To be, or not to be … (protected by an SPC)

Case No. O2107_001 ¦ Main hearing of 21 August 2017

Note that Hepp Wenger Ryffel AG is involved in this matter on behalf of the plaintiff.

This case is all about the SPC granting practice in Switzerland, ie whether or not – and if so, how – the granting practice shall be brought in line with the recent case law of the CJEU post-Medeva.

The question of whether or not a product is protected by a basic patent is decisive for an SPC both in the European Community (Regulation (EC) No. 469/2009, Art. 3 lit. a) and Switzerland (Art. 140b(1) lit. a PatA).

Towards this end, the so-called ‘infringement test’ has been applied in Switzerland since the Supreme Court’s decision BGE 124 III 375 – Fosinopril in 1998. On the contrary, the CJEU explicitly disapproved the ‘infringement test’ with its decision CJEU C-322/10 – Medeva in 2011.

Gilead's Truvada
Gilead’s Truvada®

For more background information see this Blog here and the official court information about the hearing.

The pleadings initially focussed on two issues, ie the relevance of the reasons for harmonization given by the CJEU for Switzerland; and the differently phrased criteria used by the CJEU in its decisions post-Medeva. The court had explicitly invited the parties to extend their pleading to these two issues.

Plaintiff essentially argued that the ratio legis of the Swiss SPC regulation requires that the ‘infringement test’ be set aside, and that this change of practice shall be applicable with immediate effect for SPCs granted under the Fosinopril regime. It has been referred to various other European jurisdictions where this has been the outcome in parallel proceedings.

On the contrary, defendant argued with multiple lines of defense. First, when the legal situation of 2006 was applied, the case should be dismissed. Only if it was now decided in favour of a change of practice, it would still need to be decided whether or not this should have retroactive effect. If one were to accept a retroactive effect, the criteria established by the CJEU would need to assessed. The parties disagreed whether the CJEU has established a sufficiently consistent approach.

All in all, the hearing took very long. The plaintiff’s reply was finished after 2h at about 12am; defendant asked for a break of 2h to adapt his rejoinder which then took about 3h. It remains to be seen whether reply/rejoinder in a hearing in main proceedings is a model for success.

The parties did not enter into settlement discussions.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2107_001 ¦ Main hearing of 21 August 2017

Mepha Pharma AG ./. Gilead Sciences Inc.

Panel of Judges:

  • Dr. Dieter BRÄNDLE
  • Dr. Tobias BREMI
  • Dr. Christoph GASSER
  • Prof. Dr. Daniel KRAUS
  • Marco ZARDI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Simon HOLZER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)
  • Dr. Andreas SCHÖLLHORN (LS Partner), assisting in patent matters

THE BASIC PATENT

Download (PDF, 1.75MB)

COURT INFORMATION ABOUT THE HEARING

Download (PDF, 48KB)

NOTES BEFORE AND FROM THE HEARING

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BREAKING: FPC to assess SPC granting practice

Case No. O2017_001 ¦ Main hearing of 21 August 2017 @ 10am

Note that Hepp Wenger Ryffel AG is involved in this matter on behalf of the plaintiff.

The FPC published a leaflet earlier today with key bibliographic details of a hearing in the matter O2017_001 (watch out for a link ‘weitere Informationen’ on the list of public hearings):

Further information on the hearing

Such a leaflet has been published for the very first time; it is only available in German language, at least for the time being.

Gilead's Truvada
Truvada®

Nullity of the SPC C00915894 is at stake. The basic patent is EP 0 915 894 B1; see EPO Register and Swissreg.

The pharmaceutical is Gilead‘s Truvada®, a combination of tenofovir disoproxil fumarate and emtricitabine. The medication is used to treat and prevent HIV/AIDS.

Emtricitabine
Emtricitabine
Tenofovir disoproxil fumarate
Tenofovir disoproxil fumarate

The question of whether or not a product is protected by a basic patent is decisive for an SPC both in the European Community (Regulation (EC) No. 469/2009, Art. 3 lit. a) and Switzerland (Art. 140b(1) lit. a PatA).

This appears to be an easy decision at first glance, but the devil is in the detail:

(C) The Court of Justice of the European Union
(C) The Court of Justice of the European Union

Thus, the latest judgements of the CJEU and the Swiss Supreme Court are not in line anymore. The key issue in this matter is whether the Swiss SPC granting practice is to be brought in line with the case law of the CJEU.

When it got public in 2015 that the Swiss Federal Institute of Intellectual Property (FIIP) intended to change its practice to bring it in line with the CJEU case law, some commentators felt that this would draw Switzerland’s SPC granting practice into a future mess. However, this obviously also depends on whose side you’re on. We’ll see …

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_001 ¦ Main hearing of 21 August 2017 @ 10am

Mepha Pharma AG ./. Gilead Sciences Inc.

BASIC PATENT

Download (PDF, 1.75MB)

SUMMARY

Download (PDF, 48KB)

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