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Millennium Pharmaceuticals Inc. v. Teva Nederland B.V., Pharmachemie B.V., Teva Pharma B.V., Teva Pharmaceuticals Europe B.V. and Teva API B.V., Summary Judge of the District Court of The Hague, 25 July 2017, Case no. ECLI:NL:RBDHA:2017:8259

The present dispute concerns an alleged infringement of the rights of Millennium Pharmaceuticals Inc. (“Millennium”) as vested in the Dutch Supplementary Protection Certificate NL300151 for ‘Bortezomib or a pharmaceutically accepted ester thereof, if desired in the form of a pharmaceutically accepted salt thereof’.

EP 0 788 360 (“EP 360”) is the basic patent for Millennium’s Dutch SPC, which covers the compound ‘Bortezomib’. This compound is a so-called proteasome inhibitor, used for the treatment of multiple myeloma and mantle cell lymphoma.

Teva Nederland B.V. is the holder of a market authorization for ‘Bortezomib Teva’, a mannitol ester of Bortezomib that falls under the scope of protection of Millennium’s SPC.

Bortezomib Teva is registered on the name of Pharmachemie B.V. in the so-called “G-Standaard“, which is the Dutch database containing information on all remedies (medicines, medical devices and homeopathic medicines) that are or may become available at pharmacies, as published by “Z-Index“, a subsidiary of the Dutch professional association for pharmacists.

In the present summary proceedings, Millennium claims, in short, that Teva, by marketing Bortezomib Teva, directly and/or indirectly infringes Millennium’s rights as vested in the Dutch SPC.

In Germany and Portugal, nullity proceedings in relation to parallel national SPC’s are pending and the Federal Court of Ottawa in its judgment dated 26 February 2016 considers the Canadian basic patent corresponding to EP 360 to be invalid due to a lack of inventive step. In the Netherlands, proceedings on the merits for the nullification of Millennium’s Dutch SPC are also pending.

Teva in the present summary proceedings primarily argues that Bortezomib concerns a non-inventive selection from the compounds disclosed in the closest prior art, WO 81/13904 (“WO 904”), and alternatively, for the event Bortezomib is not considered to be a selection from the compounds disclosed in WO 904, that Bortezomib is not inventive because the technical problem to be solved would then be ‘providing an alternative compound to those disclosed in WO 904 that does not bring about a novel or unexpected effect’.

The Summary Judge first of all rejects Millennium’s claims vis-à-vis Teva Pharma B.V., Teva Pharmaceuticals Europe B.V. and Teva API B.V., as Millennium did not refute Teva’s arguments that in any event these entities have not infringed and do not infringe the Dutch SPC.

The Summary Judge for its validity assessment assumes that Bortezomib can be seen as a selection from the compounds disclosed in WO 904 (as argued by Teva) and takes this patent as the starting point for the application of the problem-solution-approach.

The Summary Judge considers that the difference between WO 904 and the relevant patent claim is that the latter concerns a specific selection from the millions of compounds disclosed in WO 904 and that the technical effect of this selection is (a compound with) increased proteasome inhibition.

Teva’s arguments that this effect had not been made (sufficiently) plausible are rejected and the Summary Judge formulates the technical problem to be solved as ‘providing a compound with increased proteasome inhibition in the set of compounds disclosed in WO 904’.

The Summary Judge subsequently considers that Teva did not submit any documents containing pointers to the solution of the technical problem and rejects Teva’s arguments that the (increased) effect of Bortezomib would be in line with the expectations of the skilled person and the (alleged) invention (thus) merely consists of a non-inventive selection from a broad field as meant in the Annex to Part G of Chapter VIII of the European Patent Office’s Guidelines (under 3.1 (iv) (b)).

Contrary to the Federal Court of Ottawa, the Summary Judge considers Millennium’s SPC to be valid, grants the preliminary injunction and orders Pharmachemie to have Bortezomib Teva removed from the G-Standaard.

A copy of the decision can be read here.

Headnote: Tim Iserief, NautaDutilh