Speedy Drafting Or Drafting For Priority?

Lessons from the Court of Appeal in Hospira & Mylan vs Novartis ([2013] EWCA Civ 1663)

The Court of Appeal has recently handed down a decision focusing on issues of priority and the extent to which isolated disclosures in the detailed description of an earlier application of all of the features a later claim may support the right to priority for that claim. Specifically considered was the teaching that can be derived from a simple statement of a preferred dosage range for a pharmaceutical. This decision can be viewed as a general lesson for the drafting of all effective priority documents in Europe and specific guidance on how European courts construe certain disclosures of dosage ranges. With dosage regimes emerging as an area of patentable new invention and becoming more and more relevant commercially as personalised medicine fast becomes a reality, this guidance is timely.

The single claim under consideration claimed the use of a zoledronate medicine for the treatment of osteoporosis where the medicine is adapted for intravenous administration in a unit dosage form which comprises from about 2 up to about 10mg of zoledronate, wherein the period between administrations is about once a year. The priority filing referred to all of these features at some point in its text, and even one or two in combination with some of the others, but the complete combination of the claim was not. Notably, the dosage range was not disclosed in connection with the specific route of administration (intravenous) or with the specific medical indication (osteoporosis). Novartis' case was, however, that the text of the priority filing should be read as a whole and, when it is, the link between the various features of the claim can be seen to run through the entire document.

The Court made reference to the relevant law on priority at the EPO and in the UK (Art. 87 and 88 EPC and Section 5 of the UK Patents Act 1977) and reaffirmed that, although the language differs, the two provisions must be taken to mean the same thing, i.e. that priority can only be acknowledged if the skilled person can derive the subject-matter of the claims directly and unambiguously, using common general knowledge, from the previous application as a whole. The Court cautioned against the practice of simply tracing the sources of a plurality of claim features in a previous application and not considering their interplay with the other features of the claim or the context in which they are...