Source: https://www.patentlitigation.ch/no-further-grounds-for-nullity-of-an-spc-beyond-art-140k-of-the-patent-act/
Timestamp: 2019-04-25 04:50:00+00:00

Document:
Following-up on a decision granting interim injunctive relief (reported here), the present decision in main proceedings now confirms this outcome. I have reported about the hearing in main proceedings on this Blog here.
As indicated earlier, the defendant neither disputed validity of the basic patent EP 0 716 606 B1 of Genzyme Corporation, nor that the subject-matter of the SPC C00716606/01 is covered by the basic patent or that the attacked embodiment (sevelamer carbonate) is covered by the SPC. Rather, the defendant (only) alleged that the SPC is invalid because the office wrongfully granted re-establishment of rights (Art. 47 PatA) with respect to the time limit for filing the SPC application under Art. 140f PatA.
Artikel 140k Nichtigkeit: Absatz 1: Neben dem Erlöschen bzw. der Sistierung des Zertifikats müssen auch die Gründe festgelegt werden, sie seine Nichtigkeit herbeiführen.
Further, the decision reviews the CJEU’s case law and notes that the grounds for nullity according to Art. 15 of the EU SPC Regulation 469/2009 have never been held to be an open list. Rather, the CJEU only interpreted Art. 3, violation of which is referred to as a ground for nullity in Art. 15 of the EU SPC Regulation.
The FPC notes that the defendant could have appealed the decision of reinstatement (Art. 48 ff APA in the version of 09 December 2003), together with the decision of grant of the SPC – but failed to do so. The decision is thus formally final, and the defendant has to live with it.
If there is a take away message for practitioners in this decision, then it is surely to watch out for fresh grants (not only of SPCs, but also patents, trademarks, designs, etc.), to not miss the 30 days(!) time limit for an appeal; Art. 50(1) APA. This will be the only chance to fight against e.g. a wrongful reinstatement — which is more than you will ever get e.g. at the EPO where there is no such chance at all; but still, you need to act quickly.
the profit margin of a generic is 50%.
Based on these rules of thumb, and the plaintiffs’ own statement of an annual turnover in Switzerland of CHF 2.25m p.a., the FPC considered the the value in dispute as CHF 750k, for the roughly two years of protection at stake before the SPC will finally lapse in February 2019.
The decision has been appealed to the Supreme Court.
The decision has also been discussed by Simon Holzer on Kluwer Patent Blog.

References: Art. 140
 Art. 15
 CJEU 
 Art. 3
 Art. 15
 Art. 50