Hospira UK Ltd & Anor v Novartis AG

For priority, the claimed subject matter must be disclosed in the priority application as a whole so that the skilled person can derive it directly and unambiguously using common general knowledge. Open-ended claims may cover only doses and intervals that are in fact effective, but remain insufficient if the skilled team must undertake a substantial clinical research programme to discover which embodiments work. In pharmaceutical research, an obvious-to-try route requires a fair or reasonable prospect of success. The court must evaluate all relevant circumstances, including alternative research avenues, effort, motivation and prospects of success.

Hospira UK Limited and Generics (U.K.) Limited trading as Mylan sought revocation of European Patents (UK) Nos 1 296 689 and 1 591 122, owned by Novartis AG. The patents concerned intermittent intravenous administration of zoledronate for treating osteoporosis, with intervals of at least about six months.

The challenges alleged lack of priority, obviousness over Boutsen, and insufficiency. The priority issue concerned whether the claims were supported by the United States priority application PD2. The obviousness issue concerned whether the skilled team would move from intravenous pamidronate evidence in Boutsen to the claimed zoledronate regimens. The insufficiency issue concerned the breadth of open-ended dose and interval claims.

1. Priority. None of the claims was entitled to priority from PD2. The skilled person had to derive the claimed subject matter directly and unambiguously from the earlier application as a whole. PD2 did not link zoledronate, osteoporosis, intravenous administration and intervals of at least six months in its general disclosure. Example 5 disclosed only particular regimens and did not disclose efficacy across the breadth of the claims.
2. Construction. The open-ended claims covered doses and intervals which worked, rather than every possible dose and interval beyond the stated minimum. Their potential scope nevertheless extended to long intervals and doses beyond the specific examples.
3. Obviousness. Applying the structured approach in Pozzoli v BDMO SA, the skilled team would regard Boutsen as relevant to zoledronate but would not translate its pamidronate regimen or dose directly. BMD data supported both single and three-monthly treatment, while CTX data favoured three-monthly treatment. The prospects of success for six- or 12-monthly zoledronate were highly uncertain. Considering the motivation, alternative research avenues, effort and prospects of success, the claimed step was not obvious.
4. Insufficiency. The relevant claims were not enabled across their breadth. The skilled team would need to conduct a substantial programme of clinical trials to discover effective doses and dosing intervals, imposing an undue burden.
5. Disposition. Both patents were invalid for lack of priority. Claims 1, 2 and 5 of patent 689 and claims 1, 2, 6 and 7 of patent 122 were additionally invalid for insufficiency. None of the claims was obvious over Boutsen.