COPENHAGEN, Denmark, March 31, 2017 (GLOBE NEWSWIRE) -- Forward Pharma A/S (FWP) (“Forward Pharma” or the “Company”), a biopharmaceutical company that commenced development in 2005 of FP187, a proprietary formulation of DMF (dimethyl fumarate) for the treatment of inflammatory and neurological indications, today announced that it intends to file an appeal challenging today’s decision by the Patent Trial and Appeal Board (“PTAB”) of the United States Patent and Trademark Office (“USPTO”) in Patent Interference No. 106,023 regarding claims of Forward Pharma’s patent application 11/576,871 (the “’871 application”) that cover a method of treating multiple sclerosis (“MS”) with a 480 mg per day dose of DMF, the approved dose of Tecfidera®.
In today’s decision, the PTAB ruled that the claims of the ’871 application are not patentable due to a lack of adequate written description.
Forward Pharma intends to appeal today’s interference decision to the U.S. Court of Appeals for the Federal Circuit in Washington, D.C. The appeal is expected to last twelve months or longer.
“While we are disappointed in the decision issued by the PTAB, we continue to believe the claims in the ’871 application are patentable and that we are entitled to priority over Biogen Inc. (“Biogen”), and therefore we intend to appeal the decision,” commented Claus Bo Svendsen, CEO of Forward Pharma.
On January 17, 2017, Forward Pharma announced that it entered into a binding agreement with two wholly owned subsidiaries of Biogen and certain additional parties to enter into a Settlement and License Agreement (the “License Agreement”). On February 9, 2017, Forward Pharma received a non-refundable cash fee of $1.25 billion from Biogen in connection with the execution and delivery of the License Agreement. If Forward Pharma is successful in its anticipated appeal to the U.S. Court of Appeals for the Federal Circuit and the ’871 application issues with claims covering treatment for MS by orally administering 480 mg per day of DMF, we anticipate that Biogen would be obligated to pay future royalties on net sales in the U.S. of Biogen products, including Tecfidera®, indicated for treating MS that, but for the rights granted under the License Agreement, would infringe a Company patent, provided that other conditions of the License Agreement are satisfied. Among the conditions that needs to be satisfied for any royalty to be payable by Biogen to Forward Pharma is the absence of generic entry in a particular country having a particular impact as defined by the License Agreement.
If Forward Pharma is successful in its anticipated appeal and Biogen obtains an exclusive license to all intellectual property in the United States that is owned by Forward Pharma (the “U.S. Licensed Intellectual Property”) under the License Agreement and other conditions are satisfied, a royalty of 10% would be payable by Biogen on net sales in the U.S. of applicable infringing products from January 1, 2021 to December 31, 2028 (increasing to 20% from January 1, 2029) until the earlier of the expiration or invalidation of the patents owned by Forward Pharma in the U.S. Biogen’s existing perpetual, irrevocable, co-exclusive license to all of the U.S. Licensed Intellectual Property will be converted into an irrevocable exclusive license to all of the U.S. Licensed Intellectual Property if all of the terms and conditions of the License Agreement are met within the time period set forth in the License Agreement, including the absence of legal restraints and termination or expiration of any required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. If Biogen does not obtain an exclusive license, and provided that other conditions of the License Agreement are satisfied, Biogen will maintain a co-exclusive license with respect to the U.S. Licensed Intellectual Property, and the royalties payable by Biogen to Forward Pharma on its net sales in the U.S. of applicable infringing products would instead be 1% from January 1, 2023, and Forward Pharma would retain the right to commercialize in the U.S. or assign its U.S. co-exclusive rights, on one occasion only, to a single third party.
About Forward Pharma:
Forward Pharma A/S is a Danish biopharmaceutical company that commenced development in 2005 of FP187, a proprietary formulation of DMF (dimethyl fumarate) for the treatment of inflammatory and neurological indications. The Company owns a significant intellectual property (IP) portfolio related to DMF formulations. The Company granted to Biogen an irrevocable license to all of our IP through the recent Settlement and License Agreement and received from Biogen a non-refundable cash fee of $1.25 billion on February 9, 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, the anticipated appeal of the U.S. interference, Hart-Scott-Rodino (HSR) antitrust clearance and the EP2801355 opposition outcome in Europe.
Our principal executive offices are located at Østergade 24A, 1st Floor, 1100 Copenhagen K, Denmark and our American Depositary Shares are publicly traded on NASDAQ Stock Market (FWP). For more information about the Company’s products and developments, please visit our web site at http://www.forward-pharma.com.
Forward Pharma A/S Media Contact:
Sharon Klahre, Director, Investor Relations
Forward Pharma USA, LLC
7 Skyline Drive
Hawthorne, NY 10532
The Ruth Group
Forward Looking Statements:
Certain statements in this press release may constitute “forward-looking statements” of Forward Pharma A/S (the “Company”) 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,” “hope,” “would”, “may”, 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, the following: the satisfaction of certain conditions, and the accuracy of certain representations of the Company, in the Settlement and License Agreement entered into with subsidiaries of Biogen Inc. and certain other parties thereto; the Company’s ability to obtain, maintain, enforce and defend issued patents with royalty-bearing claims; the issuance and term of patents; the Company’s ability to prevail in or obtain a favorable decision in any patent interference or European opposition proceeding, after all appeals; risks to the sales of Tecfidera®, including from competition, generic challenges, regulatory involvement and pricing pressures; risks and uncertainties related to 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; risks related to the timing, amount (if any) and tax consequences of any distribution to shareholders; 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 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, 2015. We are providing this information as of the date of this presentation 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.
Forward Pharma A/S