English Patents Court* grants Novartis a preliminary injunction against generics company Dr Reddy’s in respect of patented breast cancer drug, providing a provisional validity opinion that is inconsistent with co-pending opposition proceedings at the EPO
The patent under litigation was the UK patent stemming from EP 2 269 603 which, although granted, was also the subject of an opposition at the EPO. The EPO’s Opposition Division (at first instance) had decided that claim1 included impermissible added subject matter (under Article 123(2) EPC) and therefore revoked the patent. This decision is under appeal, so the patent remains in force pending the resolution of the appeal.
The supposed added subject matter concerned an amendment made during prosecution in which the combination of rapamycin with exemestane was claimed for use in treating breast cancer. The EPO followed long-standing practice which effectively means that when compounds are presented in two lists in a patent specification, to isolate specific individual compounds from each list and combine them can constitute teaching not present in the application as filed – added subject matter – absent any pointer which leads to the specific combination. Exemestane was only disclosed in a list of exemplary aromatase inhibitors, with no indication that it was preferred or more effective. The combination was hence regarded as an artificial creation which had no basis in the application as filed.
The Patents Court, in contrast, pointed out that the specification taught that rapamycin could beneficially be combined with ‘aromatase inhibitors’, and for this reason the combination with one of the listed examples of these was therefore clearly ‘disclosed’. This ‘provisional’ view was regarded as being sufficiently clear cut to justify the granting of a preliminary injunction against Dr Reddy’s, pending the outcome of the full infringement hearing.
This case is interesting for several reasons. It confirms that English courts are willing to grant preliminary injunctions where the prima facie validity and infringement case is strong, and also that they may do so notwithstanding co-pending EPO appeal proceedings taking place in which the litigated patent could in due course be found to be void ab initio. For the patent practitioner it confirms the widely held belief that the EPO (and its Appeal Boards) tends to adopt a stricter added subject matter standard that the English Patents Court.
* EWHC 92 (Pat)