Forward Pharma Announces Rescheduling of the EP2801355 Appeal Hearing to September 6, 2021 due to COVID-19 Restrictions
January 12 2021 - 4:30PM
Forward Pharma A/S (NASDAQ:FWP) (“we,” “Forward” or the “Company”),
today announced that due to ongoing precautionary measures against
the spread of the novel coronavirus (“COVID-19”), the Technical
Board of Appeal (the “TBA”) of the European Patent Office (the
“EPO”) again has rescheduled the oral hearing of the appeal against
the decision of the Opposition Division that revoked the EP2801355
patent (the “’355 Patent”). The new hearing date is set for
September 6, 2021.
About Forward Pharma: Forward
Pharma A/S is a Danish biopharmaceutical company that
commenced development in 2005 of 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 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 Biogen’s net sales of Tecfidera® or other DMF
products for multiple sclerosis outside the U.S., dependent on,
among other things, a favorable outcome in Europe with respect to
the Opposition Proceeding, including any appeal thereto.
Our 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
Capital Market (FWP). For more information about the Company,
please visit our website at http://www.forward-pharma.com.
About the European Intellectual Property
Proceedings
On January 29, 2018, the Opposition Division of the
EPO concluded the oral proceedings concerning the ‘355 Patent (the
“Opposition Proceeding”). The Opposition Division revoked the ‘355
Patent after considering oppositions from several opponents. On
March 22, 2018, the Opposition Division issued its detailed reasons
for the decision. On May 7, 2018, the Company appealed the
Opposition Division’s decision to the TBA and filed its detailed
grounds of appeal on August 1, 2018. The case was scheduled to be
heard on February 2, 2021, but on January 12, 2021, the Company
received notice from the EPO that, as a result of the ongoing
COVID-19 pandemic, the appeal would be postponed to September 6,
2021. Management expects the TBA to issue a ruling on the same day
as the hearing, with a fully reasoned decision approximately two
months following the hearing.
If the Company receives a favorable ruling
following the TBA hearing, it is expected that the TBA will remit
the case to the Opposition Division, in order for the Opposition
Division to resolve the remaining elements of the original
opposition. Management estimates that this process would take
approximately two to three years. However, delays can occur that
would extend the time needed for the Opposition Division to reach a
conclusion on the remaining elements of the original opposition.
The Company is not entitled to any royalty payments from the
Settlement and License Agreement (the “License Agreement”) by and
among the Company and two wholly-owned subsidiaries of Biogen, Inc.
(collectively, “Biogen”) until and unless all remaining elements of
the original opposition are resolved in the Company’s favor. As
such, the earliest time the Company may expect to receive any
revenues from the License Agreement, if at all, is 2024.
If the Company receives an unfavorable ruling
following the TBA hearing, it would, for all practical purposes,
represent an unsuccessful outcome of the Opposition Proceeding,
resulting in no royalties being due to the Company from Biogen
based on Biogen’s future net sales outside the United States, as
defined in the License Agreement. The Company may request a
rehearing of the TBA hearing with the Enlarged Board of Appeal of
the EPO in an effort to overturn an unfavorable outcome, but the
likelihood of getting a rehearing is low. The denial of a request
to rehear would end the Opposition Proceeding in favor of the
opponents.
Forward Pharma A/S Investor Relations
Contact:
Forward Pharma A/S Claus Bo Svendsen, MD, PhD Chief
Executive Officer Investor Relations
investors@forward-pharma.com
Solebury Trout John Graziano
jgraziano@troutgroup.com +1 (646) 378 2942
Forward Pharma A/S
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: our ability to obtain,
maintain, enforce and defend issued patents with royalty-bearing
claims; our ability to prevail in or obtain a favorable decision in
the Opposition Proceeding, after all appeals; and the expected
timing for key activities and an ultimate ruling in such legal
proceedings. 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, 2019. 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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