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Medical devices left out in the cold

12 March 2015

A recent decision from the EPO has confirmed that medical devices cannot be protected using second medical use claims.

T773/10 concerns an appeal from an Examination Division decision to refuse a patent application for a dialysis membrane. The membrane itself was known. The applicant was attempting to get patent protection based on its new use in dialysis for the treatment of multiple myeloma, and had formulated a Swiss-type second medical use claim to cover this.

The applicant argued that the provisions that allow “substances or compositions” to be patentable in this format should be interpreted broadly to cover medical devices, in this case the membrane. The Board of Appeal did not agree and maintained that the application should be refused for lack of novelty because the second medical use provisions did not apply.

The applicant had also requested that questions concerning the applicability of second medical use claims to medical devices be referred to the Enlarged Board of Appeal, citing another case T2003/08 in which a claim to a new use of a column for an extracorporeal treatment had been allowed. The Board denied the referral request and distinguished from T2003/08 on the basis that it was not the column as such that was regarded as the “substance or composition”, but a ligand within the column that constituted an active ingredient which was responsible for the therapeutic effect. T2003/08 was reported by us here.

It appears that our conclusions following that case still apply, that a practical ‘test’ for whether or not a therapeutic treatment can be protected as a second medical use will be whether or not the therapeutic effect is achieved by means of a chemical entity or composition of chemical entities.


Elizabeth Swan
Life Sciences & Chemistry

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This publication is a general summary of the law. It should not replace legal advice tailored to your specific circumstances.

© Withers & Rogers LLP, March 2015