In its recent decision, T 1635/09 (OJ EPO 542, 2011), Technical Board of Appeal 3.3.02 of the European Patent Office (EPO) has commented on the second medical use of a medicament under the European Patent Convention (EPC). The decision was made in the appeal proceedings of an opposition concerning a compound for oral contraception containing a minimized concentration of hormones.

In general, a method comprising the step of administering a contraceptive to a human being is not regarded as a method of treatment by the EPO, since pregnancy is not a disease. In the decided case, a use of a composition as an oral contraceptive has been claimed, wherein the concentrations of hormones were selected at such low levels that the likely pathological side-effects could be prevented or reduced. Due to the reduction of unwanted side-effects, the claimed use was regarded as having a therapeutic effect. Accordingly, the Technical Board of Appeal considered the claimed use to be a therapeutic method excluded from patentability under Article 53(c) EPC.

As outlined in decision G 1/03 of the Enlarged Board of Appeal, an undisclosed disclaimer may be introduced to disclaim non-patentable subject matter, such as subject matter contravening Article 53(c) EPC. In the present case however, it has been ruled that the introduction of a disclaimer rendering the claimed use “non-therapeutic” contravenes Article 84 EPC. In particular, the Board held that in the claimed use a non-therapeutic use in the form of a contraceptive is inseparably associated with a therapeutic use in the form of the prevention or reduction of pathological side-effects, which cannot be removed by limiting the claim to a "non-therapeutic use".

During the oral proceedings the Technical Board of Appeal decided on the sufficiency of disclosure of a contraceptive, wherein the concentration of a particular hormone was defined as being equivalent to a particular amount of another hormone. It was decided that this definition is vague and a person skilled in the art would need a series of tests to determine the exact concentration of the hormone. The decision indicates that time-consuming and ethically questionable tests are unreasonable if the claimed invention could have been defined, without any limitation of its scope, by features which would have rendered such a series of tests superfluous for the purpose of reproducibility by the skilled person.

Since no protection for the above use of a composition as an oral contraceptive could be obtained, the patent proprietor reformulated the claim as a second medical use. However, the Technical Board of Appeal was of the opinion that a reformulation of the claim as a Swiss-type claim contravenes Article 123(3) EPC. In particular, the Technical Board of Appeal stated that the Swiss-type claim is considered to be a process of manufacture. Since a process of manufacture also provides protection for the resulting product per se, the scope of protection is broadened if the claimed use as granted is reformulated as a Swiss-type claim.

Regarding the formulation as a second medical use according to Article 54(5) EPC, the Technical Board of Appeal decided that this would be inadmissible, since the patent had been granted before the EPC2000 entered into force. Nevertheless, the decision indicates that a reformulation as a purpose-related product claim would broaden the scope of protection of the patent as granted, since such a claim would be directed to the actual product. Thus, the Technical Board of Appeal concluded that the conversion of a claim for the use of a substance or composition for a specific purpose into a Swiss-type claim or a purpose-related product claim within the meaning of Article 54(5) EPC would result in an extension of protection.

The finding of the Technical Boards of Appeal is at odds with jurisprudence of the Federal High Court of Germany, which has explicitly outlined in its decision, “Trigonellin” (X ZR 177/98), that the scope of protection conferred by a second medical use claim corresponds to the scope of protection of a normal use claim.

Download the full text Decision of Technical Board of Appeal under:
http://www.mueller-bore.de/tl_files/Decisions_EPO/Decision_of_Technical_Board_of_Appeal.pdf

Should you have any questions, please feel free to contact lenhard@mueller-bore.de.