Clovis Oncology announces positive hearing for Rubraca in Europe

Wednesday December 5, 2018 0 comments Tags: Boulder, Clovis Oncology, Rubraca, Patrick J. Mahaffy, Rucaparib

BOULDER -- Clovis Oncology, Inc. (NASDAQ:CLVS) today announced after opposition proceedings at The Hague, Netherlands, that the European Patent Office upheld claims of European Patent 2534153 in amended form covering certain crystalline forms of rucaparib camsylate, including rucaparib S-camsylate Form A, the crystalline form in Rubraca.Clovis_Oncology_logoUSE

In its oral decision announced at the hearing, the Opposition Division upheld claims, narrowed from the originally granted patent, to certain crystalline forms of rucaparib camsylate, Clovis said.

These forms include, but are not limited to, the commercial product. The European Opposition Division found patentability of the claimed forms based on the inventiveness of these crystalline forms and a constellation of unexpected properties.

The European patent was opposed by two opponents. Clovis and/or either opponent have an opportunity to appeal the decision of the European Opposition Division within two months of the written decision, which is expected in the next few months.

If appealed, all claims in the originally granted patent will remain in force until the Technical Board of Appeal issues its decision, Clovis said.

In addition to the rucaparib camsylate patent protection confirmed through at least 2031, the commercial form of Rubraca is also entitled to European regulatory exclusivity until at least 2028 (and 2029 if an indication in a second tumor type is approved).

Also, Clovis said it has filed for supplementary protection certificate (SPC) extension on this rucaparib camsylate patent in various European countries, which if approved, would provide extension of protection until 2033 under this patent.

“We are very pleased with the outcome of the opposition proceedings today, but more importantly, we are gratified that the European Patent Office acknowledged the innovation behind this invention and upheld robust patent protection for Rubraca in Europe,” said Patrick J. Mahaffy, Clovis president and CEO.

“This patent represents an important component of the intellectual property for Rubraca and we are happy that the Opposition Division upheld the relevant claims of the patent that cover the commercial form of Rubraca as well as other forms of rucaparib camsylate.

“We look forward to commercializing Rubraca in Europe and with this outcome, we are well-positioned to do so for a very long time.”