defendant holding patent concerned with therapeutic agents for treatment of range of diseases by preventing growth of associated blood vessels
Regeneron Pharmaceuticals Inc v Genentech; Bayer Pharma AG v Genentech: ChD (Pat) (Mr Justice Floyd): 22 March 2012
The defendant was the holder of a patent concerned with therapeutic agents for the treatment of a range of diseases by preventing the growth of blood vessels associated with them.
In particular, the patent had been concerned with agents that inhibited the action of vascular endothelial growth factor (VEGF). The patent had explained that endothelial cells had been an important component for the development of new blood vessels and capillaries. Those cells proliferated during angiogenesis or neo-vascularisation disease or disorder.
Further, it had been explained in the patent that a number of molecules had been reported to induce proliferation of endothelial cells, among which had been fibroblast growth factors, platelet-derived endothelial cell growth factors and VEGF. The patent had been addressed to a team concerned with the development of a therapeutic agent for use in the treatment of non-neoplastic neo-vascular conditions, and had been said to include a team of vascular biologist and molecular biologists.
The claimant companies (R and B) applied for revocation of the patent on the grounds of lack of novelty and lack of inventive step over a single prior art citation and insufficiency of description. R had been planning to market a product, VTE, for treatment of age-related macular degeneration of the eye. B was a licensee of R in respect of VTE. The defendant counterclaimed, alleging that VTE had infringed its patent, and the claimants accordingly also sought a declaration of non-infringement.
The issues for determination, accordingly, were what would a person skilled in the art have understood the language of the claim to have meant and whether VTE was an isolated VEGF receptor with the effect that it had infringed the defendant’s patent.
The court ruled: (1) The skilled person would have understood that the range of diseases had been those characterised by excessive undesired angiogenesis. There had been no evidence that anyone skilled in the art would have had any difficulty in identifying a disease that had been characterised by undesirable, excessive angiogenesis, and one which had not.
Further, the skilled person would not have understood that the patentee had been saying that the treatment would necessarily have successfully dealt with anything other than undesired angiogenesis in the range of diseases. Thus, the skilled person would not have understood that the treatment would necessarily have dealt with other aspects of the disease that had been independent of angiogenesis (see , ,  of the judgment).
(2) With respect to the obviousness and insufficiency cases, at the filing date, there had been nothing approaching a concluded view as to what, if any, of the many growth factors that had been identified would have been the right or best one to target for therapeutic purposes. Each of the growth factors had its enthusiasts, but there had been no way of predicting which of the growth factors would have been necessary for pathological angiogenesis.
With regard to the allegation that VTE had infringed the defendant’s patent, VTE was an effective antagonist of VEGF, as its nomenclature had suggested. It bound VEGF to a sufficient degree to achieve a therapeutic effect. It accordingly fell plainly within the language of the claim as it would be understood by a skilled reader. It followed that the patent had not been invalid on any of the alleged grounds, but had been infringed (see , , , ,  of the judgment).
Andrew Waugh QC and Thomas Mitcheson (instructed by Simmons & Simmons) for B; Richard Meade QC and Mark Chacksfield (instructed by Bird & Bird) for R; Michael Tappin QC and Isabel Jamal (instructed by Marks & Clerk Solicitors) for the defendant.