The European Patent Convention 2000 (“EPC 2000”), which entered into force on 13 December 2007, will introduce wide ranging changes to substantive patent law throughout Europe. Of particular interest to the life sciences sector will be the changes introduced in respect of the protection of second and subsequent medical uses of known substances.
At present, the EPO allows a first medical use of a substance to be patented, i.e. in claims of the form “substance X for use as a medicament”. But claims in this form for the use of the same substance for treatment of a further medical condition (i.e. a second or subsequent medical use) are not permitted. This restriction stems from the fact that methods for treatment are specifically excluded from patentability and claims for second and subsequent uses are considered to fall foul of this prohibition. As a result, so-called Swiss-style or “second medical use” claims (i.e. the use of compound X in the manufacture of a medicament for the treatment of disease Y) have traditionally been used to circumvent the problem. Such claims get round the exclusion by inserting a requirement for “manufacture”.
Under the EPC 2000 however, Swiss-style claims will no longer be necessary as purpose-related product protection for a second (and subsequent)medical use of a known substance can be achieved by using a simplified claim, for example, the language “substance X for use in a method for treating medical condition Y”.
The source of this change is Article 54(4) of the EPC 2000 which provides that the state of the art “shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Article 53(c) [method of treatment of the human/animal body], provided that its use for any such method is not comprised in the state of the art.”
Swiss-style claims are still possible under the EPC 2000 but are no longer required, although applicants may be well advised to continue including Swiss style claims in addition to the ‘new’ format claims until the national courts and/or EPO Board of Appeal have decisively clarified that there are no substantive differences in the scope of protection offered by the respective claims formats.
These changes apply to all European patent applications still pending when the EPC 2000 came into force on 13 December and to those filed thereafter.