The ‘infringement test’ is (still) alive in Switzerland, surrounded by post-Medeva EU

Case No. O2017_001 ¦ Decision of 3 October 2017 ¦ “Nichtigkeit eines ESZ; Überprüfung der bisherigen Rechtsprechung zu Kombinationspräparaten; Klageabweisung”

Nullity of the supplementary protection certificate C00915894 has been at stake; see this Blog here and here for some background information. The basic patent is EP 0 915 894 B1; see EPO Register and Swissreg.

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).

It was beyond dispute between the parties that the subject-matter of the SPC (Tenofovir Disoproxilfumarat + Emtricitabin) is protected by the basic patent EP’894. The so-called ‘infringement test’ that has been applied in Switzerland since the Supreme Court’s decision BGE 124 III 375 – Fosinopril in 1998 was thus met.

On the contrary, the CJEU disapproved the ‘infringement test’ with its decision CJEU C-322/10 – Medeva of 2011, and plaintiff argued that the ‘infringement test’ should no longer be applied in Switzerland either.

The FPC held that it is not appropriate to change the practice, and affirmed the ‘infringement test’ – at least for the time being.

The FPC’s reasons are as follows:

1. The law is clear

It is (only) required by the law that the product is protected by a patent; Art. 140b(1) lit. a PatA. The Supreme Court had held in the Fosinopril decision that it is not necessary that the product be explicitly named and described in the patent (‘ausdrücklich genannt und beschrieben’). Rather, it is decisive whether the product is covered by the scope of the basic patent. Well, that’s the ‘infringement test’.

The FPC notes in passing that the Introduction of further criteria might require a change to the law.

Die Einführung zusätzlicher, über den […] Schutz durch das Basispatent hinausgehende Anforderungen an das Basispatent für die Erteilung von Schutzzertifikaten würden wohl eine entsprechende Regelung durch den Gesetzgeber voraussetzen.

2. The rationale of Medeva is not applicable for Switzerland

The CJEU aimed to harmonize the SPC practice in the EU in order to preclude ‘obstacles to the free movement of medical prodcuts with the EU that would affect the establishment and functioning of the internal market’; see ¶24 of Medeva.

Switzerland is not part of that internal market, in particular not for medical products with state-regulated prices. Further, the FPC notes that the EU has harmonised the grant of market authorizations by the European Medicines Agency; Regulation (EC) No 726/2004. On the contrary, Switzerland has its own market approval procedure via Swissmedic; Therapeutic Products Act, TPA. The FPC concludes that even if one were to change the Swiss pratice in accordance with Medeva, this would not result in harmonised protection by SPCs with the EU.

3. Voluntary alignment with Medeva would not improve legal certainty and consistency

The FPC analysed the CJEU’s series of decisions dealing with SPCs, i.e.

• C-322/10 – Medeva;
• C-518/10 – Yeda 
• C-630/10 – University of Queensland
• C-6/11 – Daiichi Sankyo
• C-493/12 – Eli Lilly
• C-443/12 – Actavis/Sanofi

The FPC held that the CJEU had been asked to answer essentially the very same question again and again, i.e. what exactly the criteria are to decide whether or not a product is ‘protected’ by the basic patent.

In the FPC’s view, Medeva raised more questions than it answered, and this uncertainty has not yet been resolved by the CJEU’s subsequent decisions. Defendant referred to the different wording used by the CJEU as ‘salad’. The FPC notes that this might well be an oversimplification. But still, the FPC identifies a terminological muddle, or at least a substantial unclarity.

Wenn die Beklagte die Formulierungen des EuGH als ‘Salat’ bezeichnet […], greift das wohl auch zu kurz, aber ein gewisses ‘terminologisches Durcheinander’, wie die Beklagte das auch nennt, oder zumindest eine erhebliche Unklarheit, scheint durchaus vorzuliegen.

The FPC further noted that yet another referral to the CJEU has been made by Arnold J in the co-pending case in the U.K.; see [2017] EWHC 13 (Pat). Undoubtedly, Arnold J has immense knowledge and experience in SPC matters. The FPC took the fact that Arnold J again seeks advice from the CJEU on the question

What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?

as a further indication of the substantial uncertainty even in the EU. In the court’s view, an attempt to harmonise the Swiss practice in alignment with Medeva would not improve legal certainty and consistency.

4. Application of the Medeva principles in the case at hand would not give a clear result

Finally, the FPC holds that it was unclear whether or not the unspecific reference to ‘optionally other therapeutic ingredients’ in claim 27 of the basic patent would be sufficient to meet the CJEU’s criteria, i.e. ‘specified in the wording of the claim’.

In sum:

The FPC holds that if harmonisation with the CJEU case-law should be made at all, it would be too early: In the court’s view, there is just not yet a comprehensible and practicable case-law to align with.

Sollte überhaupt eine Harmonisierung mit der EuGH-Rechtsprechung in Betracht gezogen werden, scheint deshalb auf jeden Fall der Zeitpunkt, die Schweizer Rechtsprechung anzupassen, verfrüht, solange seitens des EuGH nicht eine nachvollziehbare und eindeutig umsetzbare Rechtsprechung vorliegt. Ein Versuch der Übernahme der Rechtsprechung des EuGH im gegenwärtigen Zeitpunkt würde nur eine Erhöhung der Rechtsunsicherheit nach sich ziehen. […] Deshalb ist, jedenfalls solange keine etablierte und die Rechtssicherheit sowohl für die Antragsteller als auch für die Dritten erhöhende Rechtsprechung des EuGH vorliegt, eine Änderung der Schweizer Rechtsprechung in keiner Weise angezeigt. Die strengen Voraussetzungen für eine Praxisänderung [BGE 138 III 270 , r. 2.2.2] sind eindeutig nicht erfüllt.

Two further aspects of the decision relate to the costs:

First, the parties had agreed on the English language to be used by the parties; Art. 36(3) PatCA. The main hearing, however, was held in German on request of the defendant. This required translation at the main hearing, and the defendant has to bear the costs for the interpreter.

Second, the FPC did not order any reimbursement of expenses incurred by defendant’s patent attorney. Note that expenses for assisting patent attorneys are not reimbursed  according to a tariff (unlike the compensation for legal representation); see Art. 3 lit. a and Art. 9(2) CostR-PatC.

The requested amount has to be specified and substantiated, preferably by means of a detailed debit note. This has not been done, and the FPC accordingly did not award reimbursement of such unspecified and unsubstantiated expenses for the assisting patent attorney.

The decision is not yet final.

Reported by Martin WILMING

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BIBLIOGRAPHY

Case No. O2017_001 ¦ Decision of 3 October 2017 ¦ “Nichtigkeit eines ESZ; Überprüfung der bisherigen Rechtsprechung zu Kombinationspräparaten; Klageabweisung”

Mepha Pharma AG ./. Gilead Sciences Inc.

Panel of Judges:

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

Judge-rapporteur:

• Dr. Tobias BREMI

Court Clerk:

• Susanne ANDERHALDEN

Representative(s) of Plaintiff:

• Andrea MONDINI (TIMES Attorneys)
• Dr. Andreas WELCH (Hepp Wenger Ryffel), assisting in patent matters

Representative(s) of Defendant:

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

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DECISION IN FULL

Download (PDF, 320KB)

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THE BASIC PATENT

Download (PDF, 1.75MB)

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