Forward Pharma Announces New Date for the EP2801355 Appeal Hearing due to COVID-19
May 12 2020 - 5:00PM
Forward Pharma A/S (NASDAQ:FWP) (“we,” “Forward” or the “Company”),
today announced that due to current 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”) 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 February 2,
2021.
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 June 18, 2020, but on May 12, 2020, the Company received
notice from the EPO that, as a result of the ongoing COVID-19
pandemic, the appeal would instead be heard by the TBA on February
2, 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.
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.
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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