Under both the European Patent Convention (EPC) 1973 and the EPC 2000, methods of treating a human or animal by surgery or therapy are not susceptible to industrial application and therefore are not patentable.
Nevertheless, the EPC 1973 provided for the possibility of patenting a substance for use as a medicament where the substance itself was known but its suitability for use as a medicament had not previously been disclosed (known as first medical use).
In Case G5/83 the European Patent Office (EPO) Enlarged Board of Appeal held that a claim directed to the use of a substance or composition for the manufacture of a medicament for a specified (new) therapeutic application was also allowable under the EPC 1973. This so-called "Swiss-type" claim could effectively be used to patent second and further medical uses. Ever since G5/83 was issued, ample case law has developed regarding the question of whether a claim in second-medical use format concerning new dosage regimens or new forms of administration should be considered to be in breach of the provision of Article 52(4) of the EPC. The issue was believed to be settled in Genentech (T1020/03), in which the Enlarged Board of Appeal observed that where a substance has already been suggested for some therapeutic use, Article 52(4) allows a novel and inventive claim to the preparation of the composition for that medical use, irrespective of the amount of detail given regarding the use. Novelty and inventive step could result from the prescribed method treatment, not only from the intended medical indication.
With respect to medical use, the EPC 2000 differs from the EPC 1973 in that it provides for the patentability (subject to the requirements of novelty and inventive step) of a known substance or composition not only for its first use as a medicament, but also for further medical uses (Article 54(5)). This change was (only) intended to “eliminate any legal uncertainty on the patentability of further medical uses” and “unambiguously [to] permit purpose-related product protection for each further new medical use of a substance or composition already known as a medicine” (see Official Journal, EPO, 2007, Special Edition 4). Under the EPC 2000 a medical use claim may also still take the form of a Swiss-type claim.
However, the decision of the EPO Board of Appeal in Kos Life Sciences (T1319/04) once again cast doubt on the possibility of delimiting medical use claims from the prior art on the basis of features concerning dosage regimes (or other features of the treatment method). In that case the board was asked to decide on the allowability under the EPC 2000 of a Swiss-type claim which differed from the prior art only in that it stated that the medicament was to be administered once a day before going to sleep. The board referred the following questions to the Enlarged Board of Appeal (G 2/08):
"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?
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?
3. Are any special considerations applicable when interpreting and applying Articles 53(c) and 54(5) EPC 2000?"
The essence of Decision T1319/04 concerns merely the transition to the EPC 2000, rather than the more fundamental question of whether the Board of Appeal took a correct position on dosage regimes in T1020/03.
This view was adopted by the England and Wales Court of Appeal in Actavis UK Limited v Merck & Co Inc ( EWHC Civ 444). In that decision the Court of Appeal observed that it was almost certainly right to contend that “the board in Kos Life Sciences at no point cast doubt on Genentec”, and that “the board considered that the law established in Genentech should be carried over into EPC 2000 – hence its consideration in Section 5.1 of the travaux préparatoires to EPC 2000”. According to the Court of Appeal, the real point of the reference was to obtain an early confirmation that the EPC 2000 did not change the position established in Genentech.
There are no indications that practice with regard to dosage regimes (or other method of treatment features) is about to change under the EPC 2000; therefore, interested parties should still pursue patent protection in relation to such inventions.
Finally, according to German national jurisprudence (BGH-Carvediol II, X ZR 236/01) regarding dosage regimes, the exact wording of a claim might be decisive in that the language “wherein the medicament is prepared for” is considered allowable, but not the language “wherein the medicament is administered”. Although there are no indications that this issue will become relevant before the EPO, it does pose the risk that a claim granted by the EPO may be held invalid in Germany. Therefore, it would be wise to include the literal basis for both options in European patent applications.