EPO - second medical use provisions do not apply to medical devices

January 2015

The EPO has dealt a blow to patent proprietors in the medical sector by confirming that the second medical use provisions of Art 54(5) EPC do not apply to medical devices.  

In decision T-0073/10  an EPO appeal board concluded confidently that the scope of the term “substance or composition” in Art 54(5) EPC does not extend to all products for a specific use in a method referred to in Art 53(c) EPC:

“…methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.” 

Further arguments that that the specific medical device in question in this case should be considered a “substance or composition” were given short shrift. 

Claim 1 of the patent in question, EP1852136 - Use of a dialysis membrane for preparing a haemodialysis unit for reducing blood free light chain concentration, had been drafted as a second-medical-use claim, in the Swiss-type format, but it defined the use of a device to produce an appliance for medical purposes.  The Examining Division held that the special approach to novelty assessment of such a claim, for substances and compositions, was not applicable, and the claims was therefore anticipated.

The applicant appealed, and argued that as claim 1 was directed to a new use of a membrane, there was a newly discovered technical effect.  They further argued that the legislative history which led to Art 54(5) EPC did not indicate that other medical products, besides “medicaments” or “drugs”, had been deliberately excluded from the exception. 

Ultimately, the Board came to the conclusion that the scope of the term “substance or composition” in Art 54(5) EPC does not extend to all products for a specific use in a method referred to in Art 53(c) EPC. In contrast to T2003/08, which allowed a claim directed to a new use of a column for extracorporeal treatment, the claimed dialysis membrane in question here did not contain any further substance or composition which would constitute an “active” ingredient.

The appellant’s request to refer some very interesting questions to the EBA (in paragraph VII of T-0073/10  ) was also denied.

The appeal board’s statement in the case that it is not their task to draft legal provisions is, of course, correct.  However, our view is that the legal provision in question is illogical to make a distinction between medicaments/drugs and medical devices, both of which are used in methods for treatment of the human or animal body.  Consequently, in our opinion, T-0073/10 is a case of an illogical legal provision being correctly applied.

This update was prepared by Vanessa Stainthorpe , Partner in our Sheffield office. 

If you would like further advice on this or any other matter, please contact Vanessa at vstainthorpe@hgf.com  (Tel: +44(0) 114 274 3700), or your usual HGF representative or visit our Contact Page to get in touch with your nearest HGF office.