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(1) Hospira UK Ltd (2) Generics (UK) Ltd (t/a Mylan) v Novartis AG [2013] EWCA Civ 1663

Case Summary  |  Judgment  |  11 December 2013


Michael Tappin QC  recently appeared with Tom Mitcheson for Hospira and Generics, the successful respondents to an appeal brought by Novartis against the invalidation of one of its patents.

Novartis’ patent related to the use of a particular member of the bisphosphonate class of drugs, zoledronate. Claim 7 claimed the use of zoledronate for the treatment of osteoporosis, administered intravenously about once a year at a particular range of doses.

At first instance, Arnold J had invalidated claim 7 as a result of a lack of priority from a US patent application (known as ‘PD2’) [2013] EWHC 516 (Pat). On appeal, Novartis contended that Arnold J had erred in holding that there was no clear and unambiguous disclosure of the subject matter of claim 7 in PD2, by reason of his failure to read the latter as a whole.

Giving judgment, Floyd LJ, with whom Tomlinson and Patten LJJ agreed, dismissed the appeal. It was held that while PD2 did disclose the dosage range of claim 7 for annual administration, the relevant part of the disclosure did not teach the reader that this dosage regimen was for intravenous administration for the treatment of osteoporosis. There was no doubt that the skilled person would not read the relevant passage as teaching that the dosage regimen could be used regardless of the condition being treated and the mode of administration. There had been nothing in the expert evidence before the judge to displace that view. Arnold J had been right to conclude that claim 7 was not entitled to priority from PD2.