Kilburn & Strode LLP

The EPO's Enlarged Board of Appeal rules that dosage regimes can be patented, but signals the death knell for "Swiss-type" use claims

In Decision G2/08 the EPO's Enlarged Board of Appeal (EBA) has ruled that medical use claims directed to new and inventive dosage regimes are allowable. This gives the prospect of extending patent coverage to new and inventive drug administration regimes, potentially increasing the time a drug may be under patent protection.

At the same time, the EBA ruled that the Swiss-type medical use claims are not allowable under EPC 2000, completing the move away from this format of claims started by the introduction of EPC2000.

Prior to G2/08 there had been conflicting Technical Boards of Appeal decisions as to whether a dosage regime could impart novelty to a medical use claim, or whether it would simply be considered a method of medical treatment unable to impart novelty. To clarify this issue the EBA was asked the following questions and gave the following answers:

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?

YES - Where it is already known to use a medicament to treat an illness, Article 54(5) EPC does not exclude that this medicament can be patented for use in a different 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?

YES - 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.

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

YES - Where the subject matter of a claim is rendered novel only by new therapeutic use of a medicament, such a claim may no longer have the format of a so-called Swiss-type claim as instituted by Decision G5/83.

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 the new situation.

The answer to question 3 will signal the end to Swiss-type claims in Europe. G2/08 will, however, have no retroactive effect. Instead, Swiss-type claims will not be allowed in future applications where the filing date (or, if priority has been claimed, the priority date) is later than three months after publication of G2/08 in the EPO Official Journal.

The full Decision is available from the EPO's website at:

http://documents.epo.org/projects/babylon/eponet.nsf/0/1c9976e4866080a2c12576cf00417e3e/$FILE/G2_08_en.pdf

For more information, please see our briefing note Below, or contact your usual Kilburn & Strode Advisor.

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