Forward Pharma Provides Update on the Decision of the Federal Circuit in its Appeal of the U.S. Patent Interference
October 24 2018 - 10:42AM
Forward Pharma A/S (NASDAQ: FWP) (“Forward” or the “Company”) today
announced that the U.S. Court of Appeals for the Federal Circuit
(the “Federal Circuit”) has affirmed the decision of the Patent
Trial and Appeal Board (the “PTAB”) in the interference proceeding
(the “Interference”) between Forward’s U.S. Patent Application No.
11/576,871 (the “’871 application”) and an issued Biogen patent.
“We are disappointed with the Federal Circuit’s decision to
affirm the decision of the PTAB. As we have indicated
throughout the appeal process, under the Settlement and License
Agreement with Biogen, a positive outcome from the Interference
after exhaustion of all appeals is among the conditions that must
be satisfied for future royalties from the net sales of Tecfidera®
in the United States to be payable to Forward,” said Dr. Claus Bo
Svendsen, Chief Executive Officer of Forward.
Forward is currently considering its options and response to the
decision. The appeal of the decision in the European EP2801355
patent opposition is progressing as planned and Forward continues
to explore opportunities for cost optimisation to match the focused
strategy.
About Forward Pharma: Forward Pharma A/S
is a Danish biopharmaceutical company that commenced development in
2005 of FP187®, a proprietary formulation of DMF for the treatment
of inflammatory and neurological indications. The Company granted
to Biogen an irrevocable license to all of its IP through the
Settlement and License Agreement and received from Biogen a
non-refundable cash fee of $1.25 billion in February 2017, with the
return of EUR 917.7 million to shareholders through a capital
reduction in September 2017. The Company has the opportunity to
receive royalties from Biogen on sales of Tecfidera® or other DMF
products for MS, dependent on, among other things, successfully
appealing the U.S. interference and a favorable outcome in Europe
with respect to the EP2801355 Opposition Proceedings, including any
appeal thereto.
The principal executive offices are located at Østergade 24A,
1st Floor, 1100 Copenhagen K, Denmark and our American
Depositary Shares are publicly traded on the Nasdaq Stock
Market (FWP). For more information about the Company,
please visit our website at http://www.forward-pharma.com.
Publicly available information from the U.S. Court of Appeals
for the Federal Circuit can be located at
https://ecf.cafc.uscourts.gov/ and
https://cafc.uscourts.gov/.
Forward Pharma A/S Investor Relations Contact:
Forward Pharma A/S Dr. Claus Bo Svendsen, Chief Executive
Officer Investor Relationsinvestors@forward-pharma.com
Solebury Trout John Grazianojgraziano@troutgroup.com +1 (646)
378 2942
Forward Looking Statements: Certain statements
in this press release may constitute “forward-looking statements”
of Forward Pharma A/S within the meaning of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include,
but are not limited to, statements which contain language such as
“believe,” “expect,” “anticipate,” “estimate,” “would,” “may,”
“plan,” and “potential.” Forward-looking statements are predictions
only, which involve known and unknown risks, uncertainties and
other factors that may cause actual results to be materially
different from those expressed in such statements. Many such risks,
uncertainties and other factors are taken into account as part of
our assumptions underlying these forward-looking statements and
include, among others, risks related to the following: the
satisfaction of certain conditions in the Settlement and License
Agreement entered into with subsidiaries of Biogen Inc. and certain
other parties thereto; our ability to obtain, maintain, enforce and
defend issued patents with royalty-bearing claims; our ability to
prevail in the interference proceedings after all appeals and
obtain issuance of the ’871 application; our ability to prevail in
or obtain a favorable decision in the ‘355 patent European
Opposition Proceedings, after all appeals; the expected timing for
key activities and an ultimate ruling in such legal proceedings;
the issuance and term of our patents; future sales of Tecfidera®,
including impact on such sales from competition, generic
challenges, regulatory involvement and pricing pressures; the
scope, validity and enforceability of our intellectual property
rights in general and the impact on us of patents and other
intellectual property rights of third parties; and our ability to
generate revenue from product sales in the U.S. directly or through
an assignee of our U.S. co-exclusive license rights in the event
Biogen does not obtain an exclusive license from us in the U.S.
Certain of these and other risk factors are identified and
described in detail in certain of our filings with the United
States Securities and Exchange Commission, including our Annual
Report on Form 20-F for the year ended December 31, 2017. We are
providing this information as of the date of this release and do
not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new
information, future events or otherwise.
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