Truvada®: PrEPared for a decision on the scope of an SPC

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Case No. O2017_023 | Hearing of 4 April 2019

Note that Hepp Wenger Ryffel is involved in this case on behalf of the defendant.
Gilead’s Truvada®

This case is about an alleged infringement of Gilead’s SPC C00915894; the basic patent is EP 0 915 894 B1 (see EPO Register and Swissreg). Gilead’s product is Truvada®, a pharmaceutical for the treatment of HIV-1 infection. The present main proceedings are following-up on summary proceedings S2017_006 when the FPC granted interim injunctive relief; see this Blog here.

Validity of the SPC is not an issue anymore, it has already been affirmed by the Supreme Court; see this Blog here.

The supplementary protection certificate C00915894 is at stake; see the official court information about the hearing. The basic patent is EP 0 915 894 B1; see EPO Register and Swissreg.

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 embodiment instead comprises tenofovir disoproxil phosphate.

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

The parties agreed to disagree on this issue in the hearing. Gilead insisted that the ‘typical product definition’ has to be applied, in a sense that the fumarate is only to be understood as a ‘reference’ for the assessment of whether or not yet another salt form has the same pharmacological effect. If it had, then it should be considered ‘the same product’.

On the other hand, Mepha argued that the term ‘product’ is defined in Art. 140a(2) PatA, and it is to be construed within the context of the PatA; the Therapeutic Products Act (TPA) was not relevant in this respect. Thus, infringement has to be assessed as it is routinely done, i.e. deciding on whether there is literal infringment or infringement under the DoE. Mepha argued that the SPC is neither literally infringed, nor under the DoE.

The expert opinion of the judge-rapporteur held that the SPC was infringed, apparently essentially along the line of Gilead’s arguments. Still, in case the court followed the expert opinion, Mepha requested the court to provide a full assessment of infringement in the judgment, also including an assessment of literal infringement and infringement under the DoE. The Supreme Court would then be in a position to review the whole matter at once and in a timely manner, without the need to remit the case back to the FPC to carry out yet another assessment.

As mentioned above, Truvada® is a pharmaceutical for the treatment of HIV-1 infection. But Mepha recently obtained the market authorization of its Emtricitabin-Tenofovir-Mepha® in Switzerland also for PrEP – which is short for Pre-Exposure Prophylaxis; see Swissmedic Journal 02/19. More information on PrEP can be found on Gilead’s website here. However, Gilead currrently has no MA for PrEP in Switzerland; Mepha’s MA is the only one in Switzerland for this indication.

PrEP likely is the reason why this case attracted quite some public attention. There has even been an organised Facebook event in St. Gallen; and flyer have been distributed, see here and here.

Groupe sida‘ activists

On a sidenote, when a member of the audience wore a shirt with one of these slogans on it, the presiding judge held that this was an attempt to influence the judges, and thus ordered him to either hide the slogan / change clothes; or to leave the court room.

The NZZ reported on the matter, as well as the ‘Tagesschau‘:

 
Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_023 | Hearing of 4 April 2019

Gilead Sciences Inc.
./.
Mepha Pharma AG

Panel of Judges:

  • Dr. Christoph GASSER
  • Dr. Tobias BREMI
  • Marco ZARDI

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

  • Dr. Simon HOLZER (MLL)
  • Dr. Andreas SCHÖLLHORN (LSP), assisting in patent matters

Representative(s) of Defendant:

ANNOUNCEMENT

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