Second Medical Use Patenting in Europe

Summary
In decision G2/08, the Enlarged Board of Appeal have confirmed that a European patent may be granted for a substance for use in a novel and inventive treatment of a disease, where the same substance is already known for the treatment of the same disease. This is the case even where the treatment differs from the known treatment by providing a new mode of administration of the substance (e.g. a dosage regime). The Enlarged Board have also stated that the previously allowable “Swiss” format of claim (“use of a compound in the preparation of a medicament for the treatment of a condition”) is no longer acceptable under the revised European Patent Convention.

Background
European patent application number 94306847.8 (“the application”) featured a claim directed to the use of a nicotinic acid derivative for manufacture of a medicament for the treatment by oral administration once per day prior to sleep of hyperlipidaemia. The prior art disclosed the use of nicotinic acid for preparation of a medicament for the treatment of the same condition.

The Examining Division concluded that the novel feature (the timing of administration of the compound) was a method of treatment of the human body, and therefore fell within a category excluded from patentability by the European Patent Convention. Consequently, this feature could not be used in the assessment of novelty, and the claim was anticipated by the prior art disclosing the use of an identical substance for the treatment of an identical indication.

The decision was appealed. The Board of Appeal considered the matter, and 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 any special considerations applicable when interpreting and applying Articles 53(c) and 54(5) EPC 2000 ?
   

The Enlarged Board conducted an analysis of the operative legal provisions: Article 53(c) EPC, which prohibits the patenting of methods of treatment of the body by therapy; and Articles 54(4) and (5), which create the legal fiction of novelty of a known substance for use in any medical method (the substance being unknown as a medicament), and for use in a specific method (the substance being unknown for use in an identical method).

In reaching their conclusion, the Enlarged Board referred to the case law of the member states, the Vienna Convention on the Law of Treaties, and the preparatory documents pertaining to the revision of the European Patent Convention. They also considered the impact that the changes introduced by the revised European Patent Convention would have on earlier Enlarged Board case law.

Emphasis was placed on the wording of Article 54(5) EPC, which refers to the patentability of a substance for any specific use prohibited by Article 53(c). To impose the requirement that the “specific use” related to the treatment of a different disease would be to arbitrarily introduce a distinction which the legislation does not make.

Answering the first question in the affirmative, the Enlarged Board stated that the intention of the revision of the European Patent Convention was to enshrine in statute the established case law of the Enlarged Board (and subsequent Board of Appeal decisions). The settled case law of the Boards was to allow the patenting (albeit in “Swiss” form) of uses of substances in the treatment of illnesses, even where the novelty of the methods lay in the dosage regime, group of patients selected or technical effect, rather than the treatment of a completely new disease. Giving this wide interpretation to the uses potentially patentable, the Board saw no reason to exclude the specific methods mentioned in question 2, and also answered this in the affirmative.

In answering the third question, the Enlarged Board examined the legal status of claims in the Swiss format. This form of claim had originally been approved by the earlier Enlarged Board decision in order to fill a lacuna in protection afforded by the earlier version of the European Patent Convention. Since this gap had subsequently been filled, the necessity for this type of claim no longer existed.

The Enlarged Board stated that such claims were open to patentability objections, as the features conferring novelty and inventive step did not technically relate to the claimed manufacturing process. This form of claim is therefore no longer allowable. This provision is not retroactive, and will come into force three months after the publication of the decision in the Official Journal.

Effect on Practice
The decision provides useful clarification on the scope of subsequent therapeutic uses of known substances in Europe, and is substantially in line with the majority of preceding decisions under the earlier version of the European Patent Convention. Provided that a therapeutic method involving a known substance fulfils the requirements of novelty and inventive step, it will be possible to obtain protection for the substance for use in such a method.

Practitioners will wish to review pending applications to ensure that second medical use claims are in the correct format. Cleveland attorneys have been recommending this format of claim since the introduction of the revised version of the European Patent Convention.