Call for comments for C-673/18 (Santen v INPI)

The UK IPO is seeking comments on CJEU case C-673/18 by 2 January 2019 with a view to lodging observations with the CJEU.  The case was previously reported on the SPC Blog here. If you would like to comment on this case, please email policy@ipo.gov.uk referencing the case number in the subject heading. 

As a refresher, the questions referred to the CJEU in this case is as follows:

“1 - Should the notion of different application within the meaning of the CJEU Neurim decision of 19 July 2012, C-130/11, be strictly understood, i.e.:

- be limited to the case of a human application following a veterinary application,
- or concern an indication in a new therapeutic field, in the sense of a new medical specialty, compared to the previous MA, or a drug in which the active principle exerts an action different from that which it exerts in the drug that was the subject of the first MA;
- or more generally, in the light of the objectives of Regulation (EC) No 469/2009 aiming at establishing a balanced system taking into account all the interests at stake, including those of public health, be assessed according to more stringent criteria than those used for the assessment of the patentability of the invention;

or, on the contrary, should it be understood in an extensive way, i.e. including not only different therapeutic indications and diseases, but also different formulations, dosages and/or modes of administration?

2 - Does the notion of application falling within the scope of protection conferred by the basic patent within the meaning of the CJEU Neurim decision of 19 July 2012, C-130/11, imply that the scope of the basic patent should be consistent with that of the MA invoked and, therefore, limit itself to the new medical use corresponding to the therapeutic indication of said MA?”