Patent Law

Guest Post by Paul Cole, visiting professor of IP law at Bournemouth University

Dosage Regime/ABBOTT RESPIRATORY  G 0002/08 ? 19 Feburary 2010

Patentability of the present application was governed by EPC 2000 rather than EPC 1973, and the referring Appeal Board considered it an important point of law whether medicaments for use in therapeutic treatments could be considered novel where the only feature of novelty was a dosage regime. The claim before the Board was directed to:

"The use of nicotinic acid or a compound metabolized to nicotinic acid by the body ? for the manufacture of a sustained release medicament for use in the treatment by oral administration once per day prior to sleep, of hyperlipidaemia ? "

The Enlarged Board was first asked to consider the general question: when a medicament was known for use to treat an illness could patents subsequently be granted further new and inventive treatments of the same illness. Under EPC 1973, such further patents had been granted with Swiss-form use claims directed to treatment of new patient groups (T 0019/06, T 0383/90 and T 0233/96), new modes of administration (T 0051/93 and T 0138/95) and different technical effects relating to truly new applications (T 0290/86. T 0254/93 and T 1020/03). The Board held that it was not the intention of the legislators in framing EPC 2000 to change the patent protection available for further therapeutic uses.  Use of a composition as a medicament for unspecified therapy was permitted as a first medical indication and for a specified therapy was permitted as a second medical indication.

A second and more specific question was directed to patentability where the only novel feature was a new and inventive dose regime. The Enlarged Board held that this question should be answered in the affirmative provided that there was a new technical effect, see also UK decision Activis v Merck [2008] EWCA Civ. 444 and German decision X ZR 236/01 Carvedilol II, 19 December 2006.

As to any appropriate change in EPO practice, simple use claims were now permitted under the changes introduced by EPC 2000. Since the reasons for granting Swiss-form use claims had disappeared with the entry into force of EPC 2000, there was no reason to maintain the "praetorian" approach suggested in case G 0005/83, and such claims would no longer be permitted. As to the transitional provisions governing this change in practice:

"The Enlarged Board of Appeal is aware of the fact that patents have been granted and many applications are still pending seeking patent protection for claims of this type. In order to ensure legal certainty and to protect legitimate interests of applicants, the abolition of this possibility by the interpretation of the new law given by the Enlarged Board in this decision shall therefore have no retroactive effect, and an appropriate time limit of three months after publication of the present decision in the Official Journal of the EPO is set in order for future applications to comply with this new situation. In this respect the relevant date for future applications is their date of filing or, if priority has been claimed, their priority date."

The present decision can be seen as an uncontroversial but welcome restatement of the law that will give greater certainty both for applications and oppositions before the EPO and for the enforceability of the resulting patents in the EPC contracting states. Connoisseurs of verbal abuse may, however, wonder whether it was wise to attach the label "praetorian" which at least to English readers has implications of dishonesty, corruption and perhaps subversion to the former Swiss form claim practice whose acceptance by the national courts of the EU contracting states was at times grudging.