EPO's medicine has a bitter aftertaste

The recent decision, G2/08, of the EPO's Enlarged Board of Appeal EBA, hopefully brings to an end the confusion surrounding the patentability of dosage regimens in Europe. The EBA has clarified that dosage regimens are patentable, bringing the EPO back into line with the position taken by the UK Court of Appeal in Actavis UK Limited v Merck & Co Inc.

In G2/08, the patent application concerned had been refused because, amongst other reasons, the novelty of the claimed subject matter lay in the dosage regimen according to which a drug was delivered. According to the EPO Examining Division, this aspect was excluded as being a method of treatment. Accordingly, the claim was considered to lack novelty. On reviewing the case, the Technical Board of Appeal decided that the question of patentability of a medicament for use in therapy, wherein the only novel feature lay in a dosage regimen, was an important question of law, requiring clarification from the EBA. As is the usual form, a number of questions were referred to the EBA and were answered as follows:

Q1: 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?

A1: Where it is already known to use a medicament to treat an illness, Article 54(5) EPC does not exclude that this medicament be patented for use in a different treatment by therapy of the same illness.

Q2: 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 (sic.)?

A2: Such patenting is also not excluded where a dosage regime is the only feature claimed which is not comprised in the state of the art.

Q3: Are any special considerations applicable when interpreting and applying Articles 53(c) and 54(5) EPC 2000?

A3: Where the subject matter of a claim is rendered novel only by a new therapeutic use of a medicament, such claim may no longer have the format of a so-called Swiss-type claim as instituted by decision G 5/83.

A time-limit of three months after publication of the present decision in the Official Journal of the European Patent Office is set in order that future applicants comply with this new situation. 

Questions 1 and 2 refer to the situation in the case in question, where a particular medicament is known to be useful in the treatment of a particular disease, and the applicant is seeking patent protection for a new way of treating that disease using the same medicament. For example, the medicine may be administered via a different route, or a different dosage regimen may be employed. The EBA made it clear that such subject matter is patentable; in other words, it will be possible to obtain patent protection for new dosage regimens or other novel aspects of pharmacological treatment.

The answer to question 3 is a small "fly in the ointment" of an otherwise positive decision for most patentees in this area. It relates to the language to be used when claiming second or subsequent medical uses of known compounds and follows the recent law change based on EPC 2000. Under the previous law, EPC 1973, and following the decision G5/83 of the EBA, "Swiss-style" claims were used to get around the exclusion from patentability of methods of treatment. Such claims were written in the form:

"Use of compound X in the preparation of a medicament for the treatment of disease Y."

EPC 2000, in Article 54(5), now expressly permits the patenting of products for use in second or subsequent therapeutic methods. Claims for such inventions are to be written in the form of a purpose-limited product claim:

"Compound X, for use in the treatment of disease Y."

Details about dosage regimens etc. may be added to the end of such a claim. Following the entry into force of EPC 2000, it has been the approach of many European practitioners to include both the Swiss-style claims and the purpose-limited product claims, the scope of the two not yet having been compared by any of the national courts. In the answer to question 3 of G2/08, the EBA states that this will no longer be possible, forbidding the inclusion of Swiss-style claims. This is a slight concern, given that the relative scopes of the two claim styles have not yet been determined. In a further twist, the EBA has removed the retroactive effect of this part of the decision so as to avoid the need to amend present applications and patents. Rather, the change in allowable claim style will only affect applications a having priority date more than 3 months after the date of publication of the decision. Given this opportunity, it may seem prudent for applicants to maintain the Swiss-style claims in current applications and, where possible, also to include purpose-limited product claims just in case the two may be considered to have different scope by the national courts.

It is not altogether clear that the EBA actually has the power to remove the retroactive effect of part of a decision, or to introduce the three month time limit. Nevertheless, since there is no review procedure for EBA decisions, it is uncertain that this can even be challenged. It may be worth future applicants considering the inclusion of Swiss-style claim wording within the patent description. This wording could then form the basis of a claim to be added at a later stage of prosecution, should the decision in G2/08 be amended in this respect.

Rachel Wallis
Life Sciences & Chemistry Group