EPO – Enlarged Board of Appeal decides on dosage regime – Swiss-type claims no longer available
Posted: February 22nd, 2010
EPO, Enlarged Board of Appeal, 19 February 2010, Decision No. G 02/08 – Dosage regime/ABBOT RESPIRATORY
The Enlarged Board of Appeal (EBA) answered the questions referred to it in T 1319/04 (OJ EPO 2009, 36) as follows:
Where it is already known to use a medicament to treat an illness, Article 54 (5) EPC does not exclude that this medicament be patented for use in a different treatment by therapy of the same illness.
Such patenting is also not excluded where a dosage regime is the only feature claimed which is not comprised in the state of the art.
Where the subject matter of a claim is rendered novel only by a new therapeutic use of a medicament, such claim may no longer have the format of a so called Swiss-type claim as instituted by decision G 5/83. A time-limit of three months after publication of the present decision in the Official Journal of the European Patent Office is set in order that future applicants comply with this new situation.
The question whether a patent can be obtained for further medical indications was answered in the affirmative as early as 1984 by the Enlarged Board of Appeal (EBA) creating in its first decisions (inter alia G 5/83) a specific notion of novelty for inventions in the medical field. However, final legal certainty was not achieved since not all national courts of the Contracting States were prepared to follow the EBA’s approach. This situation prompted the legislator to act and he introduced into the EPC 2000 Article 54 (5) according to which a substance already known as a medicine and claimed for any specific use in medical treatment within the meaning of Article 53 (c) EPC is to be considered novel, provided that such specific use is not comprised in the state of the art.
The EBA notes that, even under the EPC 1973, the case law following G 5/83 allowed Swiss-type claims not only for the treatment of further illnesses but also for new forms of administration, novel groups of subjects treated and different technical effects. Whereas indication may be interpreted stricto sensu in the sense of a disease not yet treated by the claimed substance, the EBA points to the more general wording “any specific use” in Article 54 (5) (emphasis in the original) in conjunction with the intention of the legislator to maintain the status quo of available protection and holds that the provision is not limited to the treatment of a further illness.
The EBA refrains from defining dosage regime any further and confines itself to the statement that there is no reason to give a new dosage regime a different treatment than the one given to any other specific use acknowledged in the case law.
Addressing the problem of 'evergreening', the decision stresses that in addition to the legal fiction of Article 54 (5) EPC, the whole body of jurisprudence relating to the assessment of novelty and inventive step applies. In particular, the criteria to be applied for selection inventions are mentioned.
As to the further availability of Swiss-type claims, the EBA states that the “special approach to the derivation of novelty” for further medical indications in G 5/83 constituted an adequate but exceptional solution to close a loophole in the provisions of the EPC 1973. The cause of this approach ceasing, the effect also had to cease. In order to ensure legal certainty and to protect legitimate interests of applicants, the Board orders that the abolition of the possibility to get Swiss-type claims allowed shall have no retrospective effect. A time limit of three months from publication of G 2/08 in OJ EPO is set. Only applications which have a date of filing or priority after this time limit have to comply with the new situation.
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