EPLAW PATENT BLOG

UK – Hospira v. Novartis

Posted: January 10th, 2014

Hospira UK Ltd and Generics (UK) Ltd v Novartis AG Court of Appeal, [2013] EWCA Civ 1663 Patten LJ, Tomlinson LJ, Floyd LJ

In its judgment of 19 December 2013, the Court of Appeal dismissed Novartis’ appeal against a decision of Arnold J that a claim, namely claim 7, of Novartis’ patent EP(UK) 1 296 689 was invalid due to lack of entitlement to its claimed priority date. 

EP’689, related to the use of zoledronate (a member of the bisphosphonate class of drugs) for the treatment of, amongst other things, osteoporosis.  Claim 7 contained, in combination, features directed to: (i) the drug (zoledronate), (ii) the fact that the drug is for the treatment of osteoporosis, (iii) the mode of administration (intravenous), (iv) the range of dosage sizes (about 2-10 mg) and (v) the dosing interval (about once a year).  At first instance, Arnold J decided that claim 7 was invalid because it was not entitled to its claimed priority from US Patent Application No 267689 (“PD2”).  This was the sole finding appealed by Novartis. 

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Disclosure of PD2

PD2 disclosed the use of bisphosphonates for the treatment of conditions of abnormally increased bone turnover, such as osteoporosis.  It disclosed intravenous administration as being one preferred mode of administration.  It also disclosed the option of a one year dosing interval.

In relation to dosage, PD2 included a passage which stated that “a dose of from about 2 up to about 10 mg may be used for once a year dosing” (referred to as “the 2-10 mg once a year passage”). This passage came immediately after a reference to single dose unit forms containing 0.5 to 500mg which would be suitable for, but not limited to, intravenous infusion.  The passage also contained a reminder that dosage will depend on other factors, which were discussed elsewhere in the patent as including method of administration and condition to be treated.

Example 5 of PD2 related to the intravenous administration of zoledronate for the treatment of post-menopausal osteoporosis.  The dosage sizes and intervals included 4 mg every 12 months, as well as other regimens including 0.25, 0.5 and 1 mg every 3 months and 2 mg every 6 months.  Total annual dosages therefore ranged from 1 to 4 mg per year. 

Priority

The Court of Appeal explained that the problem for Novartis was that the disclosure of PD2 was either too general or too specific:  the “2-10 mg once a year passage” disclosed nothing about dosing range for any specific mode of administration or for the condition to be treated; and Example 5 disclosed that intravenous administration of a 4 mg dosage once a year is effective to treat post-menopausal osteoporosis, but nothing about what other doses could be used at that dosage interval. 

Novartis argued that reading PD2 as a whole disclosed claim 7 in full and that the skilled reader would understand from the overall document that it is not just 4 mg that is effective intravenously for osteoporosis, but the range of 2-10 mg as well.  

This submission was rejected as it was held to depend on reading the “2-10 mg once a year passage” as saying that 2-10 mg is a suitable dosage range regardless of the mode of administration or the condition to be treated.  Instead, the Court of Appeal agreed with Arnold J’s finding that the skilled person would read the passage to mean that, depending on the method of administration and the targeted condition, some doses within this range may be suitable.  The Court also agreed that the expert evidence provided at trial did not displace the view that there was no disclosure in PD2 of using 2-10 mg of zoledronate once a year by intravenous administration to treat osteoporosis.  

Accordingly, the Court of Appeal found that claim 7 was not in respect of an invention that was disclosed in PD2, and was therefore not entitled to its priority date.  As a consequence of such loss of priority, claim 7 of EP’689 was invalid. 

Read the decision here:

Head note: Amy Crouch and Sara de Sousa  

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