The final curtain: The salt form identified in an SPC doesn’t matter (much)

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Case No. 4A_274/2019 (Supreme Court) | Decision of 26 November 2019, on appeal against O2017_023  (FPC) | Decision of 3 May 2019 | ‘SPC, salt form’

DISCLOSURE NOTICE

Hepp Wenger Ryffel is involved in this case on behalf of the appellant / defendant.

Readers of this Blog will recall the infringement case of Gilead’s SPC C00915894; the basic patent is EP 0 915 894 B1 (see EPO Register and Swissreg). Gilead’s products are Truvada® and Atripla® which are pharmaceuticals for the treatment of HIV-1 infection.

The dispute is all about whether or not the scope of an SPC that specifically refers to a unique salt form does extend to other salts. The SPC concerns ‘tenofovir disoproxil fumarat + emtricitabin’ (emphasis added). Mepha’s attacked generics (Swissmedic MAs No. 66181 and 66217) instead comprise tenofovir disoproxil phosphate.

Now, is that still the same ‘product’ in the sense of Art. 140d PatA?

The FPC had issued a PI in summary proceeding S2017_006; see this Blog here. Validity of the SPC was not an issue anymore, this had already been affirmed by the Supreme Court; see this Blog here. Later, the finding of infringement had been confirmed in main proccedings O2017_023; see this Blog here.

Mepha appealed. But with reference to the ECJ’s reasons given in C-392/97Farmitalia (¶¶ 17-22), the Supreme Court has confirmed the FPC’s finding of infringement in late 2019:

If derivatives are covered by the scope of protection of a patent which have the same pharmacological effect as the product listed in the marketing authorisation, they are also protected by the SPC.

... with the same pharmacological effect as the product identified in the MA are covered by the SPC, to the extent they are also covered by the basic patent.

Accordingly, the Supreme Court dismissed the appeal.

This could have been it. But the Supreme Court also expanded on the FPC’s secondary line of reasons with respect to infringement of the SPC under the DoE. And this is where things went somewhat astray, in my opinion.

It appears as if the Supreme Court considered the scope of a patent to be a matter of fact, not a matter of law.

Loosely translated (third to fifth and last sentence of the above citation):

The complaint is based on the assumption that combinations of active substances are not covered by the basic patent. As mentioned, however, it was bindingly established by the lower court that combinations were covered by the scope of the basic patent. Since submissions with reference to facts that differ from those established in the contested decision cannot be taken into account, the complaint made by the appellant cannot be considered. […] Here, too, the appellant fails to recognise that the fumarate salt of the active substance tenofovir-disoproxil is covered by the basic patent according to the binding findings of the lower court.

Clearly, it was not in dispute that the scope of the basic patent covered the attacked embodiment — what I hope is the reason why the Supreme Court holds that this has been ‘bindingly established’ by the FPC. Else, the Supreme Court surely reviews issues of scope; see e.g. 4A_131/2016Urinalventil and 4A_208/2017Pemetrexed.

But coverage by the scope of the basic patent is only one of many aspects in the assessment of infringement of an SPC under the DoE; see O2017_023, ¶¶ 35 et seqq. I have the vague feeling that the Supreme Court missed the point here. But be this as it may, this obiter dictum is irrelevant for the outcome of the matter.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. 4A_274/2019 (Supreme Court) | Decision of 26 November 2019, on appeal against O2017_023  (FPC) | Decision of 3 May 2019 | ‘SPC, salt form’

Mepha Pharma AG (Appellant / Defendant)
./.
Gilead Sciences Inc. (Respondent / Plaintiff)

Panel of Judges:

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

Court Clerk:

    •  Nicolas CURCHOD

Representative(s) of Plaintiff / Respondent:

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

Representative(s) of Defendant:

SUPREME COURT DECISION

on appeal against decision O2017_023 of 3 May 2019:
4A_274/2019 26 November 2019

SECOND FPC DECISION

in main proceedings, following up on decision S2017_006 of 12 October 2017:
O2017_023 3 May 2019

FIRST FPC DECISION

in summary proceedings:
S2017_006 12 October 2017

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