PDL BioPharma Receives Letter from Genentech Relating to European Patents
INCLINE VILLAGE, Nev., Aug. 13 /PRNewswire-FirstCall/ -- PDL
BioPharma, Inc. (PDL) (NASDAQ:PDLI)
announced today it has received a facsimile letter from Genentech
asserting that Avastin®, Herceptin®, Lucentis® and
Xolair® (the Genentech Products) do not infringe supplementary
protection certificates (SPCs) granted by various countries in
Europe to PDL and is seeking a response from PDL to these
assertions. The letter was received at 4:00 pm PDT on Wednesday,
August 11, 2010.
The letter does not suggest that the Genentech Products do not
infringe PDL's United States patents to the extent that such
Genentech Products are made, used or sold in the United States,
including Genentech Products that are made in the United States and
sold elsewhere. As a result, PDL anticipates that Genentech will
continue to make royalty payments on such activities.
PDL's SPCs covering the Genentech Products effectively extend
its European patent protection generally until December 2014,
except that the SPCs for Herceptin will generally expire in July
2014. PDL's SPCs were applied for and granted by the relevant
national patent offices in Europe and by their terms specifically
cover the Genentech Products. PDL believes that these SPCs are
enforceable against the Genentech Products and intends to
vigorously assert its SPC-based patent rights.
Genentech does not state what actions, if any, it intends to
take with respect to its assertions and specifically stated that
the letter is not "intended to comment on the validity of PDL's
SPCs in Europe." However, we note that Genentech and PDL entered
into a settlement agreement related to certain intellectual
property disputes in 2003 which imposes limitations on Genentech's
ability to challenge infringement of PDL's patent rights which we
believe apply in this instance, for example, by requiring Genentech
to establish non-infringement of its products by a considerably
higher standard than that typically applied by the courts. In
addition, in the settlement agreement, Genentech waived its right
to challenge the validity of PDL's patent rights, including its
SPCs. Certain breaches of this settlement agreement will subject
Genentech to substantial liquidated and other damages.
Royalties on sales of the Genentech Products that are made and
sold outside the United States accounted for approximately 30
percent of PDL's revenue in the first half of 2010.
About PDL BioPharma
PDL pioneered the humanization of monoclonal antibodies and, by
doing so, enabled the discovery of a new generation of targeted
treatments for cancer and immunologic diseases. PDL is focused on
maximizing the value of its antibody humanization patents and
related assets. The Company receives royalties on sales of a number
of humanized antibody products marketed today based on patents that
expire in late 2014. For more information, please visit
NOTE: PDL BioPharma and the PDL BioPharma logo are considered
trademarks of PDL BioPharma, Inc.
This press release contains forward-looking statements. Each of
these forward-looking statements involves risks and uncertainties.
Actual results may differ materially from those, express or
implied, in these forward-looking statements. Factors that may
cause differences between current expectations and actual results
include, but are not limited to, the following:
-- The expected rate of growth in royalty-bearing product sales by PDL's existing licensees; -- The relative mix of royalty-bearing Genentech products manufactured and sold outside the U.S. versus manufactured or sold in the U.S.; -- The ability of our licensees to receive regulatory approvals to market and launch new royalty-bearing products and whether such products, if launched, will be commercially successful; -- Changes in any of the other assumptions on which PDL's projected royalty revenues are based; -- The outcome of pending litigation or disputes; and -- The failure of licensees to comply with existing license agreements, including any failure to pay royalties due.
Other factors that may cause PDL's actual results to differ
materially from those expressed or implied in the forward-looking
statements in this press release are discussed in PDL's filings
with the SEC, including the "Risk Factors" section of its annual
and quarterly reports filed with the SEC. Copies of PDL's filings
with the SEC may be obtained at the "Investors" section of PDL's
website at www.pdl.com. PDL expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in PDL's expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are based
for any reason, except as required by law, even as new information
becomes available or other events occur in the future. All
forward-looking statements in this press release are qualified in
their entirety by this cautionary statement.
Source: PDL BioPharma, Inc.
Web Site: http://www.pdl.com/
Posted: August 2010