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 found.

In reaching its decision the Court relied on expert evidence to construe a disclosure which teaches a dosage regime of 2 up to about 10mg of zoledronate about once a year, but which does not teach a specific route of administration for such a regime or the specific medical indications that are treated by that regime.Since the application as a whole referred in general to the treatment of conditions associated with abnormally increased bone turnover via a number of differing administration routes, on the balance of this expert evidence, the Court decided that the skilled man would understand this teaching to amount to that of a range of doses that would be suitable to cover the use of zoledronate in the treatment of the many conditions associated with abnormally increased bone turnover via any route of administration, with some routes/conditions requiring dosages at the lower end, others at the upper end, and many in between.As a result, in the absence of being informed otherwise, the skilled man would not have taken the disclosure of this dosage range as a preferred dosage range for the treatment of osteoporosis via intravenous administration (even though it was clear from the application as a whole that osteoporosis was a preferred target disease and intravenous administration was a notable route of administration). The specific combination of this dosage range with the teaching of intravenous administration and the treatment of osteoporosis was therefore not a combination that was directly and unambiguously derivable from the priority document and the claim was not entitled to priority.

This decision emphasises the dangers in succumbing to the temptation of corner-cutting at the priority filing stage.  Specifically in the context of pharmaceutical therapies, a detailed description filled with boiler plate dosage ranges might not provide adequate support for future claims to the use of such ranges in specific treatment contexts.  If the inventive concept is likely to lie in the use of specific dosage regimes to treat specific medical indications, the draftsman must take the time to consider which doses can be used in which treatment contexts and make sure his disclosure includes such specific combinations of dose, condition to be treated and administration route.  

This decision also serves as a reminder to those beyond the pharmaceutical field of how strictly priority provisions are applied in Europe and how a “planting the flag” approach to a priority filing may well result in a priority application that will be unable to provide sufficient support in Europe for later claims more specific embodiments/combinations. Applicants would be well advised to resist the temptation to cut costs at this crucial stage of an application by filing a cursory description of their invention and instead plan to invest time and money in drafting a full application, ideally engaging the services of an experienced European Patent Attorney.