COPENHAGEN, Denmark, April 14, 2015 (GLOBE NEWSWIRE) -- Forward Pharma A/S (Nasdaq:FWP) (the "Company") announced today that an interference was declared by the Patent Trial and Appeal Board (PTAB) on April 13, 2015 between the Company's patent application 11/576,871 (the "'871 patent application") and Biogen's issued patent 8,399,514 (the "'514 patent"). The PTAB designated the Company as the "Senior Party" in the interference based on the Company's earlier patent application filing date.
The '871 patent application is one of several applications filed by the Company containing claims to methods of treating multiple sclerosis ("MS") with 480 mg of dimethyl fumarate ("DMF") per day. Biogen's '514 patent also claims treating MS with about 480 mg of DMF per day. Should the Company prevail in the interference, the Company's '871 patent application will issue and the claims of Biogen's '514 patent will be cancelled.
In addition to the '871 patent application, the Company's intellectual property portfolio includes two other U.S. pending patent applications numbered 14/213,399 and 14/212,503 and three European pending patent applications numbered EP14172398.1, EP14172390.8 and EP14172396.5, as well as a German utility model, all of which include claims to compositions or methods for treating MS with 480 mg of DMF per day.
"This is a key step in advancing our intellectual property in the U.S. covering the use of 480 mg per day of DMF in MS," commented Peder Andersen, CEO of Forward Pharma. "We look forward to the start of the interference proceeding and additional progress with our five other pending patent applications in the U.S. and in Europe covering the 480 mg daily dose of DMF."
Forward Pharma's lead drug in development, FP187, is a proprietary DMF formulation. Biogen markets Tecfidera®, a product containing DMF as the active ingredient for the treatment of MS. It was approved by the FDA in March 2013 and by the European Commission in February 2014. Worldwide sales of Tecfidera® as reported by Biogen totaled over $2.9 billion in 2014, of which approximately $2.5 billion was in the U.S.
Additional information on the patent interference is available by accessing the PAIR website http://pair.uspto.gov and http://www.uspto.gov/web/offices/pac/mpep/mpep-2300.html.
Background on Interference Proceedings
An interference is an administrative proceeding at the USPTO that is used to determine which party was the first to invent a common invention claimed by the parties. The party with the earliest effective filing date to the common invention is designated "senior party" and is entitled to the presumption that it is the first inventor. During an interference, each party can dispute the patentability of the other party's claims, challenge the senior party designation and present evidence of dates of invention prior to the effective filing date. In an initial motions phase, a three judge panel at the PTAB decides any patentability and senior party issues raised. If that decision does not resolve the interference, then after priority proofs are submitted in a second, priority phase, the three judge panel enters final judgment on priority (i.e., who was first to invent).
About Forward Pharma:
Forward Pharma A/S is a Danish biopharmaceutical company developing FP187, a proprietary formulation of DMF (dimethyl fumarate) for the treatment of inflammatory and neurological indications. Since our founding in 2005, we have worked to advance unique formulations of DMF, which is an immune modulator, as a therapeutic agent to improve the health and well-being of patients with immune disorders including multiple sclerosis. FP187, our clinical candidate, is a DMF formulation in a delayed and slow release oral dose.
Our principal executive offices are located at Østergade 24A, 1, 1100 Copenhagen K, Denmark and our American Depositary Shares are publicly traded on NASDAQ Stock Market (symbol: FWP). For more information about the Company's products and developments, please visit our web site at 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
Certain statements in this press release may constitute "forward-looking statements" of 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," "hope," "would" 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 Company's ability to obtain, maintain and defend issued patents with protective claims; the commencement of any patent interference or infringement action; the Company's ability to prevail in or obtain a favorable decision in any such action; the Company's ability to recover damages in any such action; uncertainties relating to our development plans and activities, including the results, timing, cost and location thereof; 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 right of third parties. 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, 2014.