IP Cases & Articles

Novartis v Hospira: A Strict Approach to Priority

Part 2 of Novartis v Hospira follows the article in our August newsletter on the granting of interim injunctions. In Part 2 of this case, the Court of Appeal has decided on the priority entitlement of one of Novartis’ zoledronic acid second medical use patents EP(UK) 1 296 689.

Readers may recall that in the earlier reported case, Arnold J decided that EP(UK) 1 296 689 was invalid due to a prior art document published between the priority and filing date of the patent. Following this decision, Novartis appealed on the basis that claim 7 was entitled to priority. Claim 7 covered Novartis’ commercial product ACLASTA, and was of commercial importance to all parties.

Claim 7 claimed priority from two US applications: US 597135 (P1) and US 267689P (P2). The point at issue for the Court of Appeal was whether P2 disclosed the subject-matter of claim 7. Claim 7 included the following five features:

i. the drug (zoledronate);

ii. use of the drug for the treatment of osteoporosis;

iii. mode of administration (intravenous);

iv. range of dosage sizes (about 2 up to about 10 mg); and

v. dosing interval (about once a year).

In relation to point (i) above, P2 disclosed that:

a unit dose of from about 1 up to about 10 mg may be used. For example…from about 1 to about 5 mg may be used for dosing once every 6 months; whereas a dose of from about 2 up to about 10 mg may be used for once a year dosing.

This “2-10 mg once a year” passage followed a teaching relating to unit dose forms of infusion solutions containing 0.5 to 500 mg of active ingredient, which were suitable for, but not limited to intravenous infusion. The passage also mentioned that the unit dose used depended upon potency of the active ingredient and dosing interval “amongst other things”, for example, method of administration and condition.

P2 also contained five examples. The most relevant was example 5, which concerned a phase II 12 month clinical trial of zoledronate for the treatment of post-menopausal osteoporosis. Either zoledronate or placebo was administered intravenously and dosage sizes and intervals included 4 mg every 12 months.

The problem faced by Novartis was that the disclosure of P2 was either too general or too specific for the combination of features (i) to (v) required by claim 7.

Novartis argued that although the “2-10 mg once a year” passage didn’t specifically mention the treatment of osteoporosis, this was part of the general teaching and the focus of P2. In addition, Novartis submitted that intravenous administration was one of the principal routes taught in both the description and in Example 5, and that because Example 5 included studies using less than 4 mg of zoledronate at more frequent intervals, the 4 mg dose would be understood by the skilled person as not the only possible dose. They alleged that the Judge at first instance had erred by failing to read P2 as a whole. The Court of Appeal disagreed.

The court held that there was nothing to link the dosage sizes and intervals with the other features of claim 7. The “2-10 mg once a year” passage was too general since it told the skilled person nothing about dosage range for any particular method of administration, and example 5 was too specific since it related to 4 mg, once a year, administered intravenously to patients with post-menopausal osteoporosis.

The court held that Novartis’ arguments relied on reading the “2-10 mg once a year” passage as saying that this dosage size and interval could be used independently of the condition being treated and the method of administration. Instead the court read this passage as: depending on the method of administration and the condition being treated, some doses within this range may be suitable. This reading was said to be supported by the other disclosures in the patent and the common general knowledge that dosage is critically dependent on condition and method of administration.

Thus claim 7 was held not to be entitled to priority from P2. It therefore followed that the patent was invalid and the appeal was dismissed.

Comments

This decision demonstrates a very strict approach being taken by the UK courts to priority, especially since all of the elements of claim 7 were disclosed in P2. It does, however, make clear that a link between individual features is required in order for a combination claim to be entitled to priority.

If you have any questions on priority, please contact your usual D Young & Co advisor.

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