UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of
Report (Date of Earliest Event Reported): August 11,
2010
PDL
BioPharma, Inc.
(Exact
name of Company as specified in its charter)
000-19756
(Commission
File Number)
|
Delaware
|
94-3023969
|
|
|
(State
or Other Jurisdiction of
|
(I.R.S.
Employer Identification No.)
|
|
|
Incorporation)
|
932
Southwood Boulevard
Incline
Village, Nevada 89451
(Address
of principal executive offices, with zip code)
(775)
832-8500
(Company’s
telephone number, including area code)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the Company under any of the following
provisions:
|
¨
|
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
|
|
¨
|
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
|
¨
|
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
|
|
¨
|
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
|
Item
8.01 Other Events.
On August
13, 2010, PDL BioPharma, Inc. (the “Company”) issued a press release discussing
its receipt of a facsimile letter from Genentech and Genentech’s assertion that
four of Genentech’s licensed products do not infringe the Company’s
supplementary protection certificates based on the Company’s 0 451 216 patent in
Europe. The press release is attached hereto as Exhibit 99.1 and is
incorporated herein by reference.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
|
Exhibit
No.
|
Description
|
|
|
99.1
|
Press
Release, Dated August 13, 2010
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Company has duly
caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
| PDL BIOPHARMA, INC. | |||
|
(Company)
|
|||
|
|
By:
|
/s/ Christine R. Larson | |
| Christine R. Larson | |||
| Vice President and Chief Financial Officer | |||
Dated: August
13, 2010
EXHIBIT
INDEX
|
Exhibit
No.
|
Description
|
|
|
99.1
|
Press
Release, Dated August 13, 2010
|
Contacts:
|
Cris
Larson
PDL BioPharma, Inc.
775-832-8505
Cris.Larson@pdl.com
|
Jennifer
Williams
Cook Williams Comm.
360-668-3701
Jennifer@cwcomm.org
|
PDL
BioPharma Receives Letter from Genentech
Relating
to European Patents
INCLINE
VILLAGE, NV, August 13, 2010 – 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
www.pdl.com.
NOTE: PDL
BioPharma and the PDL BioPharma logo are considered trademarks of PDL BioPharma,
Inc.
Forward-Looking
Statements
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.
###
2