No further grounds for nullity of an SPC beyond Art. 140k of the Patent Act

Case No. O2017_016 ¦ Decision of 12 June 2018 ¦ “Verletzung Ergänzendes Schutzzertifikat; Sevelamer”

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.

The FPC now confirms that the list of grounds for nullity of an SPC as set forth in Art. 140k PatA is exhaustive. The alleged wrongful reinstatement is thus no valid ground of nullity. In particular, the decision refers to the dispatch of the Federal Council when the SPCs had been enacted, i.e. the note that Art. 140k is to define the grounds for nullity:

Artikel 140k Nichtigkeit: Absatz 1: Neben dem Erlöschen bzw. der Sistierung des Zertifikats müssen auch die Gründe festgelegt werden, sie seine Nichtigkeit herbeiführen.

CJEU’s logo

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.

Yet another interesting aspect of the decision is the assessment of the value in dispute. The parties heavily disagreed. Plaintiffs had considered it to be CHF 5m, while the defendant only estimated it to be CHF 500k. The FPC had thus to decide on this issue, too; Art. 91(2) CPC. Towards this end, it relied on some interesting rules of thumb:

  1. one third of the turnover of the originator’s product is replaced by the generic within about 2 years;
  2. 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.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_016 ¦ Decision of 12 June 2018 ¦ “Verletzung Ergänzendes Schutzzertifikat; Sevelamer”

  1. Genzyme Corporation
  2. Sanofi-Aventis (Suisse) SA

./.

Salmon Pharma GmbH

Panel of Judges:

  • Dr. Ralph SCHLOSSER
  • Dr. Tobias BREMI
  • Dr. Stefan KOHLER
  • Dr. Daniel Kraus
  • Dr. Andreas SCHÖLLHORN SAVARY

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Requester:

Representative(s) of Respondent:

  • Dr. Robert BRINER (CMS)

DECISION IN FULL

Fullscreen view (new tab)

BASIC PATENT

Fullscreen view (new tab)

BE ON THE KNOW

Enter your name and email address below to subscribe to this Blog and to receive new posts by email.

Print Friendly, PDF & Email

Leave a Reply

Your email address will not be published.