AbbVie Announces Global Resolution of HUMIRA® (adalimumab) Patent Disputes with Fresenius Kabi
- Agreements Provide Non-Exclusive License to Fresenius Kabi for HUMIRA-Related Intellectual Property in the U.S. Effective September 30, 2023, and in Other Markets on Different Dates
- Fresenius Kabi Acknowledges Validity of AbbVie's Intellectual Property for HUMIRA
Oct 18, 2018, 08:50 ET
NORTH CHICAGO, Ill., Oct. 18, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today global resolution of all intellectual property-related litigation with Fresenius Kabi over its proposed biosimilar adalimumab product. Under the terms of the settlement agreements, AbbVie will grant to Fresenius Kabi a non-exclusive license to AbbVie's intellectual property relating to HUMIRA beginning on certain dates in certain countries where AbbVie has intellectual property:
- In the U.S., the Fresenius Kabi license period will begin on September 30, 2023 and will not be accelerated by the entry of companies who have already taken a license.
- In the European Union, Fresenius Kabi can launch upon approval from the European Medicines Agency.
Fresenius Kabi will pay royalties to AbbVie for licensing its HUMIRA patents and acknowledges the validity of the licensed patents. AbbVie will make no payments to Fresenius Kabi. The precise terms are confidential between the parties. All litigation pending between the parties will be dismissed.
AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2017 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
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