The Swedish Patent and Market Court of Appeal applies "Abraxis" in rejecting Supplementary Protection Certificate

In its ruling of  19 December (2019  here), the Swedish Patent and Market Court of Appeal rejected the appeal of Allergan concerning the application for a Supplementary Protection Certificate (SPC) for  its product botulinumtoxin type A. The Court  denied  as well the request for a preliminary ruling regarding the interpretation of Article 3(d) and what is meant by “first marketing authorization”.

The basic patent referred to in the application is  EP 09175439, which provided in the first claim  that the patent covers: 

“A botulinum toxin for use in the treatment of urge incontinence by increasing the bladder capacity of the patient, the botulinum toxin being for administration by injection into the lateral wall of the bladder”.

According to the SPC application, the first marketing authorization for the product at hand is from 2013 for the pharmaceutical Botox. There is, however, an even earlier marketing authorization from 2011. According to Allergan, the fact that there are two marketing authorizations for the same basic patent should not be prohibit both being granted an SPC, provided  that the scope of the two marketing authorizations  is not overlapping. 

The Patent and Market Court of Appeal  ruled that, according to Article 3(d),  the  2013 marketing authorization may not be considered  the first marketing authorization,  pointing to established CJEU case-law, such as in MIT (C-431/04, EU:C:2006:291), here and Yissum (C-202/05, EU:C:2007:214), here.  Nevertheless, according to the Court, one also has  to examine whether the 2013 marketing authorization could be an acceptable first marketing authorization in accordance withf the exception introduced in the CJEU ruling in the Neurim case (C-130/11, ECLI:EU:C:2012:489 ).

 In that case, the CJEU provided that the earlier marketing authorization for the same substance for its use as a sheep reproduction regulation would not constitute “a first marketing authorization” for the use of the same substance against human insomnia. The Neurim case has  thus opened up the possibility to receive an SPC for a second medical indication.  That said, in the 2019 Abraxis case ( C-443/17, EU:C:2019:238), the CJEU limited the scope of the Neurim exception to a minimum (see this Kat’s post on the Abraxis case). 

This Kat will always be amused and amazed by SPC cases

The Swedish Patent and Market Court of Appeal provided that  for the Neurim exception to apply, the use according to the basic patent’s first claim, which is in fact covered by the marketing authorization from 2013,  differs from the one covered by the 2011 marketing authorization.  To  decide whether the two marketing authorizations are overlapping, the Court proceeded to the interpretation of the first patent claim and concluded that  it concerns the use of botulinumtoxin for the treatment of urge incontinence in patients suffering from neuronally-mediated urologic and related disorders. As such,  the use that corresponds to the 2013 marketing authorization  does  not differ from the 2011 authorization.

The 2011 marketing authorization covered patients suffering  from  a damaged spinal cord, a patient group that is an example of patients suffering from “neuronally-mediated urologic disorders” .  This means that the 2013 marketing authorization  was  not the first marketing authorization for botulinumtoxin, and thus  an SPC may not be granted. The Court concluded as well that there is no need for a preliminary ruling in this case.

Cases such as this  show the challenge posed for national courts as they engage in in-depth patent claims interpretation, on the one hand, while  considering the content and scope of a marketing authorization, on the other. In other words, the challenges national courts face when applying the SPC Regulation.