The Supreme Court sets the ‘infringement test’ aside — but with a ‘Swiss touch’

Supreme Court
Case No. 4A_576/2017 | Decision of 11 June 2018 | Appeal against decision O2017_001 of 3 October 2017

Note that Hepp Wenger Ryffel is involved in this matter on behalf of the plaintiff.
Gilead's Truvada
Gilead’s Truvada®

Please see this Blog here for a summary of the first instance decision of the FPC.

Nullity of the supplementary protection certificate C00915894 has been at stake. The basic patent is EP 0 915 894 B1; see EPO Register and Swissreg. On a more general level, this case was all about what it needs for a product to be protected by a basic patent, which is a prerequisite for an SPC both in the EU (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 covered by the basic patent EP’894. The so-called ‘infringement test’ that had been applied in Switzerland since the Supreme Court’s decision BGE 124 III 375 – Fosinopril in 1998 was thus met. However, the CJEU explicitly disapproved the ‘infringement test’ with its decision CJEU C-322/10 – Medeva of 2011, and the plaintiff argued that the ‘infringement test’ should no longer be applied in Switzerland, either.

The FPC had held that it is not appropriate to change the practice. On the contrary, the Supreme Court did now exactly that.

In first place, the Supreme Court reviewed the practice of the CJEU which initially left it to the national courts to decide on what it meant to be protected by a basic patent. Essentially two lines of jurisprudence developed thereafter, i.e. the disclosure theory (‘Offenbarungstheorie’) and the infringement test (‘Verletzungstest’). Only later, the CJEU disapproved the ‘infringement test’; CJEU C-322/10 – Medeva.

The Supreme Court noted that the Swiss SPC legislation had been enacted with the explicit aim to make it materially the same as in the European Union. The ‘infringement test’ cannot achieve this aim anymore, and it thus cannot be maintained; ¶2.2.5-2.2.6:

Die Auslegung […] weicht konzeptionell ab von der Auslegung durch den EuGH. […] Das vom schweizerischen Gesetzgeber angestrebte Zeil, das Schutzniveau für das Institut der ergänzenden Schutzzertifikate  mit demjenigen im benachbarten Ausland in Einklang zu bringen, wird damit verfehlt. […] An  BGE 124 III 375 kann nicht festgehalten werden.


Noteworthy, the Supreme Court also briefly touched the IPI’s prior initiative to amend its SPC granting practice in light of the CJEU’s Medeva case law, and the positive feedback that had been received from (at least some of) the interested circles. The Supreme Court notes that this was a strong indication that the Swiss practice should indeed be changed, and the IPI’s initiative thus paid off. Still, it was good that the IPI’s initiative had been put on hold in view of the present proceedings. In my humble opinion, any change of practice while BGE 124 III 375 – Fosinopril was still formally applicable would have been premature. Just imagine the consequences if the granting practice had been changed and the Supreme Court later did not abstain from the ‘infringement test'(!), for any reason whatsoever. Dreadful.

Now, what is the test instead? Practitioners are familiar with the subtle twists in the various decisions of the CJEU. This is not further clarified in the present decision. Unsurprisingly, the Swiss Supreme Court essentially only summarizes the criteria of these decisions, ¶2.2.6:

Bezeichnet ein Grundpatent nur einen von zwei Wirkstoffen, kann ein Erzeugnis […] nicht als ergänzendes Schutzzertifikat beanspruch werden, wenn es aus zwei Wirkstoffen zusammengesetzt ist. Art. 140b PatG ist vielmehr […] so auszulegen, dass die Wirkstoffe des Erzeugnisses im Grundpatent beansprucht werden müssen, indem sie in den Patentansprüchen benannt werden, oder indem sich die Patentansprüche – im Lichte der Beschreibung ([…]) ausgelegt – zumindest stillschweigend, aber notwendigerweise auf diese Wirkstoffe beziehen, und zwar in spezifischer Art und Weise.

The ‘Swiss touch’

But the Supreme Court did not just change the practice. It did so with a smooth ‘Swiss touch’: Already granted SPCs shall not be affected by the change of practice. The Supreme Court held that, as a rule, formally final administrative decisions cannot be reconsidered or reversed on the basis of a change in case law. In the Supreme Court’s view, the public interest in equal treatment hardly exists in the context of an SPC, contrary to e.g. in social insurance issues. Apart from the fact that the number of SPCs — irrespective of their economic importance — is rather small, the purpose of granting them is precisely to grant privileges to their owners. If a change of the case law now restricts the conditions for granting SPCs in certain cases, the interests of the other market participants are given a higher weighting and the interests — including public interests in health care — are weighed up differently. However, this change in valuation and consideration of the interests involved does not justify the withdrawal of acquired legal positions, in the Supreme Court’s view; see ¶3.6. No national court in the European Union took this approach when the ‘infringement test’ had been abandoned, to the best of my knowledge.

Now, what is next? Respondent’s counsel already noted on Kluwer Patent Blog that it remains unclear how pending SPC applications shall be dealt with, but they suggested that the infringement test should also apply in these cases. I feel this could well be handled differently. No subjective right has yet been granted in these cases, and I cannot readily see an overriding interest of the applicants to still get SPCs granted contrary to the changed practice. To strike a balance, one might as well just give applicants a chance to amend their pending applications in view of the changed practice instead.

Reported by Martin WILMING

BIBLIOGRAPHY

Supreme Court
Case No. 4A_576/2017 | Decision of 11 June 2018 | Appeal against decision O2017_001 of 3 October 2017

Mepha Pharma AG
./.
Gilead Sciences Inc.

Panel of Judges:

  • Dr. Christina KISS
    • Dr. Kathrin KLETT
    • Dr. Fabienne HOHL
    • Dr. Martha NIQUILLE
    • Marie-Chantal MAY CANELLAS

Court Clerk:

  •  Dr. Matthias LEEMANN

Representative(s) of Plaintiff / Appellant:

Representative(s) of Defendant / Respondent:

  • Dr. Simon HOLZER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)
  • Dr. Michael RITSCHER (MLL)

SUPREME COURT DECISION

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Inofficial English translation, as provided by Defendant’s Counsel on EPLAW Blog:

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FIRST INSTANCE DECISION

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THE BASIC PATENT

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3 Replies to “The Supreme Court sets the ‘infringement test’ aside — but with a ‘Swiss touch’”

  1. The Advocate General’s opinion in parallel proceedings C-121/17 at the CJEU can be found here. He suggests:
    “A product is protected by a patent within the meaning of Article 3(a) of that regulation if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the claims of the basic patent. In the case of a combination of active ingredients, each active ingredient in that combination must be specifically, precisely and individually identifiable in the wording of the claims of the basic patent.”

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