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News
22 February 2010
Dosage regimes and Swiss-type claims: Enlarged Board decision
The Enlarged Board of Appeal of the EPO has decided, in Decision G 2/08, that there is no exclusion against obtaining a patent for the use of a known medicament to treat an illness where the only novel feature of the treatment is a new and inventive dosage regime.
In the same decision, the Enlarged Board has decided that the Swiss-type claim format for second and subsequent medical uses, i.e. a claim directed to the "use of a substance or composition for the manufacture of a medicament for a specified therapeutic application", will no longer be an appropriate claim format for future applications. There is no retroactive effect to this part of the decision, so that existing applications and patents using the Swiss-type claim wording will not be prejudiced.
In our opinion the decision is to be welcomed, since it liberalises and clarifies the practice of the EPO with its approval of dosage regimes. Furthermore, by signalling that Swiss-type claims are not going to be accepted in future, the drafting of claims for second and subsequent medical uses will be simplified and clarified. Each of these parts of the Decision is discussed in more depth below.
To link directly to a PDF copy of Decision G 2/08 on the EPO website, click here.
Dosage Regimes
The original referral to the Enlarged Board concerned a patent application for the use of nicotinic acid and a group of related compounds, for the manufacture of a sustained release medicament, for use in the treatment by oral administration once per day prior to sleep, of hyperlipidaemia.
The only novel feature of the claimed invention was the dosage regime, i.e. the administration "once per day prior to sleep". The prior art disclosed the same compounds in sustained release oral formulation to treat hyperlipidaemia.
Under the revised version of the European Patent Convention now in force, there is specific provision for both a first medical use, and for second (or subsequent) medical uses of known substances. The provision for second medical uses says that where a substance or composition is known in a first medical use, the novelty provisions of the EPC shall not exclude the patentability of that substance or composition "for any specific use in [a therapeutic method] provided that such use is not comprised in the state of the art."
The Enlarged Board had to decide if the wording "specific use" implied a narrow restriction to a new disease which was not yet known to be treatable by that substance, or if any new and inventive treatment regime was patentable, even if this involved treating the same disease with the same substance.
The Board has decided that there is no basis in the legislation for the narrower interpretation, and that the "specific use" conferring patentability may reside in something other than the treatment of a different illness such as, for example, a new dosage regime to treat the same illness.
The Enlarged Board has warned that, even if the novelty is found in the dosage regime, the claim as whole must still involve an inventive step. Thus, for example, where the broad parameters of a dosage regime are known from the prior art, and the claim is directed to specific selections within the known regime, this will be treated like any other selection invention, and the applicant will be required to show an inventive step for the particular parameters chosen.
Swiss-type Claims
The EPO refused in its early years to grant patents directed to second and subsequent medical uses. A series of cases was referred to the Enlarged Board in 1983 to deal with this issue, and in Decision G 5/83 the Enlarged Board identified what it now recognises as "a loophole". The Enlarged Board approved a claim wording which had been held allowable by the Swiss Patent Office, which defined the new use in terms of the manufacture of the medicament rather than in terms of the therapeutic treatment per se, e.g. "Use of X in the manufacture of a medicament to treat Y". The precise breadth of this claim wording was never thoroughly tested in the European courts, but it has been suggested by the Enlarged Board and by others that the wording was necessarily narrower than a straightforward "method of treatment" claim or a claim taking the form "Compound/Composition X for use in treating disease Y".
In this most recent decision, the Enlarged Board has admitted that the Swiss-type claim was a legal construct designed to exploit a loophole, and has indicated that, while such claims were valid and remain valid in pending applications and granted patents, the EPO should not in the future grant such claims. Instead, the EPO will be prepared to grant second / subsequent medical use claims in the form: "Compound/Composition X for use in treating disease Y".
This change in practice at the EPO does not affect the substantive issue of what is patentable in relation to medical inventions, but only the claim format that can be used. Indeed the part of the decision dealing with dosage regimes makes it clear that the effect of the decision overall is to give broader coverage for therapeutic use inventions.
This change has not been made retrospective. The change in practice will be applied only to cases for which the priority date or filing date is more than three months after the publication of Decision G 2/08 in the EPO's Official Journal. That publication has not taken place at the date of writing this summary, the decision only having been announced on February 19, 2010.
We would nevertheless suggest that, where Swiss-type claims are pending before the EPO, or when drafting cases for filing in Europe, the Swiss-type claim format should be replaced where possible by "compound/composition for use" claims.
