In case G 02/08 The Enlarged Board of Appeal of the European Patent Office recently ruled that where it is already known to use a particular medicament to treat a particular illness, it is still possible to secure patent protection for a new and inventive dosage regime in respect of the same medicament used to treat the same illness. However such claims should no longer be drafted in the 'Swiss claim' format.

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In the case of G 02/08, The Enlarged Board of Appeal of the European Patent Office (EPO) ruled on the admissibility of claims directed to new therapeutic uses of known medicaments. The case is of considerable importance to the pharmaceutical industry, where new patents are often sought to protect novel and inventive uses of medicines. Such claims have, in recent years, often been drafted in the form of 'Swiss claims'.

Swiss Claims

Swiss claims in the form 'the use of compound X in the manufacture of a medicament for a specified therapeutic use Y' have long been accepted by the EPO and UK IPO since the landmark case of Eisai (G5/83). Eisai allowed a Swiss form claim for a 'new therapeutic use' of a medicament, irrespective of whether or not the medicament was already known.

This form of claim was commonly used to overcome the two hurdles that had previously prevented such claims being granted, namely that (i) the drug itself is not novel, and (ii) that the use of the drug should not be patentable as it relates to a 'method of treatment of the human or animal body', which is excluded from patentability under the European Patent Convention (EPC).

In the EPO case of Genentech (T1020/03), and in other similar cases, the EPO has confirmed that it follows from Eisai that a novel dosage regime can confer novelty to a Swiss form claim.

Revised European Patent Convention

The EPC has been revised, with its most recent incarnation, the EPC 2000, coming into force on 13 December 2007. Amongst other things, the new provisions of the EPC 2000 (revised Articles 53(c), 54(4) and 54(5)) sought to codify the law in relation to new therapeutic uses of known medicaments. The provisions of the EPC 2000 apply to any patent applications to the EPO yet to be applied for, or pending, as at 13 December 2007.

G 02/08

The questions referred to the Enlarged Board of Appeal in G 02/08 were:

(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?

(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?

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

The Enlarged Board of Appeal answered that:

(1) Yes. Article 54(5) EPC now provides for patent protection of a known substance or composition for 'any specific use' of the said product in a method of therapy provided this use is new and inventive.

(2) Yes, there is no reason to treat a feature consisting of a dosage regime of a known medicament differently to any other specific use.

The EPO also stipulated that a claimed dosage regime must not only be verbally different from what was described in the state of the art but also reflect a different technical teaching.

(3) As the new Article 54(5) EPC now permits purpose-related product protection for any further specific use of a known medicament in a method of therapy, the use of the 'Swiss claim' form is no longer necessary, and will no longer be permissible. The Enlarged Board of Appeal set a time limit of three months from the date of publication of this decision to allow future applicants to comply with the decision.

Broader Protection

The case provides welcome confirmation that the new provisions of the EPC allow purpose related product protection for any new further specific use of a known medicament in a method of therapy. As the Enlarged Board of Appeal stated in its judgment, it appears that the rights conferred on the patentee by the article 54(5) EPC are likely to be broader than that allowed under the old Swiss-form claims.

As decisions of the EPO are not strictly binding in the courts of England and Wales, it remains to be seen whether Swiss claims will still be allowable in the UK. Ironically it was the Court of Appeal case of Actavis v Merck (www.law-now.com/law-now/2008/noveltyofswissmay08.htm) in which the Court of Appeal decided to follow the 'settled' view of the EPO to allow claims for dosage regimes in Swiss-form. However the decision of Actavis v Merck related to the law as set out in the Patents Act 1977 before new amendments, that mirror the changes made in the EPC 2000, came into force. It is likely that G 02/08 would be persuasive in assisting the national courts interpret the new provisions of the Patents Act 1977, which allow purpose–related product protection and were specifically drafted and enacted in order to reflect the changes made to the EPC.

This article was written for Law-Now, CMS Cameron McKenna's free online information service. To register for Law-Now, please go to www.law-now.com/law-now/mondaq

Law-Now information is for general purposes and guidance only. The information and opinions expressed in all Law-Now articles are not necessarily comprehensive and do not purport to give professional or legal advice. All Law-Now information relates to circumstances prevailing at the date of its original publication and may not have been updated to reflect subsequent developments.

The original publication date for this article was 02/03/2010.