Anton Balazh /
20 June 2014Big PharmaAndrew Wright and Tom Harding

Not just for medicaments: broadening horizons in Europe

A recent decision by the Board of Appeal (BoA) of the European Patent Office (EPO), T 2003/08, has changed the criteria for second medical use patent protection in Europe. Here we examine the implications for protection by second medical use claims, with a focus on areas that may not fit the traditional concept of a ‘medicament’.

Although it is generally not possible to patent methods of treatment of humans or animals in Europe, due to their legislative exclusion from patentability, there has been a long-established principle of allowing equivalent patent protection by reformatting ‘method of treatment’ claims as ‘medical use’ claims.

Protection is available if either an active substance or composition is used in medicine for the first time (‘first medical use’), or if it has been used in medicine previously but is now being used in a new therapy (‘second medical use’).

For many years, the accepted format of a second medical use claim in Europe was based on language explicitly approved by the EPO’s Enlarged Board of Appeal (decision G 5/83), which takes the form:

“Use of [a specified substance or composition] for the manufacture of a medicament for the treatment of a [specified therapeutic application].”

This format clearly applies to active substances or compositions that are used in the preparation of readily-recognisable ‘medicaments’. However, other forms of treatment can sometimes involve the presentation of active substances or compositions in the form of devices that are not generally regarded as a medicament.

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