Clovis Oncology Announces Positive Outcome in European Opposition Proceeding Related to Rubraca®
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Claims directed to Rubraca crystalline
forms upheld -
Patent Protection for Rubraca in Europe confirmed until at least
2031
BOULDER, Colo.–(BUSINESS WIRE)–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.
Contacts
Breanna Burkart
303.625.5023
bburkart@clovisoncology.com
Anna Sussman
303.625.5022
asussman@clovisoncology.com
