Michael Tappin KC appeared for the Claimants (Sandoz) and Justin Turner KC appeared for the Defendant (Biogen). Sandoz sought revocation of Biogen’s patent and an Arrow declaration, while Biogen counterclaimed for infringement.
Biogen’s patent in suit, EP 967, related to a method for assessing the risk of progressive multifocal leukoencephalopathy (PML) in multiple sclerosis (MS) patients based on their anti-JC virus (JCV) antibody levels. Sandoz had been developing its own assay for detecting levels of anti-JCV antibodies, which was the subject of the counterclaim. The Arrow declaration was sought in view of the existence of a pending divisional application deriving from the parent application for the patent.
Mr Justice Mellor held that the patent was invalid due to insufficiency as it did not provide adequate guidance for the skilled person to achieve the claimed invention without undue burden. Sandoz also succeeded on its breadth of claim insufficiency attack against certain claims of the patent. As a result, Biogen’s counterclaim for infringement fell away. Mr Justice Mellor also held that Sandoz was not offering the claimed process for use in the UK, though if it had been and if the patent were valid, the use of Sandoz’s assay would infringe claim 1 of the patent on an application of the doctrine of equivalents. Mr Justice Mellor declined to make the Arrow declaration as that would be to usurp the function of the EPO.