Hospira UK Generics (UK) Ltd (t/a Mylan) v Novartis AG

Priority for a patent claim is available only where the skilled person can derive the claimed subject matter directly and unambiguously, using common general knowledge, from the priority document as a whole. A broad disclosure of a drug, condition, administration route and dosing interval does not necessarily disclose their particular combination. Nor may a general dosage range be treated as suitable for every condition and administration route where the document states that dosage depends on those matters. A specific clinical example may not disclose other doses at the same interval. The claimed regimen therefore lacked priority because the priority document did not link 2–10 mg of zoledronate once yearly, intravenously, to osteoporosis treatment.

Novartis owned a patent concerning the use of zoledronate for treating osteoporosis. Claim 7 specified intravenous administration, a unit dose of about 2–10 mg and administration about once yearly. Hospira and Mylan brought revocation proceedings. Arnold J held that claim 7 was not entitled to priority from PD2 and was consequently invalid: [2013] EWHC 516 (Pat). Novartis appealed only the priority finding. The central issue was whether PD2 disclosed the claimed combination as a single invention, rather than disclosing its constituent features only in separate general passages and a specific clinical example.

1. Disposition. The Court of Appeal unanimously dismissed the appeal. Claim 7 was not entitled to priority from PD2, so the patent was invalid because an intervening publication became available against it.
2. Applicable standard. Article 87(1) of the European Patent Convention and section 5 of the Patents Act 1977 use different wording, but section 130(7) requires the provisions to be construed consistently. The governing question, stated in G2/98 “Same Invention” [2001] OJEPO 413, is whether the skilled person can derive the claimed subject matter directly and unambiguously, using common general knowledge, from the priority application as a whole. Unilin Beheer BV v Berry Floor NV [2004] EWCA (Civ) 1021 and the examples in Pharmacia Corp v Merck & Co Inc [2002] RPC 41 and Beloit Technologies Inc. and another v Valmet Paper Machinery Inc. and another [1995] RPC 705 illustrated that the substance of the disclosure, rather than a formula or aggregation of separately disclosed features, controls.
3. Application to PD2. PD2 identified zoledronate, osteoporosis, intravenous administration and long dosing intervals, but its 2–10 mg once-yearly passage did not link that range to any particular condition or administration method. The specification expressly stated that dosage depended on matters including the condition and route. Example 5 was specific to intravenous treatment of post-menopausal osteoporosis and showed efficacy for 4 mg once yearly, but did not disclose the wider 2–10 mg range for that regimen. The expert evidence did not establish the missing link.
4. Efficacy. The court decided the appeal solely on disclosure and therefore did not need to determine efficacy separately. It observed that, if PD2 had disclosed the claimed regimen, the phrase for the treatment of osteoporosis would have been construed consistently in the patent and PD2 and would imply an effective regimen.

1. Court of Appeal (Civil Division) dismissed Novartis’s appeal and upheld the finding that claim 7 lacked priority.
2. High Court of Justice, Chancery Division Arnold J held that claim 7 was not entitled to priority from PD2 and was invalid: [2013] EWHC 516 (Pat).