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Hospira UK Ltd v Novartis AG [2013] EWHC 516 (Pat)

Case Summary  |  Judgment  |   2 April 2013

 

Michael Tappin QC recently acted for Generics (UK) Ltd (t/a Mylan), the second claimant in Hospira UK Ltd v Novartis AG [2013] EWHC 516 (Pat). This was a claim for revocation of two European patents relating to the intravenous administration of zoledronate for the treatment of osteoporosis, at intervals of at least six months.

The claimants attacked validity on three grounds. First, they argued that the patents were not entitled to priority from a US patent application and were therefore invalid over an article published during the intervening period. Secondly, they argued that the patents were obvious over an abstract which disclosed infrequesnt intravenous administration of pamidronate. Thirdly, they argued that several claims were insufficient since they were open-ended and embraced all dosages of the medicine and/or all intervals of administration.

Mr Justice Arnold concluded that the patents were invalid. On priority, the Court held that the earlier US application did not relate to “the same invention” as required by Article 87(1) EPC and s 5(2)(a) of the Patents Act 1977, and could not support a priority claim. The obviousness attack failed. However, the claims were insufficient. Zoledronate would not treat osteoporosis irrespective of dosage and the interval between administrations. This placed an undue burden on the skilled team to identify which dosages and dosage intervals would be effective, which would entail extensive clinical trials.

Accordingly, the patents were invalid and the claim for revocation succeeded.