Bortezomib - Netherlands

On July 25, 2017 The Hague district court delivered its judgment in Bortezomib SPC challenge brought by Teva.

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 0788360 (“EP 360”) is the basic patent for Millennium’s Dutch SPC, which covers the compound ‘Bortezomib’ which patent expired on October 26, 2015. EP 360 is the base patent for Supplementary Protection Certificate (NL) 300151 for 'Bortezomib or a pharmaceutically acceptable ester thereof, optionally in the form of a pharmaceutically acceptable salt thereof' & in force until 27 April 2019. 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. 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 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. 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 said that the patent claims that improved inhibition is sufficiently plausible. Millenium has made this insight in the light of subpoena using Tables II-VII, which summarizes the results of a number of experiments. Bortezomib is one of the clearly better compounds in all these experiments, both in terms of activity and selectivity. In addition, Teva did not perform any experiments or show that it should be seen (at present), while on the contrary, its expert acknowledges that bortezomib was one of the better compounds investigated by the inventors. 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)).

Finally Summary Judge considers Millennium’s SPC to be valid, grants the preliminary injunction and orders Bortezomib Teva to be removed from the G-Standard. 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.