New dosage regimes can be patentable inventions
The Enlarged Board of Appeal of the European Patent Office has handed down its decision in case G2/08. This decision relates to the interpretation of the ‘method of treatment’ exclusion to patentability.
In Europe, methods of treatment of the human or animal body by surgery or therapy are not patentable. The reasoning behind this exclusion is that a medical professional should not be prevented from freely treating a patient by the existence of a patent.
However, a patent can be obtained for a substance or composition to be used in such treatment, and there are particular provisions of the law relating to this. Article 54(4) EPC states that a patent may be granted for a substance or composition for use as a medicament, notwithstanding that the substance or composition per se was previously known. This is known as the ‘first medical use’. In addition, Article 54(5) EPC states that a patent may be obtained for a substance or composition which was previously known for use as a medicament, where the specific use was not previously known. This is known as the ‘second medical use’, and the law specifically allowing this came into force in December 2007.
In most cases where Article 54(5) EPC is relevant, the specific use referred to is the particular disease being treated. For example, if a patent claimed compound X for use as a medicament, a second patent could claim compound X for use in the treatment of disease Y, and a third patent could claim compound X for use in the treatment of disease Z, provided that the utility of compound X in the treatment of Y or Z had not previously been disclosed.
In the case leading to the referral to the Enlarged Board, Kos Life Sciences had filed a patent application claiming a known medicament where the only difference between their application and the prior art was the stipulation of a dosage regime. The application was refused by the Examining Division for lack of novelty and inventive step over the prior art, as they considered that the dosage regime was a method of treatment’ and, as such, was excluded from patentability.
Kos Life Sciences appealed this decision. The Board of Appeal considered that this was a point of law of fundamental importance and referred the question to the Enlarged Board of Appeal (EBA). In the referral they asked particularly whether, where it is already known to use a particular medicament to treat an illness, could this medicament be patented for use in a different, new and inventive treatment of the same illness and, if so, is this also possible where the only novel feature is a new and inventive dosage regime?
The EBA considered that the wording of Article 54(5) EPC states that the “specific use” of the substance or composition must be new, and that there is nothing in the law to indicate that this specific use must be a disease. The EBA went on to say that it is not within their remit to read into the wording of the law a distinction that the law does not make, and that they could not consider the phrase “specific use” to be limited to specific diseases. They therefore concluded that the new use referred to in Article 54(5) EPC need not be the treatment of a different disease, but could be a new and inventive treatment of the same illness.
With regard to whether a dosage regime is covered by the ‘method of treatment’ exclusion to patentability, the EBA considered that since the aim of the ‘method of treatment’ exclusion is to keep the legal status quo for medical uses, and it constitutes an exception to the general principle that patents can be granted in all fields of technology, it should be interpreted narrowly. Having stated that the term “specific use” did not limit a second medical use claim to being for a different illness, they did not see any reason why a dosage regime should be excluded from being considered a “specific use”.
Prior to 2007 and the revision of the law, a second medical use could only be claimed by using the so-called ‘Swiss-type’ claim. This format claims a compound for use in the manufacture of a medicament for the treatment of a particular disease. As part of their decision the EBA stated that, by virtue of the new Article 54(5) EPC which specifically allows claims to a second medical use, the reasoning that allowed Swiss-type claims is redundant and these claims will no longer be allowable. Second medical use claims should now be written in the ‘use-dependent product format’, which claims a compound for use in the treatment of a particular, specified disease.
Transitional provisions for the abolition of Swiss-type claims have been put in place. Pending applications will not be affected by the ruling, and a three month period from the publication of the G2/08 decision has been set for future applications to comply. The decision was published on 28 October 2010, and the three month period will therefore expire on 28 January 2011. Any patent application filed after, or with the earliest priority date after, 28 January 2011 should not contain Swiss-type claims.
This decision reinforces that a narrow interpretation should be placed on the ‘method of treatment’ exclusion to patentability, and specifically states that a dosage regime does not fall under this exclusion. In addition, it clarifies the format in which claims to a second medical use should be written, an approach which it appears most contracting states to the European Patent Convention will follow.
13 December 2010