Clovis Oncology Announces Positive Outcome in European Opposition Proceeding Related to Rubraca®
Clovis Oncology, Inc. (NASDAQ:CLVS) announced today 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.
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. 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.
In addition to the rucaparib camsylate patent protection through at least 2031 confirmed today, 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 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, President and CEO of Clovis Oncology. “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.”
About Rubraca ® (rucaparib)
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian, metastatic castration-resistant prostate, and bladder cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca. Rubraca is an unlicensed medical product outside of the U.S. and Europe.
Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, and has additional offices in San Francisco and Oakland, California and Cambridge, UK. Please visit clovisoncology.com for more information.
To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expectation of the expiration of and the coverage provided by certain patents in our portfolio and regulatory exclusivities. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the actions by the European Patent Office, European regulatory agencies, and third-party challenges to the validity, enforceability or scope of our patents. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.
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