PDL BioPharma, Inc. (NASDAQ:PDLI) Files An 8-K Other EventsItem 8.01 Other Events.
On June 8, 2018, Noden Pharma DAC (“Noden”), a wholly owned subsidiary of PDL BioPharma, Inc. (the “Company”), entered into a Settlement Agreement (the “Settlement Agreement”) with Anchen Pharmaceuticals, Inc. and its affiliates (“Anchen”) to resolve the patent litigation relating to Anchen’s Abbreviated New Drug Application (“ANDA”) seeking approval from the U.S. Food and Drug Administration to market a generic version of Noden’s Tekturna® product.
The patent litigation proceedings relate to U.S. Patent No. 8,617.595, which expires in February 2026, and is described in further detail in Part II, Item 1 (referencing Note 12 “Commitments and Contingencies” to the Company’s Notes to Condensed Consolidated Financial Statements in Part I, Item 1 thereof) of the Company’s Quarterly Report on Form 10-Q filed May 9, 2018. Under the terms of the Settlement Agreement, the parties agreed to file a stipulation of dismissal with the United States District Court for the District of Delaware to facilitate dismissal of the litigation in its entirety, with prejudice.
Under the Settlement Agreement, Noden grants Anchen a non-exclusive, royalty free, fully paid up and non-transferable license to manufacture and commercialize in the United States a generic version of Tekturna which is described in Anchen’s ANDA, and Anchen agrees to not commercialize its generic version of Tekturna prior to March 1, 2019. The license grant excludes certain formulations covered by the ‘595 patent which closely relate to the commercial formulation of Tekturna marketed by Noden. The Settlement Agreement further includes releases by each party for liabilities associated with the litigation and an acknowledgement from Anchen that the ‘595 patent claims are valid and enforceable.
In accordance with the terms of the Settlement Agreement, the parties will submit the Settlement Agreement to the U.S. Federal Trade Commission and the Antitrust Division of the U.S. Department of Justice for review.
About PDL BioPharma, Inc. (NASDAQ:PDLI)
PDL BioPharma, Inc., formerly Protein Design Labs, Inc., manages a portfolio of patents and royalty assets, consisting of its Queen et al. patents, license agreements with various biotechnology and pharmaceutical companies, and royalty and other assets acquired. The Company provides non-dilutive growth capital and financing solutions to late-stage public and private healthcare companies and offers immediate financial monetization of royalty streams to companies, academic institutions and inventors. It evaluates its investments based on the quality of the income generating assets and potential returns on investment. It is focused on intellectual property asset management, acquiring income generating assets and maximizing value for its stockholders, among others. It receives royalties on sales of over ten humanized antibody products, which include Avastin, Herceptin, Xolair, Kadcyla, Tysabri, Actemra, Gazyva and Entyvio all of which are approved for use.