Hospira and Mylan commenced proceedings for revocation of European Patents (UK) Nos. 1296689 and 1591122. Both concerned the administration of bisphosphonates, in particular, zoledronic acid or a salt – zoledronate – at intervals of at least six months for the treatment of osteoporosis.
It was accepted by Novartis that, if the patents were not entitled to one of their priority claims, then both patents would be invalid due to an intervening publication (Reid et al, “A single annual injection of the bisphosphonate …, Bone 28(5), S89 (2001)). The judge (Arnold J) conducted a thorough analysis of the relevant priority document and concluded that none of the patent claims was entitled to the claimed priority. For example, although the priority document disclosed a unit dose form of 1-10 mg, this was not linked to the other features of the claims.
Furthermore, several of the patent claims were also held to be invalid for insufficiency. The claims in issue required the skilled team to carry out a substantial program of clinical trials to find out what doses and dosing intervals were efficacious – they were not enabled across their breadth and were therefore insufficient.
Read the decision (in English) here.
Head note: Graham Burnett-Hall