In the decision, the Enlarged Board of Appeal considered the following questions:
Question 1: Where it is already known to use a particular medicament to treat a particular illness, can this known medicament be patented under the provisions of Articles 53(c) and 54(5) EPC 2000 for use in a different, new and inventive treatment by therapy of the same illness?
Answer: 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.
Question 2: If the answer to question 1 is yes, is such patenting also possible where the only novel feature of the treatment is a new and inventive dosage regime?
Answer: 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.
Question 3: Are any special considerations applicable when interpreting and applying Articles 53(c) and 54(5) EPC 2000?
Answer: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.
In the reasons for the decision, the Enlarged Board emphasized the already existing case law from the Boards of Appeal which had followed the decision G 5/83. G 5/83 was the decision introducing the so-called Swiss-type claims as a way of claiming second and further medical uses without violating Article 52(4) EPC 1973 (which in essence corresponds to Article 53(c) EPC 2000). The further case law from the Boards of Appeal had largely come to the conclusion that the “further medical use” was not restricted to new diseases, but could be any further medical use.
The Enlarged Board also reasoned that the Travaux Preparatoires of the EPC 2000 concerning Article 54(5) and 53(c) EPC 2000 emphasized keeping the status quo as far as the case law of the Boards of Appeal was concerned.
The Enlarged Board further emphasized that under Article 54(5) EPC 2000 any new use not comprised in the state of the art is novel. Thus, known compounds, known as being used for treating a particular disease may still be considered novel if for example: The group of patients is new, the use relates to a new mode of administration, or the dosage regime is new.
In summary, the decision G 2/08 largely maintains status quo for the patentability of new medical use at the EPO. However, in the future only the claim format according to Article 54(5) EPC will be allowed. The Swiss-type format can therefore no longer be used. This change is not retroactive, though, and any granted EP patents under opposition may keep the Swiss-type format.
Contact Henrik Skødt or Anne Schouboe for more information on the G 2/08 decision.
