Recently, the Enlarged Board of Appeal, in case G 2/08,issued a decision on the patentability of a method for therapy in which the new and inventive feature was a new dose regimen for an already known drug and medical indication.
The case was appealed from a decision of the examining division refusing a patent application having a Swiss-type second medical use claim along the following lines:
1. The use of [a compound] for the manufacture of a sustained release medicament for use in the treatment by oral administration once a day prior to sleep, of hyperlipidaemia […]. Earlier documents already disclosed the use of the compound for treatment of hyperlipidaemia and the examining division argued that the specific drug regime reflected a medical activity excluded from patentability under Art. 52(4) EPC 1973.
In the appeal (T1319/04), the Board of Appeal first concluded that, since the application was still deemed to be pending on 13 December 2007, the new provisions of Art. 53(c), 54(4) and (5) EPC 2000 would now be applicable.
The Board of Appeal considered that the question of patentability of a second medical use where the only feature likely to confer novelty is a dosage regime was a question on an important point of law. Therefore, it referred the following questions to the Enlarged Board:
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 there any special considerations applicable when interpreting and applying Articles 53(c) and 54(5) EPC 2000?
As usual, the Enlarged Board invited not only the appellant and the president of the EPO to submit comments, but also solicited the filing of amicus briefs.
The Enlarged Board started off by mentioning that the objective of the exclusion of Art. 53(c) EPC was to provide that non-commercial and non-industrial medical activities were free from restraint, i.e. for reasons of public health. The new Art. 54(5) EPC expressly allows patent protection of substances or compositions already known as medicines, provided their use in a method referred to in Art. 53(c) EPC be specific and not comprised in the state of the art. Since Art. 54(5) EPC refers to “any specific use”, it would be at odds with the principle of good faith, as laid down in Art. 31(1) of the Vienna Convention to give this term a limitative meaning. The Vienna Convention also does not prescribe that exceptions should be construed narrowly. In this case, it cannot be said that Art. 54(4) and (5) EPC constitute exceptions to the absolute prohibition of patenting methods of therapy. On the contrary, they constitute provisions of equal rank aimed at allowing patent protection for products, substances or compositions. This equal ranking also follows from the legislative history.
Second medical use
In relation to the answer to question 1, the Enlarged Board argues that under the old EPC the case law indicated that a second medical use, as defined in G 5/83, was not necessarily restricted to a disease not yet treated (i.e. a novel medical indication for the substance or composition). Since it was clear from the preparatory documents of EPC 2000 that the legislator intended to codify the existing second medical use practice, the principles laid down in the existing case law should be maintained, i.e. a broad interpretation of the wording “any specific use”.
Such a broad interpretation would then also include novel and inventive dosage regimes, even if the drug was already known to be applicable for the same disease.
With respect to the third question, the Enlarged Board especially consideredthe consequences of the new Art. 54(5) EPC in relation to the Swisstype claims. As was mentioned in G 5/83, the Swiss-type claim for second medical use was a “special approach to the derivation of novelty” and, therefore, constituted a narrow exception to the principles governing novelty. Art. 54(4) EPC now permits purpose-related product protection for any further specific use of a known medicament and hence, the necessity for a Swiss-type claim has ceased. According to the Enlarged Board, this also means that the use of Swiss-type claims must cease and it has therefore ruled that these will no longer be accepted. In order to accommodate users of the patent system, this rule will not have any retroactive effect, but will only be applicable three months from the publication of the present decision in the Official Journal of the EPO (which, at the publication date of this article,
still has not occurred).
With respect to the actual protection conferred by Art. 54(5), the Enlarged Board argued that the practice which was established pursuant to the case law of EPC 1973 should be maintained according to the intention of the legislator and thus, a broad interpretation of “any specific use” was opted for.